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CHADS2 predicts postop atrial fibrillation
PHOENIX – For every unit increase in baseline CHADS2 score, the risk of postop atrial fibrillation increases by 17%, according to a retrospective chart review of 1,550 adults who had major vascular or thoracic surgery at the Mayo Clinic in Rochester, Minn.
On multivariate analysis, postop day 1 Sequential Organ Failure Assessment score (HR 1.08, 95% CI 1.03-1.12, per unit increase) and cumulative fluid balance (HR 1.03, 95% CI 1.01-1.06, per 1,000 mL) also correlated with the risk for new-onset atrial fibrillation (AF).
Baseline calcium channel blockers protected against new-onset AF (HR 0.52, 95% CI 0.37-0.73), but, paradoxically, the risk increased with baseline (HR 1.78, 95% CI 1.24-2.56) and postop (HR 1.44, 95% CI 1.05-1.99) beta-blocker use.
The relationship of CHADS2 to new-onset AF (HR 1.17, 95% CI 1.04-1.31) could prove handy in the surgical ICU because “everyone is familiar with it, and it’s easy to calculate.” CHADS2 (heart failure, hypertension, age, diabetes, prior stroke) has also recently been shown to predict AF after cardiac surgery, said lead investigator Kirstin Kooda, Pharm.D., a critical care pharmacist at Mayo.
The beta-blocker finding was a surprise, since beta-blockers are a standard AF treatment, Dr. Kooda said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. About 80% (175) of new-onset AF patients were on baseline beta-blockers, versus about 68% (892) who did not develop AF. Patients using beta-blockers received them the morning of surgery, and resumed them a median of 7 hours afterward. There were no significant differences in heart rates during surgery.
The team excluded patients with any history of AF and censored patients if they developed it, so the drugs’ use probably wasn’t related to a concern about the condition. Just under 70% of patients in both groups had baseline hypertension, another indication for the drugs.
Even so, the finding is probably real given the number of patients in the study. Most likely, the drugs were markers for additional risk factors not captured in the study, Dr. Kooda said.
Overall, 112 (20.7%) of the 540 thoracic patients and 107 (11%) of the 1,010 vascular patients developed new-onset AF a median of 55 hours after surgery. The incidence difference and timing are in line with previous reports.
The mean age in the AF group was 70 years, and in the non-AF group it was 66 years. In both, 65% were men, 5% had heart failure, 30% had diabetes, and 10% had prior strokes. Patients with pacemakers and recent myocardial infarctions – also possible settings for beta-blockers – were excluded from the trial.
The majority of the vascular cases were open aortic aneurysms, aortic bypasses, and thrombectomies or endarterectomies of central arteries. Most of the thoracic surgeries were lobectomies, pneumonectomies, and wedge or chest wall resections.
PHOENIX – For every unit increase in baseline CHADS2 score, the risk of postop atrial fibrillation increases by 17%, according to a retrospective chart review of 1,550 adults who had major vascular or thoracic surgery at the Mayo Clinic in Rochester, Minn.
On multivariate analysis, postop day 1 Sequential Organ Failure Assessment score (HR 1.08, 95% CI 1.03-1.12, per unit increase) and cumulative fluid balance (HR 1.03, 95% CI 1.01-1.06, per 1,000 mL) also correlated with the risk for new-onset atrial fibrillation (AF).
Baseline calcium channel blockers protected against new-onset AF (HR 0.52, 95% CI 0.37-0.73), but, paradoxically, the risk increased with baseline (HR 1.78, 95% CI 1.24-2.56) and postop (HR 1.44, 95% CI 1.05-1.99) beta-blocker use.
The relationship of CHADS2 to new-onset AF (HR 1.17, 95% CI 1.04-1.31) could prove handy in the surgical ICU because “everyone is familiar with it, and it’s easy to calculate.” CHADS2 (heart failure, hypertension, age, diabetes, prior stroke) has also recently been shown to predict AF after cardiac surgery, said lead investigator Kirstin Kooda, Pharm.D., a critical care pharmacist at Mayo.
The beta-blocker finding was a surprise, since beta-blockers are a standard AF treatment, Dr. Kooda said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. About 80% (175) of new-onset AF patients were on baseline beta-blockers, versus about 68% (892) who did not develop AF. Patients using beta-blockers received them the morning of surgery, and resumed them a median of 7 hours afterward. There were no significant differences in heart rates during surgery.
The team excluded patients with any history of AF and censored patients if they developed it, so the drugs’ use probably wasn’t related to a concern about the condition. Just under 70% of patients in both groups had baseline hypertension, another indication for the drugs.
Even so, the finding is probably real given the number of patients in the study. Most likely, the drugs were markers for additional risk factors not captured in the study, Dr. Kooda said.
Overall, 112 (20.7%) of the 540 thoracic patients and 107 (11%) of the 1,010 vascular patients developed new-onset AF a median of 55 hours after surgery. The incidence difference and timing are in line with previous reports.
The mean age in the AF group was 70 years, and in the non-AF group it was 66 years. In both, 65% were men, 5% had heart failure, 30% had diabetes, and 10% had prior strokes. Patients with pacemakers and recent myocardial infarctions – also possible settings for beta-blockers – were excluded from the trial.
The majority of the vascular cases were open aortic aneurysms, aortic bypasses, and thrombectomies or endarterectomies of central arteries. Most of the thoracic surgeries were lobectomies, pneumonectomies, and wedge or chest wall resections.
PHOENIX – For every unit increase in baseline CHADS2 score, the risk of postop atrial fibrillation increases by 17%, according to a retrospective chart review of 1,550 adults who had major vascular or thoracic surgery at the Mayo Clinic in Rochester, Minn.
On multivariate analysis, postop day 1 Sequential Organ Failure Assessment score (HR 1.08, 95% CI 1.03-1.12, per unit increase) and cumulative fluid balance (HR 1.03, 95% CI 1.01-1.06, per 1,000 mL) also correlated with the risk for new-onset atrial fibrillation (AF).
Baseline calcium channel blockers protected against new-onset AF (HR 0.52, 95% CI 0.37-0.73), but, paradoxically, the risk increased with baseline (HR 1.78, 95% CI 1.24-2.56) and postop (HR 1.44, 95% CI 1.05-1.99) beta-blocker use.
The relationship of CHADS2 to new-onset AF (HR 1.17, 95% CI 1.04-1.31) could prove handy in the surgical ICU because “everyone is familiar with it, and it’s easy to calculate.” CHADS2 (heart failure, hypertension, age, diabetes, prior stroke) has also recently been shown to predict AF after cardiac surgery, said lead investigator Kirstin Kooda, Pharm.D., a critical care pharmacist at Mayo.
The beta-blocker finding was a surprise, since beta-blockers are a standard AF treatment, Dr. Kooda said at the Critical Care Congress, sponsored by the Society for Critical Care Medicine. About 80% (175) of new-onset AF patients were on baseline beta-blockers, versus about 68% (892) who did not develop AF. Patients using beta-blockers received them the morning of surgery, and resumed them a median of 7 hours afterward. There were no significant differences in heart rates during surgery.
The team excluded patients with any history of AF and censored patients if they developed it, so the drugs’ use probably wasn’t related to a concern about the condition. Just under 70% of patients in both groups had baseline hypertension, another indication for the drugs.
Even so, the finding is probably real given the number of patients in the study. Most likely, the drugs were markers for additional risk factors not captured in the study, Dr. Kooda said.
Overall, 112 (20.7%) of the 540 thoracic patients and 107 (11%) of the 1,010 vascular patients developed new-onset AF a median of 55 hours after surgery. The incidence difference and timing are in line with previous reports.
The mean age in the AF group was 70 years, and in the non-AF group it was 66 years. In both, 65% were men, 5% had heart failure, 30% had diabetes, and 10% had prior strokes. Patients with pacemakers and recent myocardial infarctions – also possible settings for beta-blockers – were excluded from the trial.
The majority of the vascular cases were open aortic aneurysms, aortic bypasses, and thrombectomies or endarterectomies of central arteries. Most of the thoracic surgeries were lobectomies, pneumonectomies, and wedge or chest wall resections.
AT THE CRITICAL CARE CONGRESS
Key clinical point: Postop atrial fibrillation is more likely if patients go into surgery with an elevated CHADS 2 score.
Major finding: For every unit increase in baseline CHADS2 score, there is a 17% increase in the risk of new-onset AF following major vascular or thoracic surgery (HR 1.17, 95% CI 1.04-1.31).
Data source: Retrospective chart review of 1,550 adult patients.
Disclosures: The investigators said they had no disclosures. No outside funding was reported for the work.
Rivaroxaban and enoxaparin had comparable rates for VTE prophylaxis after hip and knee surgery
There were no significant differences between the anticoagulants rivaroxaban (Xarelto) and enoxaparin (Lovenox) in terms of venous thromboembolism prophylaxis, infection, reoperation, transfusion, or major bleeding complications after primary hip and knee arthroplasty, according to a study published in the Journal of Arthroplasty.
In a non–industry-funded retrospective cohort study, Dr. Michael A. Charters of Henry Ford Health System in Detroit and his associates looked at 2,406 patients who underwent total hip and knee arthroplasty between 2009 and 2011. Of the 1,762 patients ultimately included in the study, 1,113 (63.2%) received enoxaparin and 649 (36.8%) received rivaroxaban for VTE prophylaxis. The deep venous thrombosis rate of the enoxaparin group was 1.8%, compared with 0.9% in the rivaroxaban group (P = .208) and the pulmonary embolism rate of the enoxaparin group was 0.7%, compared with 0.3% in the rivaroxaban group (P = .437).
“For standard primary THA [total hip arthroplasty] and TKA [total knee arthroplasty], these medications appear to be equally effective without increased adverse events,” the researchers said.
Read the full article at: The Journal of Arthoplasty 2015 (www.arthroplastyjournal.org/article/S0883-5403%2815%2900120-5/abstract).
There were no significant differences between the anticoagulants rivaroxaban (Xarelto) and enoxaparin (Lovenox) in terms of venous thromboembolism prophylaxis, infection, reoperation, transfusion, or major bleeding complications after primary hip and knee arthroplasty, according to a study published in the Journal of Arthroplasty.
In a non–industry-funded retrospective cohort study, Dr. Michael A. Charters of Henry Ford Health System in Detroit and his associates looked at 2,406 patients who underwent total hip and knee arthroplasty between 2009 and 2011. Of the 1,762 patients ultimately included in the study, 1,113 (63.2%) received enoxaparin and 649 (36.8%) received rivaroxaban for VTE prophylaxis. The deep venous thrombosis rate of the enoxaparin group was 1.8%, compared with 0.9% in the rivaroxaban group (P = .208) and the pulmonary embolism rate of the enoxaparin group was 0.7%, compared with 0.3% in the rivaroxaban group (P = .437).
“For standard primary THA [total hip arthroplasty] and TKA [total knee arthroplasty], these medications appear to be equally effective without increased adverse events,” the researchers said.
Read the full article at: The Journal of Arthoplasty 2015 (www.arthroplastyjournal.org/article/S0883-5403%2815%2900120-5/abstract).
There were no significant differences between the anticoagulants rivaroxaban (Xarelto) and enoxaparin (Lovenox) in terms of venous thromboembolism prophylaxis, infection, reoperation, transfusion, or major bleeding complications after primary hip and knee arthroplasty, according to a study published in the Journal of Arthroplasty.
