Clinical question: What is the association of palliative care programs on quality of life, symptoms, and survival for patients and their caregivers?

Background: Palliative care programs have expanded across the country: More than 65% of U.S. hospitals have such a program. Efforts have been made to assess their effectiveness for terminally ill patients and their caregivers.

Study design: Systematic review and meta-analysis of 43 randomized controlled trials.

Setting: Not applicable

Synopsis: Two reviewers independently assessed 43 trials (12,731 patients and 2,479 caregivers) with the main outcomes being quality of life, symptom burden, survival, mood, advance care planning, site of death, health care satisfaction, resource utilization, and health care expenditures. Estimates of QOL were translated to units of the Functional Assessment of Chronic Illness Therapy–palliative care scale (FACIT-Pal) instrument and symptom burden was translated into the Edmonton Symptom Assessment Scale (ESAS). Palliative care was associated with statistically and clinically significant improvements in patient QOL at the 1- to 3-month follow-up (standardized mean difference, 0.46; 95% CI, 0.08-0.83; FACIT-Pal mean difference, 11.36) and symptom burden at the 1- to 3-month follow-up (standardized mean difference, −0.66; 95% CI, −1.25 to −0.07; ESAS mean difference, −10.30).

Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.

Clinical question: What is the association of palliative care programs on quality of life, symptoms, and survival for patients and their caregivers?

Background: Palliative care programs have expanded across the country: More than 65% of U.S. hospitals have such a program. Efforts have been made to assess their effectiveness for terminally ill patients and their caregivers.

Study design: Systematic review and meta-analysis of 43 randomized controlled trials.

Setting: Not applicable

Synopsis: Two reviewers independently assessed 43 trials (12,731 patients and 2,479 caregivers) with the main outcomes being quality of life, symptom burden, survival, mood, advance care planning, site of death, health care satisfaction, resource utilization, and health care expenditures. Estimates of QOL were translated to units of the Functional Assessment of Chronic Illness Therapy–palliative care scale (FACIT-Pal) instrument and symptom burden was translated into the Edmonton Symptom Assessment Scale (ESAS). Palliative care was associated with statistically and clinically significant improvements in patient QOL at the 1- to 3-month follow-up (standardized mean difference, 0.46; 95% CI, 0.08-0.83; FACIT-Pal mean difference, 11.36) and symptom burden at the 1- to 3-month follow-up (standardized mean difference, −0.66; 95% CI, −1.25 to −0.07; ESAS mean difference, −10.30).

Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.

Clinical question: What is the association of palliative care programs on quality of life, symptoms, and survival for patients and their caregivers?

Background: Palliative care programs have expanded across the country: More than 65% of U.S. hospitals have such a program. Efforts have been made to assess their effectiveness for terminally ill patients and their caregivers.

Study design: Systematic review and meta-analysis of 43 randomized controlled trials.

Setting: Not applicable

Synopsis: Two reviewers independently assessed 43 trials (12,731 patients and 2,479 caregivers) with the main outcomes being quality of life, symptom burden, survival, mood, advance care planning, site of death, health care satisfaction, resource utilization, and health care expenditures. Estimates of QOL were translated to units of the Functional Assessment of Chronic Illness Therapy–palliative care scale (FACIT-Pal) instrument and symptom burden was translated into the Edmonton Symptom Assessment Scale (ESAS). Palliative care was associated with statistically and clinically significant improvements in patient QOL at the 1- to 3-month follow-up (standardized mean difference, 0.46; 95% CI, 0.08-0.83; FACIT-Pal mean difference, 11.36) and symptom burden at the 1- to 3-month follow-up (standardized mean difference, −0.66; 95% CI, −1.25 to −0.07; ESAS mean difference, −10.30).

Dr. Cerceo is an assistant professor in the Division of Hospital Medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.

ORLANDO – A relatively simple mechanical tool to move the esophagus away from the energy delivered during ablation of atrial fibrillation (AF) does what it is supposed to do, according to data from a multicenter observational study presented at the AF Symposium 2017.

When esophageal temperature during the ablation procedure was monitored in 101 consecutive cases, no recording exceeded 38° C, according to Valay Parikh, MD, a clinical cardiac electrophysiology fellow working under Dhanunjaya Lakkireddy, MD, at the Kansas University Medical Center, Kansas City.

