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Poor health literacy raises readmission risk
JACKSONVILLE, FLA. – Low health literacy is a common problem in Veterans Affairs health systems, and patients with low health literacy scores are 50% more likely to return to the hospital within 30 days of discharge after surgery than patients with high health literacy, investigators found in a study of surgery patients at VA medical centers.
“Low health literacy is prevalent among VA surgery patients and is associated with surgical readmissions,” said Samantha Baker, MD, of the University of Alabama at Birmingham and the VA Birmingham Healthcare System. She presented the findings at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
This study used an instrument developed by Lisa Chew, MD, at the University of Washington to determine health literacy scores (Fam Med. 2004;36:588-94). The instrument uses three questions: how often patients have someone else help them read hospital materials; whether they have problems learning about a medical condition because they have difficulty understanding written information; and how confident they are in filling out their own medical forms. Answers are given on a scale of 0-4, with 12 points being the highest score for poor health literacy. This study considered adequate health literacy to be a score of 0-3, and 4-12 as “possibly inadequate health literacy.”
“Of the 722 patients who took the survey, 39.2% had a score of 0; 33.2% had a score of 4 or more,” Dr. Baker said.
The adequate health literacy group had significantly lower rates of unplanned readmissions and a trend toward lower emergency department visits than the possibly inadequate health literacy group, 11.7% vs. 22.5% (P = .003) for the former and 18.7% vs. 24.2% (P = .08) for the latter, Dr. Baker said.
She noted that the ethnic makeup of the groups was similar and the differences in health literacy among the ethnic groups were not statistically significant.
She also mentioned that those with adequate health literacy tended to be younger – 64 vs. 66.9 years – and more likely to be women (“but our number is low for females in the VA,” Dr. Baker said). She added that married patients tended to have lower heath literacy than did single patients.”
The 30-day surgical readmission rate was 13.7% for patients with high health literacy and 22.5% for those with low health literacy. Patients with inadequate health literacy were 53% more likely to be readmitted to the hospital within 30 days of their index operation, she said. Each one-unit increase in health literacy scores – meaning an increase in inadequate health literacy – increased an individual’s risk of readmission by about 6% on an adjusted basis, Dr. Baker said.
“Future work is going to be focused on identifying these patients and developing the interventions to educate and empower this vulnerable population before they are discharged,” Dr. Baker said.
Dr. Baker and coauthors reported having no financial disclosures.
SOURCE: Baker S et al. Academic Surgical Congress.
JACKSONVILLE, FLA. – Low health literacy is a common problem in Veterans Affairs health systems, and patients with low health literacy scores are 50% more likely to return to the hospital within 30 days of discharge after surgery than patients with high health literacy, investigators found in a study of surgery patients at VA medical centers.
“Low health literacy is prevalent among VA surgery patients and is associated with surgical readmissions,” said Samantha Baker, MD, of the University of Alabama at Birmingham and the VA Birmingham Healthcare System. She presented the findings at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
This study used an instrument developed by Lisa Chew, MD, at the University of Washington to determine health literacy scores (Fam Med. 2004;36:588-94). The instrument uses three questions: how often patients have someone else help them read hospital materials; whether they have problems learning about a medical condition because they have difficulty understanding written information; and how confident they are in filling out their own medical forms. Answers are given on a scale of 0-4, with 12 points being the highest score for poor health literacy. This study considered adequate health literacy to be a score of 0-3, and 4-12 as “possibly inadequate health literacy.”
“Of the 722 patients who took the survey, 39.2% had a score of 0; 33.2% had a score of 4 or more,” Dr. Baker said.
The adequate health literacy group had significantly lower rates of unplanned readmissions and a trend toward lower emergency department visits than the possibly inadequate health literacy group, 11.7% vs. 22.5% (P = .003) for the former and 18.7% vs. 24.2% (P = .08) for the latter, Dr. Baker said.
She noted that the ethnic makeup of the groups was similar and the differences in health literacy among the ethnic groups were not statistically significant.
She also mentioned that those with adequate health literacy tended to be younger – 64 vs. 66.9 years – and more likely to be women (“but our number is low for females in the VA,” Dr. Baker said). She added that married patients tended to have lower heath literacy than did single patients.”
The 30-day surgical readmission rate was 13.7% for patients with high health literacy and 22.5% for those with low health literacy. Patients with inadequate health literacy were 53% more likely to be readmitted to the hospital within 30 days of their index operation, she said. Each one-unit increase in health literacy scores – meaning an increase in inadequate health literacy – increased an individual’s risk of readmission by about 6% on an adjusted basis, Dr. Baker said.
“Future work is going to be focused on identifying these patients and developing the interventions to educate and empower this vulnerable population before they are discharged,” Dr. Baker said.
Dr. Baker and coauthors reported having no financial disclosures.
SOURCE: Baker S et al. Academic Surgical Congress.
JACKSONVILLE, FLA. – Low health literacy is a common problem in Veterans Affairs health systems, and patients with low health literacy scores are 50% more likely to return to the hospital within 30 days of discharge after surgery than patients with high health literacy, investigators found in a study of surgery patients at VA medical centers.
“Low health literacy is prevalent among VA surgery patients and is associated with surgical readmissions,” said Samantha Baker, MD, of the University of Alabama at Birmingham and the VA Birmingham Healthcare System. She presented the findings at the Association for Academic Surgery/Society of University Surgeons Academic Surgical Congress.
This study used an instrument developed by Lisa Chew, MD, at the University of Washington to determine health literacy scores (Fam Med. 2004;36:588-94). The instrument uses three questions: how often patients have someone else help them read hospital materials; whether they have problems learning about a medical condition because they have difficulty understanding written information; and how confident they are in filling out their own medical forms. Answers are given on a scale of 0-4, with 12 points being the highest score for poor health literacy. This study considered adequate health literacy to be a score of 0-3, and 4-12 as “possibly inadequate health literacy.”
“Of the 722 patients who took the survey, 39.2% had a score of 0; 33.2% had a score of 4 or more,” Dr. Baker said.
The adequate health literacy group had significantly lower rates of unplanned readmissions and a trend toward lower emergency department visits than the possibly inadequate health literacy group, 11.7% vs. 22.5% (P = .003) for the former and 18.7% vs. 24.2% (P = .08) for the latter, Dr. Baker said.
She noted that the ethnic makeup of the groups was similar and the differences in health literacy among the ethnic groups were not statistically significant.
She also mentioned that those with adequate health literacy tended to be younger – 64 vs. 66.9 years – and more likely to be women (“but our number is low for females in the VA,” Dr. Baker said). She added that married patients tended to have lower heath literacy than did single patients.”
The 30-day surgical readmission rate was 13.7% for patients with high health literacy and 22.5% for those with low health literacy. Patients with inadequate health literacy were 53% more likely to be readmitted to the hospital within 30 days of their index operation, she said. Each one-unit increase in health literacy scores – meaning an increase in inadequate health literacy – increased an individual’s risk of readmission by about 6% on an adjusted basis, Dr. Baker said.
“Future work is going to be focused on identifying these patients and developing the interventions to educate and empower this vulnerable population before they are discharged,” Dr. Baker said.
Dr. Baker and coauthors reported having no financial disclosures.
SOURCE: Baker S et al. Academic Surgical Congress.
REPORTING FROM THE ACADEMIC SURGICAL CONGRESS
Key clinical point:
Major finding: The 30-day surgical readmission rate was 13.7% for patients with high health literacy and 22.5% for those with low health literacy.
Data source: Analysis of 722 patients who had general, vascular, or thoracic surgery at four VA Medical Centers from August 2015 to June 2017.
Disclosures: Dr. Baker and coauthors reported having no financial disclosures.
Source: Baker S et al. Academic Surgical Congress.
Laparoscopic procedure safer for SBO in elderly patients
JACKSONVILLE, FLA. – Octogenarians with small-bowel obstruction are about seven times more likely to have open than laparoscopic surgery, but the minimally invasive approach in these patients has been found to reduce their hospital stays and risk of pneumonia afterward, according to results of an observational study of data from the American College of Surgeons National Surgical Quality Improvement Program database.
Dr. Chang said, “Our study was able to show that age and the presence of preoperative sepsis are associated with mortality rather than procedure type, and that there are procedure-type risks associated with open procedures.”
The observational study analyzed 103 laparoscopic and 692 open operations for small-bowel obstruction (SBO) in patients 80 and older from 2006 to 2014. Characteristics of the open and laparoscopic group – age, gender, body mass index, and race – were similar, although the open group had higher American Society of Anesthesiologists classification and incidence of preoperative sepsis, Dr. Chang said.
“Unadjusted outcomes showed longer length of stay [and] higher postoperative mortality and rates of postoperative pneumonia in the open cases vs. laparoscopic,” she said. “But after we made adjustments for preoperative risk variables, age and the presence of preoperative sepsis were associated with mortality, not the operative approach.” Length of stay was 4 days for the laparoscopic patients vs. 8 days for open (P less than .0001).
The researchers performed logistical regression analysis and found that mortality risk rose slightly with age (odds ratio, 1.11; P = .0311) but almost quadrupled with preoperative sepsis (OR, 3.77; P = .0287) regardless of open or laparoscopic approach. For postoperative pneumonia, risk factors were male gender (OR, 2.68; P = .0003) and open procedure (OR, 5.03; P = .0282).
“Our study elucidates that the octogenarian with small-bowel obstruction due to adhesive disease may benefit from an initial laparoscopic approach,” Dr. Change said. “Further prospective studies are warranted.”
Dr. Chang and coauthors reported having no financial disclosures.
acssurgerynews@frontlinemedcom.com
SOURCE: Chang E et al. Academic Surgical Congress.
JACKSONVILLE, FLA. – Octogenarians with small-bowel obstruction are about seven times more likely to have open than laparoscopic surgery, but the minimally invasive approach in these patients has been found to reduce their hospital stays and risk of pneumonia afterward, according to results of an observational study of data from the American College of Surgeons National Surgical Quality Improvement Program database.
Dr. Chang said, “Our study was able to show that age and the presence of preoperative sepsis are associated with mortality rather than procedure type, and that there are procedure-type risks associated with open procedures.”
The observational study analyzed 103 laparoscopic and 692 open operations for small-bowel obstruction (SBO) in patients 80 and older from 2006 to 2014. Characteristics of the open and laparoscopic group – age, gender, body mass index, and race – were similar, although the open group had higher American Society of Anesthesiologists classification and incidence of preoperative sepsis, Dr. Chang said.
“Unadjusted outcomes showed longer length of stay [and] higher postoperative mortality and rates of postoperative pneumonia in the open cases vs. laparoscopic,” she said. “But after we made adjustments for preoperative risk variables, age and the presence of preoperative sepsis were associated with mortality, not the operative approach.” Length of stay was 4 days for the laparoscopic patients vs. 8 days for open (P less than .0001).
The researchers performed logistical regression analysis and found that mortality risk rose slightly with age (odds ratio, 1.11; P = .0311) but almost quadrupled with preoperative sepsis (OR, 3.77; P = .0287) regardless of open or laparoscopic approach. For postoperative pneumonia, risk factors were male gender (OR, 2.68; P = .0003) and open procedure (OR, 5.03; P = .0282).