In a non–industry-funded retrospective cohort study, Dr. Michael A. Charters of Henry Ford Health System in Detroit and his associates looked at 2,406 patients who underwent total hip and knee arthroplasty between 2009 and 2011. Of the 1,762 patients ultimately included in the study, 1,113 (63.2%) received enoxaparin and 649 (36.8%) received rivaroxaban for VTE prophylaxis. The deep venous thrombosis rate of the enoxaparin group was 1.8%, compared with 0.9% in the rivaroxaban group (P = .208) and the pulmonary embolism rate of the enoxaparin group was 0.7%, compared with 0.3% in the rivaroxaban group (P = .437).
“For standard primary THA [total hip arthroplasty] and TKA [total knee arthroplasty], these medications appear to be equally effective without increased adverse events,” the researchers said.
Read the full article at: The Journal of Arthoplasty 2015 (www.arthroplastyjournal.org/article/S0883-5403%2815%2900120-5/abstract).
ACS NSQIP hospitals steadily improve surgical outcomes
Surgical performance data gathered within the American College of Surgeons, National Surgical Quality Improvement Program (ACS NSQIP) from the period of 2006-2013 indicate improved performance by most participating hospitals over time. In the categories of mortality, morbidity, and surgical site infections (SSI), the ratio of observed to expected surgery-related adverse events declined over time, showing that with increasing years of participation in ACS NSQIP, hospitals saw cumulative reductions in observed/expected ratios.
Dr. Clifford Y. Ko, coauthor of the report, an ACS Fellow and professor of surgery at David Geffen School of Medicine, University of California Los Angeles, spoke in an interview about the results, which were published in Annals of Surgery.
“An important finding from our study is that hospitals get better when they participate in ACS NSQIP, and the longer they are in the program, the better they get. It means that if hospitals commit to going on the journey of quality improvement, the longer they are on that journey, the better they get, the more experience they get in quality improvement, and the more their outcomes improve.
“Another important point that became evident from the analysis was that the biggest area for improvement is in the rate of complications, more so than mortality. The mortality rate is already low, and the number of preventable deaths is low. There are many more preventable complications than preventable deaths. The data show that risk-adjusted complications decrease over time because many opportunities lie in decreasing rates of infection, blood clot, pneumonia, urinary tract infection, and others. Whatever rate the hospital starts in ACS NSQIP, there is more opportunity to realize improvements in the number of complications than in mortality.”
The researchers used clinical data collected from 2006 to 2013 from 515 hospitals participating in ACS NSQIP.
Hospitals participating in the program receive semiannual reports that benchmark performance compared to other similar institutions. But the performance benchmarks are continuously updated to reflect current practices across groups of similar institutions, so individual hospitals cannot gauge whether their performance improves over time relative to fixed standard.
“The aim of the study was to determine if over several years hospitals who participated in ACS NSQIP got better. Benchmarking data provides feedback, but does not indicate whether over time hospitals improve. Our analysis looked at hospital performance longitudinally to evaluate if they got better from year to year,” said Dr. Ko.
To make meaningful comparisons of surgical outcomes, expected outcomes were calculated based on risk adjustments to compensate for differences in patient characteristics and the risk profile of procedures performed. Dr. Ko explained, “Large, tertiary institutions that care for very sick patients, or very complex cases, are expected to have worse outcomes than hospitals that perform more common procedures with lower expected event rates. In this analysis, the results of interest are the trends in observed/expected (O/E) event rates, which adjust for these risks.”
For all hospitals, 62%, 70%, and 65% had negative slopes for mortality, morbidity, and any SSI, respectively. The O/E ratios for mortality, morbidity, and SSI declined with each year of participation in the program, and the slope of the decline was steepest for morbidity and SSI. SSI is the most common complication and largely mirrors morbidity. For hospitals in the program at least 3 years, annual reductions in mortality, morbidity, and SSI were estimated to be 0.8%, 3.1%, and 2.6%, respectively.
One of the hallmarks of ACS NSQIP is the accuracy of the data, which come directly from medical records. In a large study comparing clinical with billing (or administrative) data, Dr. Ko and colleagues found the accuracy of billing data to be low.
“In a 2-year study we merged clinical and administrative data from over 100,000 patients and found the agreement to be poor. Billing data had a detection rate for SSI of 25% and a false-positive rate of 70%,” he said.
“In developing programs to improve patient care, we want to base our work on the most accurate data possible. Our analysis shows that hospitals committed to using ACS NSQIP improve over time.”
The authors reported having no financial disclosures.
Surgical performance data gathered within the American College of Surgeons, National Surgical Quality Improvement Program (ACS NSQIP) from the period of 2006-2013 indicate improved performance by most participating hospitals over time. In the categories of mortality, morbidity, and surgical site infections (SSI), the ratio of observed to expected surgery-related adverse events declined over time, showing that with increasing years of participation in ACS NSQIP, hospitals saw cumulative reductions in observed/expected ratios.
Dr. Clifford Y. Ko, coauthor of the report, an ACS Fellow and professor of surgery at David Geffen School of Medicine, University of California Los Angeles, spoke in an interview about the results, which were published in Annals of Surgery.
“An important finding from our study is that hospitals get better when they participate in ACS NSQIP, and the longer they are in the program, the better they get. It means that if hospitals commit to going on the journey of quality improvement, the longer they are on that journey, the better they get, the more experience they get in quality improvement, and the more their outcomes improve.
“Another important point that became evident from the analysis was that the biggest area for improvement is in the rate of complications, more so than mortality. The mortality rate is already low, and the number of preventable deaths is low. There are many more preventable complications than preventable deaths. The data show that risk-adjusted complications decrease over time because many opportunities lie in decreasing rates of infection, blood clot, pneumonia, urinary tract infection, and others. Whatever rate the hospital starts in ACS NSQIP, there is more opportunity to realize improvements in the number of complications than in mortality.”
The researchers used clinical data collected from 2006 to 2013 from 515 hospitals participating in ACS NSQIP.
Hospitals participating in the program receive semiannual reports that benchmark performance compared to other similar institutions. But the performance benchmarks are continuously updated to reflect current practices across groups of similar institutions, so individual hospitals cannot gauge whether their performance improves over time relative to fixed standard.
“The aim of the study was to determine if over several years hospitals who participated in ACS NSQIP got better. Benchmarking data provides feedback, but does not indicate whether over time hospitals improve. Our analysis looked at hospital performance longitudinally to evaluate if they got better from year to year,” said Dr. Ko.
To make meaningful comparisons of surgical outcomes, expected outcomes were calculated based on risk adjustments to compensate for differences in patient characteristics and the risk profile of procedures performed. Dr. Ko explained, “Large, tertiary institutions that care for very sick patients, or very complex cases, are expected to have worse outcomes than hospitals that perform more common procedures with lower expected event rates. In this analysis, the results of interest are the trends in observed/expected (O/E) event rates, which adjust for these risks.”
For all hospitals, 62%, 70%, and 65% had negative slopes for mortality, morbidity, and any SSI, respectively. The O/E ratios for mortality, morbidity, and SSI declined with each year of participation in the program, and the slope of the decline was steepest for morbidity and SSI. SSI is the most common complication and largely mirrors morbidity. For hospitals in the program at least 3 years, annual reductions in mortality, morbidity, and SSI were estimated to be 0.8%, 3.1%, and 2.6%, respectively.
One of the hallmarks of ACS NSQIP is the accuracy of the data, which come directly from medical records. In a large study comparing clinical with billing (or administrative) data, Dr. Ko and colleagues found the accuracy of billing data to be low.
“In a 2-year study we merged clinical and administrative data from over 100,000 patients and found the agreement to be poor. Billing data had a detection rate for SSI of 25% and a false-positive rate of 70%,” he said.
“In developing programs to improve patient care, we want to base our work on the most accurate data possible. Our analysis shows that hospitals committed to using ACS NSQIP improve over time.”
The authors reported having no financial disclosures.
Surgical performance data gathered within the American College of Surgeons, National Surgical Quality Improvement Program (ACS NSQIP) from the period of 2006-2013 indicate improved performance by most participating hospitals over time. In the categories of mortality, morbidity, and surgical site infections (SSI), the ratio of observed to expected surgery-related adverse events declined over time, showing that with increasing years of participation in ACS NSQIP, hospitals saw cumulative reductions in observed/expected ratios.
Dr. Clifford Y. Ko, coauthor of the report, an ACS Fellow and professor of surgery at David Geffen School of Medicine, University of California Los Angeles, spoke in an interview about the results, which were published in Annals of Surgery.
“An important finding from our study is that hospitals get better when they participate in ACS NSQIP, and the longer they are in the program, the better they get. It means that if hospitals commit to going on the journey of quality improvement, the longer they are on that journey, the better they get, the more experience they get in quality improvement, and the more their outcomes improve.
“Another important point that became evident from the analysis was that the biggest area for improvement is in the rate of complications, more so than mortality. The mortality rate is already low, and the number of preventable deaths is low. There are many more preventable complications than preventable deaths. The data show that risk-adjusted complications decrease over time because many opportunities lie in decreasing rates of infection, blood clot, pneumonia, urinary tract infection, and others. Whatever rate the hospital starts in ACS NSQIP, there is more opportunity to realize improvements in the number of complications than in mortality.”
The researchers used clinical data collected from 2006 to 2013 from 515 hospitals participating in ACS NSQIP.
Hospitals participating in the program receive semiannual reports that benchmark performance compared to other similar institutions. But the performance benchmarks are continuously updated to reflect current practices across groups of similar institutions, so individual hospitals cannot gauge whether their performance improves over time relative to fixed standard.
“The aim of the study was to determine if over several years hospitals who participated in ACS NSQIP got better. Benchmarking data provides feedback, but does not indicate whether over time hospitals improve. Our analysis looked at hospital performance longitudinally to evaluate if they got better from year to year,” said Dr. Ko.
To make meaningful comparisons of surgical outcomes, expected outcomes were calculated based on risk adjustments to compensate for differences in patient characteristics and the risk profile of procedures performed. Dr. Ko explained, “Large, tertiary institutions that care for very sick patients, or very complex cases, are expected to have worse outcomes than hospitals that perform more common procedures with lower expected event rates. In this analysis, the results of interest are the trends in observed/expected (O/E) event rates, which adjust for these risks.”
For all hospitals, 62%, 70%, and 65% had negative slopes for mortality, morbidity, and any SSI, respectively. The O/E ratios for mortality, morbidity, and SSI declined with each year of participation in the program, and the slope of the decline was steepest for morbidity and SSI. SSI is the most common complication and largely mirrors morbidity. For hospitals in the program at least 3 years, annual reductions in mortality, morbidity, and SSI were estimated to be 0.8%, 3.1%, and 2.6%, respectively.
One of the hallmarks of ACS NSQIP is the accuracy of the data, which come directly from medical records. In a large study comparing clinical with billing (or administrative) data, Dr. Ko and colleagues found the accuracy of billing data to be low.
“In a 2-year study we merged clinical and administrative data from over 100,000 patients and found the agreement to be poor. Billing data had a detection rate for SSI of 25% and a false-positive rate of 70%,” he said.
“In developing programs to improve patient care, we want to base our work on the most accurate data possible. Our analysis shows that hospitals committed to using ACS NSQIP improve over time.”
The authors reported having no financial disclosures.
FROM ANNALS OF SURGERY
Key clinical point: As length of hospital participation in ACS NSQIP increased, the ratio of observed/expected surgery-related adverse events declined.
Major finding: Improvements in morbidity were observed in 70% of participating hospitals; for surgical site infections, in 65% of hospitals; for mortality, in 62% of hospitals.
Data source: Clinical data from 2006 to 2013 from 515 hospitals participating in ACS NSQIP.
Disclosures: The authors reported having no financial disclosures.
ACP guidelines for preventing, treating pressure ulcers
Alternating-air and low-air-loss mattresses and overlays have little data to support their use for preventing or treating pressure ulcers, the Clinical Guidelines Committee of the American College of Physicians has concluded.
