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Survey: Bias against female surgeons persists
BALTIMORE – Most male surgeons welcome and support their female colleagues in the workplace, but a survey of male surgeons reports that bias against women in surgery persists, and may be even more acute among younger surgeons, according to a presentation at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.
“Is there a bias against women in surgery?” asked Michalina Jadick, who presented the results on behalf of AdventHealth Hospital Tampa. “Yes, there is, and understanding this problem is imperative when learning how to fix it.”
A freshman at Boston University who conducted the survey of male surgeons as part of a mentoring program for young women at AdventHealth, Ms. Jadick reported on results of an online survey completed by 190 male surgeons. She noted that, while women represent more than 50% of medical school students, they constitute only 19% of general surgeons in the United States. “Especially in the face of a projected shortage of practicing surgeons, it is more important now than ever to investigate, understand, and work to eliminate the barriers encountered by this large and unique talent pool,” she said.
The anonymous survey was extensive, including 70 five-point Likert-scale questions and 63 multiple choice and binary answers. Regarding the male surgeons who completed the survey, 84% were attendings with more than 5 years of experience, and 8% had less than 5 years in surgery. The remainder were residents, fellows and interns.
When asked if women are as capable as their male counterparts, 80% agreed, with the remainder split between “disagree” or “no opinion.”
“Although this is very small in comparison, that’s actually pretty significant,” Ms. Jadick said of the 10% who disagreed.
When asked if women make good surgeons, 67% agreed, 10% disagreed, and 23% selected neither. “We found that older male surgeons were more likely to believe women make successful surgeons, as opposed to younger male doctors,” Ms. Jadick said. She called this finding “surprising” because younger doctors are expected to have more progressive ideas. “However, this response seems to indicate otherwise, and that’s an important part of the conversation.”
When asked if women have the same advancement opportunities as men, 75% agreed and 9% disagreed. When the question was flipped – that is, if men have more opportunities than women – 32% agreed and 43% disagreed. Half of responders concurred that women are discouraged from entering surgery because program directors question their ability to complete surgical training, yet 95% agreed that men and women residents receive equal training. “This is especially a problem,” Ms. Jadick said of the latter finding.
The survey also found wide disparities in how male surgeons feel about family roles. A high percentage – 80% – agreed that a woman can be both a good surgeon and a good parent. But an even higher percentage – 96% – said a man could be good in both roles. “When looking at the disagreement to these statements, 13% said it is not possible for a woman to be both a good surgeon and a good parent, while not one single male respondent said the same for men,” Ms. Jadick said. Of the men surveyed, 84% agreed that female surgeons are under greater pressure than men to balance work and family life.
Exploring the family issue even deeper, 46% of the respondents said that having children adversely affects a female surgeon professionally, whereas only 9% said the same of men. Conversely, 31% said children do not affect a female surgeon’s career, but 81% said children do not affect a male surgeon’s career.
“Clearly the topic of family obligations is a huge issue in the context of gender discrimination against women in surgery, and this is the case even though many have indicated that women and men have similar commitment to families outside of work,” Ms. Jadick said. “This has proven to be a big part of the issue in the past and likely moving forward as well. That’s why it’s of paramount importance for us to take this into consideration and understand that it’s happening.”
When asked about working with women in the operating room, 20% of male respondents agreed that women surgeons are aggressive coworkers, and 19% said that it’s easier to work with male colleagues. This attitude may be a function of the stereotype of women being deferential to leadership rather than assuming it, she said.
When asked frankly if discrimination exists in surgery today, 43% answered “yes” – but 57% said “no” or “unsure.”
“This finding clearly portrays the problem does persist in surgery, and therefore, it’s very important for [male] surgeons in particular to remain aware of that problem and actively work to eliminate that disparity within that work environment,” Ms. Jadick said.
However, the 57% who said discrimination is not a problem is more unsettling, she said. “That’s incredibly significant because the first step to solving any problem is recognizing that there is one,” Ms. Jadick said. “However, then we must commit to solving it. Only by promoting an equitable and inclusive work environment that promotes the engagement of women can we improve the future of surgery for the betterment of all of its stakeholders, especially patients.”
Ms. Jadick had no financial relationships to disclose.
BALTIMORE – Most male surgeons welcome and support their female colleagues in the workplace, but a survey of male surgeons reports that bias against women in surgery persists, and may be even more acute among younger surgeons, according to a presentation at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.
“Is there a bias against women in surgery?” asked Michalina Jadick, who presented the results on behalf of AdventHealth Hospital Tampa. “Yes, there is, and understanding this problem is imperative when learning how to fix it.”
A freshman at Boston University who conducted the survey of male surgeons as part of a mentoring program for young women at AdventHealth, Ms. Jadick reported on results of an online survey completed by 190 male surgeons. She noted that, while women represent more than 50% of medical school students, they constitute only 19% of general surgeons in the United States. “Especially in the face of a projected shortage of practicing surgeons, it is more important now than ever to investigate, understand, and work to eliminate the barriers encountered by this large and unique talent pool,” she said.
The anonymous survey was extensive, including 70 five-point Likert-scale questions and 63 multiple choice and binary answers. Regarding the male surgeons who completed the survey, 84% were attendings with more than 5 years of experience, and 8% had less than 5 years in surgery. The remainder were residents, fellows and interns.
When asked if women are as capable as their male counterparts, 80% agreed, with the remainder split between “disagree” or “no opinion.”
“Although this is very small in comparison, that’s actually pretty significant,” Ms. Jadick said of the 10% who disagreed.
When asked if women make good surgeons, 67% agreed, 10% disagreed, and 23% selected neither. “We found that older male surgeons were more likely to believe women make successful surgeons, as opposed to younger male doctors,” Ms. Jadick said. She called this finding “surprising” because younger doctors are expected to have more progressive ideas. “However, this response seems to indicate otherwise, and that’s an important part of the conversation.”
When asked if women have the same advancement opportunities as men, 75% agreed and 9% disagreed. When the question was flipped – that is, if men have more opportunities than women – 32% agreed and 43% disagreed. Half of responders concurred that women are discouraged from entering surgery because program directors question their ability to complete surgical training, yet 95% agreed that men and women residents receive equal training. “This is especially a problem,” Ms. Jadick said of the latter finding.
The survey also found wide disparities in how male surgeons feel about family roles. A high percentage – 80% – agreed that a woman can be both a good surgeon and a good parent. But an even higher percentage – 96% – said a man could be good in both roles. “When looking at the disagreement to these statements, 13% said it is not possible for a woman to be both a good surgeon and a good parent, while not one single male respondent said the same for men,” Ms. Jadick said. Of the men surveyed, 84% agreed that female surgeons are under greater pressure than men to balance work and family life.
Exploring the family issue even deeper, 46% of the respondents said that having children adversely affects a female surgeon professionally, whereas only 9% said the same of men. Conversely, 31% said children do not affect a female surgeon’s career, but 81% said children do not affect a male surgeon’s career.
“Clearly the topic of family obligations is a huge issue in the context of gender discrimination against women in surgery, and this is the case even though many have indicated that women and men have similar commitment to families outside of work,” Ms. Jadick said. “This has proven to be a big part of the issue in the past and likely moving forward as well. That’s why it’s of paramount importance for us to take this into consideration and understand that it’s happening.”
When asked about working with women in the operating room, 20% of male respondents agreed that women surgeons are aggressive coworkers, and 19% said that it’s easier to work with male colleagues. This attitude may be a function of the stereotype of women being deferential to leadership rather than assuming it, she said.
When asked frankly if discrimination exists in surgery today, 43% answered “yes” – but 57% said “no” or “unsure.”
“This finding clearly portrays the problem does persist in surgery, and therefore, it’s very important for [male] surgeons in particular to remain aware of that problem and actively work to eliminate that disparity within that work environment,” Ms. Jadick said.
However, the 57% who said discrimination is not a problem is more unsettling, she said. “That’s incredibly significant because the first step to solving any problem is recognizing that there is one,” Ms. Jadick said. “However, then we must commit to solving it. Only by promoting an equitable and inclusive work environment that promotes the engagement of women can we improve the future of surgery for the betterment of all of its stakeholders, especially patients.”
Ms. Jadick had no financial relationships to disclose.
BALTIMORE – Most male surgeons welcome and support their female colleagues in the workplace, but a survey of male surgeons reports that bias against women in surgery persists, and may be even more acute among younger surgeons, according to a presentation at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.
“Is there a bias against women in surgery?” asked Michalina Jadick, who presented the results on behalf of AdventHealth Hospital Tampa. “Yes, there is, and understanding this problem is imperative when learning how to fix it.”
A freshman at Boston University who conducted the survey of male surgeons as part of a mentoring program for young women at AdventHealth, Ms. Jadick reported on results of an online survey completed by 190 male surgeons. She noted that, while women represent more than 50% of medical school students, they constitute only 19% of general surgeons in the United States. “Especially in the face of a projected shortage of practicing surgeons, it is more important now than ever to investigate, understand, and work to eliminate the barriers encountered by this large and unique talent pool,” she said.
The anonymous survey was extensive, including 70 five-point Likert-scale questions and 63 multiple choice and binary answers. Regarding the male surgeons who completed the survey, 84% were attendings with more than 5 years of experience, and 8% had less than 5 years in surgery. The remainder were residents, fellows and interns.
When asked if women are as capable as their male counterparts, 80% agreed, with the remainder split between “disagree” or “no opinion.”
“Although this is very small in comparison, that’s actually pretty significant,” Ms. Jadick said of the 10% who disagreed.
When asked if women make good surgeons, 67% agreed, 10% disagreed, and 23% selected neither. “We found that older male surgeons were more likely to believe women make successful surgeons, as opposed to younger male doctors,” Ms. Jadick said. She called this finding “surprising” because younger doctors are expected to have more progressive ideas. “However, this response seems to indicate otherwise, and that’s an important part of the conversation.”
When asked if women have the same advancement opportunities as men, 75% agreed and 9% disagreed. When the question was flipped – that is, if men have more opportunities than women – 32% agreed and 43% disagreed. Half of responders concurred that women are discouraged from entering surgery because program directors question their ability to complete surgical training, yet 95% agreed that men and women residents receive equal training. “This is especially a problem,” Ms. Jadick said of the latter finding.
The survey also found wide disparities in how male surgeons feel about family roles. A high percentage – 80% – agreed that a woman can be both a good surgeon and a good parent. But an even higher percentage – 96% – said a man could be good in both roles. “When looking at the disagreement to these statements, 13% said it is not possible for a woman to be both a good surgeon and a good parent, while not one single male respondent said the same for men,” Ms. Jadick said. Of the men surveyed, 84% agreed that female surgeons are under greater pressure than men to balance work and family life.
Exploring the family issue even deeper, 46% of the respondents said that having children adversely affects a female surgeon professionally, whereas only 9% said the same of men. Conversely, 31% said children do not affect a female surgeon’s career, but 81% said children do not affect a male surgeon’s career.
