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Cangrelor offers advantages for antiplatelet management in PCI
PARIS – Parenteral cangrelor is a potent antiplatelet agent that provides similar anti-ischemic effects but a significantly lower risk of major bleeding than the popular combination of clopidogrel plus a glycoprotein IIb/IIIa inhibitor in patients undergoing elective or urgent percutaneous coronary intervention.
Moreover, cangrelor (Kengreal), a rapid-acting and reversible intravenous platelet P2Y12 inhibitor, cuts the blood transfusion requirement by more than half, Dr. Muthiah Vaduganathan reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
These findings, based upon a propensity score–matched exploratory pooled analysis of individual patient-level data from the three phase III CHAMPION trials, suggest that cangrelor alone is an attractive alternative to clopidogrel plus a glycoprotein IIb/IIIa inhibitor (GPI) for antiplatelet management in percutaneous coronary intervention (PCI), according to Dr. Vaduganathan of Brigham and Women’s Hospital, Boston.
CHAMPION PLATFORM (N Engl J Med 2009 Dec 10;361[24]:2330-41), CHAMPION PCI (N Engl J Med 2009 Dec 10;361[24]:2318-29), and CHAMPION PHOENIX (N Engl J Med 2013 Apr 11;368[14]:1303-13) collectively included nearly 25,000 patients randomized to cangrelor versus standard therapy for platelet inhibition in elective or urgent PCI. The trials, which established that cangrelor led to fewer ischemic complications within 30 days post PCI than did clopidogrel plus a GPI, led to Food and Drug Administration approval of the drug in 2015. Cangrelor is also approved in Europe.
The cangrelor and clopidogrel groups differed in terms of baseline bleeding risk. For example, the clopidogrel-treated patients were younger, more likely to be male, had fewer comorbid conditions, and more often presented with an acute coronary syndrome. In order to accurately assess the bleeding risk associated with the two antiplatelet strategies, Dr. Vaduganathan and coinvestigators engaged in propensity score matching on the basis of 16 baseline clinical variables. They identified two closely matched cohorts consisting of 1,021 patient pairs.
The 1,021 patients in the cangrelor-alone group had a 2.6% rate of the primary composite efficacy endpoint consisting of all-cause mortality, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours. Although this was 21% lower than the 3.3% rate in the clopidogrel plus GPI group, the difference didn’t achieve statistical significance because of the relatively small sample size.
In contrast, the rate of major bleeding within 48 hours by ACUITY (Acute Catheterization and Urgent Intervention Triage) criteria did differ significantly between the two groups: 3.6% with cangrelor and 5.8% with clopidogrel plus a GPI, for a 39% relative risk reduction in favor of the newer agent. Major bleeding rates were also lower in the cangrelor-treated patients on the GUSTO (Global Utilization of Streptokinase and TPA for Occluded Coronary Arteries) and TIMI (Thrombolysis in Myocardial Infarction) scales, although those trends didn’t achieve significance. The blood transfusion requirement was significantly lower in the cangrelor group: 1% versus 2.1%, for a 55% relative risk reduction.
Dr. Vaduganathan said the CHAMPION investigators’ future plans include examining the possibility of a favorable pharmacologic interaction between cangrelor and bivalirudin, a combination seeing increasing use in the United States.
“Finally, I think it’ll be important moving forward to look at comparative effectiveness data – either observational or randomized – as well as cost-effectiveness data between potent parenteral antiplatelet strategies,” he concluded.
Session chair Dr. Anthony Gershlick of Glenfield General Hospital in Leicester, England, commented that while he found this analysis of the CHAMPION data quite interesting, they are of little relevance in Europe, where cardiologists seldom use GPIs as part of their up-front PCI management strategy, instead resorting to those agents mainly as bailout therapy.
The U.S. situation is very different, according to Dr. Vaduganathan. American cardiologists use GPI therapy in about one-third of PCIs.
The CHAMPION trials were funded by the Medicines Co. Dr. Vaduganathan reported having no relevant financial conflicts.
PARIS – Parenteral cangrelor is a potent antiplatelet agent that provides similar anti-ischemic effects but a significantly lower risk of major bleeding than the popular combination of clopidogrel plus a glycoprotein IIb/IIIa inhibitor in patients undergoing elective or urgent percutaneous coronary intervention.
Moreover, cangrelor (Kengreal), a rapid-acting and reversible intravenous platelet P2Y12 inhibitor, cuts the blood transfusion requirement by more than half, Dr. Muthiah Vaduganathan reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
These findings, based upon a propensity score–matched exploratory pooled analysis of individual patient-level data from the three phase III CHAMPION trials, suggest that cangrelor alone is an attractive alternative to clopidogrel plus a glycoprotein IIb/IIIa inhibitor (GPI) for antiplatelet management in percutaneous coronary intervention (PCI), according to Dr. Vaduganathan of Brigham and Women’s Hospital, Boston.
CHAMPION PLATFORM (N Engl J Med 2009 Dec 10;361[24]:2330-41), CHAMPION PCI (N Engl J Med 2009 Dec 10;361[24]:2318-29), and CHAMPION PHOENIX (N Engl J Med 2013 Apr 11;368[14]:1303-13) collectively included nearly 25,000 patients randomized to cangrelor versus standard therapy for platelet inhibition in elective or urgent PCI. The trials, which established that cangrelor led to fewer ischemic complications within 30 days post PCI than did clopidogrel plus a GPI, led to Food and Drug Administration approval of the drug in 2015. Cangrelor is also approved in Europe.
The cangrelor and clopidogrel groups differed in terms of baseline bleeding risk. For example, the clopidogrel-treated patients were younger, more likely to be male, had fewer comorbid conditions, and more often presented with an acute coronary syndrome. In order to accurately assess the bleeding risk associated with the two antiplatelet strategies, Dr. Vaduganathan and coinvestigators engaged in propensity score matching on the basis of 16 baseline clinical variables. They identified two closely matched cohorts consisting of 1,021 patient pairs.
The 1,021 patients in the cangrelor-alone group had a 2.6% rate of the primary composite efficacy endpoint consisting of all-cause mortality, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours. Although this was 21% lower than the 3.3% rate in the clopidogrel plus GPI group, the difference didn’t achieve statistical significance because of the relatively small sample size.
In contrast, the rate of major bleeding within 48 hours by ACUITY (Acute Catheterization and Urgent Intervention Triage) criteria did differ significantly between the two groups: 3.6% with cangrelor and 5.8% with clopidogrel plus a GPI, for a 39% relative risk reduction in favor of the newer agent. Major bleeding rates were also lower in the cangrelor-treated patients on the GUSTO (Global Utilization of Streptokinase and TPA for Occluded Coronary Arteries) and TIMI (Thrombolysis in Myocardial Infarction) scales, although those trends didn’t achieve significance. The blood transfusion requirement was significantly lower in the cangrelor group: 1% versus 2.1%, for a 55% relative risk reduction.
Dr. Vaduganathan said the CHAMPION investigators’ future plans include examining the possibility of a favorable pharmacologic interaction between cangrelor and bivalirudin, a combination seeing increasing use in the United States.
“Finally, I think it’ll be important moving forward to look at comparative effectiveness data – either observational or randomized – as well as cost-effectiveness data between potent parenteral antiplatelet strategies,” he concluded.
Session chair Dr. Anthony Gershlick of Glenfield General Hospital in Leicester, England, commented that while he found this analysis of the CHAMPION data quite interesting, they are of little relevance in Europe, where cardiologists seldom use GPIs as part of their up-front PCI management strategy, instead resorting to those agents mainly as bailout therapy.
The U.S. situation is very different, according to Dr. Vaduganathan. American cardiologists use GPI therapy in about one-third of PCIs.
The CHAMPION trials were funded by the Medicines Co. Dr. Vaduganathan reported having no relevant financial conflicts.
PARIS – Parenteral cangrelor is a potent antiplatelet agent that provides similar anti-ischemic effects but a significantly lower risk of major bleeding than the popular combination of clopidogrel plus a glycoprotein IIb/IIIa inhibitor in patients undergoing elective or urgent percutaneous coronary intervention.
Moreover, cangrelor (Kengreal), a rapid-acting and reversible intravenous platelet P2Y12 inhibitor, cuts the blood transfusion requirement by more than half, Dr. Muthiah Vaduganathan reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
These findings, based upon a propensity score–matched exploratory pooled analysis of individual patient-level data from the three phase III CHAMPION trials, suggest that cangrelor alone is an attractive alternative to clopidogrel plus a glycoprotein IIb/IIIa inhibitor (GPI) for antiplatelet management in percutaneous coronary intervention (PCI), according to Dr. Vaduganathan of Brigham and Women’s Hospital, Boston.
CHAMPION PLATFORM (N Engl J Med 2009 Dec 10;361[24]:2330-41), CHAMPION PCI (N Engl J Med 2009 Dec 10;361[24]:2318-29), and CHAMPION PHOENIX (N Engl J Med 2013 Apr 11;368[14]:1303-13) collectively included nearly 25,000 patients randomized to cangrelor versus standard therapy for platelet inhibition in elective or urgent PCI. The trials, which established that cangrelor led to fewer ischemic complications within 30 days post PCI than did clopidogrel plus a GPI, led to Food and Drug Administration approval of the drug in 2015. Cangrelor is also approved in Europe.
The cangrelor and clopidogrel groups differed in terms of baseline bleeding risk. For example, the clopidogrel-treated patients were younger, more likely to be male, had fewer comorbid conditions, and more often presented with an acute coronary syndrome. In order to accurately assess the bleeding risk associated with the two antiplatelet strategies, Dr. Vaduganathan and coinvestigators engaged in propensity score matching on the basis of 16 baseline clinical variables. They identified two closely matched cohorts consisting of 1,021 patient pairs.
The 1,021 patients in the cangrelor-alone group had a 2.6% rate of the primary composite efficacy endpoint consisting of all-cause mortality, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours. Although this was 21% lower than the 3.3% rate in the clopidogrel plus GPI group, the difference didn’t achieve statistical significance because of the relatively small sample size.
In contrast, the rate of major bleeding within 48 hours by ACUITY (Acute Catheterization and Urgent Intervention Triage) criteria did differ significantly between the two groups: 3.6% with cangrelor and 5.8% with clopidogrel plus a GPI, for a 39% relative risk reduction in favor of the newer agent. Major bleeding rates were also lower in the cangrelor-treated patients on the GUSTO (Global Utilization of Streptokinase and TPA for Occluded Coronary Arteries) and TIMI (Thrombolysis in Myocardial Infarction) scales, although those trends didn’t achieve significance. The blood transfusion requirement was significantly lower in the cangrelor group: 1% versus 2.1%, for a 55% relative risk reduction.
Dr. Vaduganathan said the CHAMPION investigators’ future plans include examining the possibility of a favorable pharmacologic interaction between cangrelor and bivalirudin, a combination seeing increasing use in the United States.
“Finally, I think it’ll be important moving forward to look at comparative effectiveness data – either observational or randomized – as well as cost-effectiveness data between potent parenteral antiplatelet strategies,” he concluded.
Session chair Dr. Anthony Gershlick of Glenfield General Hospital in Leicester, England, commented that while he found this analysis of the CHAMPION data quite interesting, they are of little relevance in Europe, where cardiologists seldom use GPIs as part of their up-front PCI management strategy, instead resorting to those agents mainly as bailout therapy.
The U.S. situation is very different, according to Dr. Vaduganathan. American cardiologists use GPI therapy in about one-third of PCIs.
The CHAMPION trials were funded by the Medicines Co. Dr. Vaduganathan reported having no relevant financial conflicts.
AT EUROPCR 2016
Key clinical point: Cangrelor in patients undergoing PCI offers similar protection against ischemic events, compared with clopidogrel plus a glycoprotein IIb/IIIa inhibitor, but with significantly less major bleeding risk.
Major finding: The 48-hour rate of major bleeding as defined by the ACUITY scale was 3.6% with cangrelor alone, compared with 5.8% with clopidogrel plus a glycoprotein IIb/IIIa inhibitor.
Data source: This propensity score–matched analysis included 1,021 pairs of patients drawn from the three phase III CHAMPION trials.
Disclosures: The CHAMPION trials were funded by the Medicines Co. The presenter reported having no relevant financial conflicts.
Repeat SICU admissions should trigger palliative care consult
ICU readmission was most predictive of the need for palliative care among patients in the surgical intensive care unit, based on a study of six potential trigger criteria associated with in-hospital death or discharge to hospice.
To facilitate proactive case findings of patients who would benefit from a palliative care consult, a team of surgical ICU and palliative care clinicians at the Icahn School of Medicine at Mount Sinai, N.Y., developed and tested a system of palliative care triggers. The study was published online in the Journal of Critical Care (http://dx.doi.org/10.1016/j.jcrc.2016.04.010).
Based on a literature review, the researchers created a six-item list of potential triggers for palliative care: length of stay over 10 days, ICU readmission, intensivist referral, status post cardiac arrest, metastatic cancer, and a match of two or more on a set of secondary criteria.
Data were collected for the period from Sept. 4, 2013, through May 30, 2014, at the surgical ICU of a 1,170-bed tertiary medical center. Patients who received a palliative care consultation were compared with those who did not, and the trigger list was tested for accuracy in predicting patient outcomes. The primary outcomes were hospital death, hospice discharge, and a combined endpoint of these two outcomes. Patients who died in the hospital or were released to hospice care were assumed to be those most in need of a palliative care consult.
Bivariate analysis was done to calculate the unadjusted odds ratios of individual triggers to each of these outcomes. Then, the team used logistic regression analysis to calculate the adjusted odds ratios of triggers to outcomes.