The tool is a stylet constructed from a nickel-titanium (nitinol) alloy. Malleable at room temperature, the stylet is inserted into an 18 Fr orogastric (OG) tube. Firmer at body temperature, the stylet within the OG tube is maneuvered to displace the esophagus away from the adjacent left atrium when radiofrequency ablation (RFA) is being administered.

The tool, marketed under the brand name EsoSure, was first made available almost 2 years ago, but the recently completed multicenter observational study was conducted to provide a more systematic evaluation of its safety and efficacy in routine use. In this study, 101 consecutive patients scheduled for RFA for AF had their esophagus displaced by the stylet during the procedure. The temperature of the esophagus as well as any adverse events involving the upper gastrointestinal tract were evaluated during the procedure. Patients were then followed for at least 6 months.

“The principal finding of our study is that mechanical displacement of the esophagus with the help of the EsoSure device is safe and provides sufficient room to deliver the intended energy at the site of ablation without any rise in temperature over 38° C,” Dr. Parikh reported.

The mean age of the 101 patients who participated in this study was 65 years. About half were female. The mean body mass index (BMI) was 32 kg/m². The mean CHA₂DS₂-VASc score was 2.4. Barium x-rays were used to confirm esophageal displacement.

After the procedure, patients were discharged on a proton pump inhibitor and sucralfate, which inhibits pepsin activity and protects against ulceration. Follow-up endoscopy was performed only when medically indicated, but all patients were evaluated over the course of follow-up for odynophagia, dysphagia, hematemesis, dyspepsia, and other GI symptoms.

Pulmonary vein isolation (PVI) was achieved successfully in all cases. Although there was a rapid temperature rise at the site of ablation over the course of RFA, the esophagus was adequately displaced from the source of energy, as confirmed with the absence of significant temperature rises in this tissue. The mean esophageal displacement was 2.53 cm.

The only complication in this series, occurring in 7% of patients, was dysphagia. All cases of dysphagia developed immediately or soon after the procedure. All were mild, and all resolved within several days. There were no late GI complications observed, although Dr. Parikh acknowledged that no follow-up endoscopy was performed to rule out any esophageal injury.

In contrast, without the deviation permitted by the esophageal retractor, the rapid rise in temperature “could have precluded PVI,” Dr. Parikh maintained. He said that the retractor permitted the esophagus to be cleared from potential injury, as indicated by the lack of a temperature rise in esophageal tissue, in 100% of the cases. He noted that the tool is now in routine use at his center.

According to Dr. Lakkireddy, this tool is already in routine use at several centers across the country. The goal of this study was to provide an objective documentation of the ability of the device to enable successful posterior wall isolation during PVI without esophageal injury.

“It helped us get to the endpoint without a problem 100% of the time,” Dr. Lakkireddy reported.

Dr. Parikh has no industry relationships relevant to this study.

ORLANDO – A relatively simple mechanical tool to move the esophagus away from the energy delivered during ablation of atrial fibrillation (AF) does what it is supposed to do, according to data from a multicenter observational study presented at the AF Symposium 2017.

When esophageal temperature during the ablation procedure was monitored in 101 consecutive cases, no recording exceeded 38° C, according to Valay Parikh, MD, a clinical cardiac electrophysiology fellow working under Dhanunjaya Lakkireddy, MD, at the Kansas University Medical Center, Kansas City.

The tool is a stylet constructed from a nickel-titanium (nitinol) alloy. Malleable at room temperature, the stylet is inserted into an 18 Fr orogastric (OG) tube. Firmer at body temperature, the stylet within the OG tube is maneuvered to displace the esophagus away from the adjacent left atrium when radiofrequency ablation (RFA) is being administered.

The tool, marketed under the brand name EsoSure, was first made available almost 2 years ago, but the recently completed multicenter observational study was conducted to provide a more systematic evaluation of its safety and efficacy in routine use. In this study, 101 consecutive patients scheduled for RFA for AF had their esophagus displaced by the stylet during the procedure. The temperature of the esophagus as well as any adverse events involving the upper gastrointestinal tract were evaluated during the procedure. Patients were then followed for at least 6 months.