“Clearly the topic of family obligations is a huge issue in the context of gender discrimination against women in surgery, and this is the case even though many have indicated that women and men have similar commitment to families outside of work,” Ms. Jadick said. “This has proven to be a big part of the issue in the past and likely moving forward as well. That’s why it’s of paramount importance for us to take this into consideration and understand that it’s happening.”
When asked about working with women in the operating room, 20% of male respondents agreed that women surgeons are aggressive coworkers, and 19% said that it’s easier to work with male colleagues. This attitude may be a function of the stereotype of women being deferential to leadership rather than assuming it, she said.
When asked frankly if discrimination exists in surgery today, 43% answered “yes” – but 57% said “no” or “unsure.”
“This finding clearly portrays the problem does persist in surgery, and therefore, it’s very important for [male] surgeons in particular to remain aware of that problem and actively work to eliminate that disparity within that work environment,” Ms. Jadick said.
However, the 57% who said discrimination is not a problem is more unsettling, she said. “That’s incredibly significant because the first step to solving any problem is recognizing that there is one,” Ms. Jadick said. “However, then we must commit to solving it. Only by promoting an equitable and inclusive work environment that promotes the engagement of women can we improve the future of surgery for the betterment of all of its stakeholders, especially patients.”
Ms. Jadick had no financial relationships to disclose.
REPORTING FROM SAGES 2019
Anxiety can impact patient satisfaction after GERD surgery
BALTIMORE – according to a study from the Ohio State University presented at the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons.
Carla Holcomb, MD, a minimally invasive surgery/bariatric fellow at the Ohio State’s Wexner Medical Center, Columbus, reported the upshot of the study findings. “Preoperative counseling is especially important regarding postoperative expectations in patients with anxiety,” she said.
The retrospective study evaluated 271 patients who had laparoscopic Nissen fundoplication (LNF) during 2011-2016 at the medical center, comparing outcomes in patients who were on serotonin-modulating medication for depression (n = 103), benzodiazepines for anxiety (n = 44), or neither (n = 124). The researchers evaluated a number of metrics – DeMeester score of esophageal acid exposure, pre- and postoperative health-related quality of life, and postoperative antacid use and need for endoscopic dilation – across all cohorts. While some scores among the anxiety cohort trended higher (DeMeester score of 43 vs. 38 for the no-anxiety patients) they were not statistically significant, Dr. Holcomb noted. Patients taking antidepressants reported similar subjective outcomes and satisfaction rates to those not taking antidepressants.
However, when patients were queried about their overall satisfaction after laparoscopic Nissen fundoplication 77%-87% in the no-depression, depression, and no-anxiety groups reported they were satisfied, while only 37% of those in the anxiety group did so. That is based on a response rate of 53% to a telephone inquiry 15 months after LNF.
“The patients who had anxiety looked vastly different from the rest of the population,” said Dr. Holcomb. “Patients taking antidepressants reported similar objective outcomes and high satisfaction rates, [compared with] patients not taking antidepressants after LNF, and although LNF does improve gastroesophageal reflux disease symptoms in patients taking anxiolytics, they rarely achieve satisfaction in long-term follow-up.”
Among the study limitations Dr. Holcomb acknowledged were the 53% long-term response rate and not knowing if an anatomical reason may explain the higher health-related quality of life scores in the anxiety group – 7 vs. 4 in the no-anxiety group – at long-term follow-up, although the overall score was low at 5.
Dr. Holcomb had no relevant financial disclosures.
SOURCE: Holcomb CN et al. SAGES 2019, Session SS04.
BALTIMORE – according to a study from the Ohio State University presented at the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons.
Carla Holcomb, MD, a minimally invasive surgery/bariatric fellow at the Ohio State’s Wexner Medical Center, Columbus, reported the upshot of the study findings. “Preoperative counseling is especially important regarding postoperative expectations in patients with anxiety,” she said.
The retrospective study evaluated 271 patients who had laparoscopic Nissen fundoplication (LNF) during 2011-2016 at the medical center, comparing outcomes in patients who were on serotonin-modulating medication for depression (n = 103), benzodiazepines for anxiety (n = 44), or neither (n = 124). The researchers evaluated a number of metrics – DeMeester score of esophageal acid exposure, pre- and postoperative health-related quality of life, and postoperative antacid use and need for endoscopic dilation – across all cohorts. While some scores among the anxiety cohort trended higher (DeMeester score of 43 vs. 38 for the no-anxiety patients) they were not statistically significant, Dr. Holcomb noted. Patients taking antidepressants reported similar subjective outcomes and satisfaction rates to those not taking antidepressants.
However, when patients were queried about their overall satisfaction after laparoscopic Nissen fundoplication 77%-87% in the no-depression, depression, and no-anxiety groups reported they were satisfied, while only 37% of those in the anxiety group did so. That is based on a response rate of 53% to a telephone inquiry 15 months after LNF.
“The patients who had anxiety looked vastly different from the rest of the population,” said Dr. Holcomb. “Patients taking antidepressants reported similar objective outcomes and high satisfaction rates, [compared with] patients not taking antidepressants after LNF, and although LNF does improve gastroesophageal reflux disease symptoms in patients taking anxiolytics, they rarely achieve satisfaction in long-term follow-up.”
Among the study limitations Dr. Holcomb acknowledged were the 53% long-term response rate and not knowing if an anatomical reason may explain the higher health-related quality of life scores in the anxiety group – 7 vs. 4 in the no-anxiety group – at long-term follow-up, although the overall score was low at 5.
Dr. Holcomb had no relevant financial disclosures.
SOURCE: Holcomb CN et al. SAGES 2019, Session SS04.
BALTIMORE – according to a study from the Ohio State University presented at the annual meeting of the Society of American Gastrointestinal Endoscopic Surgeons.
Carla Holcomb, MD, a minimally invasive surgery/bariatric fellow at the Ohio State’s Wexner Medical Center, Columbus, reported the upshot of the study findings. “Preoperative counseling is especially important regarding postoperative expectations in patients with anxiety,” she said.
The retrospective study evaluated 271 patients who had laparoscopic Nissen fundoplication (LNF) during 2011-2016 at the medical center, comparing outcomes in patients who were on serotonin-modulating medication for depression (n = 103), benzodiazepines for anxiety (n = 44), or neither (n = 124). The researchers evaluated a number of metrics – DeMeester score of esophageal acid exposure, pre- and postoperative health-related quality of life, and postoperative antacid use and need for endoscopic dilation – across all cohorts. While some scores among the anxiety cohort trended higher (DeMeester score of 43 vs. 38 for the no-anxiety patients) they were not statistically significant, Dr. Holcomb noted. Patients taking antidepressants reported similar subjective outcomes and satisfaction rates to those not taking antidepressants.
However, when patients were queried about their overall satisfaction after laparoscopic Nissen fundoplication 77%-87% in the no-depression, depression, and no-anxiety groups reported they were satisfied, while only 37% of those in the anxiety group did so. That is based on a response rate of 53% to a telephone inquiry 15 months after LNF.
“The patients who had anxiety looked vastly different from the rest of the population,” said Dr. Holcomb. “Patients taking antidepressants reported similar objective outcomes and high satisfaction rates, [compared with] patients not taking antidepressants after LNF, and although LNF does improve gastroesophageal reflux disease symptoms in patients taking anxiolytics, they rarely achieve satisfaction in long-term follow-up.”
Among the study limitations Dr. Holcomb acknowledged were the 53% long-term response rate and not knowing if an anatomical reason may explain the higher health-related quality of life scores in the anxiety group – 7 vs. 4 in the no-anxiety group – at long-term follow-up, although the overall score was low at 5.
Dr. Holcomb had no relevant financial disclosures.
SOURCE: Holcomb CN et al. SAGES 2019, Session SS04.
REPORTING FROM SAGES 2019
Key clinical point: Patients on anxiolytics for anxiety would benefit from counseling before laparoscopic Nissen fundoplication.
Major finding: Fewer than 40% of patients with anxiety reported satisfaction after LNF despite vast improvement in reflux symptoms.
Study details: Retrospective cohort, single-center study with a prospectively maintained database of 271 patients who had laparoscopic Nissen fundoplication during 2011-2016.
Disclosures: Dr. Holcomb had no financial relationships to disclose
Source: Holcomb CN et al. SAGES 2019, Session SS04.
Robotic sleeve gastrectomy may heighten organ space infection risk
While most outcomes are similar between robotic surgery and laparoscopic surgery for sleeve gastrectomy, the robotic approach carried a greater risk of organ space infection, according to the findings from a large clinical trial of more than 100,000 patients.
The study’s authors analyzed 107,726 sleeve gastrectomy operations in the Metabolic and Bariatric Surgery Association and Quality Improvement Program data registry (MBSAQIP), 7,385 of which were robotic sleeve gastrectomy (RSG). Peter William Lundberg, MD, and his coauthors of St. Luke’s University Health Network, Bethlehem, Pa., evaluated the safety of RSG vs. laparoscopic sleeve gastrectomy (LSG). The study was the first and largest comparing the two approaches to sleeve gastrectomy, the researchers noted.
“According to the MBSAQIP database, the robotic approach demonstrates a significantly higher rate of organ space infection while trending toward a lower rate of bleeding and 30-day reoperation and intervention,” Dr. Lundberg and his coauthors said.
Overall mortality was 0.07% in both groups (P = .49). The overall rates of significant adverse events were similar in both groups – 1.3% for LSG and 1.1% for RSG (P = .14) – as were bleeding rates – 0.5% and 0.4% (P = .003), respectively. The investigators characterized the slightly lower rates for RSG as “insignificant.”
RSG, however, had three times the rate of organ space infection than did the laparoscopic approach, 0.3% vs. 0.1% (P = .79). “Considering the enthusiasm with which robotics has been adopted by some bariatric surgeons, this is a sobering finding,” Dr. Lundberg noted.
The study determined that the use of staple-line reinforcement (SLR) alone significantly reduced the rate of bleeding regardless of approach by 31% on average (P = .0005). “This risk reduction was enhanced when SLR was combined with oversewing of the staple line,” Dr. Lundberg and his colleagues noted – an average reduction of 42% (P = .0009).
RSG took longer on average, 89 minutes vs. 63 minutes (P less than .0001), and the average length of stay was almost identical, 1.7 for RSG vs. 1.6 days for LSG. Reoperation rates within 30 days were also similar: 0.7% for RSG vs. 0.8% for LSG (P = .003).
“As surgeons continue to adopt and develop new technology, ongoing monitoring and reporting of safety and outcomes data are advised to maintain the high standards for outcomes in bariatric surgery,” Dr. Lundberg and his coauthors said.
The study researchers had no financial conflicts.
SOURCE: Lundberg PW et al. Surg Obes Relat Dis. 2018 Oct 25. doi:10.1016/j.soard.2018.10.015.
While most outcomes are similar between robotic surgery and laparoscopic surgery for sleeve gastrectomy, the robotic approach carried a greater risk of organ space infection, according to the findings from a large clinical trial of more than 100,000 patients.