“Our study elucidates that the octogenarian with small-bowel obstruction due to adhesive disease may benefit from an initial laparoscopic approach,” Dr. Change said. “Further prospective studies are warranted.”
Dr. Chang and coauthors reported having no financial disclosures.
acssurgerynews@frontlinemedcom.com
SOURCE: Chang E et al. Academic Surgical Congress.
JACKSONVILLE, FLA. – Octogenarians with small-bowel obstruction are about seven times more likely to have open than laparoscopic surgery, but the minimally invasive approach in these patients has been found to reduce their hospital stays and risk of pneumonia afterward, according to results of an observational study of data from the American College of Surgeons National Surgical Quality Improvement Program database.
Dr. Chang said, “Our study was able to show that age and the presence of preoperative sepsis are associated with mortality rather than procedure type, and that there are procedure-type risks associated with open procedures.”
The observational study analyzed 103 laparoscopic and 692 open operations for small-bowel obstruction (SBO) in patients 80 and older from 2006 to 2014. Characteristics of the open and laparoscopic group – age, gender, body mass index, and race – were similar, although the open group had higher American Society of Anesthesiologists classification and incidence of preoperative sepsis, Dr. Chang said.
“Unadjusted outcomes showed longer length of stay [and] higher postoperative mortality and rates of postoperative pneumonia in the open cases vs. laparoscopic,” she said. “But after we made adjustments for preoperative risk variables, age and the presence of preoperative sepsis were associated with mortality, not the operative approach.” Length of stay was 4 days for the laparoscopic patients vs. 8 days for open (P less than .0001).
The researchers performed logistical regression analysis and found that mortality risk rose slightly with age (odds ratio, 1.11; P = .0311) but almost quadrupled with preoperative sepsis (OR, 3.77; P = .0287) regardless of open or laparoscopic approach. For postoperative pneumonia, risk factors were male gender (OR, 2.68; P = .0003) and open procedure (OR, 5.03; P = .0282).
“Our study elucidates that the octogenarian with small-bowel obstruction due to adhesive disease may benefit from an initial laparoscopic approach,” Dr. Change said. “Further prospective studies are warranted.”
Dr. Chang and coauthors reported having no financial disclosures.
acssurgerynews@frontlinemedcom.com
SOURCE: Chang E et al. Academic Surgical Congress.
REPORTING FROM THE ACADEMIC SURGICAL CONGRESS
Key clinical point: and older.
Major finding: The open procedure had an odds ratio five times greater than laparoscopic surgery for risk of pneumonia after the operation in this age group (OR, 5.03; P =.0282).
Data source: Observational study of 103 laparoscopic and 692 open cases of surgery for SBO in the ACS NSQIP database from 2006 to 2014.
Disclosures: Dr. Chang and coauthors reported having no financial disclosures.
Source: Chang E et al. Academic Surgical Congress.
Spray-dried plasma inches toward clinical trials
SAN DIEGO – Spray-dried plasma compared well with fresh frozen plasma in two in vitro studies, but clinical studies are needed to confirm the findings, researchers reported at the annual meeting of the American Association of Blood Banks.
The product’s logistical benefits include ease of transport, stability at room temperature, and the ability to be rapidly reconstituted – attributes that make it particularly useful in combat situations and prehospital settings where it is impractical to administer fresh frozen plasma (FFP).
The advantages of reconstituted blood products in combat settings have prompted recent efforts to speed their availability. The Food and Drug Administration and the Department of Defense recently announced a joint program to expedite the FDA’s review of products that could diagnose, treat, or prevent life-threatening conditions facing U.S. military personnel. It would be a fast-track process similar to how the FDA handles the breakthrough designation program.
In the first study, the investigators compared spray-dried plasma (SpDP) and FFP in reconstituted whole blood to test their hypothesis that SpDP is not inferior to FFP in facilitating platelet adhesion and thrombus formation, as evaluated by using a microfusion assay.
“Trauma is frequently associated with the use of plasma,” said Rachel S. Bercovitz, MD, MS, of the BloodCenter of Wisconsin and associate professor of pediatrics (hematology, oncology, and stem cell transplantation) at Northwestern University, Chicago.
Compared with FFP, SpDP can be reconstituted in 5 minutes and has more than 80% of the procoagulation and anticoagulation proteins, she explained. “Factor 8 levels were lower in the spray-dried plasma and were about at the 70% level of FFP. The other factor that was reduced, as compared to the FFP, was the von Willebrand factor (vWF), which was about 60% in SpDP compared to FFP.”
Whole blood was obtained from healthy volunteers and red blood cells (RBCs) were separated from platelet-rich plasma, and following standard procedures, resuspended in either SpDP or FFP and recombined with the packed red blood cells to create reconstituted whole blood with hematocrit of 34%-40% and 150,000-250,000 platelets per mcL.
After fluorescent labeling, the samples were flowed through a type I collagen-coated microchannel and still images of adherent platelets and thrombi were captured in order to calculate surface area coverage along the length of the channel. Next, the investigators used a ratio paired t-test to compare surface area coverage in SpDP versus FFP. The margin of noninferiority was 20% (SpDP/FFP greater than 0.8).
A total of six batches of SpDP and FFP were evaluated with 17 donors, and there was no statistical difference between the SpDP versus FFP pairs (P = .7558).
The mean ratio of SpDP versus FFP was 1.21 with a 95% confidence interval of 0.84-1.57. The surface area coverage in samples that were reconstituted with SpDP were, on average, 20% greater than in samples reconstituted with FFP. The lower limit of the 95% confidence interval was a difference of 16%, and therefore lower than the a priori determined margin of noninferiority of 20%.
“We found that SpDP is not inferior to FFP in supporting platelet adhesion and thrombus formation in our in vitro model,” Dr. Bercovitz said. “We feel that these in vitro assays support further in vivo studies of safety and efficacy of spray dried plasma.”
In a second study, Michael A. Meledeo, PhD, of the U.S. Army Institute of Surgical Research (coagulation and blood research), and his colleagues examined methods of reconstituting SpDP. They noted that a single unit process has been developed that produces a long-lived and readily stored SpDP product, which decreased high-molecular-weight multimers of vWF but increased low-molecular-weight multimers. vWF is critical in the process of platelet adhesion and thrombus formation, Dr. Meledeo said.
The researchers examined different reconstitution solutions: FFP, FFP with glycine, regular SpDP without pretreatment and rehydrated with glycine-hydrochloride:glycine, SpDP pretreated with glycine-HCl, or glycine-HCl:glycine and rehydrated with water.
Several in vitro analyses were performed, including measurement of vWF activity, fibrin polymerization kinetics, thrombin generation, coagulation properties and platelet adhesion to collagen.
Pretreated SpDP had better vWF activity, compared with regular SpDP (P less than .05). As compared with FFP, fibrin polymerization density was slightly lower in regular SpDP (0.879 vs. 0.742 optical density; P less than .01), although generation of thrombin was similar.
The researchers also found that the bicarbonate/base excess were lower in SpDP samples versus FFP (P less than .001). Thromboelastography results (used to measure coagulation properties) remained unchanged in plasma-only samples, but clot strength in reconstructed whole blood was reduced in all SpDP samples, compared with FFP (63.82 vs. 55-59.38; P less than .01).
Finally, platelet adhesion was equivalent in pretreated SpDP samples and FFP, while with regular SpDP, it was improved as compared with all other samples (71.53% surface coverage vs. 30.26%-43.87%; P less than .05).
“Based on these results, spray dried plasma was equivalent or superior to FFP in most of the in vitro hemostasis assays,” Dr. Meledeo said. “Reconstitution with glycine-HCl or glycine-HCl:glycine induced a superior von Willebrand function, but it was inferior in terms of supporting a flowing platelet adhesion to collagen.”
Dr. Bercovitz and Dr. Meledeo reported having no financial disclosures.
hematologynews@frontlinemedcom.com
SOURCES: Bercovitz R et al. AABB 17 Abstract C20-A02B; Meledeo M et al. AABB 17 Abstract C21-A02B.
SAN DIEGO – Spray-dried plasma compared well with fresh frozen plasma in two in vitro studies, but clinical studies are needed to confirm the findings, researchers reported at the annual meeting of the American Association of Blood Banks.
The product’s logistical benefits include ease of transport, stability at room temperature, and the ability to be rapidly reconstituted – attributes that make it particularly useful in combat situations and prehospital settings where it is impractical to administer fresh frozen plasma (FFP).
The advantages of reconstituted blood products in combat settings have prompted recent efforts to speed their availability. The Food and Drug Administration and the Department of Defense recently announced a joint program to expedite the FDA’s review of products that could diagnose, treat, or prevent life-threatening conditions facing U.S. military personnel. It would be a fast-track process similar to how the FDA handles the breakthrough designation program.
In the first study, the investigators compared spray-dried plasma (SpDP) and FFP in reconstituted whole blood to test their hypothesis that SpDP is not inferior to FFP in facilitating platelet adhesion and thrombus formation, as evaluated by using a microfusion assay.
“Trauma is frequently associated with the use of plasma,” said Rachel S. Bercovitz, MD, MS, of the BloodCenter of Wisconsin and associate professor of pediatrics (hematology, oncology, and stem cell transplantation) at Northwestern University, Chicago.
Compared with FFP, SpDP can be reconstituted in 5 minutes and has more than 80% of the procoagulation and anticoagulation proteins, she explained. “Factor 8 levels were lower in the spray-dried plasma and were about at the 70% level of FFP. The other factor that was reduced, as compared to the FFP, was the von Willebrand factor (vWF), which was about 60% in SpDP compared to FFP.”
Whole blood was obtained from healthy volunteers and red blood cells (RBCs) were separated from platelet-rich plasma, and following standard procedures, resuspended in either SpDP or FFP and recombined with the packed red blood cells to create reconstituted whole blood with hematocrit of 34%-40% and 150,000-250,000 platelets per mcL.
After fluorescent labeling, the samples were flowed through a type I collagen-coated microchannel and still images of adherent platelets and thrombi were captured in order to calculate surface area coverage along the length of the channel. Next, the investigators used a ratio paired t-test to compare surface area coverage in SpDP versus FFP. The margin of noninferiority was 20% (SpDP/FFP greater than 0.8).
A total of six batches of SpDP and FFP were evaluated with 17 donors, and there was no statistical difference between the SpDP versus FFP pairs (P = .7558).
The mean ratio of SpDP versus FFP was 1.21 with a 95% confidence interval of 0.84-1.57. The surface area coverage in samples that were reconstituted with SpDP were, on average, 20% greater than in samples reconstituted with FFP. The lower limit of the 95% confidence interval was a difference of 16%, and therefore lower than the a priori determined margin of noninferiority of 20%.
“We found that SpDP is not inferior to FFP in supporting platelet adhesion and thrombus formation in our in vitro model,” Dr. Bercovitz said. “We feel that these in vitro assays support further in vivo studies of safety and efficacy of spray dried plasma.”