Of the 512 patients admitted to the SICU in the study period, those not discharged by the end of the study were excluded, leaving 492 patients in the study.
Bivariate analysis found that all of the triggers were significantly associated with in-hospital death. With the multivariate analysis and adjusted odds ratios, SICU readmission, status post cardiac arrest, metastatic cancer, and secondary triggers were significantly associated with hospital death.
For the combined outcome of hospital death or release to hospice care, the relationships were stronger. In particular, repeat SICU readmissions and metastatic cancer triggers were strongly associated with the combined outcome (odds ratio, 19.41, CI 5.81-54.86 and OR, 16.40, CI 4.69-57.36, respectively). The secondary triggers did not show the same strength of association, although they were associated significantly with the combined outcome (OR, 4.41, CI 2.05-9.53).
The most prominent finding is the strength of repeat SICU admissions with the hospital death or release to hospice. The strong relationship between repeat SICU admission and outcomes led the researchers to conclude “that one might consider adapting this clinical criterion as a standalone criterion. This would require all patients who are readmitted to the SICU to be seen by palliative care to assess their overall goals of care and understanding of their serious illness. This approach may be particularly useful for smaller palliative care teams that do not have the resources to screen daily with a series of triggers.”
The American Federation of Aging Research and the National Institute on Aging funded the study.
ICU readmission was most predictive of the need for palliative care among patients in the surgical intensive care unit, based on a study of six potential trigger criteria associated with in-hospital death or discharge to hospice.
To facilitate proactive case findings of patients who would benefit from a palliative care consult, a team of surgical ICU and palliative care clinicians at the Icahn School of Medicine at Mount Sinai, N.Y., developed and tested a system of palliative care triggers. The study was published online in the Journal of Critical Care (http://dx.doi.org/10.1016/j.jcrc.2016.04.010).
Based on a literature review, the researchers created a six-item list of potential triggers for palliative care: length of stay over 10 days, ICU readmission, intensivist referral, status post cardiac arrest, metastatic cancer, and a match of two or more on a set of secondary criteria.
Data were collected for the period from Sept. 4, 2013, through May 30, 2014, at the surgical ICU of a 1,170-bed tertiary medical center. Patients who received a palliative care consultation were compared with those who did not, and the trigger list was tested for accuracy in predicting patient outcomes. The primary outcomes were hospital death, hospice discharge, and a combined endpoint of these two outcomes. Patients who died in the hospital or were released to hospice care were assumed to be those most in need of a palliative care consult.
Bivariate analysis was done to calculate the unadjusted odds ratios of individual triggers to each of these outcomes. Then, the team used logistic regression analysis to calculate the adjusted odds ratios of triggers to outcomes.
Of the 512 patients admitted to the SICU in the study period, those not discharged by the end of the study were excluded, leaving 492 patients in the study.
Bivariate analysis found that all of the triggers were significantly associated with in-hospital death. With the multivariate analysis and adjusted odds ratios, SICU readmission, status post cardiac arrest, metastatic cancer, and secondary triggers were significantly associated with hospital death.
For the combined outcome of hospital death or release to hospice care, the relationships were stronger. In particular, repeat SICU readmissions and metastatic cancer triggers were strongly associated with the combined outcome (odds ratio, 19.41, CI 5.81-54.86 and OR, 16.40, CI 4.69-57.36, respectively). The secondary triggers did not show the same strength of association, although they were associated significantly with the combined outcome (OR, 4.41, CI 2.05-9.53).
The most prominent finding is the strength of repeat SICU admissions with the hospital death or release to hospice. The strong relationship between repeat SICU admission and outcomes led the researchers to conclude “that one might consider adapting this clinical criterion as a standalone criterion. This would require all patients who are readmitted to the SICU to be seen by palliative care to assess their overall goals of care and understanding of their serious illness. This approach may be particularly useful for smaller palliative care teams that do not have the resources to screen daily with a series of triggers.”
The American Federation of Aging Research and the National Institute on Aging funded the study.
ICU readmission was most predictive of the need for palliative care among patients in the surgical intensive care unit, based on a study of six potential trigger criteria associated with in-hospital death or discharge to hospice.
To facilitate proactive case findings of patients who would benefit from a palliative care consult, a team of surgical ICU and palliative care clinicians at the Icahn School of Medicine at Mount Sinai, N.Y., developed and tested a system of palliative care triggers. The study was published online in the Journal of Critical Care (http://dx.doi.org/10.1016/j.jcrc.2016.04.010).
Based on a literature review, the researchers created a six-item list of potential triggers for palliative care: length of stay over 10 days, ICU readmission, intensivist referral, status post cardiac arrest, metastatic cancer, and a match of two or more on a set of secondary criteria.
Data were collected for the period from Sept. 4, 2013, through May 30, 2014, at the surgical ICU of a 1,170-bed tertiary medical center. Patients who received a palliative care consultation were compared with those who did not, and the trigger list was tested for accuracy in predicting patient outcomes. The primary outcomes were hospital death, hospice discharge, and a combined endpoint of these two outcomes. Patients who died in the hospital or were released to hospice care were assumed to be those most in need of a palliative care consult.
Bivariate analysis was done to calculate the unadjusted odds ratios of individual triggers to each of these outcomes. Then, the team used logistic regression analysis to calculate the adjusted odds ratios of triggers to outcomes.
Of the 512 patients admitted to the SICU in the study period, those not discharged by the end of the study were excluded, leaving 492 patients in the study.
Bivariate analysis found that all of the triggers were significantly associated with in-hospital death. With the multivariate analysis and adjusted odds ratios, SICU readmission, status post cardiac arrest, metastatic cancer, and secondary triggers were significantly associated with hospital death.
For the combined outcome of hospital death or release to hospice care, the relationships were stronger. In particular, repeat SICU readmissions and metastatic cancer triggers were strongly associated with the combined outcome (odds ratio, 19.41, CI 5.81-54.86 and OR, 16.40, CI 4.69-57.36, respectively). The secondary triggers did not show the same strength of association, although they were associated significantly with the combined outcome (OR, 4.41, CI 2.05-9.53).
The most prominent finding is the strength of repeat SICU admissions with the hospital death or release to hospice. The strong relationship between repeat SICU admission and outcomes led the researchers to conclude “that one might consider adapting this clinical criterion as a standalone criterion. This would require all patients who are readmitted to the SICU to be seen by palliative care to assess their overall goals of care and understanding of their serious illness. This approach may be particularly useful for smaller palliative care teams that do not have the resources to screen daily with a series of triggers.”
The American Federation of Aging Research and the National Institute on Aging funded the study.
FROM THE JOURNAL OF CRITICAL CARE
Key clinical point: A list of tested triggers can predict the need of surgical ICU patients for a palliative care consultation.
Major finding: Readmission to the surgical ICU was strongly associated with the study endpoint of hospital death or release to hospice (odds ratio 19.41, CI 5.81-54.86).
Data source: A case review of all 492 patients admitted to the surgical intensive care facility at a 1,170-bed, tertiary care medical center.
Disclosures: The American Federation of Aging Research and the National Institute on Aging funded the study.
Patients: Intraperitoneal chemotherapy ‘worth it’ for ovarian cancer
WASHINGTON – Intraperitoneal chemotherapy may be unpleasant and interfere with daily life, but the large majority of women who received it for ovarian cancer agreed that it was the right choice for them.
A small survey of women who completed up to six cycles of the treatment found that most women did experience side effects, including fatigue, pain, and gastrointestinal issues. Despite those problems, more than 80% said they felt the regimen was “worth it,” and more than 90% said they would recommend it to another woman.
“Outpatient administration of chemotherapy appears to be feasible with acceptable toxicities and high completion rates,” Dr. Kristin Gotimer said at the annual meeting of the American College of Obstetricians and Gynecologists. “Toxicities were troublesome, and they did definitely affect quality of life; but almost none of our patients regretted being treated – even the ones who experienced recurrent disease.”
Dr. Gotimer of the Winthrop University Hospital, Mineola, N.Y., discussed a retrospective study of 98 women who underwent intraperitoneal chemotherapy for a gynecologic cancer from 2006 to 2014. Mean age of the patients was 58 years. Most women (71%) had ovarian cancer, and most cancer (70%) was stage IIIC or higher. All patients underwent cytoreductive surgery before starting chemotherapy.
Almost all women were prescribed six cycles of the regimen, which consisted of IV paclitaxel on day 1, intraperitoneal cisplatin on day 2, and intraperitoneal paclitaxel on day 8. Overall, 73% of patients completed their prescribed treatment. Among those prescribed six cycles, 71% completed all of them. Of the 26 patients who discontinued, 12 did so because of port complications, and 14 did so because of toxicities.
The most commonly reported side effects were gastrointestinal effects, fatigue, and neuropathy. Grade 3/4 toxicities were most often fatigue, neuropathy, and pain; those occurred in about 6% of patients per cycle. There were four cases of neutropenic fever; two of those resulted in treatment delays.
Seven patients had to change treatment, Dr. Gotimer said. Six switched from intraperitoneal cisplatin to intraperitoneal carboplatin, and one patient switched from IV paclitaxel to IV Abraxane. Toxicities were more likely to appear in later cycles. “The probability of starting each cycle was lower if the patient had experienced a severe toxicity in the prior cycle,” Dr. Gotimer explained.
A subset of patients (48) completed a survey about the treatment at a mean of 31 months after treatment. Of those, 92% had completed all their prescribed cycles. Disease had recurred in 21%. The three-domain survey queried the mental, physical, and social impact of the treatment.
On the physical health domain, half the group reported fatigue associated with the treatment. Others complained of pain (40%), gastrointestinal effects (37%), “chemo brain” cognitive dysfunction (29%), and alopecia (25%). A few patients experienced infections and dermatologic problems (less than 10% each).
In the mental health domain, patients most often noted stress (25%), anxiety (21%), and depression (15%) during treatment. They also said the therapy interfered with their social health, affecting work attendance (27%), housework (29%), and social interactions (19%). It also imposed a substantial time commitment, 17% of patients noted.
Despite those issues, 83% of patients endorsed intraperitoneal chemotherapy as “worth it,” and almost 90% said they would recommend it to a friend or family member considering it. Only about 5% of patients said they regretted using the treatment, although Dr. Gotimer didn’t specify what those regrets were.
Despite its small size and retrospective nature, the survey offers some clinically useful information, Dr. Gotimer noted. “We can identify modifiable side effects and develop specific interventions aimed at increasing tolerability.”
The results could also be used to “improve physician and patient understanding of realistic short- and long-term expectations to improve patient counseling,” she added.
Dr. Gotimer had no financial declarations.
On Twitter @Alz_Gal
WASHINGTON – Intraperitoneal chemotherapy may be unpleasant and interfere with daily life, but the large majority of women who received it for ovarian cancer agreed that it was the right choice for them.
A small survey of women who completed up to six cycles of the treatment found that most women did experience side effects, including fatigue, pain, and gastrointestinal issues. Despite those problems, more than 80% said they felt the regimen was “worth it,” and more than 90% said they would recommend it to another woman.
“Outpatient administration of chemotherapy appears to be feasible with acceptable toxicities and high completion rates,” Dr. Kristin Gotimer said at the annual meeting of the American College of Obstetricians and Gynecologists. “Toxicities were troublesome, and they did definitely affect quality of life; but almost none of our patients regretted being treated – even the ones who experienced recurrent disease.”
Dr. Gotimer of the Winthrop University Hospital, Mineola, N.Y., discussed a retrospective study of 98 women who underwent intraperitoneal chemotherapy for a gynecologic cancer from 2006 to 2014. Mean age of the patients was 58 years. Most women (71%) had ovarian cancer, and most cancer (70%) was stage IIIC or higher. All patients underwent cytoreductive surgery before starting chemotherapy.
Almost all women were prescribed six cycles of the regimen, which consisted of IV paclitaxel on day 1, intraperitoneal cisplatin on day 2, and intraperitoneal paclitaxel on day 8. Overall, 73% of patients completed their prescribed treatment. Among those prescribed six cycles, 71% completed all of them. Of the 26 patients who discontinued, 12 did so because of port complications, and 14 did so because of toxicities.
The most commonly reported side effects were gastrointestinal effects, fatigue, and neuropathy. Grade 3/4 toxicities were most often fatigue, neuropathy, and pain; those occurred in about 6% of patients per cycle. There were four cases of neutropenic fever; two of those resulted in treatment delays.
Seven patients had to change treatment, Dr. Gotimer said. Six switched from intraperitoneal cisplatin to intraperitoneal carboplatin, and one patient switched from IV paclitaxel to IV Abraxane. Toxicities were more likely to appear in later cycles. “The probability of starting each cycle was lower if the patient had experienced a severe toxicity in the prior cycle,” Dr. Gotimer explained.
A subset of patients (48) completed a survey about the treatment at a mean of 31 months after treatment. Of those, 92% had completed all their prescribed cycles. Disease had recurred in 21%. The three-domain survey queried the mental, physical, and social impact of the treatment.
On the physical health domain, half the group reported fatigue associated with the treatment. Others complained of pain (40%), gastrointestinal effects (37%), “chemo brain” cognitive dysfunction (29%), and alopecia (25%). A few patients experienced infections and dermatologic problems (less than 10% each).
In the mental health domain, patients most often noted stress (25%), anxiety (21%), and depression (15%) during treatment. They also said the therapy interfered with their social health, affecting work attendance (27%), housework (29%), and social interactions (19%). It also imposed a substantial time commitment, 17% of patients noted.