Many U.S. acute-care hospitals, home caregivers, and long-term nursing facilities use alternating-air and low-air-loss mattresses and overlays, even though the evidence in favor of using these surfaces is sparse and of poor quality, the guideline writers said.
The devices have not been show to actually reduce pressure ulcers. The harms have been poorly reported but could be significant. “Using these support systems is expensive and adds unnecessary burden on the health care system. Based on a review of the current evidence, lower-cost support surfaces should be the preferred approach to care,” Dr. Amir Qaseem, of the ACP, Philadelphia, and his associates wrote.
The committee performed an extensive review of the literature on pressure ulcers and compiled two Clinical Practice Guidelines – one concerning prevention (Ann. Intern. Med. 2015;162 [doi:10.7326/M14-1567]) and the other concerning treatment (Ann. Intern. Med. 2015;162 [doi:10.7326/M14-1568]) – in part because “a growing industry” has developed in recent years and aggressively pitches a wide array of products for this patient population. The guidelines present the available evidence on the comparative effectiveness of tools and strategies but state repeatedly that evidence regarding pressure ulcers is sparse and of poor quality.
The prevention guideline strongly recommends that clinicians choose advanced static mattresses or advanced static overlays rather than standard hospital mattresses for at-risk patients. Static mattresses and advanced static overlays provide a constant level of inflation or support and evenly distribute body weight. These products are among the few actually shown to reduce the incidence of pressure ulcers. They are also preferable to alternating-air mattresses and overlays, which change the distribution of pressure by inflating or deflating cells within the devices, and to low-air-loss mattresses and overlays, which use flowing air to regulate heat and humidity and adjust pressure.
Evidence is similarly poor or lacking concerning the use of other support surfaces such as heel supports or boots and a variety of wheelchair cushions. Also lacking evidence are other preventive interventions that extend beyond “usual care,” such as different types of repositioning schemes, a variety of leg elevations, various nutritional supplements, and a wide variety of skin care strategies and topical treatments.
The prevention guideline advises patient assessments to identify those at risk of developing pressure ulcers. However, there is not enough evidence to demonstrate that any one of the many risk assessment tools for this purpose is superior to the others, nor that any of these tools is superior to simple clinical judgment. Risk factors for pressure ulcers include older age; black race or Hispanic ethnicity; low body weight; cognitive impairment; physical impairments; and comorbid conditions that may affect soft-tissue integrity and healing, such as urinary or fecal incontinence, diabetes, edema, impaired microcirculation, hypoalbuminemia, and malnutrition, Dr. Qaseem and his associates wrote (Ann. Intern. Med. 2015 March 2 [doi:10.7326/M14-1567]).
The treatment guideline for patients who already have pressure ulcers similarly notes that the lack of evidence for advanced support surfaces such as alternating-air and low-air-loss mattresses and overlays. It similarly recommends advanced static mattresses or overlays for these patients.
The treatment guideline recommends protein or amino acid supplements as well as hydrocolloid or foam dressings to reduce wound size, and electrical stimulation to accelerate wound healing. The evidence for these recommendations is “weak” and of low- to moderate-quality, Dr. Qaseem and his associates said (Ann. Intern. Med. 2015 March 2 [doi:10.7326/M14-1568]).
The evidence for the safety and efficacy of hyperbaric oxygen therapy, even though it is often used to treat pressure ulcers in hospitals, is similarly inconclusive. Also lacking good-quality evidence are the use of alternating-air chair cushions, three-dimensional polyester overlays, zinc supplements, L-carnosine supplements, wound dressings other than the ones already discussed, debriding enzymes, topical phenytoin, maggot therapy, biological agents other than platelet-derived growth factor, or hydrotherapy in which wounds are cleaned using a whirlpool or pulsed lavage.
These guidelines emphasize the dire need for good science to guide both prevention and treatment of pressure ulcers. Despite the ubiquity of pressure ulcers and their potential to threaten life and limb, clinical management varies greatly. Most of the research in this field to date has been underpowered and focused on early signs of healing rather than on more definitive outcomes.
Joyce Black, Ph.D., R.N., is at the University of Nebraska Medical Center, Omaha. Her financial disclosures are available at www.acponline.org. Dr. Black made these remarks in an editorial accompanying the ACP Clinical Practice Guidelines on prevention and treatment of pressure ulcers (Ann. Intern. Med. 2015 March 2 [doi:10.1326/M15-0190]).
These guidelines emphasize the dire need for good science to guide both prevention and treatment of pressure ulcers. Despite the ubiquity of pressure ulcers and their potential to threaten life and limb, clinical management varies greatly. Most of the research in this field to date has been underpowered and focused on early signs of healing rather than on more definitive outcomes.
Joyce Black, Ph.D., R.N., is at the University of Nebraska Medical Center, Omaha. Her financial disclosures are available at www.acponline.org. Dr. Black made these remarks in an editorial accompanying the ACP Clinical Practice Guidelines on prevention and treatment of pressure ulcers (Ann. Intern. Med. 2015 March 2 [doi:10.1326/M15-0190]).
These guidelines emphasize the dire need for good science to guide both prevention and treatment of pressure ulcers. Despite the ubiquity of pressure ulcers and their potential to threaten life and limb, clinical management varies greatly. Most of the research in this field to date has been underpowered and focused on early signs of healing rather than on more definitive outcomes.
Joyce Black, Ph.D., R.N., is at the University of Nebraska Medical Center, Omaha. Her financial disclosures are available at www.acponline.org. Dr. Black made these remarks in an editorial accompanying the ACP Clinical Practice Guidelines on prevention and treatment of pressure ulcers (Ann. Intern. Med. 2015 March 2 [doi:10.1326/M15-0190]).
Alternating-air and low-air-loss mattresses and overlays have little data to support their use for preventing or treating pressure ulcers, the Clinical Guidelines Committee of the American College of Physicians has concluded.
Many U.S. acute-care hospitals, home caregivers, and long-term nursing facilities use alternating-air and low-air-loss mattresses and overlays, even though the evidence in favor of using these surfaces is sparse and of poor quality, the guideline writers said.
The devices have not been show to actually reduce pressure ulcers. The harms have been poorly reported but could be significant. “Using these support systems is expensive and adds unnecessary burden on the health care system. Based on a review of the current evidence, lower-cost support surfaces should be the preferred approach to care,” Dr. Amir Qaseem, of the ACP, Philadelphia, and his associates wrote.
The committee performed an extensive review of the literature on pressure ulcers and compiled two Clinical Practice Guidelines – one concerning prevention (Ann. Intern. Med. 2015;162 [doi:10.7326/M14-1567]) and the other concerning treatment (Ann. Intern. Med. 2015;162 [doi:10.7326/M14-1568]) – in part because “a growing industry” has developed in recent years and aggressively pitches a wide array of products for this patient population. The guidelines present the available evidence on the comparative effectiveness of tools and strategies but state repeatedly that evidence regarding pressure ulcers is sparse and of poor quality.
The prevention guideline strongly recommends that clinicians choose advanced static mattresses or advanced static overlays rather than standard hospital mattresses for at-risk patients. Static mattresses and advanced static overlays provide a constant level of inflation or support and evenly distribute body weight. These products are among the few actually shown to reduce the incidence of pressure ulcers. They are also preferable to alternating-air mattresses and overlays, which change the distribution of pressure by inflating or deflating cells within the devices, and to low-air-loss mattresses and overlays, which use flowing air to regulate heat and humidity and adjust pressure.
Evidence is similarly poor or lacking concerning the use of other support surfaces such as heel supports or boots and a variety of wheelchair cushions. Also lacking evidence are other preventive interventions that extend beyond “usual care,” such as different types of repositioning schemes, a variety of leg elevations, various nutritional supplements, and a wide variety of skin care strategies and topical treatments.
The prevention guideline advises patient assessments to identify those at risk of developing pressure ulcers. However, there is not enough evidence to demonstrate that any one of the many risk assessment tools for this purpose is superior to the others, nor that any of these tools is superior to simple clinical judgment. Risk factors for pressure ulcers include older age; black race or Hispanic ethnicity; low body weight; cognitive impairment; physical impairments; and comorbid conditions that may affect soft-tissue integrity and healing, such as urinary or fecal incontinence, diabetes, edema, impaired microcirculation, hypoalbuminemia, and malnutrition, Dr. Qaseem and his associates wrote (Ann. Intern. Med. 2015 March 2 [doi:10.7326/M14-1567]).
The treatment guideline for patients who already have pressure ulcers similarly notes that the lack of evidence for advanced support surfaces such as alternating-air and low-air-loss mattresses and overlays. It similarly recommends advanced static mattresses or overlays for these patients.
The treatment guideline recommends protein or amino acid supplements as well as hydrocolloid or foam dressings to reduce wound size, and electrical stimulation to accelerate wound healing. The evidence for these recommendations is “weak” and of low- to moderate-quality, Dr. Qaseem and his associates said (Ann. Intern. Med. 2015 March 2 [doi:10.7326/M14-1568]).
The evidence for the safety and efficacy of hyperbaric oxygen therapy, even though it is often used to treat pressure ulcers in hospitals, is similarly inconclusive. Also lacking good-quality evidence are the use of alternating-air chair cushions, three-dimensional polyester overlays, zinc supplements, L-carnosine supplements, wound dressings other than the ones already discussed, debriding enzymes, topical phenytoin, maggot therapy, biological agents other than platelet-derived growth factor, or hydrotherapy in which wounds are cleaned using a whirlpool or pulsed lavage.
Alternating-air and low-air-loss mattresses and overlays have little data to support their use for preventing or treating pressure ulcers, the Clinical Guidelines Committee of the American College of Physicians has concluded.
Many U.S. acute-care hospitals, home caregivers, and long-term nursing facilities use alternating-air and low-air-loss mattresses and overlays, even though the evidence in favor of using these surfaces is sparse and of poor quality, the guideline writers said.
The devices have not been show to actually reduce pressure ulcers. The harms have been poorly reported but could be significant. “Using these support systems is expensive and adds unnecessary burden on the health care system. Based on a review of the current evidence, lower-cost support surfaces should be the preferred approach to care,” Dr. Amir Qaseem, of the ACP, Philadelphia, and his associates wrote.
The committee performed an extensive review of the literature on pressure ulcers and compiled two Clinical Practice Guidelines – one concerning prevention (Ann. Intern. Med. 2015;162 [doi:10.7326/M14-1567]) and the other concerning treatment (Ann. Intern. Med. 2015;162 [doi:10.7326/M14-1568]) – in part because “a growing industry” has developed in recent years and aggressively pitches a wide array of products for this patient population. The guidelines present the available evidence on the comparative effectiveness of tools and strategies but state repeatedly that evidence regarding pressure ulcers is sparse and of poor quality.
The prevention guideline strongly recommends that clinicians choose advanced static mattresses or advanced static overlays rather than standard hospital mattresses for at-risk patients. Static mattresses and advanced static overlays provide a constant level of inflation or support and evenly distribute body weight. These products are among the few actually shown to reduce the incidence of pressure ulcers. They are also preferable to alternating-air mattresses and overlays, which change the distribution of pressure by inflating or deflating cells within the devices, and to low-air-loss mattresses and overlays, which use flowing air to regulate heat and humidity and adjust pressure.
Evidence is similarly poor or lacking concerning the use of other support surfaces such as heel supports or boots and a variety of wheelchair cushions. Also lacking evidence are other preventive interventions that extend beyond “usual care,” such as different types of repositioning schemes, a variety of leg elevations, various nutritional supplements, and a wide variety of skin care strategies and topical treatments.