“The principal finding of our study is that mechanical displacement of the esophagus with the help of the EsoSure device is safe and provides sufficient room to deliver the intended energy at the site of ablation without any rise in temperature over 38° C,” Dr. Parikh reported.

The mean age of the 101 patients who participated in this study was 65 years. About half were female. The mean body mass index (BMI) was 32 kg/m². The mean CHA₂DS₂-VASc score was 2.4. Barium x-rays were used to confirm esophageal displacement.

After the procedure, patients were discharged on a proton pump inhibitor and sucralfate, which inhibits pepsin activity and protects against ulceration. Follow-up endoscopy was performed only when medically indicated, but all patients were evaluated over the course of follow-up for odynophagia, dysphagia, hematemesis, dyspepsia, and other GI symptoms.

Pulmonary vein isolation (PVI) was achieved successfully in all cases. Although there was a rapid temperature rise at the site of ablation over the course of RFA, the esophagus was adequately displaced from the source of energy, as confirmed with the absence of significant temperature rises in this tissue. The mean esophageal displacement was 2.53 cm.

The only complication in this series, occurring in 7% of patients, was dysphagia. All cases of dysphagia developed immediately or soon after the procedure. All were mild, and all resolved within several days. There were no late GI complications observed, although Dr. Parikh acknowledged that no follow-up endoscopy was performed to rule out any esophageal injury.

In contrast, without the deviation permitted by the esophageal retractor, the rapid rise in temperature “could have precluded PVI,” Dr. Parikh maintained. He said that the retractor permitted the esophagus to be cleared from potential injury, as indicated by the lack of a temperature rise in esophageal tissue, in 100% of the cases. He noted that the tool is now in routine use at his center.

According to Dr. Lakkireddy, this tool is already in routine use at several centers across the country. The goal of this study was to provide an objective documentation of the ability of the device to enable successful posterior wall isolation during PVI without esophageal injury.

“It helped us get to the endpoint without a problem 100% of the time,” Dr. Lakkireddy reported.

Dr. Parikh has no industry relationships relevant to this study.

ORLANDO – A relatively simple mechanical tool to move the esophagus away from the energy delivered during ablation of atrial fibrillation (AF) does what it is supposed to do, according to data from a multicenter observational study presented at the AF Symposium 2017.

When esophageal temperature during the ablation procedure was monitored in 101 consecutive cases, no recording exceeded 38° C, according to Valay Parikh, MD, a clinical cardiac electrophysiology fellow working under Dhanunjaya Lakkireddy, MD, at the Kansas University Medical Center, Kansas City.

The tool is a stylet constructed from a nickel-titanium (nitinol) alloy. Malleable at room temperature, the stylet is inserted into an 18 Fr orogastric (OG) tube. Firmer at body temperature, the stylet within the OG tube is maneuvered to displace the esophagus away from the adjacent left atrium when radiofrequency ablation (RFA) is being administered.

The tool, marketed under the brand name EsoSure, was first made available almost 2 years ago, but the recently completed multicenter observational study was conducted to provide a more systematic evaluation of its safety and efficacy in routine use. In this study, 101 consecutive patients scheduled for RFA for AF had their esophagus displaced by the stylet during the procedure. The temperature of the esophagus as well as any adverse events involving the upper gastrointestinal tract were evaluated during the procedure. Patients were then followed for at least 6 months.

“The principal finding of our study is that mechanical displacement of the esophagus with the help of the EsoSure device is safe and provides sufficient room to deliver the intended energy at the site of ablation without any rise in temperature over 38° C,” Dr. Parikh reported.

The mean age of the 101 patients who participated in this study was 65 years. About half were female. The mean body mass index (BMI) was 32 kg/m². The mean CHA₂DS₂-VASc score was 2.4. Barium x-rays were used to confirm esophageal displacement.

After the procedure, patients were discharged on a proton pump inhibitor and sucralfate, which inhibits pepsin activity and protects against ulceration. Follow-up endoscopy was performed only when medically indicated, but all patients were evaluated over the course of follow-up for odynophagia, dysphagia, hematemesis, dyspepsia, and other GI symptoms.