Despite those issues, 83% of patients endorsed intraperitoneal chemotherapy as “worth it,” and almost 90% said they would recommend it to a friend or family member considering it. Only about 5% of patients said they regretted using the treatment, although Dr. Gotimer didn’t specify what those regrets were.
Despite its small size and retrospective nature, the survey offers some clinically useful information, Dr. Gotimer noted. “We can identify modifiable side effects and develop specific interventions aimed at increasing tolerability.”
The results could also be used to “improve physician and patient understanding of realistic short- and long-term expectations to improve patient counseling,” she added.
Dr. Gotimer had no financial declarations.
On Twitter @Alz_Gal
WASHINGTON – Intraperitoneal chemotherapy may be unpleasant and interfere with daily life, but the large majority of women who received it for ovarian cancer agreed that it was the right choice for them.
A small survey of women who completed up to six cycles of the treatment found that most women did experience side effects, including fatigue, pain, and gastrointestinal issues. Despite those problems, more than 80% said they felt the regimen was “worth it,” and more than 90% said they would recommend it to another woman.
“Outpatient administration of chemotherapy appears to be feasible with acceptable toxicities and high completion rates,” Dr. Kristin Gotimer said at the annual meeting of the American College of Obstetricians and Gynecologists. “Toxicities were troublesome, and they did definitely affect quality of life; but almost none of our patients regretted being treated – even the ones who experienced recurrent disease.”
Dr. Gotimer of the Winthrop University Hospital, Mineola, N.Y., discussed a retrospective study of 98 women who underwent intraperitoneal chemotherapy for a gynecologic cancer from 2006 to 2014. Mean age of the patients was 58 years. Most women (71%) had ovarian cancer, and most cancer (70%) was stage IIIC or higher. All patients underwent cytoreductive surgery before starting chemotherapy.
Almost all women were prescribed six cycles of the regimen, which consisted of IV paclitaxel on day 1, intraperitoneal cisplatin on day 2, and intraperitoneal paclitaxel on day 8. Overall, 73% of patients completed their prescribed treatment. Among those prescribed six cycles, 71% completed all of them. Of the 26 patients who discontinued, 12 did so because of port complications, and 14 did so because of toxicities.
The most commonly reported side effects were gastrointestinal effects, fatigue, and neuropathy. Grade 3/4 toxicities were most often fatigue, neuropathy, and pain; those occurred in about 6% of patients per cycle. There were four cases of neutropenic fever; two of those resulted in treatment delays.
Seven patients had to change treatment, Dr. Gotimer said. Six switched from intraperitoneal cisplatin to intraperitoneal carboplatin, and one patient switched from IV paclitaxel to IV Abraxane. Toxicities were more likely to appear in later cycles. “The probability of starting each cycle was lower if the patient had experienced a severe toxicity in the prior cycle,” Dr. Gotimer explained.
A subset of patients (48) completed a survey about the treatment at a mean of 31 months after treatment. Of those, 92% had completed all their prescribed cycles. Disease had recurred in 21%. The three-domain survey queried the mental, physical, and social impact of the treatment.
On the physical health domain, half the group reported fatigue associated with the treatment. Others complained of pain (40%), gastrointestinal effects (37%), “chemo brain” cognitive dysfunction (29%), and alopecia (25%). A few patients experienced infections and dermatologic problems (less than 10% each).
In the mental health domain, patients most often noted stress (25%), anxiety (21%), and depression (15%) during treatment. They also said the therapy interfered with their social health, affecting work attendance (27%), housework (29%), and social interactions (19%). It also imposed a substantial time commitment, 17% of patients noted.
Despite those issues, 83% of patients endorsed intraperitoneal chemotherapy as “worth it,” and almost 90% said they would recommend it to a friend or family member considering it. Only about 5% of patients said they regretted using the treatment, although Dr. Gotimer didn’t specify what those regrets were.
Despite its small size and retrospective nature, the survey offers some clinically useful information, Dr. Gotimer noted. “We can identify modifiable side effects and develop specific interventions aimed at increasing tolerability.”
The results could also be used to “improve physician and patient understanding of realistic short- and long-term expectations to improve patient counseling,” she added.
Dr. Gotimer had no financial declarations.
On Twitter @Alz_Gal
AT ACOG 2016
Key clinical point: Despite its challenges, most women who used intraperitoneal chemotherapy for ovarian cancer said it was a good option for them.
Major finding: More than 80% of women said the regimen was “worth it,” and more than 90% said they would recommend it to another woman.
Data source: The retrospective study comprised 98 women, 48 of whom completed a survey about their treatment.
Disclosures: Dr. Gotimer had no financial disclosures.
Care bundle reduces cesarean surgical site infections
WASHINGTON – The rate of cesarean delivery surgical site infections fell significantly at Yale New Haven (Conn.) Hospital after implementation of a multidisciplinary care bundle with protocols covering preoperative, intraoperative, and postoperative care.
An analysis of two 3-month sampling periods – one before implementation of the bundle of care and one after – showed a drop in the surgical site infection (SSI) rate among total cesarean sections from 3.4% to 2.2%.
At the annual meeting of the American College of Obstetricians and Gynecologists, Dr. Ashley Pritchard of the hospital described the care bundle and urged obstetricians to consider the impact of even small reductions in SSIs after a cesarean.
“Infection is the most common complication following cesarean delivery … 2.5%-16% of all cesarean deliveries will result in a surgical site infection, and there is significant underestimation as between 15% to 80% of infections are diagnosed after patients leave the hospital,” she said.
A cesarean delivery SSI task force created by the hospital’s obstetric patient safety program developed the care bundle after reviewing best practices, guidelines, and evidence-based reviews.
Preoperative protocols for planned cesareans focused on patient education and included a preoperative appointment and instructions for showering the night before surgery, not shaving for more than 24 hours prior to scheduled surgery, using 2% chlorhexidine wipes both the night prior to surgery and the day of surgery, and other hygiene processes.
“We know from numerous studies that chlorhexidine is superior to iodine, but we also have found that with these wipes you get a level of antibiosis on the skin surface that decreases surgical site infections at the time of incisions,” Dr. Pritchard said.
For the operative care part of the bundle, staff were reeducated about the scrubbing protocol, proper attire and limits on operating room traffic, and the correct and timely use of antibiotics (for example, a cephalosporin administered within 30 minutes of incision). Staff also watched a video and were quizzed on the proper technique and timing for preoperative skin preparation.
Increased attention was paid to normothermia and included preoperative use of warming blankets and proper temperature in the operating room and post–anesthesia care unit.
“We’ve learned from colorectal and trauma surgery that normothermia and patient warming lead to reduced SSI,” Dr. Pritchard said. “This hasn’t been proven with cesarean delivery, but we know there’s improved maternal and fetal well-being with preoperative warming.”
Postoperatively, the use of supplemental oxygen was discontinued unless clinically indicated “since it’s been shown to have no positive effect on SSI,” she said. Incision dressing application and removal were also standardized, with sterile dressings maintained for at least 24 hours – with a tag labeling the date and time of application – and no more than 48 hours. At discharge, patients were given clear discharge instructions and a postpartum appointment for an incision check.
During the 3-month sampling period prior to implementation of the care bundle, there were 382 cesarean deliveries, and 147 patients presented for a postpartum appointment (either the prescribed visit or a later “issue visit”) within 30 days (38%). Of these patients, 8.6% were diagnosed with an SSI.
In the postimplementation sampling period, which began 6 months after rollout, there were 361 cesarean deliveries at the hospital, and 297 patients (77%) presented for postpartum care. Of these patients, 2.9% were diagnosed with an SSI.
An analysis based on the total number of cesarean deliveries performed at the hospital (planned and unplanned) during the two 3-month periods showed a decline in the cesarean delivery SSI rate from 3.4% to 2.2%. “This is statistically significant. It shows a dramatic decline in the SSI rate in our patient population … a clear impact of the bundle of care,” Dr. Pritchard said.
The Yale team attributes the significant increase in postoperative visit attendance to the preoperative protocol for planned cesareans. “We think it had something to do with our creating better relationships by having [patients] present preoperatively and starting their care prior to incision,” she said.
The preoperative visit also provided an opportunity to identify and treat any active skin infections, upper respiratory infections, or chronic colonizations (without evidence of completion of treatment) before delivery. “If necessary and if possible, [we could] push back their cesarean section date to ensure adequate treatment had been achieved,” Dr. Pritchard said.
All aspects of the care bundle were rolled out simultaneously. Next steps for the New Haven team include further analysis of provider and patient views, a look at the sustainability of the bundle of care and its impact, and a cost analysis. “We reduced our SSIs, but we’ve also added a number of elements to our care spectrum, pre- and postoperatively,” Dr. Pritchard said.
For now, one thing seems clear: “We learned from cardiac and colorectal surgery that there really is strength in the bundle, that the sum of the parts is greater than the individual aspects,” she said.
Dr. Pritchard reported that she and her coinvestigators have no relevant financial disclosures.
WASHINGTON – The rate of cesarean delivery surgical site infections fell significantly at Yale New Haven (Conn.) Hospital after implementation of a multidisciplinary care bundle with protocols covering preoperative, intraoperative, and postoperative care.
An analysis of two 3-month sampling periods – one before implementation of the bundle of care and one after – showed a drop in the surgical site infection (SSI) rate among total cesarean sections from 3.4% to 2.2%.
At the annual meeting of the American College of Obstetricians and Gynecologists, Dr. Ashley Pritchard of the hospital described the care bundle and urged obstetricians to consider the impact of even small reductions in SSIs after a cesarean.
“Infection is the most common complication following cesarean delivery … 2.5%-16% of all cesarean deliveries will result in a surgical site infection, and there is significant underestimation as between 15% to 80% of infections are diagnosed after patients leave the hospital,” she said.
A cesarean delivery SSI task force created by the hospital’s obstetric patient safety program developed the care bundle after reviewing best practices, guidelines, and evidence-based reviews.
Preoperative protocols for planned cesareans focused on patient education and included a preoperative appointment and instructions for showering the night before surgery, not shaving for more than 24 hours prior to scheduled surgery, using 2% chlorhexidine wipes both the night prior to surgery and the day of surgery, and other hygiene processes.
“We know from numerous studies that chlorhexidine is superior to iodine, but we also have found that with these wipes you get a level of antibiosis on the skin surface that decreases surgical site infections at the time of incisions,” Dr. Pritchard said.
For the operative care part of the bundle, staff were reeducated about the scrubbing protocol, proper attire and limits on operating room traffic, and the correct and timely use of antibiotics (for example, a cephalosporin administered within 30 minutes of incision). Staff also watched a video and were quizzed on the proper technique and timing for preoperative skin preparation.
Increased attention was paid to normothermia and included preoperative use of warming blankets and proper temperature in the operating room and post–anesthesia care unit.
“We’ve learned from colorectal and trauma surgery that normothermia and patient warming lead to reduced SSI,” Dr. Pritchard said. “This hasn’t been proven with cesarean delivery, but we know there’s improved maternal and fetal well-being with preoperative warming.”
Postoperatively, the use of supplemental oxygen was discontinued unless clinically indicated “since it’s been shown to have no positive effect on SSI,” she said. Incision dressing application and removal were also standardized, with sterile dressings maintained for at least 24 hours – with a tag labeling the date and time of application – and no more than 48 hours. At discharge, patients were given clear discharge instructions and a postpartum appointment for an incision check.
During the 3-month sampling period prior to implementation of the care bundle, there were 382 cesarean deliveries, and 147 patients presented for a postpartum appointment (either the prescribed visit or a later “issue visit”) within 30 days (38%). Of these patients, 8.6% were diagnosed with an SSI.
In the postimplementation sampling period, which began 6 months after rollout, there were 361 cesarean deliveries at the hospital, and 297 patients (77%) presented for postpartum care. Of these patients, 2.9% were diagnosed with an SSI.
An analysis based on the total number of cesarean deliveries performed at the hospital (planned and unplanned) during the two 3-month periods showed a decline in the cesarean delivery SSI rate from 3.4% to 2.2%. “This is statistically significant. It shows a dramatic decline in the SSI rate in our patient population … a clear impact of the bundle of care,” Dr. Pritchard said.
The Yale team attributes the significant increase in postoperative visit attendance to the preoperative protocol for planned cesareans. “We think it had something to do with our creating better relationships by having [patients] present preoperatively and starting their care prior to incision,” she said.
The preoperative visit also provided an opportunity to identify and treat any active skin infections, upper respiratory infections, or chronic colonizations (without evidence of completion of treatment) before delivery. “If necessary and if possible, [we could] push back their cesarean section date to ensure adequate treatment had been achieved,” Dr. Pritchard said.
All aspects of the care bundle were rolled out simultaneously. Next steps for the New Haven team include further analysis of provider and patient views, a look at the sustainability of the bundle of care and its impact, and a cost analysis. “We reduced our SSIs, but we’ve also added a number of elements to our care spectrum, pre- and postoperatively,” Dr. Pritchard said.
For now, one thing seems clear: “We learned from cardiac and colorectal surgery that there really is strength in the bundle, that the sum of the parts is greater than the individual aspects,” she said.
Dr. Pritchard reported that she and her coinvestigators have no relevant financial disclosures.
WASHINGTON – The rate of cesarean delivery surgical site infections fell significantly at Yale New Haven (Conn.) Hospital after implementation of a multidisciplinary care bundle with protocols covering preoperative, intraoperative, and postoperative care.
An analysis of two 3-month sampling periods – one before implementation of the bundle of care and one after – showed a drop in the surgical site infection (SSI) rate among total cesarean sections from 3.4% to 2.2%.