The prevention guideline advises patient assessments to identify those at risk of developing pressure ulcers. However, there is not enough evidence to demonstrate that any one of the many risk assessment tools for this purpose is superior to the others, nor that any of these tools is superior to simple clinical judgment. Risk factors for pressure ulcers include older age; black race or Hispanic ethnicity; low body weight; cognitive impairment; physical impairments; and comorbid conditions that may affect soft-tissue integrity and healing, such as urinary or fecal incontinence, diabetes, edema, impaired microcirculation, hypoalbuminemia, and malnutrition, Dr. Qaseem and his associates wrote (Ann. Intern. Med. 2015 March 2 [doi:10.7326/M14-1567]).
The treatment guideline for patients who already have pressure ulcers similarly notes that the lack of evidence for advanced support surfaces such as alternating-air and low-air-loss mattresses and overlays. It similarly recommends advanced static mattresses or overlays for these patients.
The treatment guideline recommends protein or amino acid supplements as well as hydrocolloid or foam dressings to reduce wound size, and electrical stimulation to accelerate wound healing. The evidence for these recommendations is “weak” and of low- to moderate-quality, Dr. Qaseem and his associates said (Ann. Intern. Med. 2015 March 2 [doi:10.7326/M14-1568]).
The evidence for the safety and efficacy of hyperbaric oxygen therapy, even though it is often used to treat pressure ulcers in hospitals, is similarly inconclusive. Also lacking good-quality evidence are the use of alternating-air chair cushions, three-dimensional polyester overlays, zinc supplements, L-carnosine supplements, wound dressings other than the ones already discussed, debriding enzymes, topical phenytoin, maggot therapy, biological agents other than platelet-derived growth factor, or hydrotherapy in which wounds are cleaned using a whirlpool or pulsed lavage.
Factor XI inhibitor trims DVTs after knee replacement surgery
SAN FRANCISCO – Reducing factor XI levels with the experimental antisense oligonucleotide FXI-ASO lowered venous thromboembolism rates after total knee arthroplasty without increasing bleeding in a phase II study.
Venous thromboembolism (VTE) rates were 30% among controls (21/69) on enoxaparin (Lovenox) 40 mg, compared with 27% for patients (36/134) given FXI-ASO 200 mg and 4% for those (3/71) given FXI-ASO 300 mg. Low-dose FXI-ASO was noninferior to enoxaparin (P = .59), while the high-dose regimen was superior (P < .001).
A 4% VTE rate “has never ever been seen before in patients undergoing knee surgery,” Dr. Harry Büller said during the late-breaking abstract session at the annual meeting of the American Society of Hematology.
The strategy of targeting factor XI is based on the understanding that patients with factor XI deficiency (plasma levels < 20% of normal) have a reduced risk of deep vein thrombosis (DVT). Experimental data in mice and primates also suggest that reducing factor XI attenuates thrombosis without excess bleeding.
Among the 300 patients in the open-label study, major or clinically relevant bleeding occurred in 3% of both FXI-ASO groups and 8% of the enoxaparin group (P = .09).
The findings provide the first evidence in humans that the factor XI intrinsic pathway is one of the drivers of postoperative thrombosis and support the concept that thrombosis and hemostasis can be dissociated, said Dr. Büller of the Academic Medical Center, Amsterdam.
“FXI-ASO is a promising new investigational antithrombotic agent and I believe you are witnessing the birth of a new class of antithrombotic agents,” he concluded.
During a press conference, Dr. Büller confided to reporters that he felt like a boy in a candy store, finally able to reveal the superb study findings.
Dr. Robert Flaumenhaft of Harvard Medical School, Boston, was far less effusive in an editorial that accompanied the simultaneous publication of the study in the New England Journal of Medicine.
“Do these finding prove that reduction in factor XI levels inhibits thrombosis without affecting bleeding? The conservative answer is no,” he wrote.
Dr. Flaumenhaft observed that the incidence of clinically relevant bleeding is relatively low after knee arthroplasty, even when patients receive anticoagulants, and that this safety outcome did not differ significantly between the enoxaparin and 300-mg FXI-ASO groups.
“These results also do not make a compelling case for the clinical use of the factor XI antisense oligonucleotide over anticoagulants that are currently used for prophylaxis in patients undergoing knee arthroplasty,” he wrote.
Central to this argument are issues of convenience and questions regarding reversibility. Treatment began 36 days before surgery and was associated with a high incidence of adverse events at the injection site and factor XI levels remained about 60% lower 70 days after initiation of therapy.
The half-life of FXI-ASO is about 22 days, “which in the classical setting in terms of bleeding could be seen as something of a disadvantage,” Dr. Büller told reporters. “But if we do the next study and it shows to be safe, it turns into an advantage” … because there is the possibility of giving FXI-ASO once every 3 weeks.
Dr. Flaumenhaft closed the editorial by acknowledging that the study challenges “the current paradigm” regarding the primary mechanism responsible for fibrin formation during thrombosis. “The striking observation that reducing factor XI levels prevents thrombosis after knee arthroplasty provides the best clinical evidence to date that the intrinsic pathway is essential for thrombus formation,” he wrote.
The study was conducted at 19 centers in five countries and randomly assigned 300 patients scheduled for elective primary unilateral total-knee arthroplasty to daily enoxaparin 40 mg or three doses of FXI-ASO. The protocol was amended early on to exclude a 100-mg FXI-ASO dose.
FXI-ASO 200 mg or 300 mg was given subcutaneously beginning 36 days before surgery on days 1, 3, 5, 8, 15, 22, and 29, and 6 hours postoperatively, with a final dose on day 39.
Enoxaparin 40 mg was given subcutaneously once daily, beginning the evening before or 6-8 hours after surgery, according to investigator preference, and was continued for at least 8 days postoperatively.
The primary efficacy point was a composite of asymptomatic DVT, detected by venography, and confirmed symptomatic VTE.
At baseline, the average factor XI level was 1.23 units/mL in the enoxaparin group, 1.20 U/mL in the 200-mg group, and 1.16 U/mL in the 300-mg group.
In patients with an average factor XI level of 0.2 U/mL or less, the incidence of the primary efficacy outcome was 5%.
Isis Pharmaceuticals funded the study. Dr. Büller disclosed ties with Isis, Daiichi-Sankyo, Bayer Healthcare, Pfizer, and Bristol-Myers Squibb. Dr. Flaumenhaft reported having no disclosures.
SAN FRANCISCO – Reducing factor XI levels with the experimental antisense oligonucleotide FXI-ASO lowered venous thromboembolism rates after total knee arthroplasty without increasing bleeding in a phase II study.
Venous thromboembolism (VTE) rates were 30% among controls (21/69) on enoxaparin (Lovenox) 40 mg, compared with 27% for patients (36/134) given FXI-ASO 200 mg and 4% for those (3/71) given FXI-ASO 300 mg. Low-dose FXI-ASO was noninferior to enoxaparin (P = .59), while the high-dose regimen was superior (P < .001).
A 4% VTE rate “has never ever been seen before in patients undergoing knee surgery,” Dr. Harry Büller said during the late-breaking abstract session at the annual meeting of the American Society of Hematology.
The strategy of targeting factor XI is based on the understanding that patients with factor XI deficiency (plasma levels < 20% of normal) have a reduced risk of deep vein thrombosis (DVT). Experimental data in mice and primates also suggest that reducing factor XI attenuates thrombosis without excess bleeding.
Among the 300 patients in the open-label study, major or clinically relevant bleeding occurred in 3% of both FXI-ASO groups and 8% of the enoxaparin group (P = .09).
The findings provide the first evidence in humans that the factor XI intrinsic pathway is one of the drivers of postoperative thrombosis and support the concept that thrombosis and hemostasis can be dissociated, said Dr. Büller of the Academic Medical Center, Amsterdam.
“FXI-ASO is a promising new investigational antithrombotic agent and I believe you are witnessing the birth of a new class of antithrombotic agents,” he concluded.
During a press conference, Dr. Büller confided to reporters that he felt like a boy in a candy store, finally able to reveal the superb study findings.
Dr. Robert Flaumenhaft of Harvard Medical School, Boston, was far less effusive in an editorial that accompanied the simultaneous publication of the study in the New England Journal of Medicine.
“Do these finding prove that reduction in factor XI levels inhibits thrombosis without affecting bleeding? The conservative answer is no,” he wrote.
Dr. Flaumenhaft observed that the incidence of clinically relevant bleeding is relatively low after knee arthroplasty, even when patients receive anticoagulants, and that this safety outcome did not differ significantly between the enoxaparin and 300-mg FXI-ASO groups.
“These results also do not make a compelling case for the clinical use of the factor XI antisense oligonucleotide over anticoagulants that are currently used for prophylaxis in patients undergoing knee arthroplasty,” he wrote.
Central to this argument are issues of convenience and questions regarding reversibility. Treatment began 36 days before surgery and was associated with a high incidence of adverse events at the injection site and factor XI levels remained about 60% lower 70 days after initiation of therapy.
The half-life of FXI-ASO is about 22 days, “which in the classical setting in terms of bleeding could be seen as something of a disadvantage,” Dr. Büller told reporters. “But if we do the next study and it shows to be safe, it turns into an advantage” … because there is the possibility of giving FXI-ASO once every 3 weeks.
Dr. Flaumenhaft closed the editorial by acknowledging that the study challenges “the current paradigm” regarding the primary mechanism responsible for fibrin formation during thrombosis. “The striking observation that reducing factor XI levels prevents thrombosis after knee arthroplasty provides the best clinical evidence to date that the intrinsic pathway is essential for thrombus formation,” he wrote.
The study was conducted at 19 centers in five countries and randomly assigned 300 patients scheduled for elective primary unilateral total-knee arthroplasty to daily enoxaparin 40 mg or three doses of FXI-ASO. The protocol was amended early on to exclude a 100-mg FXI-ASO dose.
FXI-ASO 200 mg or 300 mg was given subcutaneously beginning 36 days before surgery on days 1, 3, 5, 8, 15, 22, and 29, and 6 hours postoperatively, with a final dose on day 39.
Enoxaparin 40 mg was given subcutaneously once daily, beginning the evening before or 6-8 hours after surgery, according to investigator preference, and was continued for at least 8 days postoperatively.
The primary efficacy point was a composite of asymptomatic DVT, detected by venography, and confirmed symptomatic VTE.
At baseline, the average factor XI level was 1.23 units/mL in the enoxaparin group, 1.20 U/mL in the 200-mg group, and 1.16 U/mL in the 300-mg group.
In patients with an average factor XI level of 0.2 U/mL or less, the incidence of the primary efficacy outcome was 5%.
Isis Pharmaceuticals funded the study. Dr. Büller disclosed ties with Isis, Daiichi-Sankyo, Bayer Healthcare, Pfizer, and Bristol-Myers Squibb. Dr. Flaumenhaft reported having no disclosures.
SAN FRANCISCO – Reducing factor XI levels with the experimental antisense oligonucleotide FXI-ASO lowered venous thromboembolism rates after total knee arthroplasty without increasing bleeding in a phase II study.
Venous thromboembolism (VTE) rates were 30% among controls (21/69) on enoxaparin (Lovenox) 40 mg, compared with 27% for patients (36/134) given FXI-ASO 200 mg and 4% for those (3/71) given FXI-ASO 300 mg. Low-dose FXI-ASO was noninferior to enoxaparin (P = .59), while the high-dose regimen was superior (P < .001).
A 4% VTE rate “has never ever been seen before in patients undergoing knee surgery,” Dr. Harry Büller said during the late-breaking abstract session at the annual meeting of the American Society of Hematology.