Pulmonary vein isolation (PVI) was achieved successfully in all cases. Although there was a rapid temperature rise at the site of ablation over the course of RFA, the esophagus was adequately displaced from the source of energy, as confirmed with the absence of significant temperature rises in this tissue. The mean esophageal displacement was 2.53 cm.

The only complication in this series, occurring in 7% of patients, was dysphagia. All cases of dysphagia developed immediately or soon after the procedure. All were mild, and all resolved within several days. There were no late GI complications observed, although Dr. Parikh acknowledged that no follow-up endoscopy was performed to rule out any esophageal injury.

In contrast, without the deviation permitted by the esophageal retractor, the rapid rise in temperature “could have precluded PVI,” Dr. Parikh maintained. He said that the retractor permitted the esophagus to be cleared from potential injury, as indicated by the lack of a temperature rise in esophageal tissue, in 100% of the cases. He noted that the tool is now in routine use at his center.

According to Dr. Lakkireddy, this tool is already in routine use at several centers across the country. The goal of this study was to provide an objective documentation of the ability of the device to enable successful posterior wall isolation during PVI without esophageal injury.

“It helped us get to the endpoint without a problem 100% of the time,” Dr. Lakkireddy reported.

Dr. Parikh has no industry relationships relevant to this study.

The emerging multidrug-resistant yeast organism Candida auris forms biofilms that enhance both its resistance and its virulence, according to in vitro analyses.

C. auris first attracted attention in 2009 because of its resistance to azoles and amphotericin B. Since then, it has been identified as the cause of life-threatening invasive infections worldwide, including hospital outbreaks across Asia and South America, wrote Leighann Sherry, PhD, a medical mycologist at the University of Glasgow, and her associates.

To determine whether the pathogen has the capacity to form biofilms, the investigators propagated several different strains in the laboratory and examined their development. In three separate trials, eight samples of each strain grew biofilms, which constitute “a key driver of candida pathogenicity.” In antifungal susceptibility tests, caspofungin was completely ineffective, an unexpected finding because the agent usually is highly effective against other candida species. Amphotericin B, liposomal amphotericin B, and fluconazole also were ineffective; micafungin and chlorhexidine were the most effective at clearing C. auris.

Biofilm formation “contributes not only to C. auris virulence but also to its [resistance] in hospital environments, increasing its ability to cause outbreaks,” Dr. Sherry and her associates said (Emerg. Infect. Dis. 2017 Feb;23[2]:328-31).

“Our findings suggest it is improbable that the spread and prevalence of C. auris can be controlled with antifungal stewardship approaches alone,” they noted, adding that “infection-prevention measures targeting C. auris biofilms in patients, on medical devices, and in the hospital environment will be required,” they noted.

The emerging multidrug-resistant yeast organism Candida auris forms biofilms that enhance both its resistance and its virulence, according to in vitro analyses.

C. auris first attracted attention in 2009 because of its resistance to azoles and amphotericin B. Since then, it has been identified as the cause of life-threatening invasive infections worldwide, including hospital outbreaks across Asia and South America, wrote Leighann Sherry, PhD, a medical mycologist at the University of Glasgow, and her associates.

To determine whether the pathogen has the capacity to form biofilms, the investigators propagated several different strains in the laboratory and examined their development. In three separate trials, eight samples of each strain grew biofilms, which constitute “a key driver of candida pathogenicity.” In antifungal susceptibility tests, caspofungin was completely ineffective, an unexpected finding because the agent usually is highly effective against other candida species. Amphotericin B, liposomal amphotericin B, and fluconazole also were ineffective; micafungin and chlorhexidine were the most effective at clearing C. auris.

Biofilm formation “contributes not only to C. auris virulence but also to its [resistance] in hospital environments, increasing its ability to cause outbreaks,” Dr. Sherry and her associates said (Emerg. Infect. Dis. 2017 Feb;23[2]:328-31).

“Our findings suggest it is improbable that the spread and prevalence of C. auris can be controlled with antifungal stewardship approaches alone,” they noted, adding that “infection-prevention measures targeting C. auris biofilms in patients, on medical devices, and in the hospital environment will be required,” they noted.

The emerging multidrug-resistant yeast organism Candida auris forms biofilms that enhance both its resistance and its virulence, according to in vitro analyses.