At the annual meeting of the American College of Obstetricians and Gynecologists, Dr. Ashley Pritchard of the hospital described the care bundle and urged obstetricians to consider the impact of even small reductions in SSIs after a cesarean.
“Infection is the most common complication following cesarean delivery … 2.5%-16% of all cesarean deliveries will result in a surgical site infection, and there is significant underestimation as between 15% to 80% of infections are diagnosed after patients leave the hospital,” she said.
A cesarean delivery SSI task force created by the hospital’s obstetric patient safety program developed the care bundle after reviewing best practices, guidelines, and evidence-based reviews.
Preoperative protocols for planned cesareans focused on patient education and included a preoperative appointment and instructions for showering the night before surgery, not shaving for more than 24 hours prior to scheduled surgery, using 2% chlorhexidine wipes both the night prior to surgery and the day of surgery, and other hygiene processes.
“We know from numerous studies that chlorhexidine is superior to iodine, but we also have found that with these wipes you get a level of antibiosis on the skin surface that decreases surgical site infections at the time of incisions,” Dr. Pritchard said.
For the operative care part of the bundle, staff were reeducated about the scrubbing protocol, proper attire and limits on operating room traffic, and the correct and timely use of antibiotics (for example, a cephalosporin administered within 30 minutes of incision). Staff also watched a video and were quizzed on the proper technique and timing for preoperative skin preparation.
Increased attention was paid to normothermia and included preoperative use of warming blankets and proper temperature in the operating room and post–anesthesia care unit.
“We’ve learned from colorectal and trauma surgery that normothermia and patient warming lead to reduced SSI,” Dr. Pritchard said. “This hasn’t been proven with cesarean delivery, but we know there’s improved maternal and fetal well-being with preoperative warming.”
Postoperatively, the use of supplemental oxygen was discontinued unless clinically indicated “since it’s been shown to have no positive effect on SSI,” she said. Incision dressing application and removal were also standardized, with sterile dressings maintained for at least 24 hours – with a tag labeling the date and time of application – and no more than 48 hours. At discharge, patients were given clear discharge instructions and a postpartum appointment for an incision check.
During the 3-month sampling period prior to implementation of the care bundle, there were 382 cesarean deliveries, and 147 patients presented for a postpartum appointment (either the prescribed visit or a later “issue visit”) within 30 days (38%). Of these patients, 8.6% were diagnosed with an SSI.
In the postimplementation sampling period, which began 6 months after rollout, there were 361 cesarean deliveries at the hospital, and 297 patients (77%) presented for postpartum care. Of these patients, 2.9% were diagnosed with an SSI.
An analysis based on the total number of cesarean deliveries performed at the hospital (planned and unplanned) during the two 3-month periods showed a decline in the cesarean delivery SSI rate from 3.4% to 2.2%. “This is statistically significant. It shows a dramatic decline in the SSI rate in our patient population … a clear impact of the bundle of care,” Dr. Pritchard said.
The Yale team attributes the significant increase in postoperative visit attendance to the preoperative protocol for planned cesareans. “We think it had something to do with our creating better relationships by having [patients] present preoperatively and starting their care prior to incision,” she said.
The preoperative visit also provided an opportunity to identify and treat any active skin infections, upper respiratory infections, or chronic colonizations (without evidence of completion of treatment) before delivery. “If necessary and if possible, [we could] push back their cesarean section date to ensure adequate treatment had been achieved,” Dr. Pritchard said.
All aspects of the care bundle were rolled out simultaneously. Next steps for the New Haven team include further analysis of provider and patient views, a look at the sustainability of the bundle of care and its impact, and a cost analysis. “We reduced our SSIs, but we’ve also added a number of elements to our care spectrum, pre- and postoperatively,” Dr. Pritchard said.
For now, one thing seems clear: “We learned from cardiac and colorectal surgery that there really is strength in the bundle, that the sum of the parts is greater than the individual aspects,” she said.
Dr. Pritchard reported that she and her coinvestigators have no relevant financial disclosures.
AT ACOG 2016
Key clinical point: A multidisciplinary bundle of care was effective in reducing the rate of surgical site infections with cesarean delivery.
Major finding: The rate of cesarean delivery SSIs decreased from 3.4% to 2.2% after implementation of a care bundle.
Data source: An analysis of a quality improvement project at Yale New Haven Hospital.
Disclosures: Dr. Pritchard reported that she and her coinvestigators have no relevant financial disclosures.
Emergency diverticulitis: Limited role seen for proximal diversion
LOS ANGELES – There is no difference in 30-day outcomes for patients undergoing emergency surgery for acute diverticulitis with primary anastomosis with or without proximal diversion, results from an analysis of national data showed.
“Traditionally, patients undergoing emergency surgery for diverticulitis were offered a Hartmann’s procedure,” lead study author Dr. Nathan Hite said at the annual meeting of the American Society of Colon and Rectal Surgeons. “Studies have suggested that resection with primary anastomosis and proximal diversion is a safe alternative to this procedure. That’s attractive because it’s usually a quicker operation and puts less physiologic stress on the patient. It still requires a trip to the operating room, an inpatient hospital stay, and carries a complication rate of up to 20%.”
In an effort to determine if there was a difference between 30-day outcomes in patients treated with resection and primary anastomosis with or without primary diversion, the researchers queried the American College of Surgeons National Quality Improvement Program (ACS-NSQIP) database from 2005 to 2013 to identify patients with a diagnosis of diverticula, diverticulosis, or diverticulosis of colon without bleeding who underwent emergency operations. They divided patients into two groups: 1,912 who underwent resection and primary anastomosis without proximal diversion (group 1) and 123 who underwent resection and primary anastomosis with proximal diversion (group 2). Both open and laparoscopic operations were included.
Dr. Hite, of the department of colon and rectal surgery at Ochsner Medical Center, Metairie, La., reported that the mean age of patients in groups 1 and 2 was 62 and 59 years, respectively. There were no differences in gender distribution but women were significantly older in both groups (P less than .0006). No significant differences between groups 1 and 2 were observed with respect to body mass index (29.1 vs. 28.1 kg/m2, respectively; P = .11), preoperative albumin (3.3 vs. 3.5 g/dL), preoperative hematocrit (35% vs. 28%), preoperative white blood count (13.4 vs. 13.7 x 103/mcL), or functional status (P = .71). Although patients in group 2 did not appear to be sicker at the time of surgery in terms of ASA class or wound class, they did have a higher incidence of diabetes and smoking, compared with their counterparts in group 1.
As for postoperative complications, there were no significant differences between groups 1 and 2 in the incidence of superficial skin infection (141 vs. 7; P = .76), organ space infection (36 vs. 5; P = .09), septic shock (126 vs. 3; P = .18), pulmonary embolism (20 vs. 3; P = .15), cerebrovascular accident (7 vs. 0; P = .5), myocardial infarction (15 vs. 0; P = .32), or death (88 vs. 2; P = .51). Patients in group 2 did have a significantly longer operating time, compared with those in group 1 (158 vs. 133 minutes; P less than .0001).
“Ultimately, the decision to perform a proximal diversion [or not] depends on many factors,” Dr. Hite concluded. “But our study suggests that if the patient is an appropriate candidate for reanastomosis, a diverting ostomy may be safely omitted.” He reported having no financial disclosures.
LOS ANGELES – There is no difference in 30-day outcomes for patients undergoing emergency surgery for acute diverticulitis with primary anastomosis with or without proximal diversion, results from an analysis of national data showed.
“Traditionally, patients undergoing emergency surgery for diverticulitis were offered a Hartmann’s procedure,” lead study author Dr. Nathan Hite said at the annual meeting of the American Society of Colon and Rectal Surgeons. “Studies have suggested that resection with primary anastomosis and proximal diversion is a safe alternative to this procedure. That’s attractive because it’s usually a quicker operation and puts less physiologic stress on the patient. It still requires a trip to the operating room, an inpatient hospital stay, and carries a complication rate of up to 20%.”
In an effort to determine if there was a difference between 30-day outcomes in patients treated with resection and primary anastomosis with or without primary diversion, the researchers queried the American College of Surgeons National Quality Improvement Program (ACS-NSQIP) database from 2005 to 2013 to identify patients with a diagnosis of diverticula, diverticulosis, or diverticulosis of colon without bleeding who underwent emergency operations. They divided patients into two groups: 1,912 who underwent resection and primary anastomosis without proximal diversion (group 1) and 123 who underwent resection and primary anastomosis with proximal diversion (group 2). Both open and laparoscopic operations were included.
Dr. Hite, of the department of colon and rectal surgery at Ochsner Medical Center, Metairie, La., reported that the mean age of patients in groups 1 and 2 was 62 and 59 years, respectively. There were no differences in gender distribution but women were significantly older in both groups (P less than .0006). No significant differences between groups 1 and 2 were observed with respect to body mass index (29.1 vs. 28.1 kg/m2, respectively; P = .11), preoperative albumin (3.3 vs. 3.5 g/dL), preoperative hematocrit (35% vs. 28%), preoperative white blood count (13.4 vs. 13.7 x 103/mcL), or functional status (P = .71). Although patients in group 2 did not appear to be sicker at the time of surgery in terms of ASA class or wound class, they did have a higher incidence of diabetes and smoking, compared with their counterparts in group 1.
As for postoperative complications, there were no significant differences between groups 1 and 2 in the incidence of superficial skin infection (141 vs. 7; P = .76), organ space infection (36 vs. 5; P = .09), septic shock (126 vs. 3; P = .18), pulmonary embolism (20 vs. 3; P = .15), cerebrovascular accident (7 vs. 0; P = .5), myocardial infarction (15 vs. 0; P = .32), or death (88 vs. 2; P = .51). Patients in group 2 did have a significantly longer operating time, compared with those in group 1 (158 vs. 133 minutes; P less than .0001).
“Ultimately, the decision to perform a proximal diversion [or not] depends on many factors,” Dr. Hite concluded. “But our study suggests that if the patient is an appropriate candidate for reanastomosis, a diverting ostomy may be safely omitted.” He reported having no financial disclosures.
LOS ANGELES – There is no difference in 30-day outcomes for patients undergoing emergency surgery for acute diverticulitis with primary anastomosis with or without proximal diversion, results from an analysis of national data showed.
“Traditionally, patients undergoing emergency surgery for diverticulitis were offered a Hartmann’s procedure,” lead study author Dr. Nathan Hite said at the annual meeting of the American Society of Colon and Rectal Surgeons. “Studies have suggested that resection with primary anastomosis and proximal diversion is a safe alternative to this procedure. That’s attractive because it’s usually a quicker operation and puts less physiologic stress on the patient. It still requires a trip to the operating room, an inpatient hospital stay, and carries a complication rate of up to 20%.”
In an effort to determine if there was a difference between 30-day outcomes in patients treated with resection and primary anastomosis with or without primary diversion, the researchers queried the American College of Surgeons National Quality Improvement Program (ACS-NSQIP) database from 2005 to 2013 to identify patients with a diagnosis of diverticula, diverticulosis, or diverticulosis of colon without bleeding who underwent emergency operations. They divided patients into two groups: 1,912 who underwent resection and primary anastomosis without proximal diversion (group 1) and 123 who underwent resection and primary anastomosis with proximal diversion (group 2). Both open and laparoscopic operations were included.
Dr. Hite, of the department of colon and rectal surgery at Ochsner Medical Center, Metairie, La., reported that the mean age of patients in groups 1 and 2 was 62 and 59 years, respectively. There were no differences in gender distribution but women were significantly older in both groups (P less than .0006). No significant differences between groups 1 and 2 were observed with respect to body mass index (29.1 vs. 28.1 kg/m2, respectively; P = .11), preoperative albumin (3.3 vs. 3.5 g/dL), preoperative hematocrit (35% vs. 28%), preoperative white blood count (13.4 vs. 13.7 x 103/mcL), or functional status (P = .71). Although patients in group 2 did not appear to be sicker at the time of surgery in terms of ASA class or wound class, they did have a higher incidence of diabetes and smoking, compared with their counterparts in group 1.
As for postoperative complications, there were no significant differences between groups 1 and 2 in the incidence of superficial skin infection (141 vs. 7; P = .76), organ space infection (36 vs. 5; P = .09), septic shock (126 vs. 3; P = .18), pulmonary embolism (20 vs. 3; P = .15), cerebrovascular accident (7 vs. 0; P = .5), myocardial infarction (15 vs. 0; P = .32), or death (88 vs. 2; P = .51). Patients in group 2 did have a significantly longer operating time, compared with those in group 1 (158 vs. 133 minutes; P less than .0001).
“Ultimately, the decision to perform a proximal diversion [or not] depends on many factors,” Dr. Hite concluded. “But our study suggests that if the patient is an appropriate candidate for reanastomosis, a diverting ostomy may be safely omitted.” He reported having no financial disclosures.
AT THE ASCRS ANNUAL MEETING
Key clinical point: Whether patients underwent primary anastomosis with or without proximal diversion in emergency surgery for diverticular disease has no impact on 30-day outcomes.
Major finding: Among patients undergoing emergency surgery for acute diverticulitis with primary anastomosis, no significant differences were seen in a number of 30-day outcomes when the procedure was performed without or with proximal diversion, including superficial skin infection (141 vs. 7, respectively; P = .76), organ space infection (36 vs. 5; P = .09), septic shock (126 vs. 3; P = .18), or death (88 vs. 2; P = .51).
Data source: A review of the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database from 2005 to 2013 to identify 2,035 patients with a diagnosis of diverticula, diverticulosis, or diverticulosis of colon without bleeding who underwent emergency operations.