The strategy of targeting factor XI is based on the understanding that patients with factor XI deficiency (plasma levels < 20% of normal) have a reduced risk of deep vein thrombosis (DVT). Experimental data in mice and primates also suggest that reducing factor XI attenuates thrombosis without excess bleeding.
Among the 300 patients in the open-label study, major or clinically relevant bleeding occurred in 3% of both FXI-ASO groups and 8% of the enoxaparin group (P = .09).
The findings provide the first evidence in humans that the factor XI intrinsic pathway is one of the drivers of postoperative thrombosis and support the concept that thrombosis and hemostasis can be dissociated, said Dr. Büller of the Academic Medical Center, Amsterdam.
“FXI-ASO is a promising new investigational antithrombotic agent and I believe you are witnessing the birth of a new class of antithrombotic agents,” he concluded.
During a press conference, Dr. Büller confided to reporters that he felt like a boy in a candy store, finally able to reveal the superb study findings.
Dr. Robert Flaumenhaft of Harvard Medical School, Boston, was far less effusive in an editorial that accompanied the simultaneous publication of the study in the New England Journal of Medicine.
“Do these finding prove that reduction in factor XI levels inhibits thrombosis without affecting bleeding? The conservative answer is no,” he wrote.
Dr. Flaumenhaft observed that the incidence of clinically relevant bleeding is relatively low after knee arthroplasty, even when patients receive anticoagulants, and that this safety outcome did not differ significantly between the enoxaparin and 300-mg FXI-ASO groups.
“These results also do not make a compelling case for the clinical use of the factor XI antisense oligonucleotide over anticoagulants that are currently used for prophylaxis in patients undergoing knee arthroplasty,” he wrote.
Central to this argument are issues of convenience and questions regarding reversibility. Treatment began 36 days before surgery and was associated with a high incidence of adverse events at the injection site and factor XI levels remained about 60% lower 70 days after initiation of therapy.
The half-life of FXI-ASO is about 22 days, “which in the classical setting in terms of bleeding could be seen as something of a disadvantage,” Dr. Büller told reporters. “But if we do the next study and it shows to be safe, it turns into an advantage” … because there is the possibility of giving FXI-ASO once every 3 weeks.
Dr. Flaumenhaft closed the editorial by acknowledging that the study challenges “the current paradigm” regarding the primary mechanism responsible for fibrin formation during thrombosis. “The striking observation that reducing factor XI levels prevents thrombosis after knee arthroplasty provides the best clinical evidence to date that the intrinsic pathway is essential for thrombus formation,” he wrote.
The study was conducted at 19 centers in five countries and randomly assigned 300 patients scheduled for elective primary unilateral total-knee arthroplasty to daily enoxaparin 40 mg or three doses of FXI-ASO. The protocol was amended early on to exclude a 100-mg FXI-ASO dose.
FXI-ASO 200 mg or 300 mg was given subcutaneously beginning 36 days before surgery on days 1, 3, 5, 8, 15, 22, and 29, and 6 hours postoperatively, with a final dose on day 39.
Enoxaparin 40 mg was given subcutaneously once daily, beginning the evening before or 6-8 hours after surgery, according to investigator preference, and was continued for at least 8 days postoperatively.
The primary efficacy point was a composite of asymptomatic DVT, detected by venography, and confirmed symptomatic VTE.
At baseline, the average factor XI level was 1.23 units/mL in the enoxaparin group, 1.20 U/mL in the 200-mg group, and 1.16 U/mL in the 300-mg group.
In patients with an average factor XI level of 0.2 U/mL or less, the incidence of the primary efficacy outcome was 5%.
Isis Pharmaceuticals funded the study. Dr. Büller disclosed ties with Isis, Daiichi-Sankyo, Bayer Healthcare, Pfizer, and Bristol-Myers Squibb. Dr. Flaumenhaft reported having no disclosures.
AT ASH 2014
Key clinical point: Reducing factor XI levels with FXI-ASO was effective in preventing VTE in patients undergoing knee arthroplasty and appeared safe with respect to bleeding risk.
Major finding: The primary VTE endpoint occurred in 4% of patients on FXI-ASO 300 mg, 27% on FXI-ASO 200 mg, and 30% on enoxaparin.
Data source: Open-label, parallel-group phase II study of 300 patients undergoing primary unilateral total-knee arthroplasty.
Disclosures: Isis Pharmaceuticals funded the study. Dr. Büller disclosed ties with Isis, Daiichi-Sankyo, Bayer Healthcare, Pfizer, and Bristol-Myers Squibb. Dr. Flaumenhaft reported having no disclosures.
In co-management, do what’s best for the patient in a timely fashion
Deferring management of a postop complication to the surgery team resulted in treatment delay with a serious adverse outcome.
History:
RR is a 54 year-old man with a medical history of hypertension, hyperlipidemia, obesity, and chronic left knee pain from osteoarthritis. He was admitted to the hospital and underwent an elective left total knee replacement with monitored anesthesia care, combined with a left femoral nerve block. There were no intraoperative complications. When RR awoke in the recovery unit, he was in excruciating pain. He received another femoral nerve block and was sent to the regular nursing floor around 4 p.m. By early evening, the pain in his left leg remained poorly controlled and was consistently rated as 10/10. In addition, RR’s heart rates were elevated (130-140 bpm). The orthopedic surgeon was notified of the uncontrolled pain and elevated heart rates and he requested a hospitalist consult.
Dr. Hospitalist saw RR sometime before 9 p.m. that evening. RR was somewhat sedated by opiate analgesics, and his wife was at the bedside. During the interview, she related that her husband had been taking nightly benzodiazepines for sleep for several months leading up to the surgery. Dr. Hospitalist did not examine RR’s left foot and leg, and he documented in his consult that he was deferring left leg issues such as bleeding and swelling to the orthopedic surgery team. Dr. Hospitalist’s impression was that RR had sinus tachycardia, possibly because of the benzodiazepine withdrawal. Fluids were ordered along with low-dose benzodiazepines.
Throughout the night, RR awakened and complained of severe pain. The evening nurse charted that RR was having difficulty moving the toes on his left foot and that the pulses in his foot were barely palpable. By the early morning, RR’s pulses were no longer palpable but could still be detected by Doppler. Examination by the surgical team the following morning documented that RR had decreased sensation in his left lower extremity as well. An ultrasound of the left leg was ordered and revealed a large left popliteal pseudoaneurysm with complete occlusion of the left popliteal, tibial, and peroneal arteries below the knee. The patient went to the operating room three times over the next 4 days in an attempt to revascularize the leg. Unfortunately, RR ultimately had an above-the-knee amputation (AKA) performed 9 days after his elective total knee replacement.
Complaint:
RR sought a “quality of life”–enhancing procedure for his chronic left knee pain. What he ended up with was an AKA and a significant decrease in his overall quality of life. RR was angry that his postoperative pain, which was out of proportion to what should have been expected for this type of surgery, was essentially ignored until it was too late. He blamed the surgeon and the hospitalist for failing to diagnose his condition while his leg was still salvageable.
Scientific principles:
Complications during and after total knee replacement are generally uncommon and can often be prevented with meticulous surgical technique and with attentive postoperative management. Vascular injuries in total knee arthroplasty are exceedingly rare, but careful examination of the limbs is necessary to detect signs of acute limb ischemia. The six P’s of acute ischemia include paresthesia, pain, pallor, pulselessness, poikilothermia, and paralysis. A diagnosis of acute lower extremity ischemia can generally be made based upon the history and physical examination. Once the diagnosis of acute arterial occlusion has been made, anticoagulation should be initiated. Subsequent treatment varies depending upon the classification of acute ischemia. The initial options include catheter-directed thrombolytic therapy with or without percutaneous intervention or surgery.
Complaint rebuttal and discussion:
Dr. Hospitalist defended himself by limiting his scope of responsibility. He essentially said this was a surgical complication, and it was therefore the surgical team’s responsibility to make the diagnosis. Defense experts were quick to affirm that Dr. Hospitalist was consulted for a specific issue – postoperative tachycardia – and that he performed a focused history and physical examination to address that issue. Plaintiff experts cited the Society of Hospital Medicine Hospitalist Orthopedic Co-Management Implementation Guide, which outlines that co-management is the “shared responsibility, authority, and accountability for the care of a hospitalized patient.” The Guide further states: “Inevitably, there will be circumstances where either of the co-managing services could manage a specific problem, or where it is unclear which service would be best equipped to manage a specific problem. These situations can be best managed by following two basic principles: 1) Do what is best for the patient in a timely fashion and do not assume that a problem is being handled by the other service; and 2) communicate frequently and directly with the other service.” Plaintiff experts argued that Dr. Hospitalist failed to follow both of these principles.
Conclusion:
Hospitalists are frequently co-managers of surgical patients, and thus they are in part responsible for evaluating diagnosing, and treating both medical and surgical complications. Once again, it is vital that hospitalists delineate responsibilities explicitly through direct communication and then memorialize such discussions in the medical record. In this case, the chart consultation deferred examination of the operative leg to a surgical team that claimed they were “unaware” of any issues. This case was settled on behalf of the patient for an undisclosed amount.
Dr. Michota is director of academic affairs in the hospital medicine department at the Cleveland Clinic and medical editor of Hospitalist News. He has been involved in peer review both within and outside the legal system. Read past columns at eHospitalist news.com/Lessons.
Deferring management of a postop complication to the surgery team resulted in treatment delay with a serious adverse outcome.
History:
RR is a 54 year-old man with a medical history of hypertension, hyperlipidemia, obesity, and chronic left knee pain from osteoarthritis. He was admitted to the hospital and underwent an elective left total knee replacement with monitored anesthesia care, combined with a left femoral nerve block. There were no intraoperative complications. When RR awoke in the recovery unit, he was in excruciating pain. He received another femoral nerve block and was sent to the regular nursing floor around 4 p.m. By early evening, the pain in his left leg remained poorly controlled and was consistently rated as 10/10. In addition, RR’s heart rates were elevated (130-140 bpm). The orthopedic surgeon was notified of the uncontrolled pain and elevated heart rates and he requested a hospitalist consult.
Dr. Hospitalist saw RR sometime before 9 p.m. that evening. RR was somewhat sedated by opiate analgesics, and his wife was at the bedside. During the interview, she related that her husband had been taking nightly benzodiazepines for sleep for several months leading up to the surgery. Dr. Hospitalist did not examine RR’s left foot and leg, and he documented in his consult that he was deferring left leg issues such as bleeding and swelling to the orthopedic surgery team. Dr. Hospitalist’s impression was that RR had sinus tachycardia, possibly because of the benzodiazepine withdrawal. Fluids were ordered along with low-dose benzodiazepines.
Throughout the night, RR awakened and complained of severe pain. The evening nurse charted that RR was having difficulty moving the toes on his left foot and that the pulses in his foot were barely palpable. By the early morning, RR’s pulses were no longer palpable but could still be detected by Doppler. Examination by the surgical team the following morning documented that RR had decreased sensation in his left lower extremity as well. An ultrasound of the left leg was ordered and revealed a large left popliteal pseudoaneurysm with complete occlusion of the left popliteal, tibial, and peroneal arteries below the knee. The patient went to the operating room three times over the next 4 days in an attempt to revascularize the leg. Unfortunately, RR ultimately had an above-the-knee amputation (AKA) performed 9 days after his elective total knee replacement.
Complaint:
RR sought a “quality of life”–enhancing procedure for his chronic left knee pain. What he ended up with was an AKA and a significant decrease in his overall quality of life. RR was angry that his postoperative pain, which was out of proportion to what should have been expected for this type of surgery, was essentially ignored until it was too late. He blamed the surgeon and the hospitalist for failing to diagnose his condition while his leg was still salvageable.