C. auris first attracted attention in 2009 because of its resistance to azoles and amphotericin B. Since then, it has been identified as the cause of life-threatening invasive infections worldwide, including hospital outbreaks across Asia and South America, wrote Leighann Sherry, PhD, a medical mycologist at the University of Glasgow, and her associates.

To determine whether the pathogen has the capacity to form biofilms, the investigators propagated several different strains in the laboratory and examined their development. In three separate trials, eight samples of each strain grew biofilms, which constitute “a key driver of candida pathogenicity.” In antifungal susceptibility tests, caspofungin was completely ineffective, an unexpected finding because the agent usually is highly effective against other candida species. Amphotericin B, liposomal amphotericin B, and fluconazole also were ineffective; micafungin and chlorhexidine were the most effective at clearing C. auris.

Biofilm formation “contributes not only to C. auris virulence but also to its [resistance] in hospital environments, increasing its ability to cause outbreaks,” Dr. Sherry and her associates said (Emerg. Infect. Dis. 2017 Feb;23[2]:328-31).

“Our findings suggest it is improbable that the spread and prevalence of C. auris can be controlled with antifungal stewardship approaches alone,” they noted, adding that “infection-prevention measures targeting C. auris biofilms in patients, on medical devices, and in the hospital environment will be required,” they noted.

LAS VEGAS – Two days of prophylaxis with two oral antibiotics cut the surgical site infection rate by more than half in a randomized trial with more than 400 obese women who had cesarean deliveries.

The protective effect from combined treatment with cephalexin and metronidazole was especially powerful in the most at-risk patients, women with ruptured membranes before cesarean surgery. In this subgroup prophylaxis with the two antibiotics for 2 days cut surgical site infections (SSIs) during the 30 days after surgery, from a rate of 33% in control women who received placebo to a 10% rate, a 77% relative risk reduction that was statistically significant, Carri R. Warshak, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal and Fetal Medicine.

“I am very excited that we found a way to help the kinds of women in the study, very-high-risk women, with an effective way to reduce their risk of infection,” Dr. Warshak of the University of Cincinnati said in a video interview. The obese women enrolled in the study, especially those with ruptured membranes, “have a very high risk of morbidity, so it’s very exciting that we found a way to help prevent” SSIs.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

 [email protected]

On Twitter @mitchelzoler

LAS VEGAS – Two days of prophylaxis with two oral antibiotics cut the surgical site infection rate by more than half in a randomized trial with more than 400 obese women who had cesarean deliveries.

The protective effect from combined treatment with cephalexin and metronidazole was especially powerful in the most at-risk patients, women with ruptured membranes before cesarean surgery. In this subgroup prophylaxis with the two antibiotics for 2 days cut surgical site infections (SSIs) during the 30 days after surgery, from a rate of 33% in control women who received placebo to a 10% rate, a 77% relative risk reduction that was statistically significant, Carri R. Warshak, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal and Fetal Medicine.

“I am very excited that we found a way to help the kinds of women in the study, very-high-risk women, with an effective way to reduce their risk of infection,” Dr. Warshak of the University of Cincinnati said in a video interview. The obese women enrolled in the study, especially those with ruptured membranes, “have a very high risk of morbidity, so it’s very exciting that we found a way to help prevent” SSIs.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

 [email protected]

On Twitter @mitchelzoler

LAS VEGAS – Two days of prophylaxis with two oral antibiotics cut the surgical site infection rate by more than half in a randomized trial with more than 400 obese women who had cesarean deliveries.

The protective effect from combined treatment with cephalexin and metronidazole was especially powerful in the most at-risk patients, women with ruptured membranes before cesarean surgery. In this subgroup prophylaxis with the two antibiotics for 2 days cut surgical site infections (SSIs) during the 30 days after surgery, from a rate of 33% in control women who received placebo to a 10% rate, a 77% relative risk reduction that was statistically significant, Carri R. Warshak, MD, said at the annual Pregnancy Meeting sponsored by the Society for Maternal and Fetal Medicine.

“I am very excited that we found a way to help the kinds of women in the study, very-high-risk women, with an effective way to reduce their risk of infection,” Dr. Warshak of the University of Cincinnati said in a video interview. The obese women enrolled in the study, especially those with ruptured membranes, “have a very high risk of morbidity, so it’s very exciting that we found a way to help prevent” SSIs.