Disclosures: Dr. Hite reported having no financial disclosures.
Focus on patient-level factors, postop complications to reduce readmissions
CHICAGO – Preadmission and postdischarge factors were important predictors of postoperative readmission in a large cohort of surgical patients, but the hospital course had little incremental impact on either readmissions or postdischarge complications in the cohort, according to a retrospective study of Veterans Affairs data.
The findings suggest that efforts to reduce postoperative readmissions should focus on enhanced postdischarge surveillance and early intervention, Dr. Melanie S. Morris of the University of Alabama at Birmingham reported at the annual meeting of the American Surgical Association.
To assess the relative contributions of patient factors, operative characteristics, and postoperative hospital course on readmissions, she and her colleagues evaluated 243,956 general, vascular, and orthopedic surgery patients in 121 VA hospitals. The overall readmission rate among the cohort was 11.1%, and for general, vascular, and orthopedic surgeries, the rates were 12.9%, 15.4%, and 7.6%, respectively; the average postoperative length of stay was 6.9 days, and 6.1% of patients experienced a predischarge complication.
Almost all readmissions occurred within 2 weeks of discharge, and for general surgery patients, most occurred within 1 week. The readmission rate for vascular surgery patients remained high beyond the 2-week mark.
An examination of the reasons for readmission showed that wound complications were the most common reason for readmission, and this was particularly true for vascular surgery patients, in whom 44% of readmissions were for wound complications, Dr. Morris said.
Gastrointestinal complications including ileus and obstruction were also common, accounting for nearly 28% of readmissions among general surgery patients, she said.
Importantly, when including preoperative data (such as demographics, comorbidities, social and behavioral factors, labs and vital signs, and planned procedure type), the variability in readmissions could only be explained 8.6% of the time, she said.
“Adding in operative data, such as procedure complexity and intraoperative blood transfusions, as well as postoperative course, added very little to our predictive ability. Including both of those groups, we could only explain 10% of the variation in readmission,” she said.
Including postdischarge data such as complications and emergency department utilization in the model increased predictive ability to 18%.
R2 and C-statistics comparing the sequentially built model showed that demographics and comorbidities contributed the most to predicting readmission risk, Dr. Morris said.
Modeling based on readmission reason and specialty improved predictive ability. For example, almost 12% of readmissions for wound complications among vascular surgery patients were predictable.
“Our best predictive ability was for orthopedic patients who were readmitted with pneumonia. We were able to predict that 14% of the time,” she said.
The findings were derived by merging VA Surgical Quality Improvement Program data from inpatient operations performed between 2007 and 2014 and involving at least a 2-day postoperative hospital stay, with clinical data including laboratory findings, vitals, prior health care utilization, and postoperative complications.
“We then grouped our variables of interest into the following categories: preoperative, operative, postoperative but predischarge, and postdischarge,” she explained, noting that logistic models predicting 30-day readmission were constructed by sequentially adding groups into the model. Models were compared by way of adjusted R2 and C-statistics.
Assuming postoperative readmissions are preventable suggests that they are linked to the quality of care during the index hospitalization. The current findings demonstrate the challenges in predicting readmissions, and are important given that hospitals with higher-than-expected readmission rates for certain diagnoses and procedures are fined by the Centers for Medicare & Medicaid Services; 54% of hospitals were fined in 2015, she said.
“Readmission is difficult to predict at the time of discharge despite exhaustive statistical modeling with very granular clinical patient-level detail. Preoperative patient factors and postdischarge complications contribute the most to predictive models. Efforts to decrease readmissions should focus on modifiable patient-level factors, transitions of care, and minimizing postoperative complications,” she concluded.
Dr. Morris reported having no disclosures.
The complete manuscript of this presentation is anticipated to be published in Annals of Surgery pending editorial review.
CHICAGO – Preadmission and postdischarge factors were important predictors of postoperative readmission in a large cohort of surgical patients, but the hospital course had little incremental impact on either readmissions or postdischarge complications in the cohort, according to a retrospective study of Veterans Affairs data.
The findings suggest that efforts to reduce postoperative readmissions should focus on enhanced postdischarge surveillance and early intervention, Dr. Melanie S. Morris of the University of Alabama at Birmingham reported at the annual meeting of the American Surgical Association.
To assess the relative contributions of patient factors, operative characteristics, and postoperative hospital course on readmissions, she and her colleagues evaluated 243,956 general, vascular, and orthopedic surgery patients in 121 VA hospitals. The overall readmission rate among the cohort was 11.1%, and for general, vascular, and orthopedic surgeries, the rates were 12.9%, 15.4%, and 7.6%, respectively; the average postoperative length of stay was 6.9 days, and 6.1% of patients experienced a predischarge complication.
Almost all readmissions occurred within 2 weeks of discharge, and for general surgery patients, most occurred within 1 week. The readmission rate for vascular surgery patients remained high beyond the 2-week mark.
An examination of the reasons for readmission showed that wound complications were the most common reason for readmission, and this was particularly true for vascular surgery patients, in whom 44% of readmissions were for wound complications, Dr. Morris said.
Gastrointestinal complications including ileus and obstruction were also common, accounting for nearly 28% of readmissions among general surgery patients, she said.
Importantly, when including preoperative data (such as demographics, comorbidities, social and behavioral factors, labs and vital signs, and planned procedure type), the variability in readmissions could only be explained 8.6% of the time, she said.
“Adding in operative data, such as procedure complexity and intraoperative blood transfusions, as well as postoperative course, added very little to our predictive ability. Including both of those groups, we could only explain 10% of the variation in readmission,” she said.
Including postdischarge data such as complications and emergency department utilization in the model increased predictive ability to 18%.
R2 and C-statistics comparing the sequentially built model showed that demographics and comorbidities contributed the most to predicting readmission risk, Dr. Morris said.
Modeling based on readmission reason and specialty improved predictive ability. For example, almost 12% of readmissions for wound complications among vascular surgery patients were predictable.
“Our best predictive ability was for orthopedic patients who were readmitted with pneumonia. We were able to predict that 14% of the time,” she said.
The findings were derived by merging VA Surgical Quality Improvement Program data from inpatient operations performed between 2007 and 2014 and involving at least a 2-day postoperative hospital stay, with clinical data including laboratory findings, vitals, prior health care utilization, and postoperative complications.
“We then grouped our variables of interest into the following categories: preoperative, operative, postoperative but predischarge, and postdischarge,” she explained, noting that logistic models predicting 30-day readmission were constructed by sequentially adding groups into the model. Models were compared by way of adjusted R2 and C-statistics.
Assuming postoperative readmissions are preventable suggests that they are linked to the quality of care during the index hospitalization. The current findings demonstrate the challenges in predicting readmissions, and are important given that hospitals with higher-than-expected readmission rates for certain diagnoses and procedures are fined by the Centers for Medicare & Medicaid Services; 54% of hospitals were fined in 2015, she said.
“Readmission is difficult to predict at the time of discharge despite exhaustive statistical modeling with very granular clinical patient-level detail. Preoperative patient factors and postdischarge complications contribute the most to predictive models. Efforts to decrease readmissions should focus on modifiable patient-level factors, transitions of care, and minimizing postoperative complications,” she concluded.
Dr. Morris reported having no disclosures.
The complete manuscript of this presentation is anticipated to be published in Annals of Surgery pending editorial review.
CHICAGO – Preadmission and postdischarge factors were important predictors of postoperative readmission in a large cohort of surgical patients, but the hospital course had little incremental impact on either readmissions or postdischarge complications in the cohort, according to a retrospective study of Veterans Affairs data.
The findings suggest that efforts to reduce postoperative readmissions should focus on enhanced postdischarge surveillance and early intervention, Dr. Melanie S. Morris of the University of Alabama at Birmingham reported at the annual meeting of the American Surgical Association.
To assess the relative contributions of patient factors, operative characteristics, and postoperative hospital course on readmissions, she and her colleagues evaluated 243,956 general, vascular, and orthopedic surgery patients in 121 VA hospitals. The overall readmission rate among the cohort was 11.1%, and for general, vascular, and orthopedic surgeries, the rates were 12.9%, 15.4%, and 7.6%, respectively; the average postoperative length of stay was 6.9 days, and 6.1% of patients experienced a predischarge complication.
Almost all readmissions occurred within 2 weeks of discharge, and for general surgery patients, most occurred within 1 week. The readmission rate for vascular surgery patients remained high beyond the 2-week mark.
An examination of the reasons for readmission showed that wound complications were the most common reason for readmission, and this was particularly true for vascular surgery patients, in whom 44% of readmissions were for wound complications, Dr. Morris said.
Gastrointestinal complications including ileus and obstruction were also common, accounting for nearly 28% of readmissions among general surgery patients, she said.
Importantly, when including preoperative data (such as demographics, comorbidities, social and behavioral factors, labs and vital signs, and planned procedure type), the variability in readmissions could only be explained 8.6% of the time, she said.
“Adding in operative data, such as procedure complexity and intraoperative blood transfusions, as well as postoperative course, added very little to our predictive ability. Including both of those groups, we could only explain 10% of the variation in readmission,” she said.
Including postdischarge data such as complications and emergency department utilization in the model increased predictive ability to 18%.
R2 and C-statistics comparing the sequentially built model showed that demographics and comorbidities contributed the most to predicting readmission risk, Dr. Morris said.
Modeling based on readmission reason and specialty improved predictive ability. For example, almost 12% of readmissions for wound complications among vascular surgery patients were predictable.
“Our best predictive ability was for orthopedic patients who were readmitted with pneumonia. We were able to predict that 14% of the time,” she said.
The findings were derived by merging VA Surgical Quality Improvement Program data from inpatient operations performed between 2007 and 2014 and involving at least a 2-day postoperative hospital stay, with clinical data including laboratory findings, vitals, prior health care utilization, and postoperative complications.
“We then grouped our variables of interest into the following categories: preoperative, operative, postoperative but predischarge, and postdischarge,” she explained, noting that logistic models predicting 30-day readmission were constructed by sequentially adding groups into the model. Models were compared by way of adjusted R2 and C-statistics.
Assuming postoperative readmissions are preventable suggests that they are linked to the quality of care during the index hospitalization. The current findings demonstrate the challenges in predicting readmissions, and are important given that hospitals with higher-than-expected readmission rates for certain diagnoses and procedures are fined by the Centers for Medicare & Medicaid Services; 54% of hospitals were fined in 2015, she said.
“Readmission is difficult to predict at the time of discharge despite exhaustive statistical modeling with very granular clinical patient-level detail. Preoperative patient factors and postdischarge complications contribute the most to predictive models. Efforts to decrease readmissions should focus on modifiable patient-level factors, transitions of care, and minimizing postoperative complications,” she concluded.
Dr. Morris reported having no disclosures.
The complete manuscript of this presentation is anticipated to be published in Annals of Surgery pending editorial review.
AT THE ASA ANNUAL MEETING
Key clinical point: Preadmission and postdischarge factors were important predictors of postoperative readmission in a large cohort of surgical patients, but the hospital course had little incremental impact on either readmissions or postdischarge complications.
Major finding: Including both preoperative and operative data in the model predicted only 10% of the variability in readmission rates.
Data source: A retrospective study of data for nearly 244,000 VA patients.
Disclosures: Dr. Morris reported having no disclosures.
Perioperative bundle implementation reduced SSIs after hysterectomy
INDIAN WELLS, CALIF. – Implementation of a gynecologic perioperative infection prevention bundle for patients undergoing hysterectomy in a large academic hospital led to a 53% decrease in surgical site infections (SSIs) and a 50% drop in deep and organ space infections, a retrospective study found.
“There are approximately 600,000 hysterectomies performed each year in the United States, and the infection rate is widely reported as 1%-4%,” Dr. Sarah E. Andiman said at the annual scientific meeting of the Society of Gynecologic Surgeons. “SSIs lead to increased morbidity, negative patient experiences, prolonged hospital stays, additional procedures, and increased costs. The exact costs of SSIs related to hysterectomy are not known. However, the Centers for Medicare & Medicaid Services has required public reporting of SSIs after hysterectomy since 2013.”
An interdisciplinary team at Yale–New Haven Hospital designed a perioperative gynecology-specific bundle aimed at reducing the SSI rate in hysterectomies. Dr. Andiman of the department of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., and her associates examined the efficacy of the infection prevention bundle. The primary outcome was SSI rate change, while the secondary outcome was hospital cost of admission for the initial care episode.
The bundle consists of a preoperative phase that includes chlorhexidine wipes, patient-controlled warming, and a standard antibiotic regimen consisting of 2 g of cefazolin within 1 hour of incision and 500 mg of metronidazole administered when there is a potential for bowel involvement.
The intraoperative phase of the bundle includes a standardized method of vaginal preparation with chlorhexidine and an abdominal prep with ChloraPrep. “Staff and trainees underwent training with an educational video that is available over our intranet,” Dr. Andiman said. “Also included was antibiotic redosing at 3 hours and intraoperative maintenance of temperature above 36° C.” The postoperative phase includes maintenance of a surgical dressing for 24-48 hours.
The researchers collected data prospectively according to institutional guidelines for tracking SSIs using definitions from the Centers for Disease Control and Prevention. All cases of SSIs were reviewed by a committee. In instances where the protocol was not followed, direct feedback was given to appropriate team members within 2 weeks.