Scientific principles:
Complications during and after total knee replacement are generally uncommon and can often be prevented with meticulous surgical technique and with attentive postoperative management. Vascular injuries in total knee arthroplasty are exceedingly rare, but careful examination of the limbs is necessary to detect signs of acute limb ischemia. The six P’s of acute ischemia include paresthesia, pain, pallor, pulselessness, poikilothermia, and paralysis. A diagnosis of acute lower extremity ischemia can generally be made based upon the history and physical examination. Once the diagnosis of acute arterial occlusion has been made, anticoagulation should be initiated. Subsequent treatment varies depending upon the classification of acute ischemia. The initial options include catheter-directed thrombolytic therapy with or without percutaneous intervention or surgery.
Complaint rebuttal and discussion:
Dr. Hospitalist defended himself by limiting his scope of responsibility. He essentially said this was a surgical complication, and it was therefore the surgical team’s responsibility to make the diagnosis. Defense experts were quick to affirm that Dr. Hospitalist was consulted for a specific issue – postoperative tachycardia – and that he performed a focused history and physical examination to address that issue. Plaintiff experts cited the Society of Hospital Medicine Hospitalist Orthopedic Co-Management Implementation Guide, which outlines that co-management is the “shared responsibility, authority, and accountability for the care of a hospitalized patient.” The Guide further states: “Inevitably, there will be circumstances where either of the co-managing services could manage a specific problem, or where it is unclear which service would be best equipped to manage a specific problem. These situations can be best managed by following two basic principles: 1) Do what is best for the patient in a timely fashion and do not assume that a problem is being handled by the other service; and 2) communicate frequently and directly with the other service.” Plaintiff experts argued that Dr. Hospitalist failed to follow both of these principles.
Conclusion:
Hospitalists are frequently co-managers of surgical patients, and thus they are in part responsible for evaluating diagnosing, and treating both medical and surgical complications. Once again, it is vital that hospitalists delineate responsibilities explicitly through direct communication and then memorialize such discussions in the medical record. In this case, the chart consultation deferred examination of the operative leg to a surgical team that claimed they were “unaware” of any issues. This case was settled on behalf of the patient for an undisclosed amount.
Dr. Michota is director of academic affairs in the hospital medicine department at the Cleveland Clinic and medical editor of Hospitalist News. He has been involved in peer review both within and outside the legal system. Read past columns at eHospitalist news.com/Lessons.
Deferring management of a postop complication to the surgery team resulted in treatment delay with a serious adverse outcome.
History:
RR is a 54 year-old man with a medical history of hypertension, hyperlipidemia, obesity, and chronic left knee pain from osteoarthritis. He was admitted to the hospital and underwent an elective left total knee replacement with monitored anesthesia care, combined with a left femoral nerve block. There were no intraoperative complications. When RR awoke in the recovery unit, he was in excruciating pain. He received another femoral nerve block and was sent to the regular nursing floor around 4 p.m. By early evening, the pain in his left leg remained poorly controlled and was consistently rated as 10/10. In addition, RR’s heart rates were elevated (130-140 bpm). The orthopedic surgeon was notified of the uncontrolled pain and elevated heart rates and he requested a hospitalist consult.
Dr. Hospitalist saw RR sometime before 9 p.m. that evening. RR was somewhat sedated by opiate analgesics, and his wife was at the bedside. During the interview, she related that her husband had been taking nightly benzodiazepines for sleep for several months leading up to the surgery. Dr. Hospitalist did not examine RR’s left foot and leg, and he documented in his consult that he was deferring left leg issues such as bleeding and swelling to the orthopedic surgery team. Dr. Hospitalist’s impression was that RR had sinus tachycardia, possibly because of the benzodiazepine withdrawal. Fluids were ordered along with low-dose benzodiazepines.
Throughout the night, RR awakened and complained of severe pain. The evening nurse charted that RR was having difficulty moving the toes on his left foot and that the pulses in his foot were barely palpable. By the early morning, RR’s pulses were no longer palpable but could still be detected by Doppler. Examination by the surgical team the following morning documented that RR had decreased sensation in his left lower extremity as well. An ultrasound of the left leg was ordered and revealed a large left popliteal pseudoaneurysm with complete occlusion of the left popliteal, tibial, and peroneal arteries below the knee. The patient went to the operating room three times over the next 4 days in an attempt to revascularize the leg. Unfortunately, RR ultimately had an above-the-knee amputation (AKA) performed 9 days after his elective total knee replacement.
Complaint:
RR sought a “quality of life”–enhancing procedure for his chronic left knee pain. What he ended up with was an AKA and a significant decrease in his overall quality of life. RR was angry that his postoperative pain, which was out of proportion to what should have been expected for this type of surgery, was essentially ignored until it was too late. He blamed the surgeon and the hospitalist for failing to diagnose his condition while his leg was still salvageable.
Scientific principles:
Complications during and after total knee replacement are generally uncommon and can often be prevented with meticulous surgical technique and with attentive postoperative management. Vascular injuries in total knee arthroplasty are exceedingly rare, but careful examination of the limbs is necessary to detect signs of acute limb ischemia. The six P’s of acute ischemia include paresthesia, pain, pallor, pulselessness, poikilothermia, and paralysis. A diagnosis of acute lower extremity ischemia can generally be made based upon the history and physical examination. Once the diagnosis of acute arterial occlusion has been made, anticoagulation should be initiated. Subsequent treatment varies depending upon the classification of acute ischemia. The initial options include catheter-directed thrombolytic therapy with or without percutaneous intervention or surgery.
Complaint rebuttal and discussion:
Dr. Hospitalist defended himself by limiting his scope of responsibility. He essentially said this was a surgical complication, and it was therefore the surgical team’s responsibility to make the diagnosis. Defense experts were quick to affirm that Dr. Hospitalist was consulted for a specific issue – postoperative tachycardia – and that he performed a focused history and physical examination to address that issue. Plaintiff experts cited the Society of Hospital Medicine Hospitalist Orthopedic Co-Management Implementation Guide, which outlines that co-management is the “shared responsibility, authority, and accountability for the care of a hospitalized patient.” The Guide further states: “Inevitably, there will be circumstances where either of the co-managing services could manage a specific problem, or where it is unclear which service would be best equipped to manage a specific problem. These situations can be best managed by following two basic principles: 1) Do what is best for the patient in a timely fashion and do not assume that a problem is being handled by the other service; and 2) communicate frequently and directly with the other service.” Plaintiff experts argued that Dr. Hospitalist failed to follow both of these principles.
Conclusion:
Hospitalists are frequently co-managers of surgical patients, and thus they are in part responsible for evaluating diagnosing, and treating both medical and surgical complications. Once again, it is vital that hospitalists delineate responsibilities explicitly through direct communication and then memorialize such discussions in the medical record. In this case, the chart consultation deferred examination of the operative leg to a surgical team that claimed they were “unaware” of any issues. This case was settled on behalf of the patient for an undisclosed amount.
Dr. Michota is director of academic affairs in the hospital medicine department at the Cleveland Clinic and medical editor of Hospitalist News. He has been involved in peer review both within and outside the legal system. Read past columns at eHospitalist news.com/Lessons.
Combo skin prep solution reduces cesarean SSIs in obese women
SAN DIEGO – The combination of povidone-iodine with chlorhexidine with alcohol reduced the rate of surgical site infections by 83% in obese women undergoing nonemergency cesarean deliveries, according to the results of a large randomized trial.
But among women with a lower body mass index (BMI < 40 kg/m2), there were no overall differences in surgical site infection (SSI) rates using either povidone-iodine with alcohol, chlorhexidine with alcohol, or a combination of both agents for the preparation of cesarean delivery.
“Body surface area is greater in this subset of patients, so the volume of prep solution could have played a role,” Dr. Ivan Ngai, one of the researchers, said in an interview. “Also, it’s known that the organism that colonizes skin in obese persons, compared with nonobese persons, is different, especially increased colonization by fungus. We think that’s why the prep combination played a role, because iodine is better against fungi than chlorhexidine.”
In what Dr. Ngai said is among the largest studies of its kind for cesarean deliveries, he and his associates randomized 1,404 women at greater than 37 weeks’ gestational age undergoing a nonemergent cesarean section between January 2013 and July 2014 to receive one of three preparations: povidone-iodine plus alcohol (povidone group); chlorhexidine plus alcohol (chlorhexidine group), or povidone-iodine plus alcohol and chlorhexidine plus alcohol (combination group).
The primary outcome was the rate of SSI within 30 days of the cesarean delivery. The researchers used univariate and multivariable regression models to determine whether specific prep groups and other clinical variables were independent predictors of SSI. They presented their findings at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The mean age of the study participants was 30 years old. Dr. Ngai reported that 457 women in the povidone group completed follow-up, compared with 454 in the chlorhexidine group and 454 patients in the combination group.
There were 60 (4.3%) SSIs, with no differences between skin prep groups in demographics, medical disorders, indications for cesarean, operative time, blood loss, or SSI rates. The SSI rate of 4.3% “was much lower than the 9%-14% usually reported in cesarean birth,” Dr. Ngai said. “We think it’s lower because we did not include cases of emergent cesarean delivery.”
Multivariable analysis revealed that increasing maternal BMI, excessive blood loss (greater than 1,000 mL), and preeclampsia were independent predictors of SSIs. Women in the combination group who had a BMI of 40 kg/m2 or greater had an 83% reduction in SSI (odds ratio, 0.17; P = .02).
While a formal cost analysis was not conducted, each surgical site infection averages about $3,500 extra health care dollars per event, said Dr. Ngai of the department of obstetrics and gynecology and women’s health at Albert Einstein College of Medicine, New York.
In the subgroup of patients with a BMI of 40 kg/m2 or greater, the researchers estimated that they would have to use combination prep on about 12 patients to prevent one SSI infection. This compared with using chlorhexidine prep alone on 21 patients to prevent one SSI infection.
“In a nonobese population, the difference between povidone-iodine or chlorhexidine or combination of the two with alcohol makes no difference in preventing SSI,” Dr. Ngai concluded. “But in the obese population, the combination of povidone-iodine with chlorhexidine with alcohol plays a significant role in reducing the SSI rate.”
The researchers reported having no relevant financial conflicts.
On Twitter @dougbrunk
SAN DIEGO – The combination of povidone-iodine with chlorhexidine with alcohol reduced the rate of surgical site infections by 83% in obese women undergoing nonemergency cesarean deliveries, according to the results of a large randomized trial.
But among women with a lower body mass index (BMI < 40 kg/m2), there were no overall differences in surgical site infection (SSI) rates using either povidone-iodine with alcohol, chlorhexidine with alcohol, or a combination of both agents for the preparation of cesarean delivery.
“Body surface area is greater in this subset of patients, so the volume of prep solution could have played a role,” Dr. Ivan Ngai, one of the researchers, said in an interview. “Also, it’s known that the organism that colonizes skin in obese persons, compared with nonobese persons, is different, especially increased colonization by fungus. We think that’s why the prep combination played a role, because iodine is better against fungi than chlorhexidine.”
In what Dr. Ngai said is among the largest studies of its kind for cesarean deliveries, he and his associates randomized 1,404 women at greater than 37 weeks’ gestational age undergoing a nonemergent cesarean section between January 2013 and July 2014 to receive one of three preparations: povidone-iodine plus alcohol (povidone group); chlorhexidine plus alcohol (chlorhexidine group), or povidone-iodine plus alcohol and chlorhexidine plus alcohol (combination group).