Mitchel L. Zoler/Frontline Medical News

Mitchel L. Zoler/Frontline Medical News

 [email protected]

On Twitter @mitchelzoler

Eradicating hepatitis C virus in HIV-coinfected patients was associated with a significantly lower risk of diabetes mellitus and possibly chronic renal failure, along with lower rates of deaths, HIV progression, and liver-related events, according to an observational study of 1,625 patients.

“These findings argue for the prescription of HCV therapy regardless of liver fibrosis stage in coinfected patients,” Juan Berenguer, MD, PhD, and his associates at Hospital General Universitario Gregario Marañón, Madrid. Extrahepatic manifestations of HCV infection are numerous and contribute substantially to morbidity and mortality. “To the best of our knowledge, the effect of eradication of HCV on extrahepatic manifestations of HCV has not been systematically studied in HIV/HCV-coinfected patients,” the researchers wrote in Hepatology (Hepatology 2017 Jan 21:doi:10.1002/hep.29071 [Epub ahead of print]).

©s-c-s/Thinkstock

Eradicating hepatitis C virus in HIV-coinfected patients was associated with a significantly lower risk of diabetes mellitus and possibly chronic renal failure, along with lower rates of deaths, HIV progression, and liver-related events, according to an observational study of 1,625 patients.

“These findings argue for the prescription of HCV therapy regardless of liver fibrosis stage in coinfected patients,” Juan Berenguer, MD, PhD, and his associates at Hospital General Universitario Gregario Marañón, Madrid. Extrahepatic manifestations of HCV infection are numerous and contribute substantially to morbidity and mortality. “To the best of our knowledge, the effect of eradication of HCV on extrahepatic manifestations of HCV has not been systematically studied in HIV/HCV-coinfected patients,” the researchers wrote in Hepatology (Hepatology 2017 Jan 21:doi:10.1002/hep.29071 [Epub ahead of print]).

©s-c-s/Thinkstock

Eradicating hepatitis C virus in HIV-coinfected patients was associated with a significantly lower risk of diabetes mellitus and possibly chronic renal failure, along with lower rates of deaths, HIV progression, and liver-related events, according to an observational study of 1,625 patients.

“These findings argue for the prescription of HCV therapy regardless of liver fibrosis stage in coinfected patients,” Juan Berenguer, MD, PhD, and his associates at Hospital General Universitario Gregario Marañón, Madrid. Extrahepatic manifestations of HCV infection are numerous and contribute substantially to morbidity and mortality. “To the best of our knowledge, the effect of eradication of HCV on extrahepatic manifestations of HCV has not been systematically studied in HIV/HCV-coinfected patients,” the researchers wrote in Hepatology (Hepatology 2017 Jan 21:doi:10.1002/hep.29071 [Epub ahead of print]).

©s-c-s/Thinkstock

Patients with genetically confirmed von Willebrand disease (VWD) type 2M have a relatively mild clinical phenotype, according to findings from a retrospective cross-sectional study.

In fact, three of 31 patients included in the study had a near normal laboratory phenotype. Additionally, patients with the p.Val1360Ala mutation had significantly higher values of all von Willebrand factor (VWF)-related laboratory parameters, compared with those with the p.Arg1374Cys or p.Phe1293Leu mutation, Dominique Maas reported at the European Association for Haemophilia and Allied Disorders annual meeting.

The findings underscore the importance of genotyping for making a correct diagnosis of VWD type 2M, said Ms. Maas of Radboud University Medical Center, Nijmegen, The Netherlands.

The study subjects, who had a least one VWD type 2M mutation, had a median age of 34 years and a median bleeding score of 6. Most suffered from mucocutaneous bleeding, but with low frequency compared with other VWD subtypes. The incidence of muscle hematomas, postpartum hemorrhage, and postsurgery bleeding were relatively high, however. Age and bleeding score were strongly positively correlated.

Subjects had a median VWF antigen level of 24 IU dL^-1, median VWF ristocetin cofactor activity of 6 IU dL^-1, and median VSF:RCo/VWF:Ag ratio of 0.29. The VSF collagen binding activity and VWF:Ag ratio was normal, she said.