The preintervention period was defined as the beginning of data collection through full bundle implementation, which was April 2013 through November 2014. The postbundle implementation period was December 2014 through June 2015. The analysis was limited to total abdominal, total laparoscopic, robotic-assisted total laparoscopic, and laparoscopic-assisted vaginal hysterectomies. Transvaginal and obstetric hysterectomies were excluded from the study, leaving a total of 1,763 procedures for inclusion.
Between the prebundle and postbundle period, the researchers observed a 53% decrease in SSIs and a 50% decrease in deep and organ space infections (P = .04). The difference was primarily driven by the decrease in the infection rate for total abdominal hysterectomies, Dr. Andiman said at the meeting, which was jointly sponsored by the American College of Surgeons.
The researchers also found that the cost of hospital admissions decreased 17.6% between the prebundle and postbundle period, from $7,452 per case to $6,142 per case (P = .002).
Dr. Andiman acknowledged certain limitations of the analysis, including the staggered implementation of the bundle components. “However, in the next stage of our study, we will be looking at comprehensive compliance data to examine this further,” she said. “Finally, we currently only have cost data for the cost of the hospital admission for the index surgery. We are also analyzing cost data for patients who were readmitted up to 30 days postoperatively to assess how this factors into overall costs.”
In an interview, Dr. Linda Fan, a gynecologic surgeon at Yale and the senior study author, said that a perioperative care bundle “by itself is not enough” to decrease SSI rates following hysterectomy.
“Education of staff is really important in terms of the uptake of these sorts of interventions,” she said. “As we move forward and everyone is looking at value, we have to teach people how to implement the different elements of the bundle.”
The researchers reported having no relevant financial disclosures.
INDIAN WELLS, CALIF. – Implementation of a gynecologic perioperative infection prevention bundle for patients undergoing hysterectomy in a large academic hospital led to a 53% decrease in surgical site infections (SSIs) and a 50% drop in deep and organ space infections, a retrospective study found.
“There are approximately 600,000 hysterectomies performed each year in the United States, and the infection rate is widely reported as 1%-4%,” Dr. Sarah E. Andiman said at the annual scientific meeting of the Society of Gynecologic Surgeons. “SSIs lead to increased morbidity, negative patient experiences, prolonged hospital stays, additional procedures, and increased costs. The exact costs of SSIs related to hysterectomy are not known. However, the Centers for Medicare & Medicaid Services has required public reporting of SSIs after hysterectomy since 2013.”
An interdisciplinary team at Yale–New Haven Hospital designed a perioperative gynecology-specific bundle aimed at reducing the SSI rate in hysterectomies. Dr. Andiman of the department of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., and her associates examined the efficacy of the infection prevention bundle. The primary outcome was SSI rate change, while the secondary outcome was hospital cost of admission for the initial care episode.
The bundle consists of a preoperative phase that includes chlorhexidine wipes, patient-controlled warming, and a standard antibiotic regimen consisting of 2 g of cefazolin within 1 hour of incision and 500 mg of metronidazole administered when there is a potential for bowel involvement.
The intraoperative phase of the bundle includes a standardized method of vaginal preparation with chlorhexidine and an abdominal prep with ChloraPrep. “Staff and trainees underwent training with an educational video that is available over our intranet,” Dr. Andiman said. “Also included was antibiotic redosing at 3 hours and intraoperative maintenance of temperature above 36° C.” The postoperative phase includes maintenance of a surgical dressing for 24-48 hours.
The researchers collected data prospectively according to institutional guidelines for tracking SSIs using definitions from the Centers for Disease Control and Prevention. All cases of SSIs were reviewed by a committee. In instances where the protocol was not followed, direct feedback was given to appropriate team members within 2 weeks.
The preintervention period was defined as the beginning of data collection through full bundle implementation, which was April 2013 through November 2014. The postbundle implementation period was December 2014 through June 2015. The analysis was limited to total abdominal, total laparoscopic, robotic-assisted total laparoscopic, and laparoscopic-assisted vaginal hysterectomies. Transvaginal and obstetric hysterectomies were excluded from the study, leaving a total of 1,763 procedures for inclusion.
Between the prebundle and postbundle period, the researchers observed a 53% decrease in SSIs and a 50% decrease in deep and organ space infections (P = .04). The difference was primarily driven by the decrease in the infection rate for total abdominal hysterectomies, Dr. Andiman said at the meeting, which was jointly sponsored by the American College of Surgeons.
The researchers also found that the cost of hospital admissions decreased 17.6% between the prebundle and postbundle period, from $7,452 per case to $6,142 per case (P = .002).
Dr. Andiman acknowledged certain limitations of the analysis, including the staggered implementation of the bundle components. “However, in the next stage of our study, we will be looking at comprehensive compliance data to examine this further,” she said. “Finally, we currently only have cost data for the cost of the hospital admission for the index surgery. We are also analyzing cost data for patients who were readmitted up to 30 days postoperatively to assess how this factors into overall costs.”
In an interview, Dr. Linda Fan, a gynecologic surgeon at Yale and the senior study author, said that a perioperative care bundle “by itself is not enough” to decrease SSI rates following hysterectomy.
“Education of staff is really important in terms of the uptake of these sorts of interventions,” she said. “As we move forward and everyone is looking at value, we have to teach people how to implement the different elements of the bundle.”
The researchers reported having no relevant financial disclosures.
INDIAN WELLS, CALIF. – Implementation of a gynecologic perioperative infection prevention bundle for patients undergoing hysterectomy in a large academic hospital led to a 53% decrease in surgical site infections (SSIs) and a 50% drop in deep and organ space infections, a retrospective study found.
“There are approximately 600,000 hysterectomies performed each year in the United States, and the infection rate is widely reported as 1%-4%,” Dr. Sarah E. Andiman said at the annual scientific meeting of the Society of Gynecologic Surgeons. “SSIs lead to increased morbidity, negative patient experiences, prolonged hospital stays, additional procedures, and increased costs. The exact costs of SSIs related to hysterectomy are not known. However, the Centers for Medicare & Medicaid Services has required public reporting of SSIs after hysterectomy since 2013.”
An interdisciplinary team at Yale–New Haven Hospital designed a perioperative gynecology-specific bundle aimed at reducing the SSI rate in hysterectomies. Dr. Andiman of the department of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., and her associates examined the efficacy of the infection prevention bundle. The primary outcome was SSI rate change, while the secondary outcome was hospital cost of admission for the initial care episode.
The bundle consists of a preoperative phase that includes chlorhexidine wipes, patient-controlled warming, and a standard antibiotic regimen consisting of 2 g of cefazolin within 1 hour of incision and 500 mg of metronidazole administered when there is a potential for bowel involvement.
The intraoperative phase of the bundle includes a standardized method of vaginal preparation with chlorhexidine and an abdominal prep with ChloraPrep. “Staff and trainees underwent training with an educational video that is available over our intranet,” Dr. Andiman said. “Also included was antibiotic redosing at 3 hours and intraoperative maintenance of temperature above 36° C.” The postoperative phase includes maintenance of a surgical dressing for 24-48 hours.
The researchers collected data prospectively according to institutional guidelines for tracking SSIs using definitions from the Centers for Disease Control and Prevention. All cases of SSIs were reviewed by a committee. In instances where the protocol was not followed, direct feedback was given to appropriate team members within 2 weeks.
The preintervention period was defined as the beginning of data collection through full bundle implementation, which was April 2013 through November 2014. The postbundle implementation period was December 2014 through June 2015. The analysis was limited to total abdominal, total laparoscopic, robotic-assisted total laparoscopic, and laparoscopic-assisted vaginal hysterectomies. Transvaginal and obstetric hysterectomies were excluded from the study, leaving a total of 1,763 procedures for inclusion.
Between the prebundle and postbundle period, the researchers observed a 53% decrease in SSIs and a 50% decrease in deep and organ space infections (P = .04). The difference was primarily driven by the decrease in the infection rate for total abdominal hysterectomies, Dr. Andiman said at the meeting, which was jointly sponsored by the American College of Surgeons.
The researchers also found that the cost of hospital admissions decreased 17.6% between the prebundle and postbundle period, from $7,452 per case to $6,142 per case (P = .002).
Dr. Andiman acknowledged certain limitations of the analysis, including the staggered implementation of the bundle components. “However, in the next stage of our study, we will be looking at comprehensive compliance data to examine this further,” she said. “Finally, we currently only have cost data for the cost of the hospital admission for the index surgery. We are also analyzing cost data for patients who were readmitted up to 30 days postoperatively to assess how this factors into overall costs.”
In an interview, Dr. Linda Fan, a gynecologic surgeon at Yale and the senior study author, said that a perioperative care bundle “by itself is not enough” to decrease SSI rates following hysterectomy.
“Education of staff is really important in terms of the uptake of these sorts of interventions,” she said. “As we move forward and everyone is looking at value, we have to teach people how to implement the different elements of the bundle.”
The researchers reported having no relevant financial disclosures.
AT SGS 2016
Key clinical point: Implementation of a gynecologic perioperative bundle helped reduce surgical site infections following hysterectomy.
Major finding: Between the prebundle and postbundle period, the researchers observed a 53% decrease in surgical site infections and a 50% decrease in deep and organ space infections (P = .04).
Data source: A retrospective cohort study of 1,763 hysterectomies performed before and after implementation of a gynecologic perioperative bundle designed to prevent surgical site infections.
Disclosures: The researchers reported having no relevant financial disclosures.
Chlorhexidine-alcohol skin prep reduced SSIs after abdominal hysterectomy
INDIAN WELLS, CALIF. – Using chlorhexidine-alcohol preoperative skin antisepsis at the time of abdominal hysterectomy is associated with a lower incidence of surgical site infections (SSIs), compared with using povidone-iodine antiseptic solution, a large retrospective study showed.
“Surgical site infections have been linked to longer hospital stays, higher readmission rates, and overall increased healthcare costs,” Ali Bazzi, the lead study author, said at the annual scientific meeting of the Society of Gynecologic Surgeons. “Preoperative topical skin antiseptics have decreased the rate of SSIs over the years and have led to improved patient outcomes. Current published guidelines for skin preparations, specifically abdominal hysterectomies, do not routinely specify a choice of antiseptic. With greater than 500,000 hysterectomies performed each year in the United States, and about half done via laparotomy, this can have significant clinical implications.”
In an effort to determine whether the choice of preoperative topical antisepsis independently affects SSIs, Mr. Bazzi, a fourth-year medical student at the University of Michigan, Ann Arbor, and his associates in the university’s department of gynecologic oncology evaluated chlorhexidine-gluconate in alcohol versus povidone-iodine in aqueous solution. The second objective focused on determining certain patient factors and operative predictors of SSIs.
The researchers used the Michigan Surgical Quality Collaborative database to perform a retrospective cohort analysis of patients who underwent abdominal hysterectomy from July 2012 to February 2015. The primary outcome was diagnosis of a superficial, deep, or organ space SSI within 30 days of surgery, while the primary predictor was whether the individual cases received either the chlorhexidine-alcohol or the povidone-iodine antiseptic solution.
The researchers excluded cases with missing data, preoperative sepsis or emergent operative cases, and patients on chronic steroids due to immunosuppression, since these cases were associated with a higher than baseline risk of developing SSIs. Other types of skin preparation agents did not meet a large enough sample size and thus were underpowered. These cases were not included in the final analysis. Multivariate logistic regression models estimated the independent effect of skin antiseptic choice on the rate of SSI.
Mr. Bazzi reported results from 5,074 abdominal hysterectomies. Compared with patients in the povidone-iodine group, those in the chlorhexidine-alcohol group had several medical comorbidities, demographic and perioperative factors associated with the development of SSIs, including being more likely to have a BMI of 30 kg/m2 or greater; American Society of Anesthesiology Class of 3 or greater; dependent functional status; malignancy as a preoperative indication for surgery; estimated blood loss of greater than 250 cc; and surgery lasting longer than 3 hours.
The overall rate of any SSI was 3.6%. The unadjusted SSI rates based on antiseptic choice were 3.5% in the chlorhexidine-alcohol group and 3.8% in the povidone-iodine group. After using multivariate logistic regression adjusted for population differences, the researchers determined that chlorhexidine-alcohol was associated with a 30% lower odds of developing SSIs, compared with those in the povidone-iodine group (odds ratio, 0.71; 95% confidence interval, 0.51-0.98; P = .037).
Mr. Bazzi, who begins an ob.gyn. residency at St. John Hospital and Medical Center in Detroit in July 2016, acknowledged that other qualitative factors not included in the analysis could affect the incidence of SSIs, such as operative experience, surgical technique, resident exposure, type of ligature used, and excessive use of electrosurgical devices.
He noted that future randomized, controlled trials of skin antiseptic preparations given prior to abdominal hysterectomy would be helpful. For now, “we believe that future guidelines should specify the choice of antisepsis prior to abdominal hysterectomy,” he said at the meeting, which is jointly sponsored by the American College of Surgeons.
Mr. Bazzi reported having no financial disclosures.
INDIAN WELLS, CALIF. – Using chlorhexidine-alcohol preoperative skin antisepsis at the time of abdominal hysterectomy is associated with a lower incidence of surgical site infections (SSIs), compared with using povidone-iodine antiseptic solution, a large retrospective study showed.
“Surgical site infections have been linked to longer hospital stays, higher readmission rates, and overall increased healthcare costs,” Ali Bazzi, the lead study author, said at the annual scientific meeting of the Society of Gynecologic Surgeons. “Preoperative topical skin antiseptics have decreased the rate of SSIs over the years and have led to improved patient outcomes. Current published guidelines for skin preparations, specifically abdominal hysterectomies, do not routinely specify a choice of antiseptic. With greater than 500,000 hysterectomies performed each year in the United States, and about half done via laparotomy, this can have significant clinical implications.”