The study’s authors analyzed 107,726 sleeve gastrectomy operations in the Metabolic and Bariatric Surgery Association and Quality Improvement Program data registry (MBSAQIP), 7,385 of which were robotic sleeve gastrectomy (RSG). Peter William Lundberg, MD, and his coauthors of St. Luke’s University Health Network, Bethlehem, Pa., evaluated the safety of RSG vs. laparoscopic sleeve gastrectomy (LSG). The study was the first and largest comparing the two approaches to sleeve gastrectomy, the researchers noted.
“According to the MBSAQIP database, the robotic approach demonstrates a significantly higher rate of organ space infection while trending toward a lower rate of bleeding and 30-day reoperation and intervention,” Dr. Lundberg and his coauthors said.
Overall mortality was 0.07% in both groups (P = .49). The overall rates of significant adverse events were similar in both groups – 1.3% for LSG and 1.1% for RSG (P = .14) – as were bleeding rates – 0.5% and 0.4% (P = .003), respectively. The investigators characterized the slightly lower rates for RSG as “insignificant.”
RSG, however, had three times the rate of organ space infection than did the laparoscopic approach, 0.3% vs. 0.1% (P = .79). “Considering the enthusiasm with which robotics has been adopted by some bariatric surgeons, this is a sobering finding,” Dr. Lundberg noted.
The study determined that the use of staple-line reinforcement (SLR) alone significantly reduced the rate of bleeding regardless of approach by 31% on average (P = .0005). “This risk reduction was enhanced when SLR was combined with oversewing of the staple line,” Dr. Lundberg and his colleagues noted – an average reduction of 42% (P = .0009).
RSG took longer on average, 89 minutes vs. 63 minutes (P less than .0001), and the average length of stay was almost identical, 1.7 for RSG vs. 1.6 days for LSG. Reoperation rates within 30 days were also similar: 0.7% for RSG vs. 0.8% for LSG (P = .003).
“As surgeons continue to adopt and develop new technology, ongoing monitoring and reporting of safety and outcomes data are advised to maintain the high standards for outcomes in bariatric surgery,” Dr. Lundberg and his coauthors said.
The study researchers had no financial conflicts.
SOURCE: Lundberg PW et al. Surg Obes Relat Dis. 2018 Oct 25. doi:10.1016/j.soard.2018.10.015.
While most outcomes are similar between robotic surgery and laparoscopic surgery for sleeve gastrectomy, the robotic approach carried a greater risk of organ space infection, according to the findings from a large clinical trial of more than 100,000 patients.
The study’s authors analyzed 107,726 sleeve gastrectomy operations in the Metabolic and Bariatric Surgery Association and Quality Improvement Program data registry (MBSAQIP), 7,385 of which were robotic sleeve gastrectomy (RSG). Peter William Lundberg, MD, and his coauthors of St. Luke’s University Health Network, Bethlehem, Pa., evaluated the safety of RSG vs. laparoscopic sleeve gastrectomy (LSG). The study was the first and largest comparing the two approaches to sleeve gastrectomy, the researchers noted.
“According to the MBSAQIP database, the robotic approach demonstrates a significantly higher rate of organ space infection while trending toward a lower rate of bleeding and 30-day reoperation and intervention,” Dr. Lundberg and his coauthors said.
Overall mortality was 0.07% in both groups (P = .49). The overall rates of significant adverse events were similar in both groups – 1.3% for LSG and 1.1% for RSG (P = .14) – as were bleeding rates – 0.5% and 0.4% (P = .003), respectively. The investigators characterized the slightly lower rates for RSG as “insignificant.”
RSG, however, had three times the rate of organ space infection than did the laparoscopic approach, 0.3% vs. 0.1% (P = .79). “Considering the enthusiasm with which robotics has been adopted by some bariatric surgeons, this is a sobering finding,” Dr. Lundberg noted.
The study determined that the use of staple-line reinforcement (SLR) alone significantly reduced the rate of bleeding regardless of approach by 31% on average (P = .0005). “This risk reduction was enhanced when SLR was combined with oversewing of the staple line,” Dr. Lundberg and his colleagues noted – an average reduction of 42% (P = .0009).
RSG took longer on average, 89 minutes vs. 63 minutes (P less than .0001), and the average length of stay was almost identical, 1.7 for RSG vs. 1.6 days for LSG. Reoperation rates within 30 days were also similar: 0.7% for RSG vs. 0.8% for LSG (P = .003).
“As surgeons continue to adopt and develop new technology, ongoing monitoring and reporting of safety and outcomes data are advised to maintain the high standards for outcomes in bariatric surgery,” Dr. Lundberg and his coauthors said.
The study researchers had no financial conflicts.
SOURCE: Lundberg PW et al. Surg Obes Relat Dis. 2018 Oct 25. doi:10.1016/j.soard.2018.10.015.
FROM SURGERY FOR OBESITY AND RELATED DISEASES
Key clinical point: Robotic sleeve gastrectomy carries a higher risk of organ space infection than does the laparoscopic approach.
Major finding: Rate of OSI was 0.3% with RSG and 0.1% with laparoscopic surgery.
Study details: An analysis of 107,726 patients who had sleeve gastrectomy in 2016 in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program registry.
Disclosures: Dr. Lundberg and his coauthors reported having no conflicts.
Source: Lundberg PW et al. Surg Obes Related Dis. 2018 Oct. 25. doi:10.1016/j.soard.2018.10.015.
Can higher MAP post cardiac arrest improve neurologic outcomes?
CHICAGO – A European clinical trial that targeted a mean arterial blood pressure after cardiac arrest higher than what the existing guidelines recommend found that the approach was safe, improved blood flow and oxygen to the brain, helped patients recover quicker, and reduced the number of adverse cardiac events, although it did not reduce the extent of anoxic brain damage or improve functional outcomes, the lead investigator reported at the American Heart Association scientific sessions.
The Neuroprotect trial randomly assigned 112 adult survivors of an out-of-hospital cardiac arrest who were unconscious upon admission to two study groups: early goal-directed hemodynamic optimization (EGDHO), in which researchers used a targeted mean arterial pressure (MAP) of 85-100 mm Hg and mixed venous oxygen saturation between 65% and 75% during the first 36 hours after ICU admission; and the standard care group, in which they used the guideline-recommended MAP target of 65 mm Hg, said Koen Ameloot, MD, of East Limburg Hospital in Genk, Belgium.
“EGDHO clearly improved cerebral perfusion and oxygenation, thereby for the first time providing the proof of concept for this new hemodynamic target,” Dr. Ameloot said. “However, this did not result in the reduction of the extent of anoxic brain hemorrhage or effusion rate on MRI or an improvement in functional outcome at 180 days.”
He noted the trial was predicated on improving upon the so-called “two-hit” model of cardiac arrest sequelae: the first hit being the no-flow and low-flow period before achieving restoration of spontaneous circulation; the second hit being hypoperfusion and reperfusion injury during ICU stay.
Dr. Ameloot referenced a study in which he and other coauthors reported that patients with a MAP target of 65 mm Hg “experience a profound drop of cerebral oxygen saturation during the first 12 hours of ICU stay that may cause additional brain damage” (Resuscitation. 2018;123:92-7).
The researchers explored the question of what is the optimal MAP if a target of 65 mm Hg is too low, Dr. Ameloot said. “We showed that maximal brain oxygenation is achieved with a MAP of 100 mm Hg, while lower MAPs were associated with submaximal brain perfusion and higher MAPs with excessive after-load, a reduction in stroke volume, and suboptimal cerebral oxygenation.”
During the 36-hour intervention period, the EGDHO patients received higher doses of norepinephrine, Dr. Ameloot said. “This resulted in significant improvement of cerebral oxygenation during the first 12 hours and was paralleled by significantly higher cerebral perfusion in the subset of patients in whom Doppler measurements were performed,” he said. “While patients allocated to the MAP 65 mm Hg target experienced a profound drop of cerebral oxygenation during the critical first 6-12 hours of ICU stay, cerebral oxygenation was maintained at 67% in patients assigned to EGDHO.”
However, the rate of anoxic brain damage, measured as the percentage of irreversibly damaged anoxic voxels on diffusion-weighted MRI – the primary endpoint of the study – was actually higher in the EGDHO group, 16% vs. 12%, Dr. Ameloot said. “The percentage of anoxic voxels was only a poor predictor of favorable neurological outcome at 180 days, questioning the validity of the primary endpoint,” he said. He also noted that 23% of the trial participants did not have an MRI scan because of higher than expected 5-day rates of death.
“The percentage of patients with favorable neurological outcome tended to be somewhat higher in the intervention arm, although this did not reach statistical significance at ICU discharge and at 180 days,” Dr. Ameloot said. He noted that 42% of the intervention group and 33% of controls in the full-analysis set (P = .30) and 43% and 27%, respectively, in the per-protocol set (P = .15) had a favorable neurological outcome, as calculated using the Glasgow-Pittsburgh Cerebral Performance Category scores of 1 or 2, at 180 days.
The study did not reveal any noteworthy differences in ICU stay (7 vs. 8 days, P = .13) or days on mechanical ventilation (5 vs. 7, P = .31), although fewer patients in the EGDHO group required a tracheostomy (4% vs. 18%, P = .02). The intervention group also had lower rates of cardiac events, including recurrent cardiac arrest, limb ischemia, new atrial fibrillation, and pulmonary edema (13% vs. 33%; P = .02), Dr. Ameloot said.
Future post-hoc analyses of the data will explore the hypothesis that higher blood pressure leads to improved coronary perfusion and reduced infarct size, thus improving prognosis, he added.
“Should this trial therefore be the definite end to the promising hypothesis that improving brain oxygenation might reduce the second hit in post–cardiac arrest patients? I don’t think so,” Dr. Ameloot said. He noted a few limits to the study: that the perfusion rate on MRI was a poor predictor of 180-day outcome; that more patients than expected entered the trial without receiving basic life support and with nonshockable rhythms; and that there was possibly less extensive brain damage among controls at baseline. “Only an adequately powered clinical trial can provide an answer about the effects of EGDHO in post–cardiac arrest patients,” Dr. Ameloot said.
Dr. Ameloot had no financial relationships to disclose.
SOURCE: Ameloot K et al. AHA 2018, Abstract 18620
CHICAGO – A European clinical trial that targeted a mean arterial blood pressure after cardiac arrest higher than what the existing guidelines recommend found that the approach was safe, improved blood flow and oxygen to the brain, helped patients recover quicker, and reduced the number of adverse cardiac events, although it did not reduce the extent of anoxic brain damage or improve functional outcomes, the lead investigator reported at the American Heart Association scientific sessions.
The Neuroprotect trial randomly assigned 112 adult survivors of an out-of-hospital cardiac arrest who were unconscious upon admission to two study groups: early goal-directed hemodynamic optimization (EGDHO), in which researchers used a targeted mean arterial pressure (MAP) of 85-100 mm Hg and mixed venous oxygen saturation between 65% and 75% during the first 36 hours after ICU admission; and the standard care group, in which they used the guideline-recommended MAP target of 65 mm Hg, said Koen Ameloot, MD, of East Limburg Hospital in Genk, Belgium.