Genotyping is a powerful diagnostic tool for making an appropriate diagnosis and classification of VWD. The current findings are important because understanding the correlation between genotype and phenotype improves the understanding of VWD pathogenesis and has important implications for treatment, follow-up, and genetic counseling, but has not been throughly investigated in fully genotyped patients with VWD type 2M, she said.

Ms. Maas reported having no disclosures.

[email protected]

Patients with genetically confirmed von Willebrand disease (VWD) type 2M have a relatively mild clinical phenotype, according to findings from a retrospective cross-sectional study.

In fact, three of 31 patients included in the study had a near normal laboratory phenotype. Additionally, patients with the p.Val1360Ala mutation had significantly higher values of all von Willebrand factor (VWF)-related laboratory parameters, compared with those with the p.Arg1374Cys or p.Phe1293Leu mutation, Dominique Maas reported at the European Association for Haemophilia and Allied Disorders annual meeting.

The findings underscore the importance of genotyping for making a correct diagnosis of VWD type 2M, said Ms. Maas of Radboud University Medical Center, Nijmegen, The Netherlands.

The study subjects, who had a least one VWD type 2M mutation, had a median age of 34 years and a median bleeding score of 6. Most suffered from mucocutaneous bleeding, but with low frequency compared with other VWD subtypes. The incidence of muscle hematomas, postpartum hemorrhage, and postsurgery bleeding were relatively high, however. Age and bleeding score were strongly positively correlated.

Subjects had a median VWF antigen level of 24 IU dL^-1, median VWF ristocetin cofactor activity of 6 IU dL^-1, and median VSF:RCo/VWF:Ag ratio of 0.29. The VSF collagen binding activity and VWF:Ag ratio was normal, she said.

Genotyping is a powerful diagnostic tool for making an appropriate diagnosis and classification of VWD. The current findings are important because understanding the correlation between genotype and phenotype improves the understanding of VWD pathogenesis and has important implications for treatment, follow-up, and genetic counseling, but has not been throughly investigated in fully genotyped patients with VWD type 2M, she said.

Ms. Maas reported having no disclosures.

[email protected]

Patients with genetically confirmed von Willebrand disease (VWD) type 2M have a relatively mild clinical phenotype, according to findings from a retrospective cross-sectional study.

In fact, three of 31 patients included in the study had a near normal laboratory phenotype. Additionally, patients with the p.Val1360Ala mutation had significantly higher values of all von Willebrand factor (VWF)-related laboratory parameters, compared with those with the p.Arg1374Cys or p.Phe1293Leu mutation, Dominique Maas reported at the European Association for Haemophilia and Allied Disorders annual meeting.

The findings underscore the importance of genotyping for making a correct diagnosis of VWD type 2M, said Ms. Maas of Radboud University Medical Center, Nijmegen, The Netherlands.

The study subjects, who had a least one VWD type 2M mutation, had a median age of 34 years and a median bleeding score of 6. Most suffered from mucocutaneous bleeding, but with low frequency compared with other VWD subtypes. The incidence of muscle hematomas, postpartum hemorrhage, and postsurgery bleeding were relatively high, however. Age and bleeding score were strongly positively correlated.

Subjects had a median VWF antigen level of 24 IU dL^-1, median VWF ristocetin cofactor activity of 6 IU dL^-1, and median VSF:RCo/VWF:Ag ratio of 0.29. The VSF collagen binding activity and VWF:Ag ratio was normal, she said.

Genotyping is a powerful diagnostic tool for making an appropriate diagnosis and classification of VWD. The current findings are important because understanding the correlation between genotype and phenotype improves the understanding of VWD pathogenesis and has important implications for treatment, follow-up, and genetic counseling, but has not been throughly investigated in fully genotyped patients with VWD type 2M, she said.

Ms. Maas reported having no disclosures.

[email protected]

A new generation of solulin variants is showing promise for the treatment of severe hemophilia A.

The in vitro production and characterization of these solulin variants – F376A-, M388A-, and F376A/M388A-solulin – showed that while they lost their abilities to activate protein C (an inhibitor of thrombin generation), they were still capable of activating thrombin activatable fibrinolysis inhibitor (TAFI), Yohann Repesse, PhD reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.