In an effort to determine whether the choice of preoperative topical antisepsis independently affects SSIs, Mr. Bazzi, a fourth-year medical student at the University of Michigan, Ann Arbor, and his associates in the university’s department of gynecologic oncology evaluated chlorhexidine-gluconate in alcohol versus povidone-iodine in aqueous solution. The second objective focused on determining certain patient factors and operative predictors of SSIs.
The researchers used the Michigan Surgical Quality Collaborative database to perform a retrospective cohort analysis of patients who underwent abdominal hysterectomy from July 2012 to February 2015. The primary outcome was diagnosis of a superficial, deep, or organ space SSI within 30 days of surgery, while the primary predictor was whether the individual cases received either the chlorhexidine-alcohol or the povidone-iodine antiseptic solution.
The researchers excluded cases with missing data, preoperative sepsis or emergent operative cases, and patients on chronic steroids due to immunosuppression, since these cases were associated with a higher than baseline risk of developing SSIs. Other types of skin preparation agents did not meet a large enough sample size and thus were underpowered. These cases were not included in the final analysis. Multivariate logistic regression models estimated the independent effect of skin antiseptic choice on the rate of SSI.
Mr. Bazzi reported results from 5,074 abdominal hysterectomies. Compared with patients in the povidone-iodine group, those in the chlorhexidine-alcohol group had several medical comorbidities, demographic and perioperative factors associated with the development of SSIs, including being more likely to have a BMI of 30 kg/m2 or greater; American Society of Anesthesiology Class of 3 or greater; dependent functional status; malignancy as a preoperative indication for surgery; estimated blood loss of greater than 250 cc; and surgery lasting longer than 3 hours.
The overall rate of any SSI was 3.6%. The unadjusted SSI rates based on antiseptic choice were 3.5% in the chlorhexidine-alcohol group and 3.8% in the povidone-iodine group. After using multivariate logistic regression adjusted for population differences, the researchers determined that chlorhexidine-alcohol was associated with a 30% lower odds of developing SSIs, compared with those in the povidone-iodine group (odds ratio, 0.71; 95% confidence interval, 0.51-0.98; P = .037).
Mr. Bazzi, who begins an ob.gyn. residency at St. John Hospital and Medical Center in Detroit in July 2016, acknowledged that other qualitative factors not included in the analysis could affect the incidence of SSIs, such as operative experience, surgical technique, resident exposure, type of ligature used, and excessive use of electrosurgical devices.
He noted that future randomized, controlled trials of skin antiseptic preparations given prior to abdominal hysterectomy would be helpful. For now, “we believe that future guidelines should specify the choice of antisepsis prior to abdominal hysterectomy,” he said at the meeting, which is jointly sponsored by the American College of Surgeons.
Mr. Bazzi reported having no financial disclosures.
INDIAN WELLS, CALIF. – Using chlorhexidine-alcohol preoperative skin antisepsis at the time of abdominal hysterectomy is associated with a lower incidence of surgical site infections (SSIs), compared with using povidone-iodine antiseptic solution, a large retrospective study showed.
“Surgical site infections have been linked to longer hospital stays, higher readmission rates, and overall increased healthcare costs,” Ali Bazzi, the lead study author, said at the annual scientific meeting of the Society of Gynecologic Surgeons. “Preoperative topical skin antiseptics have decreased the rate of SSIs over the years and have led to improved patient outcomes. Current published guidelines for skin preparations, specifically abdominal hysterectomies, do not routinely specify a choice of antiseptic. With greater than 500,000 hysterectomies performed each year in the United States, and about half done via laparotomy, this can have significant clinical implications.”
In an effort to determine whether the choice of preoperative topical antisepsis independently affects SSIs, Mr. Bazzi, a fourth-year medical student at the University of Michigan, Ann Arbor, and his associates in the university’s department of gynecologic oncology evaluated chlorhexidine-gluconate in alcohol versus povidone-iodine in aqueous solution. The second objective focused on determining certain patient factors and operative predictors of SSIs.
The researchers used the Michigan Surgical Quality Collaborative database to perform a retrospective cohort analysis of patients who underwent abdominal hysterectomy from July 2012 to February 2015. The primary outcome was diagnosis of a superficial, deep, or organ space SSI within 30 days of surgery, while the primary predictor was whether the individual cases received either the chlorhexidine-alcohol or the povidone-iodine antiseptic solution.
The researchers excluded cases with missing data, preoperative sepsis or emergent operative cases, and patients on chronic steroids due to immunosuppression, since these cases were associated with a higher than baseline risk of developing SSIs. Other types of skin preparation agents did not meet a large enough sample size and thus were underpowered. These cases were not included in the final analysis. Multivariate logistic regression models estimated the independent effect of skin antiseptic choice on the rate of SSI.
Mr. Bazzi reported results from 5,074 abdominal hysterectomies. Compared with patients in the povidone-iodine group, those in the chlorhexidine-alcohol group had several medical comorbidities, demographic and perioperative factors associated with the development of SSIs, including being more likely to have a BMI of 30 kg/m2 or greater; American Society of Anesthesiology Class of 3 or greater; dependent functional status; malignancy as a preoperative indication for surgery; estimated blood loss of greater than 250 cc; and surgery lasting longer than 3 hours.
The overall rate of any SSI was 3.6%. The unadjusted SSI rates based on antiseptic choice were 3.5% in the chlorhexidine-alcohol group and 3.8% in the povidone-iodine group. After using multivariate logistic regression adjusted for population differences, the researchers determined that chlorhexidine-alcohol was associated with a 30% lower odds of developing SSIs, compared with those in the povidone-iodine group (odds ratio, 0.71; 95% confidence interval, 0.51-0.98; P = .037).
Mr. Bazzi, who begins an ob.gyn. residency at St. John Hospital and Medical Center in Detroit in July 2016, acknowledged that other qualitative factors not included in the analysis could affect the incidence of SSIs, such as operative experience, surgical technique, resident exposure, type of ligature used, and excessive use of electrosurgical devices.
He noted that future randomized, controlled trials of skin antiseptic preparations given prior to abdominal hysterectomy would be helpful. For now, “we believe that future guidelines should specify the choice of antisepsis prior to abdominal hysterectomy,” he said at the meeting, which is jointly sponsored by the American College of Surgeons.
Mr. Bazzi reported having no financial disclosures.
AT SGS 2016
Key clinical point: Chlorhexidine-alcohol preoperative skin antisepsis at the time of abdominal hysterectomy was superior to povidone-iodine antiseptic solution in reducing SSIs.
Major finding: The use of chlorhexidine-alcohol preoperative skin antisepsis at the time of abdominal hysterectomy was associated with about a 30% lower odds of developing SSIs, compared with using povidone-iodine antiseptic solution (odds ratio, 0.71).
Data source: A retrospective cohort analysis of 5,074 patients who underwent abdominal hysterectomy from July 2012 to February 2015.
Disclosures: Mr. Bazzi reported having no financial disclosures.
Study identifies cognitive impairment in elderly urogynecologic patients
INDIAN WELLS, CALIF. – A rapid screening tool found that about 5% of urogynecologic patients aged 65-74 years showed signs of cognitive impairment, with that figure rising to more than 30% for patients age 85 and older, according to the results of a single-center study.
“As our gynecologic patients continue to age, it’s increasingly important that we continue to identify and manage the risk factors for cognitive decline that occur in the ambulatory and the perioperative care settings,” Dr. Elisa R. Trowbridge, lead study author, said at the annual scientific meeting of the Society of Gynecologic Surgeons. “However, data are lacking to describe the prevalence of cognitive impairment in this very specific population.”
In 2013, the Centers for Disease Control and Prevention estimated that one in eight patients older than 60 years of age deal with memory loss and confusion. However, fewer than 20% of these patients report this to their health care providers, said Dr. Trowbridge, division director of the University of Virginia Women’s Center for Continence and Pelvic Surgery in Charlottesville.
“For this reason the aim of our study was to evaluate the prevalence of cognitive impairment in a urogynecologic ambulatory population, and to evaluate the feasibility of using a standardized, validated screening questionnaire in the tertiary care setting,” she said.
The researchers invited 371 English-speaking patients aged 65 and older to participate and used two cognitive screening tools: the Mini-Cog and the AD8 (8-item Interview to Differentiate Aging and Dementia). They also used the Geriatric Depression Scale, as there is an association between depression and cognition in the elderly.
“Advantages of the Mini-Cog are that it’s administered in less than 3 minutes, it requires no special equipment, and it is not influenced by level of education, or any language variations,” Dr. Trowbridge said.
Of the 371 patients, 39 were excluded due to pre-existing cognitive impairment/dementia, active psychotic disorders, acute/unstable medical conditions, neurologic injury/disorders, alcohol/drug abuse, severe visual/hearing impairment, and illiteracy. An additional 37 patients declined to participate because they “were frustrated that we had asked to evaluate their memory,” she said. This left a total of 295 patients with a mean age of 75 years. Most (97%) were Caucasian, 62% were married, and each had an average of four major medical conditions, including hypertension, hyperlipidemia, and depression. The researchers stratified patients into three age groups: 65-74, 75-84, and 85 and older.
Cognitive impairment as measured by the Mini-Cog was identified in 5.3% of patients aged 65-74 years, 13.7% of those aged 75-84 years, and 31% of those aged 85 and older. The difference in impairment between those aged 65-74 years and those aged 75 years and older reached significance, with a P value of less than .001.
Cognitive impairment as measured by the AD8 found that all three age groups perceived themselves to have early cognitive changes: 25.9% of patients aged 65-74 years, 31.9% of those aged 75-84 years, and 40% of those aged 85 and older. There were no significant between-group differences in these results (P = .4). The most commonly identified areas of impairment were problems with thinking and memory (62%), judgment (52%), and trouble learning new tools or gadgets (44%).
Dr. Trowbridge also reported that 6.4% of the study population screened positive for depression on the Geriatric Depression Scale, with no significant differences between the age groups.
“In our study population, cognitive impairment as measured by a validated questionnaire is prevalent among women greater than 75 years of age,” she said at the meeting, which was jointly sponsored by the American College of Surgeons. “The Mini-Cog is a feasible screening tool for routine use in clinical practice that can be integrated easily into the urogynecologic evaluation. However, remember these are screening tools that effectively screen for previously unrecognized impairment, but a definitive diagnosis requires additional evaluation.”
Dr. Trowbridge reported having no financial disclosures.
INDIAN WELLS, CALIF. – A rapid screening tool found that about 5% of urogynecologic patients aged 65-74 years showed signs of cognitive impairment, with that figure rising to more than 30% for patients age 85 and older, according to the results of a single-center study.
“As our gynecologic patients continue to age, it’s increasingly important that we continue to identify and manage the risk factors for cognitive decline that occur in the ambulatory and the perioperative care settings,” Dr. Elisa R. Trowbridge, lead study author, said at the annual scientific meeting of the Society of Gynecologic Surgeons. “However, data are lacking to describe the prevalence of cognitive impairment in this very specific population.”
In 2013, the Centers for Disease Control and Prevention estimated that one in eight patients older than 60 years of age deal with memory loss and confusion. However, fewer than 20% of these patients report this to their health care providers, said Dr. Trowbridge, division director of the University of Virginia Women’s Center for Continence and Pelvic Surgery in Charlottesville.
“For this reason the aim of our study was to evaluate the prevalence of cognitive impairment in a urogynecologic ambulatory population, and to evaluate the feasibility of using a standardized, validated screening questionnaire in the tertiary care setting,” she said.
The researchers invited 371 English-speaking patients aged 65 and older to participate and used two cognitive screening tools: the Mini-Cog and the AD8 (8-item Interview to Differentiate Aging and Dementia). They also used the Geriatric Depression Scale, as there is an association between depression and cognition in the elderly.
“Advantages of the Mini-Cog are that it’s administered in less than 3 minutes, it requires no special equipment, and it is not influenced by level of education, or any language variations,” Dr. Trowbridge said.
Of the 371 patients, 39 were excluded due to pre-existing cognitive impairment/dementia, active psychotic disorders, acute/unstable medical conditions, neurologic injury/disorders, alcohol/drug abuse, severe visual/hearing impairment, and illiteracy. An additional 37 patients declined to participate because they “were frustrated that we had asked to evaluate their memory,” she said. This left a total of 295 patients with a mean age of 75 years. Most (97%) were Caucasian, 62% were married, and each had an average of four major medical conditions, including hypertension, hyperlipidemia, and depression. The researchers stratified patients into three age groups: 65-74, 75-84, and 85 and older.
Cognitive impairment as measured by the Mini-Cog was identified in 5.3% of patients aged 65-74 years, 13.7% of those aged 75-84 years, and 31% of those aged 85 and older. The difference in impairment between those aged 65-74 years and those aged 75 years and older reached significance, with a P value of less than .001.
Cognitive impairment as measured by the AD8 found that all three age groups perceived themselves to have early cognitive changes: 25.9% of patients aged 65-74 years, 31.9% of those aged 75-84 years, and 40% of those aged 85 and older. There were no significant between-group differences in these results (P = .4). The most commonly identified areas of impairment were problems with thinking and memory (62%), judgment (52%), and trouble learning new tools or gadgets (44%).
Dr. Trowbridge also reported that 6.4% of the study population screened positive for depression on the Geriatric Depression Scale, with no significant differences between the age groups.