“EGDHO clearly improved cerebral perfusion and oxygenation, thereby for the first time providing the proof of concept for this new hemodynamic target,” Dr. Ameloot said. “However, this did not result in the reduction of the extent of anoxic brain hemorrhage or effusion rate on MRI or an improvement in functional outcome at 180 days.”
He noted the trial was predicated on improving upon the so-called “two-hit” model of cardiac arrest sequelae: the first hit being the no-flow and low-flow period before achieving restoration of spontaneous circulation; the second hit being hypoperfusion and reperfusion injury during ICU stay.
Dr. Ameloot referenced a study in which he and other coauthors reported that patients with a MAP target of 65 mm Hg “experience a profound drop of cerebral oxygen saturation during the first 12 hours of ICU stay that may cause additional brain damage” (Resuscitation. 2018;123:92-7).
The researchers explored the question of what is the optimal MAP if a target of 65 mm Hg is too low, Dr. Ameloot said. “We showed that maximal brain oxygenation is achieved with a MAP of 100 mm Hg, while lower MAPs were associated with submaximal brain perfusion and higher MAPs with excessive after-load, a reduction in stroke volume, and suboptimal cerebral oxygenation.”
During the 36-hour intervention period, the EGDHO patients received higher doses of norepinephrine, Dr. Ameloot said. “This resulted in significant improvement of cerebral oxygenation during the first 12 hours and was paralleled by significantly higher cerebral perfusion in the subset of patients in whom Doppler measurements were performed,” he said. “While patients allocated to the MAP 65 mm Hg target experienced a profound drop of cerebral oxygenation during the critical first 6-12 hours of ICU stay, cerebral oxygenation was maintained at 67% in patients assigned to EGDHO.”
However, the rate of anoxic brain damage, measured as the percentage of irreversibly damaged anoxic voxels on diffusion-weighted MRI – the primary endpoint of the study – was actually higher in the EGDHO group, 16% vs. 12%, Dr. Ameloot said. “The percentage of anoxic voxels was only a poor predictor of favorable neurological outcome at 180 days, questioning the validity of the primary endpoint,” he said. He also noted that 23% of the trial participants did not have an MRI scan because of higher than expected 5-day rates of death.
“The percentage of patients with favorable neurological outcome tended to be somewhat higher in the intervention arm, although this did not reach statistical significance at ICU discharge and at 180 days,” Dr. Ameloot said. He noted that 42% of the intervention group and 33% of controls in the full-analysis set (P = .30) and 43% and 27%, respectively, in the per-protocol set (P = .15) had a favorable neurological outcome, as calculated using the Glasgow-Pittsburgh Cerebral Performance Category scores of 1 or 2, at 180 days.
The study did not reveal any noteworthy differences in ICU stay (7 vs. 8 days, P = .13) or days on mechanical ventilation (5 vs. 7, P = .31), although fewer patients in the EGDHO group required a tracheostomy (4% vs. 18%, P = .02). The intervention group also had lower rates of cardiac events, including recurrent cardiac arrest, limb ischemia, new atrial fibrillation, and pulmonary edema (13% vs. 33%; P = .02), Dr. Ameloot said.
Future post-hoc analyses of the data will explore the hypothesis that higher blood pressure leads to improved coronary perfusion and reduced infarct size, thus improving prognosis, he added.
“Should this trial therefore be the definite end to the promising hypothesis that improving brain oxygenation might reduce the second hit in post–cardiac arrest patients? I don’t think so,” Dr. Ameloot said. He noted a few limits to the study: that the perfusion rate on MRI was a poor predictor of 180-day outcome; that more patients than expected entered the trial without receiving basic life support and with nonshockable rhythms; and that there was possibly less extensive brain damage among controls at baseline. “Only an adequately powered clinical trial can provide an answer about the effects of EGDHO in post–cardiac arrest patients,” Dr. Ameloot said.
Dr. Ameloot had no financial relationships to disclose.
SOURCE: Ameloot K et al. AHA 2018, Abstract 18620
CHICAGO – A European clinical trial that targeted a mean arterial blood pressure after cardiac arrest higher than what the existing guidelines recommend found that the approach was safe, improved blood flow and oxygen to the brain, helped patients recover quicker, and reduced the number of adverse cardiac events, although it did not reduce the extent of anoxic brain damage or improve functional outcomes, the lead investigator reported at the American Heart Association scientific sessions.
The Neuroprotect trial randomly assigned 112 adult survivors of an out-of-hospital cardiac arrest who were unconscious upon admission to two study groups: early goal-directed hemodynamic optimization (EGDHO), in which researchers used a targeted mean arterial pressure (MAP) of 85-100 mm Hg and mixed venous oxygen saturation between 65% and 75% during the first 36 hours after ICU admission; and the standard care group, in which they used the guideline-recommended MAP target of 65 mm Hg, said Koen Ameloot, MD, of East Limburg Hospital in Genk, Belgium.
“EGDHO clearly improved cerebral perfusion and oxygenation, thereby for the first time providing the proof of concept for this new hemodynamic target,” Dr. Ameloot said. “However, this did not result in the reduction of the extent of anoxic brain hemorrhage or effusion rate on MRI or an improvement in functional outcome at 180 days.”
He noted the trial was predicated on improving upon the so-called “two-hit” model of cardiac arrest sequelae: the first hit being the no-flow and low-flow period before achieving restoration of spontaneous circulation; the second hit being hypoperfusion and reperfusion injury during ICU stay.
Dr. Ameloot referenced a study in which he and other coauthors reported that patients with a MAP target of 65 mm Hg “experience a profound drop of cerebral oxygen saturation during the first 12 hours of ICU stay that may cause additional brain damage” (Resuscitation. 2018;123:92-7).
The researchers explored the question of what is the optimal MAP if a target of 65 mm Hg is too low, Dr. Ameloot said. “We showed that maximal brain oxygenation is achieved with a MAP of 100 mm Hg, while lower MAPs were associated with submaximal brain perfusion and higher MAPs with excessive after-load, a reduction in stroke volume, and suboptimal cerebral oxygenation.”
During the 36-hour intervention period, the EGDHO patients received higher doses of norepinephrine, Dr. Ameloot said. “This resulted in significant improvement of cerebral oxygenation during the first 12 hours and was paralleled by significantly higher cerebral perfusion in the subset of patients in whom Doppler measurements were performed,” he said. “While patients allocated to the MAP 65 mm Hg target experienced a profound drop of cerebral oxygenation during the critical first 6-12 hours of ICU stay, cerebral oxygenation was maintained at 67% in patients assigned to EGDHO.”
However, the rate of anoxic brain damage, measured as the percentage of irreversibly damaged anoxic voxels on diffusion-weighted MRI – the primary endpoint of the study – was actually higher in the EGDHO group, 16% vs. 12%, Dr. Ameloot said. “The percentage of anoxic voxels was only a poor predictor of favorable neurological outcome at 180 days, questioning the validity of the primary endpoint,” he said. He also noted that 23% of the trial participants did not have an MRI scan because of higher than expected 5-day rates of death.
“The percentage of patients with favorable neurological outcome tended to be somewhat higher in the intervention arm, although this did not reach statistical significance at ICU discharge and at 180 days,” Dr. Ameloot said. He noted that 42% of the intervention group and 33% of controls in the full-analysis set (P = .30) and 43% and 27%, respectively, in the per-protocol set (P = .15) had a favorable neurological outcome, as calculated using the Glasgow-Pittsburgh Cerebral Performance Category scores of 1 or 2, at 180 days.
The study did not reveal any noteworthy differences in ICU stay (7 vs. 8 days, P = .13) or days on mechanical ventilation (5 vs. 7, P = .31), although fewer patients in the EGDHO group required a tracheostomy (4% vs. 18%, P = .02). The intervention group also had lower rates of cardiac events, including recurrent cardiac arrest, limb ischemia, new atrial fibrillation, and pulmonary edema (13% vs. 33%; P = .02), Dr. Ameloot said.
Future post-hoc analyses of the data will explore the hypothesis that higher blood pressure leads to improved coronary perfusion and reduced infarct size, thus improving prognosis, he added.
“Should this trial therefore be the definite end to the promising hypothesis that improving brain oxygenation might reduce the second hit in post–cardiac arrest patients? I don’t think so,” Dr. Ameloot said. He noted a few limits to the study: that the perfusion rate on MRI was a poor predictor of 180-day outcome; that more patients than expected entered the trial without receiving basic life support and with nonshockable rhythms; and that there was possibly less extensive brain damage among controls at baseline. “Only an adequately powered clinical trial can provide an answer about the effects of EGDHO in post–cardiac arrest patients,” Dr. Ameloot said.
Dr. Ameloot had no financial relationships to disclose.
SOURCE: Ameloot K et al. AHA 2018, Abstract 18620
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Forty-three percent of patients in the intervention group had a favorable neurological outcome vs. 27% of controls (P = .15).
Study details: The Neuroprotect trial was a multicenter, randomized, open-label, assessor-blinded trial of 112 post–cardiac arrest patients.
Disclosures: Dr. Ameloot had no financial relationships to disclose.
Source: Ameloot K et al. AHA 2018, Abstract 18620
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.
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
Digital alerts reduced AF-related stroke, MI rates
CHICAGO – and had significantly lower rates of death and other cardiovascular events, compared with patients on a standard admissions protocol, according to results of a randomized, controlled trial presented at the American Heart Association Scientific Sessions.
“Alert-based computerized decision support [CDS] increased the prescription of anticoagulation for stroke prevention in atrial fibrillation during hospitalization, at discharge, and at 90 days after randomization in high-risk patients,” said Gregory Piazza, MD, of Brigham and Women’s Hospital, Boston, in presenting results of the AF-ALERT trial. “The reductions in major cardiovascular events was attributable to reductions in MI and stroke/transient ischemic attack at 90 days in patients whose physicians received the alert.”
The trial evaluated 458 patients hospitalized for AF or flutter and with CHA2DS2-VASc scores of 1-8 randomly assigned to the alert (n = 258) or no-alert (n = 210) groups.
Dr. Piazza explained that for those in the alert group, the CDS system notified physicians when the patient’s CHA2DS2-VASc score increased. From there, the physician could choose to open an order template to prescribe evidence-based medications to prevent stroke, to elect to review evidence-based clinical practice guidelines, or to continue with the admissions order with an acknowledged reason for omitting anticoagulation (such as high bleeding risk, low stroke risk, high risk for falls, or patient refusal of anticoagulation).
“In patients for whom their providers were alerted, 35% elected to open the stroke-prevention order set, a very tiny percentage elected to read the AF guidelines, and about 64% exited but provided a rationale for omitting anticoagulation,” Dr. Piazza noted.