In a second study, Michael A. Meledeo, PhD, of the U.S. Army Institute of Surgical Research (coagulation and blood research), and his colleagues examined methods of reconstituting SpDP. They noted that a single unit process has been developed that produces a long-lived and readily stored SpDP product, which decreased high-molecular-weight multimers of vWF but increased low-molecular-weight multimers. vWF is critical in the process of platelet adhesion and thrombus formation, Dr. Meledeo said.
The researchers examined different reconstitution solutions: FFP, FFP with glycine, regular SpDP without pretreatment and rehydrated with glycine-hydrochloride:glycine, SpDP pretreated with glycine-HCl, or glycine-HCl:glycine and rehydrated with water.
Several in vitro analyses were performed, including measurement of vWF activity, fibrin polymerization kinetics, thrombin generation, coagulation properties and platelet adhesion to collagen.
Pretreated SpDP had better vWF activity, compared with regular SpDP (P less than .05). As compared with FFP, fibrin polymerization density was slightly lower in regular SpDP (0.879 vs. 0.742 optical density; P less than .01), although generation of thrombin was similar.
The researchers also found that the bicarbonate/base excess were lower in SpDP samples versus FFP (P less than .001). Thromboelastography results (used to measure coagulation properties) remained unchanged in plasma-only samples, but clot strength in reconstructed whole blood was reduced in all SpDP samples, compared with FFP (63.82 vs. 55-59.38; P less than .01).
Finally, platelet adhesion was equivalent in pretreated SpDP samples and FFP, while with regular SpDP, it was improved as compared with all other samples (71.53% surface coverage vs. 30.26%-43.87%; P less than .05).
“Based on these results, spray dried plasma was equivalent or superior to FFP in most of the in vitro hemostasis assays,” Dr. Meledeo said. “Reconstitution with glycine-HCl or glycine-HCl:glycine induced a superior von Willebrand function, but it was inferior in terms of supporting a flowing platelet adhesion to collagen.”
Dr. Bercovitz and Dr. Meledeo reported having no financial disclosures.
hematologynews@frontlinemedcom.com
SOURCES: Bercovitz R et al. AABB 17 Abstract C20-A02B; Meledeo M et al. AABB 17 Abstract C21-A02B.
SAN DIEGO – Spray-dried plasma compared well with fresh frozen plasma in two in vitro studies, but clinical studies are needed to confirm the findings, researchers reported at the annual meeting of the American Association of Blood Banks.
The product’s logistical benefits include ease of transport, stability at room temperature, and the ability to be rapidly reconstituted – attributes that make it particularly useful in combat situations and prehospital settings where it is impractical to administer fresh frozen plasma (FFP).
The advantages of reconstituted blood products in combat settings have prompted recent efforts to speed their availability. The Food and Drug Administration and the Department of Defense recently announced a joint program to expedite the FDA’s review of products that could diagnose, treat, or prevent life-threatening conditions facing U.S. military personnel. It would be a fast-track process similar to how the FDA handles the breakthrough designation program.
In the first study, the investigators compared spray-dried plasma (SpDP) and FFP in reconstituted whole blood to test their hypothesis that SpDP is not inferior to FFP in facilitating platelet adhesion and thrombus formation, as evaluated by using a microfusion assay.
“Trauma is frequently associated with the use of plasma,” said Rachel S. Bercovitz, MD, MS, of the BloodCenter of Wisconsin and associate professor of pediatrics (hematology, oncology, and stem cell transplantation) at Northwestern University, Chicago.
Compared with FFP, SpDP can be reconstituted in 5 minutes and has more than 80% of the procoagulation and anticoagulation proteins, she explained. “Factor 8 levels were lower in the spray-dried plasma and were about at the 70% level of FFP. The other factor that was reduced, as compared to the FFP, was the von Willebrand factor (vWF), which was about 60% in SpDP compared to FFP.”
Whole blood was obtained from healthy volunteers and red blood cells (RBCs) were separated from platelet-rich plasma, and following standard procedures, resuspended in either SpDP or FFP and recombined with the packed red blood cells to create reconstituted whole blood with hematocrit of 34%-40% and 150,000-250,000 platelets per mcL.
After fluorescent labeling, the samples were flowed through a type I collagen-coated microchannel and still images of adherent platelets and thrombi were captured in order to calculate surface area coverage along the length of the channel. Next, the investigators used a ratio paired t-test to compare surface area coverage in SpDP versus FFP. The margin of noninferiority was 20% (SpDP/FFP greater than 0.8).
A total of six batches of SpDP and FFP were evaluated with 17 donors, and there was no statistical difference between the SpDP versus FFP pairs (P = .7558).
The mean ratio of SpDP versus FFP was 1.21 with a 95% confidence interval of 0.84-1.57. The surface area coverage in samples that were reconstituted with SpDP were, on average, 20% greater than in samples reconstituted with FFP. The lower limit of the 95% confidence interval was a difference of 16%, and therefore lower than the a priori determined margin of noninferiority of 20%.
“We found that SpDP is not inferior to FFP in supporting platelet adhesion and thrombus formation in our in vitro model,” Dr. Bercovitz said. “We feel that these in vitro assays support further in vivo studies of safety and efficacy of spray dried plasma.”
In a second study, Michael A. Meledeo, PhD, of the U.S. Army Institute of Surgical Research (coagulation and blood research), and his colleagues examined methods of reconstituting SpDP. They noted that a single unit process has been developed that produces a long-lived and readily stored SpDP product, which decreased high-molecular-weight multimers of vWF but increased low-molecular-weight multimers. vWF is critical in the process of platelet adhesion and thrombus formation, Dr. Meledeo said.
The researchers examined different reconstitution solutions: FFP, FFP with glycine, regular SpDP without pretreatment and rehydrated with glycine-hydrochloride:glycine, SpDP pretreated with glycine-HCl, or glycine-HCl:glycine and rehydrated with water.
Several in vitro analyses were performed, including measurement of vWF activity, fibrin polymerization kinetics, thrombin generation, coagulation properties and platelet adhesion to collagen.
Pretreated SpDP had better vWF activity, compared with regular SpDP (P less than .05). As compared with FFP, fibrin polymerization density was slightly lower in regular SpDP (0.879 vs. 0.742 optical density; P less than .01), although generation of thrombin was similar.
The researchers also found that the bicarbonate/base excess were lower in SpDP samples versus FFP (P less than .001). Thromboelastography results (used to measure coagulation properties) remained unchanged in plasma-only samples, but clot strength in reconstructed whole blood was reduced in all SpDP samples, compared with FFP (63.82 vs. 55-59.38; P less than .01).
Finally, platelet adhesion was equivalent in pretreated SpDP samples and FFP, while with regular SpDP, it was improved as compared with all other samples (71.53% surface coverage vs. 30.26%-43.87%; P less than .05).
“Based on these results, spray dried plasma was equivalent or superior to FFP in most of the in vitro hemostasis assays,” Dr. Meledeo said. “Reconstitution with glycine-HCl or glycine-HCl:glycine induced a superior von Willebrand function, but it was inferior in terms of supporting a flowing platelet adhesion to collagen.”
Dr. Bercovitz and Dr. Meledeo reported having no financial disclosures.
hematologynews@frontlinemedcom.com
SOURCES: Bercovitz R et al. AABB 17 Abstract C20-A02B; Meledeo M et al. AABB 17 Abstract C21-A02B.
REPORTING FROM AABB 17
Key clinical point:
Major finding: Spray-dried plasma was equal to, or superior to, fresh frozen plasma in many of the in vitro assays utilized, especially when pretreated in glycine solutions.
Study details: Two in vitro assays that compared spray-dried plasma with fresh frozen plasma.
Disclosures: Dr. Bercovitz and Dr. Meledeo reported having no financial disclosures.
Sources: Bercovitz R et al. AABB 17 Abstract C20-A02B; Meledeo M et al. AABB 17 Abstract C21-A02B.
Preop physiotherapy training reduces risk of postop pulmonary complications
A single 30-minute coaching session with a physiotherapist within 6 weeks of major upper abdominal surgery significantly reduced postoperative pulmonary complications (PPC), according to the results of a prospective trial.
Ianthe Boden and her colleagues recruited 441 eligible adults scheduled for elective major upper abdominal surgery to participate in the prospective, multicenter, double-blinded, controlled superiority study to assess whether PPC outcomes were affected by preoperative physiotherapy. Consecutive participants were obtained from outpatient preadmission assessment clinics during June 2013 to August 2015; they were assigned randomly in a 1:1 ratio to the control (219) or intervention (222) groups. The median patient age was 68 years for the control and 63 for the intervention group, and each group was composed of 31% women.
Immediately after receiving the booklets, however, participants in the intervention group were also given an added 30-minute education and training session by preoperative physiotherapists. This instruction covered factors contributing to PPC occurrence, strategies to help prevention it, and three coached repetitions of breathing exercises. Emphasis was placed on initiating prescribed breathing exercises upon regaining postoperative consciousness and continuing them every hour until the patients were fully ambulatory.
The primary outcome was evaluated by masked assessors using the Melbourne group score criteria to determine PPC incidence within 14 postoperative days or by the time of hospital discharge, whichever was sooner. Nine participants, 4 from the intervention and 5 from the control group, withdrew from the study. Of the total remaining 432 participants, 85 (20%) had a documented PPC incident, including hospital acquired pneumonia, within the specified postoperative time frame, as reported in the BMJ.
Results showed that the physiotherapy group had significantly fewer PPC occurrences (27/218, 12%) than did the control group (58/214, 27%). The calculated absolute risk reduction was 15% (P less than .001). Adjustment for three of the prespecified covariates (age, respiratory comorbidity, and surgical procedure) showed PPC incidence remained halved (hazard ratio, 0.48; P = .001) for the intervention group with a number needed to treat of 7 (95% confidence interval, 5-14).
Secondary outcomes included incidence of hospital acquired pneumonia, hospital utilization, mobility, patient reported complications at 6 weeks, and mortality rates in hospital, at 6 weeks, and at 12 months. For secondary outcomes in the adjusted analysis, incidences of pneumonia were halved in the physiotherapy intervention group with a number needed to treat of 9 (95% CI, 6-21). No significant differences in secondary outcomes were detected between the control and treatment groups.
Sensitivity analysis that removed participants who had lower abdominal and laparoscopic surgery strengthened both primary and secondary outcome results to favor the preoperative physiotherapy intervention for reducing PPC. The researchers found that, in an adjusted analysis of subgroup effects, there was a gradient in reduction of PPCs according to surgical category.
Shorter lengths hospital stay and lower all-cause 12-month mortality were also associated with more experienced physiotherapists providing the preoperative education and training.
Ms. Boden and her colleagues proposed that the timing for patients to begin breathing exercises after major open upper abdominal surgery could be critical in reducing PPC incidence. Initiating breathing exercises within the first 24 hours after surgery – in contrast to the common practice of waiting 1-2 days to begin postoperative physiotherapy – could prevent general anesthesia-associated mild atelectasis from developing into severe atelectasis and PPCs.