The primary outcome was the rate of SSI within 30 days of the cesarean delivery. The researchers used univariate and multivariable regression models to determine whether specific prep groups and other clinical variables were independent predictors of SSI. They presented their findings at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The mean age of the study participants was 30 years old. Dr. Ngai reported that 457 women in the povidone group completed follow-up, compared with 454 in the chlorhexidine group and 454 patients in the combination group.
There were 60 (4.3%) SSIs, with no differences between skin prep groups in demographics, medical disorders, indications for cesarean, operative time, blood loss, or SSI rates. The SSI rate of 4.3% “was much lower than the 9%-14% usually reported in cesarean birth,” Dr. Ngai said. “We think it’s lower because we did not include cases of emergent cesarean delivery.”
Multivariable analysis revealed that increasing maternal BMI, excessive blood loss (greater than 1,000 mL), and preeclampsia were independent predictors of SSIs. Women in the combination group who had a BMI of 40 kg/m2 or greater had an 83% reduction in SSI (odds ratio, 0.17; P = .02).
While a formal cost analysis was not conducted, each surgical site infection averages about $3,500 extra health care dollars per event, said Dr. Ngai of the department of obstetrics and gynecology and women’s health at Albert Einstein College of Medicine, New York.
In the subgroup of patients with a BMI of 40 kg/m2 or greater, the researchers estimated that they would have to use combination prep on about 12 patients to prevent one SSI infection. This compared with using chlorhexidine prep alone on 21 patients to prevent one SSI infection.
“In a nonobese population, the difference between povidone-iodine or chlorhexidine or combination of the two with alcohol makes no difference in preventing SSI,” Dr. Ngai concluded. “But in the obese population, the combination of povidone-iodine with chlorhexidine with alcohol plays a significant role in reducing the SSI rate.”
The researchers reported having no relevant financial conflicts.
On Twitter @dougbrunk
SAN DIEGO – The combination of povidone-iodine with chlorhexidine with alcohol reduced the rate of surgical site infections by 83% in obese women undergoing nonemergency cesarean deliveries, according to the results of a large randomized trial.
But among women with a lower body mass index (BMI < 40 kg/m2), there were no overall differences in surgical site infection (SSI) rates using either povidone-iodine with alcohol, chlorhexidine with alcohol, or a combination of both agents for the preparation of cesarean delivery.
“Body surface area is greater in this subset of patients, so the volume of prep solution could have played a role,” Dr. Ivan Ngai, one of the researchers, said in an interview. “Also, it’s known that the organism that colonizes skin in obese persons, compared with nonobese persons, is different, especially increased colonization by fungus. We think that’s why the prep combination played a role, because iodine is better against fungi than chlorhexidine.”
In what Dr. Ngai said is among the largest studies of its kind for cesarean deliveries, he and his associates randomized 1,404 women at greater than 37 weeks’ gestational age undergoing a nonemergent cesarean section between January 2013 and July 2014 to receive one of three preparations: povidone-iodine plus alcohol (povidone group); chlorhexidine plus alcohol (chlorhexidine group), or povidone-iodine plus alcohol and chlorhexidine plus alcohol (combination group).
The primary outcome was the rate of SSI within 30 days of the cesarean delivery. The researchers used univariate and multivariable regression models to determine whether specific prep groups and other clinical variables were independent predictors of SSI. They presented their findings at the annual Pregnancy Meeting sponsored by the Society for Maternal-Fetal Medicine.
The mean age of the study participants was 30 years old. Dr. Ngai reported that 457 women in the povidone group completed follow-up, compared with 454 in the chlorhexidine group and 454 patients in the combination group.
There were 60 (4.3%) SSIs, with no differences between skin prep groups in demographics, medical disorders, indications for cesarean, operative time, blood loss, or SSI rates. The SSI rate of 4.3% “was much lower than the 9%-14% usually reported in cesarean birth,” Dr. Ngai said. “We think it’s lower because we did not include cases of emergent cesarean delivery.”
Multivariable analysis revealed that increasing maternal BMI, excessive blood loss (greater than 1,000 mL), and preeclampsia were independent predictors of SSIs. Women in the combination group who had a BMI of 40 kg/m2 or greater had an 83% reduction in SSI (odds ratio, 0.17; P = .02).
While a formal cost analysis was not conducted, each surgical site infection averages about $3,500 extra health care dollars per event, said Dr. Ngai of the department of obstetrics and gynecology and women’s health at Albert Einstein College of Medicine, New York.
In the subgroup of patients with a BMI of 40 kg/m2 or greater, the researchers estimated that they would have to use combination prep on about 12 patients to prevent one SSI infection. This compared with using chlorhexidine prep alone on 21 patients to prevent one SSI infection.
“In a nonobese population, the difference between povidone-iodine or chlorhexidine or combination of the two with alcohol makes no difference in preventing SSI,” Dr. Ngai concluded. “But in the obese population, the combination of povidone-iodine with chlorhexidine with alcohol plays a significant role in reducing the SSI rate.”
The researchers reported having no relevant financial conflicts.
On Twitter @dougbrunk
AT THE PREGNANCY MEETING
Key clinical point: The combination of povidone-iodine with chlorhexidine plus alcohol plays a significant role in reducing the rate of surgical site infections for the preparation of cesarean delivery in women with a BMI of 40 kg/m2or greater. The association was not observed in women with a lower body mass index.
Major finding: Women who received a combination of povidone-iodine with chlorhexidine plus alcohol and who had a BMI of 40 kg/m2 or greater had an 83% reduction in surgical site infections.
Data source: A randomized, controlled trial of 1,404 pregnant women undergoing nonemergent cesarean section between January 2013 and July 2014.
Disclosures:The researchers reported having no financial disclosures.
FDA approves first internal tissue adhesive for use in abdominoplasty
The Food and Drug Administration has approved a urethane-based surgical adhesive for use during abdominoplasty, the first synthetic tissue adhesive approved for internal use, the FDA announced on Feb. 4.
The approved indication for the adhesive, called TissuGlu, is for “the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.” The use of this product “will help some abdominoplasty patients get back to their daily routine after surgery more quickly than if surgical drains had been inserted,” Dr. William Maisel, deputy director for science at the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.
To apply TissuGlu, the surgeon uses a hand-held applicator to apply drops of the adhesive to the tissue surface, then positions the abdominoplasty flap in place. “Water in the patient’s tissue starts a chemical reaction that bonds the flaps together. The surgeon then proceeds with standard closure of the skin using sutures,” according to the statement, which adds that use of an internal adhesive to connect the tissue flaps “may reduce or eliminate the need for postoperative surgical draining of fluid between the abdominoplasty tissue flaps.”
The data reviewed by the FDA included a study of 130 patients who were undergoing an elective abdominoplasty; surgical drains were used in half of the patients and half received TissuGlu only. Among those who received TissuGlu only, 73% required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps, but those who needed interventions “were more likely to require another operation to insert surgical drains,” the statement said.
Patients treated with TissuGlu who did not require a surgical drain were “generally able to return to most daily activities such as showering, climbing stairs, and resuming their usual routines sooner than those who had surgical drains,” but the levels of surgery-related pain or discomfort reported by the patients were not different between the two groups.
Cohera Medical is the manufacturer of TissuGlu, which has been on the market in the European Union since 2011, according to the company.
TissuGlu was reviewed at a meeting of the FDA’s general and plastic surgery devices advisory panel in August 2014.
Information on the approval, as well as patient and physician labeling, is available on the FDA website.
The Food and Drug Administration has approved a urethane-based surgical adhesive for use during abdominoplasty, the first synthetic tissue adhesive approved for internal use, the FDA announced on Feb. 4.
The approved indication for the adhesive, called TissuGlu, is for “the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.” The use of this product “will help some abdominoplasty patients get back to their daily routine after surgery more quickly than if surgical drains had been inserted,” Dr. William Maisel, deputy director for science at the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.
To apply TissuGlu, the surgeon uses a hand-held applicator to apply drops of the adhesive to the tissue surface, then positions the abdominoplasty flap in place. “Water in the patient’s tissue starts a chemical reaction that bonds the flaps together. The surgeon then proceeds with standard closure of the skin using sutures,” according to the statement, which adds that use of an internal adhesive to connect the tissue flaps “may reduce or eliminate the need for postoperative surgical draining of fluid between the abdominoplasty tissue flaps.”
The data reviewed by the FDA included a study of 130 patients who were undergoing an elective abdominoplasty; surgical drains were used in half of the patients and half received TissuGlu only. Among those who received TissuGlu only, 73% required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps, but those who needed interventions “were more likely to require another operation to insert surgical drains,” the statement said.
Patients treated with TissuGlu who did not require a surgical drain were “generally able to return to most daily activities such as showering, climbing stairs, and resuming their usual routines sooner than those who had surgical drains,” but the levels of surgery-related pain or discomfort reported by the patients were not different between the two groups.
Cohera Medical is the manufacturer of TissuGlu, which has been on the market in the European Union since 2011, according to the company.
TissuGlu was reviewed at a meeting of the FDA’s general and plastic surgery devices advisory panel in August 2014.
Information on the approval, as well as patient and physician labeling, is available on the FDA website.
The Food and Drug Administration has approved a urethane-based surgical adhesive for use during abdominoplasty, the first synthetic tissue adhesive approved for internal use, the FDA announced on Feb. 4.
The approved indication for the adhesive, called TissuGlu, is for “the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in abdominoplasty.” The use of this product “will help some abdominoplasty patients get back to their daily routine after surgery more quickly than if surgical drains had been inserted,” Dr. William Maisel, deputy director for science at the FDA’s Center for Devices and Radiological Health, said in the statement announcing the approval.
To apply TissuGlu, the surgeon uses a hand-held applicator to apply drops of the adhesive to the tissue surface, then positions the abdominoplasty flap in place. “Water in the patient’s tissue starts a chemical reaction that bonds the flaps together. The surgeon then proceeds with standard closure of the skin using sutures,” according to the statement, which adds that use of an internal adhesive to connect the tissue flaps “may reduce or eliminate the need for postoperative surgical draining of fluid between the abdominoplasty tissue flaps.”
The data reviewed by the FDA included a study of 130 patients who were undergoing an elective abdominoplasty; surgical drains were used in half of the patients and half received TissuGlu only. Among those who received TissuGlu only, 73% required no postoperative interventions to drain fluid that had accumulated between the abdominoplasty tissue flaps, but those who needed interventions “were more likely to require another operation to insert surgical drains,” the statement said.
Patients treated with TissuGlu who did not require a surgical drain were “generally able to return to most daily activities such as showering, climbing stairs, and resuming their usual routines sooner than those who had surgical drains,” but the levels of surgery-related pain or discomfort reported by the patients were not different between the two groups.
Cohera Medical is the manufacturer of TissuGlu, which has been on the market in the European Union since 2011, according to the company.
TissuGlu was reviewed at a meeting of the FDA’s general and plastic surgery devices advisory panel in August 2014.
Information on the approval, as well as patient and physician labeling, is available on the FDA website.
VIDEO: Postsurgical readmissions present pay-for-performance challenges
The causes of most hospital readmissions after surgery may complicate the use of performance-based reimbursement to reduce such returns.
“The reasons why patients come back after surgery are due to expected complications,” not the worsening of existing medical conditions, noted Dr. Karl Y. Bilimoria of Northwestern University, Chicago, and lead author of a new study on what drives 30-day hospital readmissions after surgery (JAMA 2015;313:483-95).
In a video interview, Dr. Bilimoria discussed the challenges that the timing and causes of postsurgical readmissions present for prevention programs and for pay-for-performance initiatives.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The causes of most hospital readmissions after surgery may complicate the use of performance-based reimbursement to reduce such returns.