“In our study population, cognitive impairment as measured by a validated questionnaire is prevalent among women greater than 75 years of age,” she said at the meeting, which was jointly sponsored by the American College of Surgeons. “The Mini-Cog is a feasible screening tool for routine use in clinical practice that can be integrated easily into the urogynecologic evaluation. However, remember these are screening tools that effectively screen for previously unrecognized impairment, but a definitive diagnosis requires additional evaluation.”
Dr. Trowbridge reported having no financial disclosures.
INDIAN WELLS, CALIF. – A rapid screening tool found that about 5% of urogynecologic patients aged 65-74 years showed signs of cognitive impairment, with that figure rising to more than 30% for patients age 85 and older, according to the results of a single-center study.
“As our gynecologic patients continue to age, it’s increasingly important that we continue to identify and manage the risk factors for cognitive decline that occur in the ambulatory and the perioperative care settings,” Dr. Elisa R. Trowbridge, lead study author, said at the annual scientific meeting of the Society of Gynecologic Surgeons. “However, data are lacking to describe the prevalence of cognitive impairment in this very specific population.”
In 2013, the Centers for Disease Control and Prevention estimated that one in eight patients older than 60 years of age deal with memory loss and confusion. However, fewer than 20% of these patients report this to their health care providers, said Dr. Trowbridge, division director of the University of Virginia Women’s Center for Continence and Pelvic Surgery in Charlottesville.
“For this reason the aim of our study was to evaluate the prevalence of cognitive impairment in a urogynecologic ambulatory population, and to evaluate the feasibility of using a standardized, validated screening questionnaire in the tertiary care setting,” she said.
The researchers invited 371 English-speaking patients aged 65 and older to participate and used two cognitive screening tools: the Mini-Cog and the AD8 (8-item Interview to Differentiate Aging and Dementia). They also used the Geriatric Depression Scale, as there is an association between depression and cognition in the elderly.
“Advantages of the Mini-Cog are that it’s administered in less than 3 minutes, it requires no special equipment, and it is not influenced by level of education, or any language variations,” Dr. Trowbridge said.
Of the 371 patients, 39 were excluded due to pre-existing cognitive impairment/dementia, active psychotic disorders, acute/unstable medical conditions, neurologic injury/disorders, alcohol/drug abuse, severe visual/hearing impairment, and illiteracy. An additional 37 patients declined to participate because they “were frustrated that we had asked to evaluate their memory,” she said. This left a total of 295 patients with a mean age of 75 years. Most (97%) were Caucasian, 62% were married, and each had an average of four major medical conditions, including hypertension, hyperlipidemia, and depression. The researchers stratified patients into three age groups: 65-74, 75-84, and 85 and older.
Cognitive impairment as measured by the Mini-Cog was identified in 5.3% of patients aged 65-74 years, 13.7% of those aged 75-84 years, and 31% of those aged 85 and older. The difference in impairment between those aged 65-74 years and those aged 75 years and older reached significance, with a P value of less than .001.
Cognitive impairment as measured by the AD8 found that all three age groups perceived themselves to have early cognitive changes: 25.9% of patients aged 65-74 years, 31.9% of those aged 75-84 years, and 40% of those aged 85 and older. There were no significant between-group differences in these results (P = .4). The most commonly identified areas of impairment were problems with thinking and memory (62%), judgment (52%), and trouble learning new tools or gadgets (44%).
Dr. Trowbridge also reported that 6.4% of the study population screened positive for depression on the Geriatric Depression Scale, with no significant differences between the age groups.
“In our study population, cognitive impairment as measured by a validated questionnaire is prevalent among women greater than 75 years of age,” she said at the meeting, which was jointly sponsored by the American College of Surgeons. “The Mini-Cog is a feasible screening tool for routine use in clinical practice that can be integrated easily into the urogynecologic evaluation. However, remember these are screening tools that effectively screen for previously unrecognized impairment, but a definitive diagnosis requires additional evaluation.”
Dr. Trowbridge reported having no financial disclosures.
AT SGS 2016
Key clinical point: The Mini-Cog is a feasible screening tool for routine use in clinical practice that can be integrated easily into the urogynecologic evaluation.
Major finding: Cognitive impairment as measured by the Mini-Cog was identified in 5.3% of patients aged 65-74 years, 13.7% of those aged 75-84 years, and 31% of those aged 85 and older.
Data source: A single-center study of 295 urogynecologic patients aged 65 and older.
Disclosures: Dr. Trowbridge reported having no financial disclosures.
Thromboprophylaxis efficacy similar before and after colorectal surgery
CHICAGO – Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.
The findings also raise questions about the fairness of financial penalties imposed by the Centers for Medicare & Medicaid Services for perioperative venous thromboembolism, Dr. Karen Zaghiyan of Cedars Sinai Medical Center, Los Angeles said at the annual meeting of the American Surgical Association.
In 376 consecutive adult patients undergoing laparoscopic or open major colorectal surgery who had no occult preoperative deep vein thrombosis (DVT) on lower extremity venous duplex scan and who were randomized to preoperative or postoperative chemical thromboprophylaxis (CTP) with 5,000 U of subcutaneous heparin, no differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery, Dr. Zaghiyan said.
“There was no significant difference in our primary outcome – early postoperative VTE [venous thromboembolism] – in patients managed with postoperative or preoperative prophylaxis,” she said, noting that three patients in each group developed asymptomatic intraoperative DVT, and two additional patients in the postoperative treatment group developed asymptomatic DVT between postoperative day 0 and 2.
Two additional patients in the postoperative treatment group developed clinically significant DVT between postoperative day 2 and 30.
“Both patients had a complicated prolonged hospital course, and developed DVT while still hospitalized. This difference still did not reach statistical significance, and there were no post-discharge DVT or PEs [pulmonary embolisms] in the entire cohort,” she said.
Bleeding complications, including estimated blood loss and number receiving transfusion, were similar in the two groups, she said, noting that no patients developed heparin-induced thrombocytopenia, and that hospital stay, readmissions, and overall complications were similar between the two groups.
Study subjects had a mean age of 53 years, and 52% were women. The preoperative- and postoperative treatment groups were similar with respect to demographics and preoperative characteristics. They underwent lower extremity venous duplex just prior to surgery, immediately after surgery in the recovery room, on day 2 after surgery, and subsequently as clinically indicated.
Thromboprophylaxis in the preoperative treatment group was given in the “pre-op holding area” then 8 hours after surgery and every 8 hours thereafter until discharge. Thromboprophylaxis in the postoperative treatment group was given within 24 hours after surgery, and then every 8 hours until discharge.
Preoperative and postoperative CTP were equally safe and effective, and since occult preoperative DVT is twice as common as postoperative DVT, occurring in a surprising 4% of patients in this study, the findings support preoperative scans and anticoagulation based on the results – especially in older patients and those with comorbid disease, Dr. Zaghiyan said.
The findings could help improve patients care; although VTE prevention and chemical prophylaxis in colorectal surgery have been extensively studied, current guidelines are vague, with both the American College of Chest Physicians and the Surgical Care Improvement Project recommending that prophylaxis be initiated 24 hours prior to or after major colorectal surgery, she said.
The findings could also help avoid CMS penalties for postoperatively identified VTE,” she added.
Further, those penalties may not be supported by the clinical data; in this study, the majority of early postoperative DVTs were unpreventable, with no additional protection provided with preoperative prophylaxis, she explained.
“CMS should reevaluate the financial penalties, taking preventability into account,” she said.
Dr. Zaghiyan reported having no disclosures.
The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.
CHICAGO – Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.
The findings also raise questions about the fairness of financial penalties imposed by the Centers for Medicare & Medicaid Services for perioperative venous thromboembolism, Dr. Karen Zaghiyan of Cedars Sinai Medical Center, Los Angeles said at the annual meeting of the American Surgical Association.
In 376 consecutive adult patients undergoing laparoscopic or open major colorectal surgery who had no occult preoperative deep vein thrombosis (DVT) on lower extremity venous duplex scan and who were randomized to preoperative or postoperative chemical thromboprophylaxis (CTP) with 5,000 U of subcutaneous heparin, no differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery, Dr. Zaghiyan said.
“There was no significant difference in our primary outcome – early postoperative VTE [venous thromboembolism] – in patients managed with postoperative or preoperative prophylaxis,” she said, noting that three patients in each group developed asymptomatic intraoperative DVT, and two additional patients in the postoperative treatment group developed asymptomatic DVT between postoperative day 0 and 2.
Two additional patients in the postoperative treatment group developed clinically significant DVT between postoperative day 2 and 30.
“Both patients had a complicated prolonged hospital course, and developed DVT while still hospitalized. This difference still did not reach statistical significance, and there were no post-discharge DVT or PEs [pulmonary embolisms] in the entire cohort,” she said.
Bleeding complications, including estimated blood loss and number receiving transfusion, were similar in the two groups, she said, noting that no patients developed heparin-induced thrombocytopenia, and that hospital stay, readmissions, and overall complications were similar between the two groups.
Study subjects had a mean age of 53 years, and 52% were women. The preoperative- and postoperative treatment groups were similar with respect to demographics and preoperative characteristics. They underwent lower extremity venous duplex just prior to surgery, immediately after surgery in the recovery room, on day 2 after surgery, and subsequently as clinically indicated.
Thromboprophylaxis in the preoperative treatment group was given in the “pre-op holding area” then 8 hours after surgery and every 8 hours thereafter until discharge. Thromboprophylaxis in the postoperative treatment group was given within 24 hours after surgery, and then every 8 hours until discharge.
Preoperative and postoperative CTP were equally safe and effective, and since occult preoperative DVT is twice as common as postoperative DVT, occurring in a surprising 4% of patients in this study, the findings support preoperative scans and anticoagulation based on the results – especially in older patients and those with comorbid disease, Dr. Zaghiyan said.
The findings could help improve patients care; although VTE prevention and chemical prophylaxis in colorectal surgery have been extensively studied, current guidelines are vague, with both the American College of Chest Physicians and the Surgical Care Improvement Project recommending that prophylaxis be initiated 24 hours prior to or after major colorectal surgery, she said.
The findings could also help avoid CMS penalties for postoperatively identified VTE,” she added.
Further, those penalties may not be supported by the clinical data; in this study, the majority of early postoperative DVTs were unpreventable, with no additional protection provided with preoperative prophylaxis, she explained.
“CMS should reevaluate the financial penalties, taking preventability into account,” she said.
Dr. Zaghiyan reported having no disclosures.
The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.
CHICAGO – Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.
The findings also raise questions about the fairness of financial penalties imposed by the Centers for Medicare & Medicaid Services for perioperative venous thromboembolism, Dr. Karen Zaghiyan of Cedars Sinai Medical Center, Los Angeles said at the annual meeting of the American Surgical Association.
In 376 consecutive adult patients undergoing laparoscopic or open major colorectal surgery who had no occult preoperative deep vein thrombosis (DVT) on lower extremity venous duplex scan and who were randomized to preoperative or postoperative chemical thromboprophylaxis (CTP) with 5,000 U of subcutaneous heparin, no differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery, Dr. Zaghiyan said.
“There was no significant difference in our primary outcome – early postoperative VTE [venous thromboembolism] – in patients managed with postoperative or preoperative prophylaxis,” she said, noting that three patients in each group developed asymptomatic intraoperative DVT, and two additional patients in the postoperative treatment group developed asymptomatic DVT between postoperative day 0 and 2.
Two additional patients in the postoperative treatment group developed clinically significant DVT between postoperative day 2 and 30.
“Both patients had a complicated prolonged hospital course, and developed DVT while still hospitalized. This difference still did not reach statistical significance, and there were no post-discharge DVT or PEs [pulmonary embolisms] in the entire cohort,” she said.
Bleeding complications, including estimated blood loss and number receiving transfusion, were similar in the two groups, she said, noting that no patients developed heparin-induced thrombocytopenia, and that hospital stay, readmissions, and overall complications were similar between the two groups.
Study subjects had a mean age of 53 years, and 52% were women. The preoperative- and postoperative treatment groups were similar with respect to demographics and preoperative characteristics. They underwent lower extremity venous duplex just prior to surgery, immediately after surgery in the recovery room, on day 2 after surgery, and subsequently as clinically indicated.
Thromboprophylaxis in the preoperative treatment group was given in the “pre-op holding area” then 8 hours after surgery and every 8 hours thereafter until discharge. Thromboprophylaxis in the postoperative treatment group was given within 24 hours after surgery, and then every 8 hours until discharge.
Preoperative and postoperative CTP were equally safe and effective, and since occult preoperative DVT is twice as common as postoperative DVT, occurring in a surprising 4% of patients in this study, the findings support preoperative scans and anticoagulation based on the results – especially in older patients and those with comorbid disease, Dr. Zaghiyan said.
The findings could help improve patients care; although VTE prevention and chemical prophylaxis in colorectal surgery have been extensively studied, current guidelines are vague, with both the American College of Chest Physicians and the Surgical Care Improvement Project recommending that prophylaxis be initiated 24 hours prior to or after major colorectal surgery, she said.
The findings could also help avoid CMS penalties for postoperatively identified VTE,” she added.
Further, those penalties may not be supported by the clinical data; in this study, the majority of early postoperative DVTs were unpreventable, with no additional protection provided with preoperative prophylaxis, she explained.
“CMS should reevaluate the financial penalties, taking preventability into account,” she said.
Dr. Zaghiyan reported having no disclosures.
The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.
AT THE ASA ANNUAL MEETING
Key clinical point: Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.
Major finding: No differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery in patients treated with pre- or post-operative chemical thromboprophylaxis.
Data source: A randomized clinical trial of 376 patients.
Disclosures: Dr. Zaghiyan reported having no disclosures.