The researchers concluded that “in a general population of patients listed for elective upper abdominal surgery, a 30-minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.”
The authors reported that they received grants from the Clifford Craig Foundation; the University of Tasmania (Hobart), Australia; and the Waitemata District Health Board in Auckland, New Zealand.
SOURCE: Boden I et al. BMJ. 2018. doi: 10.1136/bmj.j5916.
A single 30-minute coaching session with a physiotherapist within 6 weeks of major upper abdominal surgery significantly reduced postoperative pulmonary complications (PPC), according to the results of a prospective trial.
Ianthe Boden and her colleagues recruited 441 eligible adults scheduled for elective major upper abdominal surgery to participate in the prospective, multicenter, double-blinded, controlled superiority study to assess whether PPC outcomes were affected by preoperative physiotherapy. Consecutive participants were obtained from outpatient preadmission assessment clinics during June 2013 to August 2015; they were assigned randomly in a 1:1 ratio to the control (219) or intervention (222) groups. The median patient age was 68 years for the control and 63 for the intervention group, and each group was composed of 31% women.
Immediately after receiving the booklets, however, participants in the intervention group were also given an added 30-minute education and training session by preoperative physiotherapists. This instruction covered factors contributing to PPC occurrence, strategies to help prevention it, and three coached repetitions of breathing exercises. Emphasis was placed on initiating prescribed breathing exercises upon regaining postoperative consciousness and continuing them every hour until the patients were fully ambulatory.
The primary outcome was evaluated by masked assessors using the Melbourne group score criteria to determine PPC incidence within 14 postoperative days or by the time of hospital discharge, whichever was sooner. Nine participants, 4 from the intervention and 5 from the control group, withdrew from the study. Of the total remaining 432 participants, 85 (20%) had a documented PPC incident, including hospital acquired pneumonia, within the specified postoperative time frame, as reported in the BMJ.
Results showed that the physiotherapy group had significantly fewer PPC occurrences (27/218, 12%) than did the control group (58/214, 27%). The calculated absolute risk reduction was 15% (P less than .001). Adjustment for three of the prespecified covariates (age, respiratory comorbidity, and surgical procedure) showed PPC incidence remained halved (hazard ratio, 0.48; P = .001) for the intervention group with a number needed to treat of 7 (95% confidence interval, 5-14).
Secondary outcomes included incidence of hospital acquired pneumonia, hospital utilization, mobility, patient reported complications at 6 weeks, and mortality rates in hospital, at 6 weeks, and at 12 months. For secondary outcomes in the adjusted analysis, incidences of pneumonia were halved in the physiotherapy intervention group with a number needed to treat of 9 (95% CI, 6-21). No significant differences in secondary outcomes were detected between the control and treatment groups.
Sensitivity analysis that removed participants who had lower abdominal and laparoscopic surgery strengthened both primary and secondary outcome results to favor the preoperative physiotherapy intervention for reducing PPC. The researchers found that, in an adjusted analysis of subgroup effects, there was a gradient in reduction of PPCs according to surgical category.
Shorter lengths hospital stay and lower all-cause 12-month mortality were also associated with more experienced physiotherapists providing the preoperative education and training.
Ms. Boden and her colleagues proposed that the timing for patients to begin breathing exercises after major open upper abdominal surgery could be critical in reducing PPC incidence. Initiating breathing exercises within the first 24 hours after surgery – in contrast to the common practice of waiting 1-2 days to begin postoperative physiotherapy – could prevent general anesthesia-associated mild atelectasis from developing into severe atelectasis and PPCs.
The researchers concluded that “in a general population of patients listed for elective upper abdominal surgery, a 30-minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.”
The authors reported that they received grants from the Clifford Craig Foundation; the University of Tasmania (Hobart), Australia; and the Waitemata District Health Board in Auckland, New Zealand.
SOURCE: Boden I et al. BMJ. 2018. doi: 10.1136/bmj.j5916.
A single 30-minute coaching session with a physiotherapist within 6 weeks of major upper abdominal surgery significantly reduced postoperative pulmonary complications (PPC), according to the results of a prospective trial.
Ianthe Boden and her colleagues recruited 441 eligible adults scheduled for elective major upper abdominal surgery to participate in the prospective, multicenter, double-blinded, controlled superiority study to assess whether PPC outcomes were affected by preoperative physiotherapy. Consecutive participants were obtained from outpatient preadmission assessment clinics during June 2013 to August 2015; they were assigned randomly in a 1:1 ratio to the control (219) or intervention (222) groups. The median patient age was 68 years for the control and 63 for the intervention group, and each group was composed of 31% women.
Immediately after receiving the booklets, however, participants in the intervention group were also given an added 30-minute education and training session by preoperative physiotherapists. This instruction covered factors contributing to PPC occurrence, strategies to help prevention it, and three coached repetitions of breathing exercises. Emphasis was placed on initiating prescribed breathing exercises upon regaining postoperative consciousness and continuing them every hour until the patients were fully ambulatory.
The primary outcome was evaluated by masked assessors using the Melbourne group score criteria to determine PPC incidence within 14 postoperative days or by the time of hospital discharge, whichever was sooner. Nine participants, 4 from the intervention and 5 from the control group, withdrew from the study. Of the total remaining 432 participants, 85 (20%) had a documented PPC incident, including hospital acquired pneumonia, within the specified postoperative time frame, as reported in the BMJ.
Results showed that the physiotherapy group had significantly fewer PPC occurrences (27/218, 12%) than did the control group (58/214, 27%). The calculated absolute risk reduction was 15% (P less than .001). Adjustment for three of the prespecified covariates (age, respiratory comorbidity, and surgical procedure) showed PPC incidence remained halved (hazard ratio, 0.48; P = .001) for the intervention group with a number needed to treat of 7 (95% confidence interval, 5-14).
Secondary outcomes included incidence of hospital acquired pneumonia, hospital utilization, mobility, patient reported complications at 6 weeks, and mortality rates in hospital, at 6 weeks, and at 12 months. For secondary outcomes in the adjusted analysis, incidences of pneumonia were halved in the physiotherapy intervention group with a number needed to treat of 9 (95% CI, 6-21). No significant differences in secondary outcomes were detected between the control and treatment groups.
Sensitivity analysis that removed participants who had lower abdominal and laparoscopic surgery strengthened both primary and secondary outcome results to favor the preoperative physiotherapy intervention for reducing PPC. The researchers found that, in an adjusted analysis of subgroup effects, there was a gradient in reduction of PPCs according to surgical category.
Shorter lengths hospital stay and lower all-cause 12-month mortality were also associated with more experienced physiotherapists providing the preoperative education and training.
Ms. Boden and her colleagues proposed that the timing for patients to begin breathing exercises after major open upper abdominal surgery could be critical in reducing PPC incidence. Initiating breathing exercises within the first 24 hours after surgery – in contrast to the common practice of waiting 1-2 days to begin postoperative physiotherapy – could prevent general anesthesia-associated mild atelectasis from developing into severe atelectasis and PPCs.
The researchers concluded that “in a general population of patients listed for elective upper abdominal surgery, a 30-minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.”
The authors reported that they received grants from the Clifford Craig Foundation; the University of Tasmania (Hobart), Australia; and the Waitemata District Health Board in Auckland, New Zealand.
SOURCE: Boden I et al. BMJ. 2018. doi: 10.1136/bmj.j5916.
FROM THE BMJ
Key clinical point: Reduction in PPC incidences corresponded to physiotherapists providing preoperative education and coaching intervention.
Major finding: Compared with the control group, Absolute risk was reduced by 15%, and seven was determined as number needed to treat.
Study details: Prospective, blinded study of 441 adult participants randomly assigned in a 1:1 ratio, comparing PPC outcomes associated with preop practices for upper abdominal surgeries.
Disclosures: The authors reported that they received grants from the Clifford Craig Foundation; the University of Tasmania (Hobart), Australia; and the Waitemata District Health Board in Auckland, New Zealand.
Source: Boden I. et al. BMJ. 2018. doi: 10.1136/bmj.j5916.
Multidisciplinary care improves surgical outcomes for elderly patients
and were able to leave the hospital after a shorter stay, according to findings from a case-control study of nearly 400 patients.
Data from previous studies suggest that preoperative assessment by geriatric experts can improve outcomes for the elderly, who are more likely than are younger patients to develop preventable postoperative complications, and “this evidence supports the formulation of a different approach to preoperative assessment and postoperative care for this population,” wrote Shelley R. McDonald, DO, of Duke University, Durham, N.C., and colleagues.
The intervention, known as the Perioperative Optimization of Senior Health (POSH), was described as “a quality improvement initiative with prospective data collection.” Patients in a geriatrics clinic within an academic center were selected for the study if they were at high risk for complications linked to elective abdominal surgery. High risk was defined as older than 85 years of age, or older than 65 years of age with conditions including cognitive impairment, recent weight loss, multiple comorbidities, and polypharmacy (JAMA Surg. 2018 Jan 3. doi: 10.1001/jamasurg.2017.5513).
The POSH intervention patients received preoperative evaluation from a team including a geriatrician, geriatric resource nurse, social worker, program administrator, and nurse practitioner from the preoperative anesthesia testing clinic. Patients and families were advised on risk management and care optimization involving cognition, comorbidities, medications, mobility, functional status, nutrition, hydration, pain, and advanced care planning.
Patients in the POSH group were on average older, had more comorbidities, and were more likely to be smokers. But despite these disadvantaging characteristics, they still had better outcomes in several important variables than did those in the control group.
The POSH group had significantly shorter hospital stays, compared with controls (4 days vs. 6 days), and significantly lower all-cause readmission rates at both 7 days (2.8% vs. 9.9%) and 30 days (7.8% vs. 18.3%). The significance persisted whether the surgeries were laparoscopic or open.
The overall complication rate was lower in the POSH group, compared with the controls, but fell short of statistical significance (44.8% vs. 58.7%, P = .01). However, rates of specific complications were significantly lower in the POSH group, compared with controls, including postoperative cardiogenic or hypovolemic shock (2.2% vs. 8.4%), bleeding, either during or after surgery (6.1% vs. 15.4%), and postoperative ileus (4.9% vs. 20.3%).
“Delirium was identified in POSH patients at higher rates than in the control group, which is not unexpected because higher postoperative delirium rates are known to be identified with increased screening,” the researchers noted. “Collaborative care allows for increasing the recognition of geriatric syndromes like delirium, more focus on symptom management, and proactively anticipating complications,” they said.
The study results were limited by several factors including a long enrollment period for the POSH patients, and potential changes in surgical protocols, the researchers said. However, the findings support the need for further research and more refined analysis to identify the most beneficial aspects of care, and to support better clinical decision making about the timing of interventions and the type of patient who could benefit, they noted.
The researchers had no financial conflicts to disclose. The John A. Hartford Foundation Center of Excellence National Program Award provided salary and database support.
SOURCE: McDonald S et al. JAMA Surg. 2018 Jan 3. doi: 10.1001/jamasurg.2017.5513.
and were able to leave the hospital after a shorter stay, according to findings from a case-control study of nearly 400 patients.