“The reasons why patients come back after surgery are due to expected complications,” not the worsening of existing medical conditions, noted Dr. Karl Y. Bilimoria of Northwestern University, Chicago, and lead author of a new study on what drives 30-day hospital readmissions after surgery (JAMA 2015;313:483-95).
In a video interview, Dr. Bilimoria discussed the challenges that the timing and causes of postsurgical readmissions present for prevention programs and for pay-for-performance initiatives.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
The causes of most hospital readmissions after surgery may complicate the use of performance-based reimbursement to reduce such returns.
“The reasons why patients come back after surgery are due to expected complications,” not the worsening of existing medical conditions, noted Dr. Karl Y. Bilimoria of Northwestern University, Chicago, and lead author of a new study on what drives 30-day hospital readmissions after surgery (JAMA 2015;313:483-95).
In a video interview, Dr. Bilimoria discussed the challenges that the timing and causes of postsurgical readmissions present for prevention programs and for pay-for-performance initiatives.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
Study: Surgical readmissions tied to new discharge complications, not prior conditions
Surgical site infection and ileus were the most frequent reason for hospital readmission within 30 days, according to an analysis of data from the National Surgical Quality Improvement Program.
The findings, published online in the Feb. 3 JAMA, suggest that policies that penalize hospitals for readmissions may be ineffective and potentially counterproductive.
Dr. Karl Y. Bilimoria of Northwestern University, Chicago, and his colleagues examined patient data from 346 hospitals participating in the American College of Surgeon’s National Surgical Quality Improvement Program (ACS NSQIP) between January 2012 and December 2012. Readmission rates and reasons were assessed for all surgical procedures and for six representative operations: bariatric surgery, colectomy or proctectomy, hysterectomy, total hip or knee arthroplasty, ventral hernia repair, and lower extremity vascular bypass (JAMA 2015;313;483-95 [doi:10.1001/jama.2014.18614]).
Of the 498, 875 patient sample, the overall readmission rate was 5.7%. For individual procedures, the readmission rate ranged from 3.8% for hysterectomy to 14.9% for lower extremity vascular bypass.
The most common reason for readmission was surgical site infection (SSI; 19.5%), ranging from 11.4% after bariatric surgery to 36.4% after lower extremity vascular bypass. Ileus was the most common reason for readmission after bariatric surgery (24.5%) and the second most common reason overall (10.3%). Other common causes for readmission included dehydration or nutritional deficiency, bleeding or anemia, venous thromboembolism, and prosthesis or graft issues (after arthroplasty and lower extremity vascular bypass procedures). Only 2% of patients were readmitted for the same complication they had experienced during their index hospitalization. Just 3% of patients readmitted for SSIs had experienced an SSI during their index hospitalization.
The results show readmissions after surgery may not be an appropriate measure for pay-for-performance and cost-containment programs, such as the Centers for Medicare & Medicaid Service’s Hospital Readmissions Reduction Program, Dr. Bilimoria said. Performance targets without accepted courses of intervention might be more prone to unintended or ineffective behaviors and consequences, he noted.
“Surgical readmissions mostly reflect postdischarge complications, and readmission rates may be difficult to reduce until effective strategies are put forth to reduce common complications such as SSI,” he said. “Efforts should focus on reducing complication rates overall than simply those that occur after discharge, and this will subsequently reduce readmission rates as well.”
On Twitter @legal_med
These findings provide an unprecedented opportunity to apply these lessons and make substantial reductions in surgical complications, Dr. Lucian L. Leape said in an editorial accompanying the study.
Changing systems is hard work and requires serious commitment. Changing hospital systems is especially difficult because of long-standing traditions and entrenched practices. Successful change requires leadership by those with the will, the determination, and the perseverance to overcome obstacles and motivate colleagues. It requires commitment, which comes from a sense of urgency and a sense of possibility.
One way to develop a sense of urgency is to translate rates into numbers – i.e., actual patients. For example, in this study, surgical site infections accounted for 19.5% of the unplanned readmissions. Even though this only represents 1% of the 498,875 ACS NSQIP patients undergoing surgery in 2012, that 1% equals 5,565 patients. Reducing that number by half would reduce pain and suffering for more than 2,700 patients. If similar success were achieved nationwide, the total would be many times that.
Dr. Lucian L. Leape is with the department of health policy and management at Harvard School of Public Health, Boston, and made these comments in an accompanying editorial (doi:10.1001/jama.2014.18666). He reported having no relevant financial disclosures.
These findings provide an unprecedented opportunity to apply these lessons and make substantial reductions in surgical complications, Dr. Lucian L. Leape said in an editorial accompanying the study.
Changing systems is hard work and requires serious commitment. Changing hospital systems is especially difficult because of long-standing traditions and entrenched practices. Successful change requires leadership by those with the will, the determination, and the perseverance to overcome obstacles and motivate colleagues. It requires commitment, which comes from a sense of urgency and a sense of possibility.
One way to develop a sense of urgency is to translate rates into numbers – i.e., actual patients. For example, in this study, surgical site infections accounted for 19.5% of the unplanned readmissions. Even though this only represents 1% of the 498,875 ACS NSQIP patients undergoing surgery in 2012, that 1% equals 5,565 patients. Reducing that number by half would reduce pain and suffering for more than 2,700 patients. If similar success were achieved nationwide, the total would be many times that.
Dr. Lucian L. Leape is with the department of health policy and management at Harvard School of Public Health, Boston, and made these comments in an accompanying editorial (doi:10.1001/jama.2014.18666). He reported having no relevant financial disclosures.
These findings provide an unprecedented opportunity to apply these lessons and make substantial reductions in surgical complications, Dr. Lucian L. Leape said in an editorial accompanying the study.
Changing systems is hard work and requires serious commitment. Changing hospital systems is especially difficult because of long-standing traditions and entrenched practices. Successful change requires leadership by those with the will, the determination, and the perseverance to overcome obstacles and motivate colleagues. It requires commitment, which comes from a sense of urgency and a sense of possibility.
One way to develop a sense of urgency is to translate rates into numbers – i.e., actual patients. For example, in this study, surgical site infections accounted for 19.5% of the unplanned readmissions. Even though this only represents 1% of the 498,875 ACS NSQIP patients undergoing surgery in 2012, that 1% equals 5,565 patients. Reducing that number by half would reduce pain and suffering for more than 2,700 patients. If similar success were achieved nationwide, the total would be many times that.
Dr. Lucian L. Leape is with the department of health policy and management at Harvard School of Public Health, Boston, and made these comments in an accompanying editorial (doi:10.1001/jama.2014.18666). He reported having no relevant financial disclosures.
Surgical site infection and ileus were the most frequent reason for hospital readmission within 30 days, according to an analysis of data from the National Surgical Quality Improvement Program.
The findings, published online in the Feb. 3 JAMA, suggest that policies that penalize hospitals for readmissions may be ineffective and potentially counterproductive.
Dr. Karl Y. Bilimoria of Northwestern University, Chicago, and his colleagues examined patient data from 346 hospitals participating in the American College of Surgeon’s National Surgical Quality Improvement Program (ACS NSQIP) between January 2012 and December 2012. Readmission rates and reasons were assessed for all surgical procedures and for six representative operations: bariatric surgery, colectomy or proctectomy, hysterectomy, total hip or knee arthroplasty, ventral hernia repair, and lower extremity vascular bypass (JAMA 2015;313;483-95 [doi:10.1001/jama.2014.18614]).
Of the 498, 875 patient sample, the overall readmission rate was 5.7%. For individual procedures, the readmission rate ranged from 3.8% for hysterectomy to 14.9% for lower extremity vascular bypass.
The most common reason for readmission was surgical site infection (SSI; 19.5%), ranging from 11.4% after bariatric surgery to 36.4% after lower extremity vascular bypass. Ileus was the most common reason for readmission after bariatric surgery (24.5%) and the second most common reason overall (10.3%). Other common causes for readmission included dehydration or nutritional deficiency, bleeding or anemia, venous thromboembolism, and prosthesis or graft issues (after arthroplasty and lower extremity vascular bypass procedures). Only 2% of patients were readmitted for the same complication they had experienced during their index hospitalization. Just 3% of patients readmitted for SSIs had experienced an SSI during their index hospitalization.
The results show readmissions after surgery may not be an appropriate measure for pay-for-performance and cost-containment programs, such as the Centers for Medicare & Medicaid Service’s Hospital Readmissions Reduction Program, Dr. Bilimoria said. Performance targets without accepted courses of intervention might be more prone to unintended or ineffective behaviors and consequences, he noted.
“Surgical readmissions mostly reflect postdischarge complications, and readmission rates may be difficult to reduce until effective strategies are put forth to reduce common complications such as SSI,” he said. “Efforts should focus on reducing complication rates overall than simply those that occur after discharge, and this will subsequently reduce readmission rates as well.”
On Twitter @legal_med
Surgical site infection and ileus were the most frequent reason for hospital readmission within 30 days, according to an analysis of data from the National Surgical Quality Improvement Program.
The findings, published online in the Feb. 3 JAMA, suggest that policies that penalize hospitals for readmissions may be ineffective and potentially counterproductive.
Dr. Karl Y. Bilimoria of Northwestern University, Chicago, and his colleagues examined patient data from 346 hospitals participating in the American College of Surgeon’s National Surgical Quality Improvement Program (ACS NSQIP) between January 2012 and December 2012. Readmission rates and reasons were assessed for all surgical procedures and for six representative operations: bariatric surgery, colectomy or proctectomy, hysterectomy, total hip or knee arthroplasty, ventral hernia repair, and lower extremity vascular bypass (JAMA 2015;313;483-95 [doi:10.1001/jama.2014.18614]).
Of the 498, 875 patient sample, the overall readmission rate was 5.7%. For individual procedures, the readmission rate ranged from 3.8% for hysterectomy to 14.9% for lower extremity vascular bypass.
The most common reason for readmission was surgical site infection (SSI; 19.5%), ranging from 11.4% after bariatric surgery to 36.4% after lower extremity vascular bypass. Ileus was the most common reason for readmission after bariatric surgery (24.5%) and the second most common reason overall (10.3%). Other common causes for readmission included dehydration or nutritional deficiency, bleeding or anemia, venous thromboembolism, and prosthesis or graft issues (after arthroplasty and lower extremity vascular bypass procedures). Only 2% of patients were readmitted for the same complication they had experienced during their index hospitalization. Just 3% of patients readmitted for SSIs had experienced an SSI during their index hospitalization.
The results show readmissions after surgery may not be an appropriate measure for pay-for-performance and cost-containment programs, such as the Centers for Medicare & Medicaid Service’s Hospital Readmissions Reduction Program, Dr. Bilimoria said. Performance targets without accepted courses of intervention might be more prone to unintended or ineffective behaviors and consequences, he noted.
“Surgical readmissions mostly reflect postdischarge complications, and readmission rates may be difficult to reduce until effective strategies are put forth to reduce common complications such as SSI,” he said. “Efforts should focus on reducing complication rates overall than simply those that occur after discharge, and this will subsequently reduce readmission rates as well.”
On Twitter @legal_med
Key clinical point: The majority of 30-day readmissions after surgery are associated with new postdischarge complications and not the worsening of medical conditions patients had when initially hospitalized.
Major finding: Of 498,875 patients, the overall unplanned readmission rate was 5.7%. Only 2% of patients were readmitted for the same complication they had experienced during their index hospitalization. The most common reason for readmission was surgical site infections (19.5%).
Data source: A study of 346 hospitals participating in the American College of Surgeon’s National Surgical Quality Improvement Program (ACS NSQIP) between January and December 2012.
Disclosures: The investigators reported no relevant conflicts of interest.