The alert group was far more likely to be prescribed anticoagulation during the hospitalization (25.8% vs. 9.5%; P less than .0001), at discharge (23.8% vs. 12.9%; P = .003), and at 90 days (27.7% vs. 17.1%; P = .007) than the control group. The alert resulted in a 55% relative risk reduction in a composite outcome of death, MI, cerebrovascular event, and systemic embolic event at 90 days (11.3% vs. 21.9%; P = .002). The alert group had an 87% lower incidence of MI at 90 days (1.2% vs. 8.6%, P = .0002) and 88% lower incidence of cerebrovascular events or systemic embolism at 90 days (0% vs. 2.4%; P = .02). Death at 90 days occurred in 10.1% in the alert group and 14.8% in the control group (P = .13).
One of the limitations of the study, Dr. Piazza noted, was that the most dramatic finding – reduction of major cardiovascular events – was a secondary, not a primary, endpoint. “CDS has the potential to be a powerful tool in prevention of cardiovascular events in patients with atrial fibrillation.”
Moderator Mintu Turakhia, MD, of Stanford (Calif.) University, questioned the low rate of anticoagulation in the study’s control arm – 9.5% – much lower than medians reported in many registries. He also asked Dr. Piazza to describe the mechanism of action for prescribing anticoagulation in these patients.
Dr. Piazza noted the study population was hospitalized patients whose providers had decided prior to their admissions not to prescribe anticoagulation; hence, the rate of anticoagulation in these patients was actually higher than expected.
Regarding the mechanism of action, “the electronic alert seems to preferentially increase the prescription of [direct oral anticoagulants] over warfarin, and that may have been one of the mechanisms,” Dr. Piazza said. Another explanation he offered were “off-target” effects whereby, if providers have a better idea of a patient’s risk for a stroke or MI, they’ll be more aggressive about managing other risk factors.
“There are a number of interventions that could be triggered if the alert prompted the provider to have a conversation with patients about their risk of stroke from AF,” he said. “This may have impact beyond what we can tell from this simple [Best Practice Advisory in the Epic EHR system]. I think we don’t have a great understanding of the full mechanisms of CDS.”
Dr. Piazza reported financial relationships with BTG, Janssen, Bristol-Myers Squibb, Daiichi Sankyo, Portola, and Bayer. Daiichi Sankyo funded the trial. Dr. Turakhia reported relationships with Apple, Janssen, AstraZeneca, VA, Boehringer Ingelheim, Cardiva Medical, Medtronic, Abbott, Precision Health Economics, iBeat, iRhythm, MyoKardia, Biotronik, and an ownership Interest in AliveCor.
CHICAGO – and had significantly lower rates of death and other cardiovascular events, compared with patients on a standard admissions protocol, according to results of a randomized, controlled trial presented at the American Heart Association Scientific Sessions.
“Alert-based computerized decision support [CDS] increased the prescription of anticoagulation for stroke prevention in atrial fibrillation during hospitalization, at discharge, and at 90 days after randomization in high-risk patients,” said Gregory Piazza, MD, of Brigham and Women’s Hospital, Boston, in presenting results of the AF-ALERT trial. “The reductions in major cardiovascular events was attributable to reductions in MI and stroke/transient ischemic attack at 90 days in patients whose physicians received the alert.”
The trial evaluated 458 patients hospitalized for AF or flutter and with CHA2DS2-VASc scores of 1-8 randomly assigned to the alert (n = 258) or no-alert (n = 210) groups.
Dr. Piazza explained that for those in the alert group, the CDS system notified physicians when the patient’s CHA2DS2-VASc score increased. From there, the physician could choose to open an order template to prescribe evidence-based medications to prevent stroke, to elect to review evidence-based clinical practice guidelines, or to continue with the admissions order with an acknowledged reason for omitting anticoagulation (such as high bleeding risk, low stroke risk, high risk for falls, or patient refusal of anticoagulation).
“In patients for whom their providers were alerted, 35% elected to open the stroke-prevention order set, a very tiny percentage elected to read the AF guidelines, and about 64% exited but provided a rationale for omitting anticoagulation,” Dr. Piazza noted.
The alert group was far more likely to be prescribed anticoagulation during the hospitalization (25.8% vs. 9.5%; P less than .0001), at discharge (23.8% vs. 12.9%; P = .003), and at 90 days (27.7% vs. 17.1%; P = .007) than the control group. The alert resulted in a 55% relative risk reduction in a composite outcome of death, MI, cerebrovascular event, and systemic embolic event at 90 days (11.3% vs. 21.9%; P = .002). The alert group had an 87% lower incidence of MI at 90 days (1.2% vs. 8.6%, P = .0002) and 88% lower incidence of cerebrovascular events or systemic embolism at 90 days (0% vs. 2.4%; P = .02). Death at 90 days occurred in 10.1% in the alert group and 14.8% in the control group (P = .13).
One of the limitations of the study, Dr. Piazza noted, was that the most dramatic finding – reduction of major cardiovascular events – was a secondary, not a primary, endpoint. “CDS has the potential to be a powerful tool in prevention of cardiovascular events in patients with atrial fibrillation.”
Moderator Mintu Turakhia, MD, of Stanford (Calif.) University, questioned the low rate of anticoagulation in the study’s control arm – 9.5% – much lower than medians reported in many registries. He also asked Dr. Piazza to describe the mechanism of action for prescribing anticoagulation in these patients.
Dr. Piazza noted the study population was hospitalized patients whose providers had decided prior to their admissions not to prescribe anticoagulation; hence, the rate of anticoagulation in these patients was actually higher than expected.
Regarding the mechanism of action, “the electronic alert seems to preferentially increase the prescription of [direct oral anticoagulants] over warfarin, and that may have been one of the mechanisms,” Dr. Piazza said. Another explanation he offered were “off-target” effects whereby, if providers have a better idea of a patient’s risk for a stroke or MI, they’ll be more aggressive about managing other risk factors.
“There are a number of interventions that could be triggered if the alert prompted the provider to have a conversation with patients about their risk of stroke from AF,” he said. “This may have impact beyond what we can tell from this simple [Best Practice Advisory in the Epic EHR system]. I think we don’t have a great understanding of the full mechanisms of CDS.”
Dr. Piazza reported financial relationships with BTG, Janssen, Bristol-Myers Squibb, Daiichi Sankyo, Portola, and Bayer. Daiichi Sankyo funded the trial. Dr. Turakhia reported relationships with Apple, Janssen, AstraZeneca, VA, Boehringer Ingelheim, Cardiva Medical, Medtronic, Abbott, Precision Health Economics, iBeat, iRhythm, MyoKardia, Biotronik, and an ownership Interest in AliveCor.
CHICAGO – and had significantly lower rates of death and other cardiovascular events, compared with patients on a standard admissions protocol, according to results of a randomized, controlled trial presented at the American Heart Association Scientific Sessions.
“Alert-based computerized decision support [CDS] increased the prescription of anticoagulation for stroke prevention in atrial fibrillation during hospitalization, at discharge, and at 90 days after randomization in high-risk patients,” said Gregory Piazza, MD, of Brigham and Women’s Hospital, Boston, in presenting results of the AF-ALERT trial. “The reductions in major cardiovascular events was attributable to reductions in MI and stroke/transient ischemic attack at 90 days in patients whose physicians received the alert.”
The trial evaluated 458 patients hospitalized for AF or flutter and with CHA2DS2-VASc scores of 1-8 randomly assigned to the alert (n = 258) or no-alert (n = 210) groups.
Dr. Piazza explained that for those in the alert group, the CDS system notified physicians when the patient’s CHA2DS2-VASc score increased. From there, the physician could choose to open an order template to prescribe evidence-based medications to prevent stroke, to elect to review evidence-based clinical practice guidelines, or to continue with the admissions order with an acknowledged reason for omitting anticoagulation (such as high bleeding risk, low stroke risk, high risk for falls, or patient refusal of anticoagulation).
“In patients for whom their providers were alerted, 35% elected to open the stroke-prevention order set, a very tiny percentage elected to read the AF guidelines, and about 64% exited but provided a rationale for omitting anticoagulation,” Dr. Piazza noted.
The alert group was far more likely to be prescribed anticoagulation during the hospitalization (25.8% vs. 9.5%; P less than .0001), at discharge (23.8% vs. 12.9%; P = .003), and at 90 days (27.7% vs. 17.1%; P = .007) than the control group. The alert resulted in a 55% relative risk reduction in a composite outcome of death, MI, cerebrovascular event, and systemic embolic event at 90 days (11.3% vs. 21.9%; P = .002). The alert group had an 87% lower incidence of MI at 90 days (1.2% vs. 8.6%, P = .0002) and 88% lower incidence of cerebrovascular events or systemic embolism at 90 days (0% vs. 2.4%; P = .02). Death at 90 days occurred in 10.1% in the alert group and 14.8% in the control group (P = .13).
One of the limitations of the study, Dr. Piazza noted, was that the most dramatic finding – reduction of major cardiovascular events – was a secondary, not a primary, endpoint. “CDS has the potential to be a powerful tool in prevention of cardiovascular events in patients with atrial fibrillation.”
Moderator Mintu Turakhia, MD, of Stanford (Calif.) University, questioned the low rate of anticoagulation in the study’s control arm – 9.5% – much lower than medians reported in many registries. He also asked Dr. Piazza to describe the mechanism of action for prescribing anticoagulation in these patients.
Dr. Piazza noted the study population was hospitalized patients whose providers had decided prior to their admissions not to prescribe anticoagulation; hence, the rate of anticoagulation in these patients was actually higher than expected.
Regarding the mechanism of action, “the electronic alert seems to preferentially increase the prescription of [direct oral anticoagulants] over warfarin, and that may have been one of the mechanisms,” Dr. Piazza said. Another explanation he offered were “off-target” effects whereby, if providers have a better idea of a patient’s risk for a stroke or MI, they’ll be more aggressive about managing other risk factors.
“There are a number of interventions that could be triggered if the alert prompted the provider to have a conversation with patients about their risk of stroke from AF,” he said. “This may have impact beyond what we can tell from this simple [Best Practice Advisory in the Epic EHR system]. I think we don’t have a great understanding of the full mechanisms of CDS.”
Dr. Piazza reported financial relationships with BTG, Janssen, Bristol-Myers Squibb, Daiichi Sankyo, Portola, and Bayer. Daiichi Sankyo funded the trial. Dr. Turakhia reported relationships with Apple, Janssen, AstraZeneca, VA, Boehringer Ingelheim, Cardiva Medical, Medtronic, Abbott, Precision Health Economics, iBeat, iRhythm, MyoKardia, Biotronik, and an ownership Interest in AliveCor.
REPORTING FROM AHA SCIENTIFIC SESSIONS
Key clinical point: A digital alert system led to improved outcomes in atrial fibrillation patients.
Major finding: Anticoagulation rates were 25.8% in the alert group versus 9.5% for controls.
Study details: AF-ALERT was a randomized, controlled trial of 458 high-risk patients with atrial fibrillation or flutter.
Disclosures: Dr. Piazza reported financial relationships with BTG, Janssen, Bristol-Myers Squibb, Daiichi Sankyo, Portola, and Bayer. Daiichi Sankyo provided funding for the study.