Data from previous studies suggest that preoperative assessment by geriatric experts can improve outcomes for the elderly, who are more likely than are younger patients to develop preventable postoperative complications, and “this evidence supports the formulation of a different approach to preoperative assessment and postoperative care for this population,” wrote Shelley R. McDonald, DO, of Duke University, Durham, N.C., and colleagues.
The intervention, known as the Perioperative Optimization of Senior Health (POSH), was described as “a quality improvement initiative with prospective data collection.” Patients in a geriatrics clinic within an academic center were selected for the study if they were at high risk for complications linked to elective abdominal surgery. High risk was defined as older than 85 years of age, or older than 65 years of age with conditions including cognitive impairment, recent weight loss, multiple comorbidities, and polypharmacy (JAMA Surg. 2018 Jan 3. doi: 10.1001/jamasurg.2017.5513).
The POSH intervention patients received preoperative evaluation from a team including a geriatrician, geriatric resource nurse, social worker, program administrator, and nurse practitioner from the preoperative anesthesia testing clinic. Patients and families were advised on risk management and care optimization involving cognition, comorbidities, medications, mobility, functional status, nutrition, hydration, pain, and advanced care planning.
Patients in the POSH group were on average older, had more comorbidities, and were more likely to be smokers. But despite these disadvantaging characteristics, they still had better outcomes in several important variables than did those in the control group.
The POSH group had significantly shorter hospital stays, compared with controls (4 days vs. 6 days), and significantly lower all-cause readmission rates at both 7 days (2.8% vs. 9.9%) and 30 days (7.8% vs. 18.3%). The significance persisted whether the surgeries were laparoscopic or open.
The overall complication rate was lower in the POSH group, compared with the controls, but fell short of statistical significance (44.8% vs. 58.7%, P = .01). However, rates of specific complications were significantly lower in the POSH group, compared with controls, including postoperative cardiogenic or hypovolemic shock (2.2% vs. 8.4%), bleeding, either during or after surgery (6.1% vs. 15.4%), and postoperative ileus (4.9% vs. 20.3%).
“Delirium was identified in POSH patients at higher rates than in the control group, which is not unexpected because higher postoperative delirium rates are known to be identified with increased screening,” the researchers noted. “Collaborative care allows for increasing the recognition of geriatric syndromes like delirium, more focus on symptom management, and proactively anticipating complications,” they said.
The study results were limited by several factors including a long enrollment period for the POSH patients, and potential changes in surgical protocols, the researchers said. However, the findings support the need for further research and more refined analysis to identify the most beneficial aspects of care, and to support better clinical decision making about the timing of interventions and the type of patient who could benefit, they noted.
The researchers had no financial conflicts to disclose. The John A. Hartford Foundation Center of Excellence National Program Award provided salary and database support.
SOURCE: McDonald S et al. JAMA Surg. 2018 Jan 3. doi: 10.1001/jamasurg.2017.5513.
and were able to leave the hospital after a shorter stay, according to findings from a case-control study of nearly 400 patients.
Data from previous studies suggest that preoperative assessment by geriatric experts can improve outcomes for the elderly, who are more likely than are younger patients to develop preventable postoperative complications, and “this evidence supports the formulation of a different approach to preoperative assessment and postoperative care for this population,” wrote Shelley R. McDonald, DO, of Duke University, Durham, N.C., and colleagues.
The intervention, known as the Perioperative Optimization of Senior Health (POSH), was described as “a quality improvement initiative with prospective data collection.” Patients in a geriatrics clinic within an academic center were selected for the study if they were at high risk for complications linked to elective abdominal surgery. High risk was defined as older than 85 years of age, or older than 65 years of age with conditions including cognitive impairment, recent weight loss, multiple comorbidities, and polypharmacy (JAMA Surg. 2018 Jan 3. doi: 10.1001/jamasurg.2017.5513).
The POSH intervention patients received preoperative evaluation from a team including a geriatrician, geriatric resource nurse, social worker, program administrator, and nurse practitioner from the preoperative anesthesia testing clinic. Patients and families were advised on risk management and care optimization involving cognition, comorbidities, medications, mobility, functional status, nutrition, hydration, pain, and advanced care planning.
Patients in the POSH group were on average older, had more comorbidities, and were more likely to be smokers. But despite these disadvantaging characteristics, they still had better outcomes in several important variables than did those in the control group.
The POSH group had significantly shorter hospital stays, compared with controls (4 days vs. 6 days), and significantly lower all-cause readmission rates at both 7 days (2.8% vs. 9.9%) and 30 days (7.8% vs. 18.3%). The significance persisted whether the surgeries were laparoscopic or open.
The overall complication rate was lower in the POSH group, compared with the controls, but fell short of statistical significance (44.8% vs. 58.7%, P = .01). However, rates of specific complications were significantly lower in the POSH group, compared with controls, including postoperative cardiogenic or hypovolemic shock (2.2% vs. 8.4%), bleeding, either during or after surgery (6.1% vs. 15.4%), and postoperative ileus (4.9% vs. 20.3%).
“Delirium was identified in POSH patients at higher rates than in the control group, which is not unexpected because higher postoperative delirium rates are known to be identified with increased screening,” the researchers noted. “Collaborative care allows for increasing the recognition of geriatric syndromes like delirium, more focus on symptom management, and proactively anticipating complications,” they said.
The study results were limited by several factors including a long enrollment period for the POSH patients, and potential changes in surgical protocols, the researchers said. However, the findings support the need for further research and more refined analysis to identify the most beneficial aspects of care, and to support better clinical decision making about the timing of interventions and the type of patient who could benefit, they noted.
The researchers had no financial conflicts to disclose. The John A. Hartford Foundation Center of Excellence National Program Award provided salary and database support.
SOURCE: McDonald S et al. JAMA Surg. 2018 Jan 3. doi: 10.1001/jamasurg.2017.5513.
FROM JAMA SURGERY
Key clinical point: A preoperative surgical intervention improved outcomes and shortened hospital stays for seniors.
Major finding: The POSH group had significantly shorter hospital stays compared with controls (4 days vs. 6 days).
Study details: The data come from a study of 183 surgery patients and 143 controls.
Disclosures: The researchers had no financial conflicts to disclose.
Source: McDonald S JAMA Surg. 2018 Jan 3. doi: 10.1001/jamasurg.2017.5513
Innovative cholecystectomy grading scale could pay off for surgeons
ORLANDO – according to a study presented at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
As payment models shift toward bundled care, providers will be more closely evaluated on their postoperative outcomes, which can vary based on the difficulty of surgery, even for relatively common procedures.
“Gallbladder disease affects roughly 20 million people annually in the United States, with laparoscopic cholecystectomy being one of the most common operations performed by the typical surgeon,” said presenter Tarik Madni, MD, of the department of surgery, University of Texas Southwestern Medical Center, Dallas. “However not all cholecystectomies are created equal; increased inflammation can lead to increased operative times, increased conversion rates, as well as increased risk of complications.”
Given the increased scrutiny of surgical procedures, the current application of modifier 22, which allows surgeons to receive greater reimbursement for a more difficult surgery, is not enough, according to Dr. Madni.
To address this shortfall, investigators developed the Parkland grading scale, a five-tiered grading system that is designed to be easy to remember, limited in the number of grades, and correlated with clinical outcomes.
To determine the grades of the scale, Dr. Madni and his fellow investigators used 200 gallbladder images collected immediately before dissection and analyzed anatomy and inflammatory characteristics.
Gallbladders with a grade 1 would be relatively normal looking, while a grade 5 gallbladder would show perforation, necrosis, or not be clearly visible because of adhesions, according to Dr. Madni.
Between September 2016 and March 2017, investigators asked 11 acute care surgeons to prospectively grade gallbladders they saw before surgery using the Parkland scale and to fill out a questionnaire describing the difficulty of the procedure afterwards.
Of 667 gallbladders graded, 60 were assessed to be grade 1 (19%), 90 were grade 2 (28%), 102 were grade 3 (32%), 28 were grade 4 (9%), and 37 were grade 5 (12%) on the Parkland scale.
Grade 1 gallbladders had a mean procedure difficulty score of 1.43, while grade 5 gallbladders had a mean difficulty of 4.46. Grade 1 gallbladders also corresponded with the shortest mean surgery time of 63.31 minutes, compared with an average of 108.13 minutes for grade 5.
Acute cholecystitis diagnosis also increased by Parkland grade, from 36.7% in grade 1 gallbladders to 83.8% in grade 5 (P less than .0001), as did open conversion rates, from 0% to 21.6% (P less than .0001).
Mean length of stay rose fivefold between grade 1 and grade 5 procedures, from around 8 hours to 36 hours, respectively (P less than .0001).
Discussant Martin Zielinski, MD, FACS, director of medical trauma clinical research at the Mayo Clinic, Rochester, Minn., recognized the importance of having a grading scale but was curious why investigators did not analyze the American Association for the Surgery of Trauma’s (AAST) Emergency General Surgery anatomic grading scale, which is already in place.
“The AAST is a uniform, anatomic grading scale to measure the severity of diseases from the 16 most common [Emergency General Surgery] diseases,” Dr. Madni responded. “Unlike our operative-only finding scale, the AAST scale gives grades 1 through 5 definitions for four categories in each disease, not just operative, but clinical, imaging, operative, and pathologic categories.”
Comparatively, the Parkland scale is less cumbersome and covers a wider range of difficulty variation, according to Dr. Madni.
In the future, Dr. Madni and his colleagues will work to compare the Parkland scale to the AAST scale and look for ways to bridge the two.
Dr. Madni reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
SOURCE: Madni T et al. EAST Scientific Assembly 2018 abstract #11.
ORLANDO – according to a study presented at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
As payment models shift toward bundled care, providers will be more closely evaluated on their postoperative outcomes, which can vary based on the difficulty of surgery, even for relatively common procedures.
“Gallbladder disease affects roughly 20 million people annually in the United States, with laparoscopic cholecystectomy being one of the most common operations performed by the typical surgeon,” said presenter Tarik Madni, MD, of the department of surgery, University of Texas Southwestern Medical Center, Dallas. “However not all cholecystectomies are created equal; increased inflammation can lead to increased operative times, increased conversion rates, as well as increased risk of complications.”
Given the increased scrutiny of surgical procedures, the current application of modifier 22, which allows surgeons to receive greater reimbursement for a more difficult surgery, is not enough, according to Dr. Madni.
To address this shortfall, investigators developed the Parkland grading scale, a five-tiered grading system that is designed to be easy to remember, limited in the number of grades, and correlated with clinical outcomes.
To determine the grades of the scale, Dr. Madni and his fellow investigators used 200 gallbladder images collected immediately before dissection and analyzed anatomy and inflammatory characteristics.
Gallbladders with a grade 1 would be relatively normal looking, while a grade 5 gallbladder would show perforation, necrosis, or not be clearly visible because of adhesions, according to Dr. Madni.
Between September 2016 and March 2017, investigators asked 11 acute care surgeons to prospectively grade gallbladders they saw before surgery using the Parkland scale and to fill out a questionnaire describing the difficulty of the procedure afterwards.
Of 667 gallbladders graded, 60 were assessed to be grade 1 (19%), 90 were grade 2 (28%), 102 were grade 3 (32%), 28 were grade 4 (9%), and 37 were grade 5 (12%) on the Parkland scale.
Grade 1 gallbladders had a mean procedure difficulty score of 1.43, while grade 5 gallbladders had a mean difficulty of 4.46. Grade 1 gallbladders also corresponded with the shortest mean surgery time of 63.31 minutes, compared with an average of 108.13 minutes for grade 5.
Acute cholecystitis diagnosis also increased by Parkland grade, from 36.7% in grade 1 gallbladders to 83.8% in grade 5 (P less than .0001), as did open conversion rates, from 0% to 21.6% (P less than .0001).
Mean length of stay rose fivefold between grade 1 and grade 5 procedures, from around 8 hours to 36 hours, respectively (P less than .0001).
Discussant Martin Zielinski, MD, FACS, director of medical trauma clinical research at the Mayo Clinic, Rochester, Minn., recognized the importance of having a grading scale but was curious why investigators did not analyze the American Association for the Surgery of Trauma’s (AAST) Emergency General Surgery anatomic grading scale, which is already in place.
“The AAST is a uniform, anatomic grading scale to measure the severity of diseases from the 16 most common [Emergency General Surgery] diseases,” Dr. Madni responded. “Unlike our operative-only finding scale, the AAST scale gives grades 1 through 5 definitions for four categories in each disease, not just operative, but clinical, imaging, operative, and pathologic categories.”
Comparatively, the Parkland scale is less cumbersome and covers a wider range of difficulty variation, according to Dr. Madni.
In the future, Dr. Madni and his colleagues will work to compare the Parkland scale to the AAST scale and look for ways to bridge the two.
Dr. Madni reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
SOURCE: Madni T et al. EAST Scientific Assembly 2018 abstract #11.
ORLANDO – according to a study presented at the annual scientific assembly of the Eastern Association for the Surgery of Trauma.
As payment models shift toward bundled care, providers will be more closely evaluated on their postoperative outcomes, which can vary based on the difficulty of surgery, even for relatively common procedures.
“Gallbladder disease affects roughly 20 million people annually in the United States, with laparoscopic cholecystectomy being one of the most common operations performed by the typical surgeon,” said presenter Tarik Madni, MD, of the department of surgery, University of Texas Southwestern Medical Center, Dallas. “However not all cholecystectomies are created equal; increased inflammation can lead to increased operative times, increased conversion rates, as well as increased risk of complications.”
Given the increased scrutiny of surgical procedures, the current application of modifier 22, which allows surgeons to receive greater reimbursement for a more difficult surgery, is not enough, according to Dr. Madni.
To address this shortfall, investigators developed the Parkland grading scale, a five-tiered grading system that is designed to be easy to remember, limited in the number of grades, and correlated with clinical outcomes.
To determine the grades of the scale, Dr. Madni and his fellow investigators used 200 gallbladder images collected immediately before dissection and analyzed anatomy and inflammatory characteristics.
Gallbladders with a grade 1 would be relatively normal looking, while a grade 5 gallbladder would show perforation, necrosis, or not be clearly visible because of adhesions, according to Dr. Madni.
Between September 2016 and March 2017, investigators asked 11 acute care surgeons to prospectively grade gallbladders they saw before surgery using the Parkland scale and to fill out a questionnaire describing the difficulty of the procedure afterwards.
Of 667 gallbladders graded, 60 were assessed to be grade 1 (19%), 90 were grade 2 (28%), 102 were grade 3 (32%), 28 were grade 4 (9%), and 37 were grade 5 (12%) on the Parkland scale.
Grade 1 gallbladders had a mean procedure difficulty score of 1.43, while grade 5 gallbladders had a mean difficulty of 4.46. Grade 1 gallbladders also corresponded with the shortest mean surgery time of 63.31 minutes, compared with an average of 108.13 minutes for grade 5.
Acute cholecystitis diagnosis also increased by Parkland grade, from 36.7% in grade 1 gallbladders to 83.8% in grade 5 (P less than .0001), as did open conversion rates, from 0% to 21.6% (P less than .0001).
Mean length of stay rose fivefold between grade 1 and grade 5 procedures, from around 8 hours to 36 hours, respectively (P less than .0001).
Discussant Martin Zielinski, MD, FACS, director of medical trauma clinical research at the Mayo Clinic, Rochester, Minn., recognized the importance of having a grading scale but was curious why investigators did not analyze the American Association for the Surgery of Trauma’s (AAST) Emergency General Surgery anatomic grading scale, which is already in place.
“The AAST is a uniform, anatomic grading scale to measure the severity of diseases from the 16 most common [Emergency General Surgery] diseases,” Dr. Madni responded. “Unlike our operative-only finding scale, the AAST scale gives grades 1 through 5 definitions for four categories in each disease, not just operative, but clinical, imaging, operative, and pathologic categories.”
Comparatively, the Parkland scale is less cumbersome and covers a wider range of difficulty variation, according to Dr. Madni.
In the future, Dr. Madni and his colleagues will work to compare the Parkland scale to the AAST scale and look for ways to bridge the two.
Dr. Madni reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
SOURCE: Madni T et al. EAST Scientific Assembly 2018 abstract #11.
REPORTING FROM EAST SCIENTIFIC ASSEMBLY
Key clinical point: A five-tiered grading system was developed to determine grades of cholecystectomy operative difficulty.
Major finding: Acute cholecystitis diagnosis also increased by Parkland grade, from 36.7% in grade 1 gallbladders to 83.8% in grade 5.
Study details: Eleven acute care surgeons graded gallbladders on initial view and then filled out a postoperative questionnaire.
Disclosures: The investigator reported no relevant financial disclosures.
Source: Madni T et al. EAST Scientifc Assembly 2018 abstract #11.
FDA bans 24 ingredients from OTC health care antiseptic products
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
Tc-325 effective for immediate GI tumor bleeding
The powder Tc-325 is effective for immediate hemostasis in patients with malignant gastrointestinal bleeding, according to results published in Gastrointestinal Endoscopy.
The compound achieved immediate hemostasis in 97.7% of patients with GI tumor bleeding, reported Alan Barkun, MD, of the division of gastroenterology at McGill University Health Centre, Montreal, and his coauthors. Conventional endoscopic hemostatic methods, by contrast, have shown highly variable hemostasis rates in prior studies, ranging from 31% to 93%, the authors said.
“Tc-325 seems to be more predictably effective in providing initial hemostasis in upper GI tumor bleeding compared with conventional methods,” they added.
The study included 88 eligible patients who initially presented with bleeding either as a result of a primary GI tumor, or metastases to the upper or lower GI tract. Almost 60% had an upper GI cancer site. Twenty-five patients died before the end of the 30-day observation period.
The recurrent bleeding rate at 72 hours was 15%. Bleeding rates at 7, 14, and 30 days’ follow-up were 7%, 7.8%, and 1.9%, respectively.
Overall, 27.3% of patients experienced repeat bleeding within 30 days of Tc-325 treatment, all from upper GI sites. No recurrent bleeding occurred from lower GI lesions. Recurrent bleeding occurred in 38% patients who did not receive definite hemostasis within 30 days.
An international normalized ratio value greater than 1.3 was significantly associated with early recurrent bleeding in univariable analysis (P = .02; odds ratio, 5.08; 95% confidence interval, 1.33-19.33), as was an Eastern Cooperative Oncology Group (ECOG) score of at least 3 (P = .049; OR, 3.94; 95% CI, 1.01-15.38). Definite hemostatic treatment was associated with less recurrent bleeding (P = .009; OR, 0.15; 95% CI, 0.04-0.62).
Factors significantly associated with 6-month survival in multivariable analysis were an ECOG score of 0-2 (P = .001; hazard ratio, 0.14; 95% CI, 0.04-0.47); cancer stage 1-3 (P = .042; HR, 0.31; 95% CI, 0.10-0.96), and receiving definite hemostastic treatment (P = .002; HR, 0.24; 95% CI, 0.09-0.59), Dr. Barkun and his colleagues reported.
Although the results show promise for Tc-325 as an immediate treatment in the case of failed standard endoscopic hemostatic techniques or when definite hemostasis via radiation, surgery, and chemotherapy are unavailable, the long-term effects are comparable with conventional methods, at least in the upper GI tract, the authors said. Better results in the lower GI tract may be attributed to the presence of gastric juice in the upper GI tract, the investigators noted.
Limitations of the study include “its retrospective design with the possibility of missing information and selective data collection,” as well as the possibility of decreased generalizability of results, Dr. Barkun and coauthors wrote. Nevertheless, its immediate effectiveness at achieving hemostasis and prevention of early bleeding indicate that the results may still be “used with confidence as guidance for any physician managing such patients,” the authors said.
The investigators did not disclose any conflicts of interest. The study was funded by the Grant for International Research Integration: Chula Research Scholar, Ratchadaphiseksomphot Endowment Fund.
SOURCE: Pittayanon R et al. Gastrointest Endosc. 2017 Nov 17. doi: 10.1016/j.gie.2017.11.013.
The powder Tc-325 is effective for immediate hemostasis in patients with malignant gastrointestinal bleeding, according to results published in Gastrointestinal Endoscopy.
The compound achieved immediate hemostasis in 97.7% of patients with GI tumor bleeding, reported Alan Barkun, MD, of the division of gastroenterology at McGill University Health Centre, Montreal, and his coauthors. Conventional endoscopic hemostatic methods, by contrast, have shown highly variable hemostasis rates in prior studies, ranging from 31% to 93%, the authors said.
“Tc-325 seems to be more predictably effective in providing initial hemostasis in upper GI tumor bleeding compared with conventional methods,” they added.
The study included 88 eligible patients who initially presented with bleeding either as a result of a primary GI tumor, or metastases to the upper or lower GI tract. Almost 60% had an upper GI cancer site. Twenty-five patients died before the end of the 30-day observation period.
The recurrent bleeding rate at 72 hours was 15%. Bleeding rates at 7, 14, and 30 days’ follow-up were 7%, 7.8%, and 1.9%, respectively.
Overall, 27.3% of patients experienced repeat bleeding within 30 days of Tc-325 treatment, all from upper GI sites. No recurrent bleeding occurred from lower GI lesions. Recurrent bleeding occurred in 38% patients who did not receive definite hemostasis within 30 days.
An international normalized ratio value greater than 1.3 was significantly associated with early recurrent bleeding in univariable analysis (P = .02; odds ratio, 5.08; 95% confidence interval, 1.33-19.33), as was an Eastern Cooperative Oncology Group (ECOG) score of at least 3 (P = .049; OR, 3.94; 95% CI, 1.01-15.38). Definite hemostatic treatment was associated with less recurrent bleeding (P = .009; OR, 0.15; 95% CI, 0.04-0.62).