All-or-none approach boosts adherence to stroke treatments
CHICAGO – Stroke patients in low to middle income care settings may frequently fail to get timely evidence-based treatments when they’re admitted to the hospital and even when they’re discharged, but a large South American study found that an “all-or-none” approach to a multistep quality-improvement program led to a significant increase in therapy adherence and smoking cessation. The results were reported at the American Heart Association scientific sessions.
“A multifaceted quality-improvement intervention did not result in a significant increase in the composite adherence score for evidence-based therapies in patients with acute ischemic stroke [AIS] or transient ischemic attack [TIA],” said M. Julia Machline-Carrion, MD, PhD, principal investigator of the BRIDGE-Stroke study and a cardiologist at the Hospital for Heart in São Paulo. “However, when using a more conservative ‘all-or-none’ approach of complete adherence, the intervention resulted in improved adherence to evidence-based therapies.”
The quality-improvement program also resulted in a significant increase in the use of thrombolysis and uptake in smoking cessation education by study participants, Dr. Machline-Carrion added.
The study randomized 1,624 patients with AIS or TIA to the multifaceted quality-improvement intervention or routine practice. The intervention consisted of a patient identification system (wristband and printed reminders), a therapeutic plan road map and checklist, case management, educational materials, interactive workshops, and periodic audit and feedback reports to each participating cluster. Colored wristbands were to help promptly identify AIS or TIA patients in the emergency department and other departments they may have been sent to later on, such as the ICU, to avoid delays in initiating recommended therapies.
On average, the composite adherence score was 85.3% for those in the intervention group vs. 77.8% for controls, Dr. Machline-Carrion said. The composite adherence score consisted of 10 quality measures, ranging from early antithrombotics and prophylaxis for deep vein thrombosis to anticoagulation for atrial fibrillation or flutter, and smoking cessation education. “There was no statistically significant difference in the composite adherence score between the intervention group and the usual-care group,” she said.
However, when the researchers applied the all-or-none model – that is, complete adherence to all 10 in-hospital quality measures – the results were strikingly different, Dr. Machline-Carrion said. “Patients in the intervention group were more likely to receive all eligible therapies,” she said: 49.2% vs. 25.3%.
“Despite the established efficacy of several interventions for the management of patients with acute ischemic stroke and transient ischemic attack, the uptake of evidence-based measures remains suboptimal, especially in low- and middle-income countries,” Dr. Machline-Carrion said.
The BRIDGE-Stroke study involved 36 hospitals in Brazil, Argentina, and Peru with full emergency department coverage, central nervous system imaging, and access to recombinant tissue plasminogen activator therapies.
Dr. Machline-Carrion disclosed financial relationships with Amgen and Boehringer Ingelheim. The Brazil Ministry of Health was the lead sponsor of the study.
SOURCE: Machline-Carrion MJ et al. AHA scientific sessions, Abstract 19361.
CHICAGO – Stroke patients in low to middle income care settings may frequently fail to get timely evidence-based treatments when they’re admitted to the hospital and even when they’re discharged, but a large South American study found that an “all-or-none” approach to a multistep quality-improvement program led to a significant increase in therapy adherence and smoking cessation. The results were reported at the American Heart Association scientific sessions.
“A multifaceted quality-improvement intervention did not result in a significant increase in the composite adherence score for evidence-based therapies in patients with acute ischemic stroke [AIS] or transient ischemic attack [TIA],” said M. Julia Machline-Carrion, MD, PhD, principal investigator of the BRIDGE-Stroke study and a cardiologist at the Hospital for Heart in São Paulo. “However, when using a more conservative ‘all-or-none’ approach of complete adherence, the intervention resulted in improved adherence to evidence-based therapies.”
The quality-improvement program also resulted in a significant increase in the use of thrombolysis and uptake in smoking cessation education by study participants, Dr. Machline-Carrion added.
The study randomized 1,624 patients with AIS or TIA to the multifaceted quality-improvement intervention or routine practice. The intervention consisted of a patient identification system (wristband and printed reminders), a therapeutic plan road map and checklist, case management, educational materials, interactive workshops, and periodic audit and feedback reports to each participating cluster. Colored wristbands were to help promptly identify AIS or TIA patients in the emergency department and other departments they may have been sent to later on, such as the ICU, to avoid delays in initiating recommended therapies.
On average, the composite adherence score was 85.3% for those in the intervention group vs. 77.8% for controls, Dr. Machline-Carrion said. The composite adherence score consisted of 10 quality measures, ranging from early antithrombotics and prophylaxis for deep vein thrombosis to anticoagulation for atrial fibrillation or flutter, and smoking cessation education. “There was no statistically significant difference in the composite adherence score between the intervention group and the usual-care group,” she said.
However, when the researchers applied the all-or-none model – that is, complete adherence to all 10 in-hospital quality measures – the results were strikingly different, Dr. Machline-Carrion said. “Patients in the intervention group were more likely to receive all eligible therapies,” she said: 49.2% vs. 25.3%.
“Despite the established efficacy of several interventions for the management of patients with acute ischemic stroke and transient ischemic attack, the uptake of evidence-based measures remains suboptimal, especially in low- and middle-income countries,” Dr. Machline-Carrion said.
The BRIDGE-Stroke study involved 36 hospitals in Brazil, Argentina, and Peru with full emergency department coverage, central nervous system imaging, and access to recombinant tissue plasminogen activator therapies.
Dr. Machline-Carrion disclosed financial relationships with Amgen and Boehringer Ingelheim. The Brazil Ministry of Health was the lead sponsor of the study.
SOURCE: Machline-Carrion MJ et al. AHA scientific sessions, Abstract 19361.
CHICAGO – Stroke patients in low to middle income care settings may frequently fail to get timely evidence-based treatments when they’re admitted to the hospital and even when they’re discharged, but a large South American study found that an “all-or-none” approach to a multistep quality-improvement program led to a significant increase in therapy adherence and smoking cessation. The results were reported at the American Heart Association scientific sessions.
“A multifaceted quality-improvement intervention did not result in a significant increase in the composite adherence score for evidence-based therapies in patients with acute ischemic stroke [AIS] or transient ischemic attack [TIA],” said M. Julia Machline-Carrion, MD, PhD, principal investigator of the BRIDGE-Stroke study and a cardiologist at the Hospital for Heart in São Paulo. “However, when using a more conservative ‘all-or-none’ approach of complete adherence, the intervention resulted in improved adherence to evidence-based therapies.”
The quality-improvement program also resulted in a significant increase in the use of thrombolysis and uptake in smoking cessation education by study participants, Dr. Machline-Carrion added.
The study randomized 1,624 patients with AIS or TIA to the multifaceted quality-improvement intervention or routine practice. The intervention consisted of a patient identification system (wristband and printed reminders), a therapeutic plan road map and checklist, case management, educational materials, interactive workshops, and periodic audit and feedback reports to each participating cluster. Colored wristbands were to help promptly identify AIS or TIA patients in the emergency department and other departments they may have been sent to later on, such as the ICU, to avoid delays in initiating recommended therapies.
On average, the composite adherence score was 85.3% for those in the intervention group vs. 77.8% for controls, Dr. Machline-Carrion said. The composite adherence score consisted of 10 quality measures, ranging from early antithrombotics and prophylaxis for deep vein thrombosis to anticoagulation for atrial fibrillation or flutter, and smoking cessation education. “There was no statistically significant difference in the composite adherence score between the intervention group and the usual-care group,” she said.
However, when the researchers applied the all-or-none model – that is, complete adherence to all 10 in-hospital quality measures – the results were strikingly different, Dr. Machline-Carrion said. “Patients in the intervention group were more likely to receive all eligible therapies,” she said: 49.2% vs. 25.3%.
“Despite the established efficacy of several interventions for the management of patients with acute ischemic stroke and transient ischemic attack, the uptake of evidence-based measures remains suboptimal, especially in low- and middle-income countries,” Dr. Machline-Carrion said.
The BRIDGE-Stroke study involved 36 hospitals in Brazil, Argentina, and Peru with full emergency department coverage, central nervous system imaging, and access to recombinant tissue plasminogen activator therapies.
Dr. Machline-Carrion disclosed financial relationships with Amgen and Boehringer Ingelheim. The Brazil Ministry of Health was the lead sponsor of the study.
SOURCE: Machline-Carrion MJ et al. AHA scientific sessions, Abstract 19361.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Intervention group received evidence-based treatments at a rate of 49.2% vs. 25.3% for controls.
Data source: BRIDGE-Stroke, a cluster-randomized trial among 36 hospitals in Brazil, Argentina, and Peru with 1,624 patients enrolled.
Disclosures: Dr. Machline-Carrion disclosed financial relationships with Amgen and Boehringer Ingelheim. The Brazil Ministry of Health was the lead sponsor of the study.
Source: Machline-Carrion MJ et al. AHA scientific sessions, Abstract 19361.
Combined novel risk factors raise coronary event rates
CHICAGO – Individuals with both elevated lipoprotein(a) levels and a family history of coronary heart disease are at a considerably higher long-term risk of atherosclerotic cardiovascular disease and coronary heart disease events than those with one risk factor alone, according to results from a large clinical study presented at the American Heart Association scientific sessions.
“Elevated lipoprotein(a) levels or a positive family history of coronary heart disease each is independently associated with cardiovascular disease risk,” said Anurag Mehta, MD, of Emory University School of Medicine, Atlanta. “This study showed that the presence of both an elevated Lp(a) level and a positive family history has an additive joint association with long-term cardiovascular risk.”
Dr. Mehta reported on an analysis of 12,149 individuals participating in the Atherosclerosis Risk in Communities (ARIC) study. All study participants were free of cardiovascular disease at the time of enrollment. The researchers measured Lp(a) levels and ascertained family history by self-report. Forty-four percent of the study participants had a family history of coronary heart disease (CHD), and 23% were black.
Median follow-up of study participants was 21 years, over which time 3,114 atherosclerotic cardiovascular disease (ASCVD) and 2,283 CHD events occurred.
Black participants had a significantly higher average plasma Lp(a) concentration than white persons, at 16.7 mg/dL vs. 5.7 mg/dL. However, plasma Lp(a) levels between participants with either a positive or a negative family history of CHD were similar on average, 7.6 mg/dL and 7.8 mg/dL, respectively.
The study pooled black and white ARIC participants by race-specific Lp(a) levels (quintiles) and stratified them into four different groups: 1. positive family history and an elevated race-specific Lp(a) level (quintile 5); 2. positive family history and nonelevated race-specific Lp(a) level (quintiles 1-4); 3. negative family history and elevated race-specific Lp(a) level; and 4. negative family history and nonelevated race-specific Lp(a) level. “There was an increase in the proportion of participants with a family history of CHD across race-specific Lp(a) quintiles, highlighting the fact that family history is associated with race-specific Lp(a) levels,” Dr. Mehta said.