Factors significantly associated with 6-month survival in multivariable analysis were an ECOG score of 0-2 (P = .001; hazard ratio, 0.14; 95% CI, 0.04-0.47); cancer stage 1-3 (P = .042; HR, 0.31; 95% CI, 0.10-0.96), and receiving definite hemostastic treatment (P = .002; HR, 0.24; 95% CI, 0.09-0.59), Dr. Barkun and his colleagues reported.
Although the results show promise for Tc-325 as an immediate treatment in the case of failed standard endoscopic hemostatic techniques or when definite hemostasis via radiation, surgery, and chemotherapy are unavailable, the long-term effects are comparable with conventional methods, at least in the upper GI tract, the authors said. Better results in the lower GI tract may be attributed to the presence of gastric juice in the upper GI tract, the investigators noted.
Limitations of the study include “its retrospective design with the possibility of missing information and selective data collection,” as well as the possibility of decreased generalizability of results, Dr. Barkun and coauthors wrote. Nevertheless, its immediate effectiveness at achieving hemostasis and prevention of early bleeding indicate that the results may still be “used with confidence as guidance for any physician managing such patients,” the authors said.
The investigators did not disclose any conflicts of interest. The study was funded by the Grant for International Research Integration: Chula Research Scholar, Ratchadaphiseksomphot Endowment Fund.
SOURCE: Pittayanon R et al. Gastrointest Endosc. 2017 Nov 17. doi: 10.1016/j.gie.2017.11.013.
The powder Tc-325 is effective for immediate hemostasis in patients with malignant gastrointestinal bleeding, according to results published in Gastrointestinal Endoscopy.
The compound achieved immediate hemostasis in 97.7% of patients with GI tumor bleeding, reported Alan Barkun, MD, of the division of gastroenterology at McGill University Health Centre, Montreal, and his coauthors. Conventional endoscopic hemostatic methods, by contrast, have shown highly variable hemostasis rates in prior studies, ranging from 31% to 93%, the authors said.
“Tc-325 seems to be more predictably effective in providing initial hemostasis in upper GI tumor bleeding compared with conventional methods,” they added.
The study included 88 eligible patients who initially presented with bleeding either as a result of a primary GI tumor, or metastases to the upper or lower GI tract. Almost 60% had an upper GI cancer site. Twenty-five patients died before the end of the 30-day observation period.
The recurrent bleeding rate at 72 hours was 15%. Bleeding rates at 7, 14, and 30 days’ follow-up were 7%, 7.8%, and 1.9%, respectively.
Overall, 27.3% of patients experienced repeat bleeding within 30 days of Tc-325 treatment, all from upper GI sites. No recurrent bleeding occurred from lower GI lesions. Recurrent bleeding occurred in 38% patients who did not receive definite hemostasis within 30 days.
An international normalized ratio value greater than 1.3 was significantly associated with early recurrent bleeding in univariable analysis (P = .02; odds ratio, 5.08; 95% confidence interval, 1.33-19.33), as was an Eastern Cooperative Oncology Group (ECOG) score of at least 3 (P = .049; OR, 3.94; 95% CI, 1.01-15.38). Definite hemostatic treatment was associated with less recurrent bleeding (P = .009; OR, 0.15; 95% CI, 0.04-0.62).
Factors significantly associated with 6-month survival in multivariable analysis were an ECOG score of 0-2 (P = .001; hazard ratio, 0.14; 95% CI, 0.04-0.47); cancer stage 1-3 (P = .042; HR, 0.31; 95% CI, 0.10-0.96), and receiving definite hemostastic treatment (P = .002; HR, 0.24; 95% CI, 0.09-0.59), Dr. Barkun and his colleagues reported.
Although the results show promise for Tc-325 as an immediate treatment in the case of failed standard endoscopic hemostatic techniques or when definite hemostasis via radiation, surgery, and chemotherapy are unavailable, the long-term effects are comparable with conventional methods, at least in the upper GI tract, the authors said. Better results in the lower GI tract may be attributed to the presence of gastric juice in the upper GI tract, the investigators noted.
Limitations of the study include “its retrospective design with the possibility of missing information and selective data collection,” as well as the possibility of decreased generalizability of results, Dr. Barkun and coauthors wrote. Nevertheless, its immediate effectiveness at achieving hemostasis and prevention of early bleeding indicate that the results may still be “used with confidence as guidance for any physician managing such patients,” the authors said.
The investigators did not disclose any conflicts of interest. The study was funded by the Grant for International Research Integration: Chula Research Scholar, Ratchadaphiseksomphot Endowment Fund.
SOURCE: Pittayanon R et al. Gastrointest Endosc. 2017 Nov 17. doi: 10.1016/j.gie.2017.11.013.
FROM GASTROINTESTINAL ENDOSCOPY
Key clinical point: Tc-325 is promising for initial hemostasis in patients with gastrointestinal tumor bleeding.
Major finding: Tc-325 achieved immediate hemostasis in 97.7% of patients with bleeding from GI tumors.
Data source: A multicenter retrospective study of 88 eligible patients with GI tumor-related hemorrhage from 2011 to 2016.
Disclosures: The authors did not disclose any conflicts of interest. The study was funded by the Grant for International Research Integration: Chula Research Scholar, Ratchadaphiseksomphot Endowment Fund.
Source: Pittayanon R et al. Gastrointest Endosc. 2017 Nov 17. doi: 10.1016/j.gie.2017.11.013.
Potential postthyroidectomy quality improvement metrics arise from study
of U.S. hospitals, suggesting to the authors that these measures could be used for quality improvement metrics.
In the study, published Nov. 29 in JAMA Surgery, hospitals with significantly lower rates of hypocalcemia were more likely to conduct postoperative parathyroid hormone level measurement as well as to prescribe vitamin D, calcium supplements, or both. Hospitals with lower RLN injury rates more frequently used energy devices and intraoperative nerve monitoring.
“Causation cannot be proven by this, but the confidence that these practice parameters are important is high,” senior author Bruce Hall, MD, PhD, vice president and chief quality officer at BJC Healthcare, and professor of surgery at Washington University, St. Louis, said in an interview. Dr. Hall is consulting director for the American College of Surgeon’s National Surgical Quality Improvement Program (NSQIP), which provided data for the analysis (JAMA Surg. 2017 Nov 29. doi: 10.1001/jamasurg.2017.4593).
The researchers examined data from 14,540 patients who underwent thyroidectomies at 98 hospitals between Jan. 1, 2013, and Dec. 31, 2015. These included 13,242 operations at 96 hospitals with complete hypocalcemia data, 13,144 operations at 95 hospitals with complete RLN data, and 13,197 operations at 95 hospitals with complete hematoma data. The primary outcome was the 30-day incidence of hypocalcemia, RLN, and hematoma. The researchers also measured 30-day mortality, surgical site infections, and hospital readmissions.
A total of 3.3% of patients experienced clinically severe hypocalcemia (0.6% after partial thyroidectomy, 4.7% after total or subtotal thyroidectomy). Another 5.7% experienced RLN (4.2% after partial, 6.6% after total or subtotal). Hematoma occurred in 1.3% of cases, but there were no significant variations in rates of hematoma across participating institutions.
For hypocalcemia and RLN injury, there were hospital outliers both on the low end of complication rates and on the high end of complication rates, defined by odds ratios with 95% confidence ratios that were greater than 1 for high outliers, or lower than 1 for low outliers. There were no outliers with respect to hematoma, suggesting that it may not be a useful barometer of hospital performance.
With respect to hypocalcemia rates, four hospitals were low outliers, and seven were high. Eight hospitals were low outliers with respect to RLN injury, and 14 were high outliers.
In the analysis of postoperative hypocalcemia, both low and high outliers measured postoperative calcium with similar frequency (68.4% vs. 71.0%; P =.09). However, high performance outliers were more likely to prescribe postoperative calcium, vitamin D, or both (76.6% vs. 66.8%; P less than .001).
Among RLN outliers, intraoperative nerve monitoring was more common in the top performing hospitals (55.7% vs. 37.7%; P less than .001), as was the use of energy devices (69.1% vs. 55.2%; P less than .001).
There was one high outlier when it came to surgical site infections, and one high and one low outlier with respect to morbidity outcomes. There were no hospital readmission outliers.
No source of funding was disclosed. Dr. Liu and Dr. Hall reported having no financial disclosures.
of U.S. hospitals, suggesting to the authors that these measures could be used for quality improvement metrics.
In the study, published Nov. 29 in JAMA Surgery, hospitals with significantly lower rates of hypocalcemia were more likely to conduct postoperative parathyroid hormone level measurement as well as to prescribe vitamin D, calcium supplements, or both. Hospitals with lower RLN injury rates more frequently used energy devices and intraoperative nerve monitoring.
“Causation cannot be proven by this, but the confidence that these practice parameters are important is high,” senior author Bruce Hall, MD, PhD, vice president and chief quality officer at BJC Healthcare, and professor of surgery at Washington University, St. Louis, said in an interview. Dr. Hall is consulting director for the American College of Surgeon’s National Surgical Quality Improvement Program (NSQIP), which provided data for the analysis (JAMA Surg. 2017 Nov 29. doi: 10.1001/jamasurg.2017.4593).
The researchers examined data from 14,540 patients who underwent thyroidectomies at 98 hospitals between Jan. 1, 2013, and Dec. 31, 2015. These included 13,242 operations at 96 hospitals with complete hypocalcemia data, 13,144 operations at 95 hospitals with complete RLN data, and 13,197 operations at 95 hospitals with complete hematoma data. The primary outcome was the 30-day incidence of hypocalcemia, RLN, and hematoma. The researchers also measured 30-day mortality, surgical site infections, and hospital readmissions.
A total of 3.3% of patients experienced clinically severe hypocalcemia (0.6% after partial thyroidectomy, 4.7% after total or subtotal thyroidectomy). Another 5.7% experienced RLN (4.2% after partial, 6.6% after total or subtotal). Hematoma occurred in 1.3% of cases, but there were no significant variations in rates of hematoma across participating institutions.
For hypocalcemia and RLN injury, there were hospital outliers both on the low end of complication rates and on the high end of complication rates, defined by odds ratios with 95% confidence ratios that were greater than 1 for high outliers, or lower than 1 for low outliers. There were no outliers with respect to hematoma, suggesting that it may not be a useful barometer of hospital performance.
With respect to hypocalcemia rates, four hospitals were low outliers, and seven were high. Eight hospitals were low outliers with respect to RLN injury, and 14 were high outliers.
In the analysis of postoperative hypocalcemia, both low and high outliers measured postoperative calcium with similar frequency (68.4% vs. 71.0%; P =.09). However, high performance outliers were more likely to prescribe postoperative calcium, vitamin D, or both (76.6% vs. 66.8%; P less than .001).
Among RLN outliers, intraoperative nerve monitoring was more common in the top performing hospitals (55.7% vs. 37.7%; P less than .001), as was the use of energy devices (69.1% vs. 55.2%; P less than .001).
There was one high outlier when it came to surgical site infections, and one high and one low outlier with respect to morbidity outcomes. There were no hospital readmission outliers.
No source of funding was disclosed. Dr. Liu and Dr. Hall reported having no financial disclosures.
of U.S. hospitals, suggesting to the authors that these measures could be used for quality improvement metrics.
In the study, published Nov. 29 in JAMA Surgery, hospitals with significantly lower rates of hypocalcemia were more likely to conduct postoperative parathyroid hormone level measurement as well as to prescribe vitamin D, calcium supplements, or both. Hospitals with lower RLN injury rates more frequently used energy devices and intraoperative nerve monitoring.
“Causation cannot be proven by this, but the confidence that these practice parameters are important is high,” senior author Bruce Hall, MD, PhD, vice president and chief quality officer at BJC Healthcare, and professor of surgery at Washington University, St. Louis, said in an interview. Dr. Hall is consulting director for the American College of Surgeon’s National Surgical Quality Improvement Program (NSQIP), which provided data for the analysis (JAMA Surg. 2017 Nov 29. doi: 10.1001/jamasurg.2017.4593).
The researchers examined data from 14,540 patients who underwent thyroidectomies at 98 hospitals between Jan. 1, 2013, and Dec. 31, 2015. These included 13,242 operations at 96 hospitals with complete hypocalcemia data, 13,144 operations at 95 hospitals with complete RLN data, and 13,197 operations at 95 hospitals with complete hematoma data. The primary outcome was the 30-day incidence of hypocalcemia, RLN, and hematoma. The researchers also measured 30-day mortality, surgical site infections, and hospital readmissions.
A total of 3.3% of patients experienced clinically severe hypocalcemia (0.6% after partial thyroidectomy, 4.7% after total or subtotal thyroidectomy). Another 5.7% experienced RLN (4.2% after partial, 6.6% after total or subtotal). Hematoma occurred in 1.3% of cases, but there were no significant variations in rates of hematoma across participating institutions.
For hypocalcemia and RLN injury, there were hospital outliers both on the low end of complication rates and on the high end of complication rates, defined by odds ratios with 95% confidence ratios that were greater than 1 for high outliers, or lower than 1 for low outliers. There were no outliers with respect to hematoma, suggesting that it may not be a useful barometer of hospital performance.
With respect to hypocalcemia rates, four hospitals were low outliers, and seven were high. Eight hospitals were low outliers with respect to RLN injury, and 14 were high outliers.
In the analysis of postoperative hypocalcemia, both low and high outliers measured postoperative calcium with similar frequency (68.4% vs. 71.0%; P =.09). However, high performance outliers were more likely to prescribe postoperative calcium, vitamin D, or both (76.6% vs. 66.8%; P less than .001).
Among RLN outliers, intraoperative nerve monitoring was more common in the top performing hospitals (55.7% vs. 37.7%; P less than .001), as was the use of energy devices (69.1% vs. 55.2%; P less than .001).
There was one high outlier when it came to surgical site infections, and one high and one low outlier with respect to morbidity outcomes. There were no hospital readmission outliers.
No source of funding was disclosed. Dr. Liu and Dr. Hall reported having no financial disclosures.
FROM JAMA SURGERY
Key clinical point: Prescription of postoperative calcium, vitamin D, or both, and greater use of intraoperative nerve monitoring may lead to fewer adverse events after thyroidectomy.
Major finding: Both low and high outliers on 30-day rates of postoperative hypocalcemia measured postoperative calcium with similar frequency (68.4% vs. 71.0%; P =.09). However, high performance outliers were more likely to prescribe postoperative calcium, vitamin D, or both (76.6% vs. 66.8%; P less than .001).
Data source: Retrospective analysis of 14,540 patients at 98 hospitals in the American College of Surgeon’s National Surgical Quality Improvement Program.
Disclosures: No source of funding was disclosed. Dr. Liu and Dr. Hall reported having no financial disclosures.
Pancreatic surgery: Similar outcomes with primary anastomosis, allografts
Pancreatic tumor involvement with the superior mesenteric vein/portal vein (SMV/PV) is common and requires exploration and resection, which has now become an integral part of routine surgical treatment. The short-term outcome of SMV/PV reconstruction with interposed cold-stored cadaveric venous allografts was found to be comparable to that of reconstruction with primary end-to-end anastomosis, according to the results of a study performed by Dyre Kleive, MD, and his colleagues.
In order to assess the optimal method of reconstructing the portal vein during pancreatic surgery, Dr. Kleive and his colleagues performed a retrospective review of all patients undergoing pancreatic surgery with venous resection and reconstruction at a single center between January 2006 and December 2015.
A total of 857 patients underwent open pancreatic surgery during the study period, of whom 171 (20%) had vascular resection and reconstruction. The study population comprised 42 patients treated with cold-stored interposition cadaveric allografts for reconstruction and 71 patients who had primary end-to-end anastomosis instead. Patients with other forms of reconstruction were excluded, according to an online report in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (2017. doi: 10.1016/j.jvsv.2017.09.003).
Early failure at the reconstruction site was defined as the presence of thrombosis or no flow or low flow within the first 30 days after surgery.
Patients in the allograft group had statistically significantly longer mean operative times, more intraoperative bleeding, more frequent use of neoadjuvant therapy, and a longer length of tumor-vein involvement than the anastomosis group.
However, there was no statistically significant difference in the number of patients with major complications (42.9% for allografts vs. 36.6% for anastomosis) or early failure at the reconstruction site (9.5% for allografts vs. 8.5% for anastomosis) between the two groups, Dr Kleive and his colleagues reported.
The proportion of patients with grade C stenosis at last available imaging scan was significantly higher in the allograft group (26/42 [61.9%] vs. 13 of 66 [19.7%] for the anastomosis group; P less than .01). A subgroup analysis of 10 patients in the allograft group showed the presence of donor-specific antibodies in all patients. This could indicate that graft rejection was a contributing factor to the statistically higher development of severe stenosis in allograft vs. anastomosis patients, the authors suggested.
“This study shows that the short-term outcome of SMV/PV reconstruction with interposed cold-stored cadaveric venous allografts is comparable to that of reconstruction with primary end-to-end anastomosis,” the researchers concluded.
Dr. Kleive and his colleagues reported that they had no conflicts of interest.
Pancreatic tumor involvement with the superior mesenteric vein/portal vein (SMV/PV) is common and requires exploration and resection, which has now become an integral part of routine surgical treatment. The short-term outcome of SMV/PV reconstruction with interposed cold-stored cadaveric venous allografts was found to be comparable to that of reconstruction with primary end-to-end anastomosis, according to the results of a study performed by Dyre Kleive, MD, and his colleagues.
In order to assess the optimal method of reconstructing the portal vein during pancreatic surgery, Dr. Kleive and his colleagues performed a retrospective review of all patients undergoing pancreatic surgery with venous resection and reconstruction at a single center between January 2006 and December 2015.
A total of 857 patients underwent open pancreatic surgery during the study period, of whom 171 (20%) had vascular resection and reconstruction. The study population comprised 42 patients treated with cold-stored interposition cadaveric allografts for reconstruction and 71 patients who had primary end-to-end anastomosis instead. Patients with other forms of reconstruction were excluded, according to an online report in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (2017. doi: 10.1016/j.jvsv.2017.09.003).
Early failure at the reconstruction site was defined as the presence of thrombosis or no flow or low flow within the first 30 days after surgery.
Patients in the allograft group had statistically significantly longer mean operative times, more intraoperative bleeding, more frequent use of neoadjuvant therapy, and a longer length of tumor-vein involvement than the anastomosis group.
However, there was no statistically significant difference in the number of patients with major complications (42.9% for allografts vs. 36.6% for anastomosis) or early failure at the reconstruction site (9.5% for allografts vs. 8.5% for anastomosis) between the two groups, Dr Kleive and his colleagues reported.
The proportion of patients with grade C stenosis at last available imaging scan was significantly higher in the allograft group (26/42 [61.9%] vs. 13 of 66 [19.7%] for the anastomosis group; P less than .01). A subgroup analysis of 10 patients in the allograft group showed the presence of donor-specific antibodies in all patients. This could indicate that graft rejection was a contributing factor to the statistically higher development of severe stenosis in allograft vs. anastomosis patients, the authors suggested.
“This study shows that the short-term outcome of SMV/PV reconstruction with interposed cold-stored cadaveric venous allografts is comparable to that of reconstruction with primary end-to-end anastomosis,” the researchers concluded.
Dr. Kleive and his colleagues reported that they had no conflicts of interest.
Pancreatic tumor involvement with the superior mesenteric vein/portal vein (SMV/PV) is common and requires exploration and resection, which has now become an integral part of routine surgical treatment. The short-term outcome of SMV/PV reconstruction with interposed cold-stored cadaveric venous allografts was found to be comparable to that of reconstruction with primary end-to-end anastomosis, according to the results of a study performed by Dyre Kleive, MD, and his colleagues.
In order to assess the optimal method of reconstructing the portal vein during pancreatic surgery, Dr. Kleive and his colleagues performed a retrospective review of all patients undergoing pancreatic surgery with venous resection and reconstruction at a single center between January 2006 and December 2015.
A total of 857 patients underwent open pancreatic surgery during the study period, of whom 171 (20%) had vascular resection and reconstruction. The study population comprised 42 patients treated with cold-stored interposition cadaveric allografts for reconstruction and 71 patients who had primary end-to-end anastomosis instead. Patients with other forms of reconstruction were excluded, according to an online report in the Journal of Vascular Surgery: Venous and Lymphatic Disorders (2017. doi: 10.1016/j.jvsv.2017.09.003).
Early failure at the reconstruction site was defined as the presence of thrombosis or no flow or low flow within the first 30 days after surgery.
Patients in the allograft group had statistically significantly longer mean operative times, more intraoperative bleeding, more frequent use of neoadjuvant therapy, and a longer length of tumor-vein involvement than the anastomosis group.
However, there was no statistically significant difference in the number of patients with major complications (42.9% for allografts vs. 36.6% for anastomosis) or early failure at the reconstruction site (9.5% for allografts vs. 8.5% for anastomosis) between the two groups, Dr Kleive and his colleagues reported.
The proportion of patients with grade C stenosis at last available imaging scan was significantly higher in the allograft group (26/42 [61.9%] vs. 13 of 66 [19.7%] for the anastomosis group; P less than .01). A subgroup analysis of 10 patients in the allograft group showed the presence of donor-specific antibodies in all patients. This could indicate that graft rejection was a contributing factor to the statistically higher development of severe stenosis in allograft vs. anastomosis patients, the authors suggested.
“This study shows that the short-term outcome of SMV/PV reconstruction with interposed cold-stored cadaveric venous allografts is comparable to that of reconstruction with primary end-to-end anastomosis,” the researchers concluded.
Dr. Kleive and his colleagues reported that they had no conflicts of interest.
FROM THE JOURNAL OF VASCULAR SURGERY: VENOUS AND LYMPHATIC DISEASES
Key clinical point:
Major finding: There was no statistically significant difference in the number of patients with major complications or early failure at the reconstruction site between the allograft and the anastomosis groups.
Data source: A retrospective review of all 171 patients undergoing pancreatic surgery with venous resection and reconstruction at a single center between January 2006 and December 2015.
Disclosures: The authors reported that they had no conflicts of interest.