“We observed that the ASCVD incidence was higher among participants with an elevated Lp(a) level or a family history of CHD as compared with participants with nonelevated Lp(a) levels and no family history,” Dr. Mehta said. “The highest ASCVD incidence was noted among participants with an elevated Lp(a) level as well as a positive family history.” Among those patients, the cumulative incidence of ASCVD events was nearly 25%, compared with 22% for those with a positive family history and nonelevated Lp(a) levels (group 2) or those with a negative family history but elevated Lp(a) levels (group 3), and 18% for those with negative family history and nonelevated Lp(a) levels.
Results for the cumulative incidence of coronary events trended similarly, Dr. Mehta noted: around 22% for group 1, 19% for group 2, 17% for group 3, and 14% for group 4.
“Having an elevated Lp(a) level as well as a family history of CHD was associated with a higher adjusted hazard for ASCVD and coronary events,” he said. Group 1 patients had a 43% greater risk for ASCVD and 68% greater risk for CHD, respectively, compared with a 16% and 30% greater risk for group 2, and 20% and 27% greater risk for group 3.
“Our findings indicate that these easily measurable nontraditional risk markers can help identify those at an elevated long-term CVD risk and may be useful for informing CVD prevention strategies among asymptomatic individuals,” Dr. Mehta said.
Dr. Mehta had no financial relationships to disclose.
SOURCE: Mehta A et al. AHA scientific sessions, Abstract AT.AOS.03 119.
CHICAGO – Individuals with both elevated lipoprotein(a) levels and a family history of coronary heart disease are at a considerably higher long-term risk of atherosclerotic cardiovascular disease and coronary heart disease events than those with one risk factor alone, according to results from a large clinical study presented at the American Heart Association scientific sessions.
“Elevated lipoprotein(a) levels or a positive family history of coronary heart disease each is independently associated with cardiovascular disease risk,” said Anurag Mehta, MD, of Emory University School of Medicine, Atlanta. “This study showed that the presence of both an elevated Lp(a) level and a positive family history has an additive joint association with long-term cardiovascular risk.”
Dr. Mehta reported on an analysis of 12,149 individuals participating in the Atherosclerosis Risk in Communities (ARIC) study. All study participants were free of cardiovascular disease at the time of enrollment. The researchers measured Lp(a) levels and ascertained family history by self-report. Forty-four percent of the study participants had a family history of coronary heart disease (CHD), and 23% were black.
Median follow-up of study participants was 21 years, over which time 3,114 atherosclerotic cardiovascular disease (ASCVD) and 2,283 CHD events occurred.
Black participants had a significantly higher average plasma Lp(a) concentration than white persons, at 16.7 mg/dL vs. 5.7 mg/dL. However, plasma Lp(a) levels between participants with either a positive or a negative family history of CHD were similar on average, 7.6 mg/dL and 7.8 mg/dL, respectively.
The study pooled black and white ARIC participants by race-specific Lp(a) levels (quintiles) and stratified them into four different groups: 1. positive family history and an elevated race-specific Lp(a) level (quintile 5); 2. positive family history and nonelevated race-specific Lp(a) level (quintiles 1-4); 3. negative family history and elevated race-specific Lp(a) level; and 4. negative family history and nonelevated race-specific Lp(a) level. “There was an increase in the proportion of participants with a family history of CHD across race-specific Lp(a) quintiles, highlighting the fact that family history is associated with race-specific Lp(a) levels,” Dr. Mehta said.
“We observed that the ASCVD incidence was higher among participants with an elevated Lp(a) level or a family history of CHD as compared with participants with nonelevated Lp(a) levels and no family history,” Dr. Mehta said. “The highest ASCVD incidence was noted among participants with an elevated Lp(a) level as well as a positive family history.” Among those patients, the cumulative incidence of ASCVD events was nearly 25%, compared with 22% for those with a positive family history and nonelevated Lp(a) levels (group 2) or those with a negative family history but elevated Lp(a) levels (group 3), and 18% for those with negative family history and nonelevated Lp(a) levels.
Results for the cumulative incidence of coronary events trended similarly, Dr. Mehta noted: around 22% for group 1, 19% for group 2, 17% for group 3, and 14% for group 4.
“Having an elevated Lp(a) level as well as a family history of CHD was associated with a higher adjusted hazard for ASCVD and coronary events,” he said. Group 1 patients had a 43% greater risk for ASCVD and 68% greater risk for CHD, respectively, compared with a 16% and 30% greater risk for group 2, and 20% and 27% greater risk for group 3.
“Our findings indicate that these easily measurable nontraditional risk markers can help identify those at an elevated long-term CVD risk and may be useful for informing CVD prevention strategies among asymptomatic individuals,” Dr. Mehta said.
Dr. Mehta had no financial relationships to disclose.
SOURCE: Mehta A et al. AHA scientific sessions, Abstract AT.AOS.03 119.
CHICAGO – Individuals with both elevated lipoprotein(a) levels and a family history of coronary heart disease are at a considerably higher long-term risk of atherosclerotic cardiovascular disease and coronary heart disease events than those with one risk factor alone, according to results from a large clinical study presented at the American Heart Association scientific sessions.
“Elevated lipoprotein(a) levels or a positive family history of coronary heart disease each is independently associated with cardiovascular disease risk,” said Anurag Mehta, MD, of Emory University School of Medicine, Atlanta. “This study showed that the presence of both an elevated Lp(a) level and a positive family history has an additive joint association with long-term cardiovascular risk.”
Dr. Mehta reported on an analysis of 12,149 individuals participating in the Atherosclerosis Risk in Communities (ARIC) study. All study participants were free of cardiovascular disease at the time of enrollment. The researchers measured Lp(a) levels and ascertained family history by self-report. Forty-four percent of the study participants had a family history of coronary heart disease (CHD), and 23% were black.
Median follow-up of study participants was 21 years, over which time 3,114 atherosclerotic cardiovascular disease (ASCVD) and 2,283 CHD events occurred.
Black participants had a significantly higher average plasma Lp(a) concentration than white persons, at 16.7 mg/dL vs. 5.7 mg/dL. However, plasma Lp(a) levels between participants with either a positive or a negative family history of CHD were similar on average, 7.6 mg/dL and 7.8 mg/dL, respectively.
The study pooled black and white ARIC participants by race-specific Lp(a) levels (quintiles) and stratified them into four different groups: 1. positive family history and an elevated race-specific Lp(a) level (quintile 5); 2. positive family history and nonelevated race-specific Lp(a) level (quintiles 1-4); 3. negative family history and elevated race-specific Lp(a) level; and 4. negative family history and nonelevated race-specific Lp(a) level. “There was an increase in the proportion of participants with a family history of CHD across race-specific Lp(a) quintiles, highlighting the fact that family history is associated with race-specific Lp(a) levels,” Dr. Mehta said.
“We observed that the ASCVD incidence was higher among participants with an elevated Lp(a) level or a family history of CHD as compared with participants with nonelevated Lp(a) levels and no family history,” Dr. Mehta said. “The highest ASCVD incidence was noted among participants with an elevated Lp(a) level as well as a positive family history.” Among those patients, the cumulative incidence of ASCVD events was nearly 25%, compared with 22% for those with a positive family history and nonelevated Lp(a) levels (group 2) or those with a negative family history but elevated Lp(a) levels (group 3), and 18% for those with negative family history and nonelevated Lp(a) levels.
Results for the cumulative incidence of coronary events trended similarly, Dr. Mehta noted: around 22% for group 1, 19% for group 2, 17% for group 3, and 14% for group 4.
“Having an elevated Lp(a) level as well as a family history of CHD was associated with a higher adjusted hazard for ASCVD and coronary events,” he said. Group 1 patients had a 43% greater risk for ASCVD and 68% greater risk for CHD, respectively, compared with a 16% and 30% greater risk for group 2, and 20% and 27% greater risk for group 3.
“Our findings indicate that these easily measurable nontraditional risk markers can help identify those at an elevated long-term CVD risk and may be useful for informing CVD prevention strategies among asymptomatic individuals,” Dr. Mehta said.
Dr. Mehta had no financial relationships to disclose.
SOURCE: Mehta A et al. AHA scientific sessions, Abstract AT.AOS.03 119.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point: .
Major finding: Patients with both risk factors had a 68% greater risk for coronary events.
Study details: Analysis of 12,149 asymptomatic participants enrolled in the ARIC study.
Disclosures: Dr. Mehta has no financial relationships to report.
Source: Mehta A et al. AHA scientific sessions, Abstract AT.AOS.03 119.
EARLY: Angiography within 2 hours of acute non-ST event cut recurrent ischemic events
CHICAGO – Coronary angiography within 2 hours of a diagnosis of non–ST-segment elevation acute coronary syndrome (NSTE-ACS) significantly reduced the risk of recurrent ischemic events as compared to angiography delayed for 12 hours or more, based on the results of the EARLY trial presented at the American Heart Association scientific sessions.
EARLY examined the impacts of not pretreating with a P2Y12-ADP antagonist and of delay before coronary angiography; all study participants received the loading dose of a P2Y12-ADP antagonist at the time of intervention. The early group received angiography within 2 hours, and a delayed group received angiography 12 or more hours after NSTE-ACS.
“Regarding the primary endpoint at 30 days, which is a composite of cardiovascular death and recurrent ischemic event, there is a fivefold lower rate of MACE [major adverse cardiovascular events] in the very-early [group as] compared to the control group,” said Laurent Bonello, MD, PhD, of University Hospital North in Marseilles, France.
The MACE rate was 4.4% in the early group and 21.3% in the delayed group. However, the reduction in MACE was largely because of a reduction in recurrent ischemic events; death rates were similar in the two groups.
The EARLY trial randomized 740 patients at 16 hospitals in France with NSTE-ACS to one of two timing strategies for intervention: within 2 hours of diagnosis, the early-intervention group, and between 12 and 72 hours after diagnosis, the delayed group. Intermediate- and high-risk patients did not receive pretreatment with a P2Y12-ADP antagonist such as clopidogrel before angiography; they received the loading dose at the time of the intervention.
On average, angiography was done within 1 hour in the early group and at 18 hours in the delayed group. Percutaneous coronary intervention (PCI) was performed on 75% of the study population; 3% underwent coronary artery bypass grafting; and 20% received medical therapy.
Dr. Bonello said the purpose of the trial was to settle some uncertainties over the management of NSTE-ACS patients regarding the benefit of pretreatment with P2Y12-ADP antagonists – namely, to evaluate the impact of the lack of pretreatment on the optimal timing of the intervention. “There are no randomized clinical trials available on this specific group of non-ST elevation acute coronary syndrome patients not pretreated for the timing of the invasive strategy,” he said.
Both groups had similar baseline characteristics, such as history of MI, PCI, and aspirin and P2Y12-ADP use, although the delayed group had a higher rate of diabetes (35% vs. 28.3%).
Regarding secondary endpoints, rates of recurrent ischemic events were 2.9% for the early group and 19.8% for the delayed group during hospitalization, and 4.1% vs. 20.7% at 30 days.
Dr. Bonello noted that rates of cardiovascular death were similar for both groups: 0.3% and 0.8% in-hospital deaths, and 0.6% and 1.1% deaths at 30 days.
The disparity in MACE between all subgroups paralleled that of the overall results with two exceptions, Dr. Bonello said: The positive effect of early intervention was less pronounced in women, and there were no differences in MACE rates among those who had interventions other than PCI.
In his discussion of the trial, Gilles Montalescot, MD, PhD, of the Institute of Cardiology at Pitié-Salpêtrière Hospital in Paris, said the EARLY trial with no P2Y12-ADP pretreatment confirms findings of studies before the ACCOAST trial (N Engl J Med. 2013;369:999-1010), that early angiography has no benefit on survival, recurrent MI, revascularization, or bleeding. While the ACCOAST trial, of which Dr. Montalescot was a principal investigator, found no benefit of pretreatment with prasugrel in patients with NTSE-ASC, the EARLY trial extends those findings to other P2Y12-ADP antagonists. “With the immediate angiography strategy, there is a trivial benefit on recurrent ischemia and length of stay, like in the previous studies, thus not related to pretreatment,” he said.
Dr. Montalescot cautioned against embracing this early-intervention strategy with no P2Y12-ADP pretreatment in all situations.
“If you have a conservative strategy for managing the NTSE-ASC patient or if you are in a center far away from a cath lab and your patients have to wait days for a test, yes, you should consider administration of the P2Y12-ADP antagonist,” Dr. Montalescot said.
Dr. Montalescot disclosed receiving grants or honoraria from ADIR, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, and Action Coeur Academic Research Organization.
Dr. Bonello reported financial relationships with AstraZeneca, Boston Scientific, Abbott, and Biotronik. The EARLY trial received funding from the French Ministry of Health.
SOURCE: Bonello B et al. AHA scientific sessions, Session LBS.04 19343.
CHICAGO – Coronary angiography within 2 hours of a diagnosis of non–ST-segment elevation acute coronary syndrome (NSTE-ACS) significantly reduced the risk of recurrent ischemic events as compared to angiography delayed for 12 hours or more, based on the results of the EARLY trial presented at the American Heart Association scientific sessions.
EARLY examined the impacts of not pretreating with a P2Y12-ADP antagonist and of delay before coronary angiography; all study participants received the loading dose of a P2Y12-ADP antagonist at the time of intervention. The early group received angiography within 2 hours, and a delayed group received angiography 12 or more hours after NSTE-ACS.
“Regarding the primary endpoint at 30 days, which is a composite of cardiovascular death and recurrent ischemic event, there is a fivefold lower rate of MACE [major adverse cardiovascular events] in the very-early [group as] compared to the control group,” said Laurent Bonello, MD, PhD, of University Hospital North in Marseilles, France.
The MACE rate was 4.4% in the early group and 21.3% in the delayed group. However, the reduction in MACE was largely because of a reduction in recurrent ischemic events; death rates were similar in the two groups.
The EARLY trial randomized 740 patients at 16 hospitals in France with NSTE-ACS to one of two timing strategies for intervention: within 2 hours of diagnosis, the early-intervention group, and between 12 and 72 hours after diagnosis, the delayed group. Intermediate- and high-risk patients did not receive pretreatment with a P2Y12-ADP antagonist such as clopidogrel before angiography; they received the loading dose at the time of the intervention.
On average, angiography was done within 1 hour in the early group and at 18 hours in the delayed group. Percutaneous coronary intervention (PCI) was performed on 75% of the study population; 3% underwent coronary artery bypass grafting; and 20% received medical therapy.
Dr. Bonello said the purpose of the trial was to settle some uncertainties over the management of NSTE-ACS patients regarding the benefit of pretreatment with P2Y12-ADP antagonists – namely, to evaluate the impact of the lack of pretreatment on the optimal timing of the intervention. “There are no randomized clinical trials available on this specific group of non-ST elevation acute coronary syndrome patients not pretreated for the timing of the invasive strategy,” he said.
Both groups had similar baseline characteristics, such as history of MI, PCI, and aspirin and P2Y12-ADP use, although the delayed group had a higher rate of diabetes (35% vs. 28.3%).
Regarding secondary endpoints, rates of recurrent ischemic events were 2.9% for the early group and 19.8% for the delayed group during hospitalization, and 4.1% vs. 20.7% at 30 days.
Dr. Bonello noted that rates of cardiovascular death were similar for both groups: 0.3% and 0.8% in-hospital deaths, and 0.6% and 1.1% deaths at 30 days.
The disparity in MACE between all subgroups paralleled that of the overall results with two exceptions, Dr. Bonello said: The positive effect of early intervention was less pronounced in women, and there were no differences in MACE rates among those who had interventions other than PCI.
In his discussion of the trial, Gilles Montalescot, MD, PhD, of the Institute of Cardiology at Pitié-Salpêtrière Hospital in Paris, said the EARLY trial with no P2Y12-ADP pretreatment confirms findings of studies before the ACCOAST trial (N Engl J Med. 2013;369:999-1010), that early angiography has no benefit on survival, recurrent MI, revascularization, or bleeding. While the ACCOAST trial, of which Dr. Montalescot was a principal investigator, found no benefit of pretreatment with prasugrel in patients with NTSE-ASC, the EARLY trial extends those findings to other P2Y12-ADP antagonists. “With the immediate angiography strategy, there is a trivial benefit on recurrent ischemia and length of stay, like in the previous studies, thus not related to pretreatment,” he said.
Dr. Montalescot cautioned against embracing this early-intervention strategy with no P2Y12-ADP pretreatment in all situations.
“If you have a conservative strategy for managing the NTSE-ASC patient or if you are in a center far away from a cath lab and your patients have to wait days for a test, yes, you should consider administration of the P2Y12-ADP antagonist,” Dr. Montalescot said.
Dr. Montalescot disclosed receiving grants or honoraria from ADIR, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, and Action Coeur Academic Research Organization.
Dr. Bonello reported financial relationships with AstraZeneca, Boston Scientific, Abbott, and Biotronik. The EARLY trial received funding from the French Ministry of Health.
SOURCE: Bonello B et al. AHA scientific sessions, Session LBS.04 19343.
CHICAGO – Coronary angiography within 2 hours of a diagnosis of non–ST-segment elevation acute coronary syndrome (NSTE-ACS) significantly reduced the risk of recurrent ischemic events as compared to angiography delayed for 12 hours or more, based on the results of the EARLY trial presented at the American Heart Association scientific sessions.
EARLY examined the impacts of not pretreating with a P2Y12-ADP antagonist and of delay before coronary angiography; all study participants received the loading dose of a P2Y12-ADP antagonist at the time of intervention. The early group received angiography within 2 hours, and a delayed group received angiography 12 or more hours after NSTE-ACS.
“Regarding the primary endpoint at 30 days, which is a composite of cardiovascular death and recurrent ischemic event, there is a fivefold lower rate of MACE [major adverse cardiovascular events] in the very-early [group as] compared to the control group,” said Laurent Bonello, MD, PhD, of University Hospital North in Marseilles, France.
The MACE rate was 4.4% in the early group and 21.3% in the delayed group. However, the reduction in MACE was largely because of a reduction in recurrent ischemic events; death rates were similar in the two groups.
The EARLY trial randomized 740 patients at 16 hospitals in France with NSTE-ACS to one of two timing strategies for intervention: within 2 hours of diagnosis, the early-intervention group, and between 12 and 72 hours after diagnosis, the delayed group. Intermediate- and high-risk patients did not receive pretreatment with a P2Y12-ADP antagonist such as clopidogrel before angiography; they received the loading dose at the time of the intervention.
On average, angiography was done within 1 hour in the early group and at 18 hours in the delayed group. Percutaneous coronary intervention (PCI) was performed on 75% of the study population; 3% underwent coronary artery bypass grafting; and 20% received medical therapy.
Dr. Bonello said the purpose of the trial was to settle some uncertainties over the management of NSTE-ACS patients regarding the benefit of pretreatment with P2Y12-ADP antagonists – namely, to evaluate the impact of the lack of pretreatment on the optimal timing of the intervention. “There are no randomized clinical trials available on this specific group of non-ST elevation acute coronary syndrome patients not pretreated for the timing of the invasive strategy,” he said.
Both groups had similar baseline characteristics, such as history of MI, PCI, and aspirin and P2Y12-ADP use, although the delayed group had a higher rate of diabetes (35% vs. 28.3%).
Regarding secondary endpoints, rates of recurrent ischemic events were 2.9% for the early group and 19.8% for the delayed group during hospitalization, and 4.1% vs. 20.7% at 30 days.
Dr. Bonello noted that rates of cardiovascular death were similar for both groups: 0.3% and 0.8% in-hospital deaths, and 0.6% and 1.1% deaths at 30 days.
The disparity in MACE between all subgroups paralleled that of the overall results with two exceptions, Dr. Bonello said: The positive effect of early intervention was less pronounced in women, and there were no differences in MACE rates among those who had interventions other than PCI.
In his discussion of the trial, Gilles Montalescot, MD, PhD, of the Institute of Cardiology at Pitié-Salpêtrière Hospital in Paris, said the EARLY trial with no P2Y12-ADP pretreatment confirms findings of studies before the ACCOAST trial (N Engl J Med. 2013;369:999-1010), that early angiography has no benefit on survival, recurrent MI, revascularization, or bleeding. While the ACCOAST trial, of which Dr. Montalescot was a principal investigator, found no benefit of pretreatment with prasugrel in patients with NTSE-ASC, the EARLY trial extends those findings to other P2Y12-ADP antagonists. “With the immediate angiography strategy, there is a trivial benefit on recurrent ischemia and length of stay, like in the previous studies, thus not related to pretreatment,” he said.
Dr. Montalescot cautioned against embracing this early-intervention strategy with no P2Y12-ADP pretreatment in all situations.
“If you have a conservative strategy for managing the NTSE-ASC patient or if you are in a center far away from a cath lab and your patients have to wait days for a test, yes, you should consider administration of the P2Y12-ADP antagonist,” Dr. Montalescot said.
Dr. Montalescot disclosed receiving grants or honoraria from ADIR, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Beth Israel Deaconess Medical, and Action Coeur Academic Research Organization.
Dr. Bonello reported financial relationships with AstraZeneca, Boston Scientific, Abbott, and Biotronik. The EARLY trial received funding from the French Ministry of Health.
SOURCE: Bonello B et al. AHA scientific sessions, Session LBS.04 19343.
REPORTING FROM THE AHA SCIENTIFIC SESSIONS
Key clinical point: Coronary angiography within 2 hours of non–ST-segment elevation acute coronary syndrome yielded improved outcomes.
Major finding: Rates of major cardiovascular events were 4.4% with early intervention and 21.3% with delayed intervention.
Study details: Prospective, multicenter, randomized clinical trial of 709 patients.
Disclosures: Dr. Bonello reported financial relationships with AstraZeneca, Boston Scientific, Abbott, and Biotronik. The trial received funding from the French Ministry of Health.
Source: Bonello B et al. AHA scientific sessions, Session LBS.04 19343.