Additionally, the double mutant F376A/M388A-solulin, which was tested ex vivo using blood samples from hemophilic A patients, was found on thromboelastography to increase clot firmness and stability. As opposed to wild type solulin, the effects were maintained even at high concentrations of F376A/M388A-solulin, said Dr. Repesse of the National Institute of Health and Medical Research, Caen, France.

An important aggravating factor when it comes to treating hemophilia involves premature fibrinolysis, which means that antifibrinolytics are of interest, he explained. Thrombomodulin is a key player in the coagulation cascade, because it activates protein C, and also in the fibrinolytic cascade, as it activates TAFI. Solulin, a soluble form of thrombomodulin, has both capabilities.

The findings with respect to the new generation of solulin variants tested in this study open new opportunities for the development of specific medications for hemophilia patients, he concluded.

Dr. Repesse reported having no disclosures.

[email protected]

A new generation of solulin variants is showing promise for the treatment of severe hemophilia A.

The in vitro production and characterization of these solulin variants – F376A-, M388A-, and F376A/M388A-solulin – showed that while they lost their abilities to activate protein C (an inhibitor of thrombin generation), they were still capable of activating thrombin activatable fibrinolysis inhibitor (TAFI), Yohann Repesse, PhD reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.

Additionally, the double mutant F376A/M388A-solulin, which was tested ex vivo using blood samples from hemophilic A patients, was found on thromboelastography to increase clot firmness and stability. As opposed to wild type solulin, the effects were maintained even at high concentrations of F376A/M388A-solulin, said Dr. Repesse of the National Institute of Health and Medical Research, Caen, France.

An important aggravating factor when it comes to treating hemophilia involves premature fibrinolysis, which means that antifibrinolytics are of interest, he explained. Thrombomodulin is a key player in the coagulation cascade, because it activates protein C, and also in the fibrinolytic cascade, as it activates TAFI. Solulin, a soluble form of thrombomodulin, has both capabilities.

The findings with respect to the new generation of solulin variants tested in this study open new opportunities for the development of specific medications for hemophilia patients, he concluded.

Dr. Repesse reported having no disclosures.

[email protected]

A new generation of solulin variants is showing promise for the treatment of severe hemophilia A.

The in vitro production and characterization of these solulin variants – F376A-, M388A-, and F376A/M388A-solulin – showed that while they lost their abilities to activate protein C (an inhibitor of thrombin generation), they were still capable of activating thrombin activatable fibrinolysis inhibitor (TAFI), Yohann Repesse, PhD reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.

Additionally, the double mutant F376A/M388A-solulin, which was tested ex vivo using blood samples from hemophilic A patients, was found on thromboelastography to increase clot firmness and stability. As opposed to wild type solulin, the effects were maintained even at high concentrations of F376A/M388A-solulin, said Dr. Repesse of the National Institute of Health and Medical Research, Caen, France.

An important aggravating factor when it comes to treating hemophilia involves premature fibrinolysis, which means that antifibrinolytics are of interest, he explained. Thrombomodulin is a key player in the coagulation cascade, because it activates protein C, and also in the fibrinolytic cascade, as it activates TAFI. Solulin, a soluble form of thrombomodulin, has both capabilities.

The findings with respect to the new generation of solulin variants tested in this study open new opportunities for the development of specific medications for hemophilia patients, he concluded.

Dr. Repesse reported having no disclosures.

[email protected]

Children with severe hemophilia in a U.K. study had generally good self-reported health-related quality of life and physical functioning, but impairment on both measures was greater in those who reported pain.

Of 123 boys with a mean age of 12 years who were included in the multicenter SO-FIT study, 110 had hemophilia A, 25 had a past inhibitor, and 9 had a current inhibitor. Prophylactic treatment was given in 120 of the boys, Kate Khair, PhD of Great Ormond Street Hospital for Children, London, reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.

In the preceding 6 months, participants experienced a median of 0 joint bleeds (range of 0-8), and a median Hemophilia Joint Health Score (HJHS) of 1 (range, 0-37). Physical function scores were good; the Haemophilia & Exercise Project questionnaire (HEP-Test-Q) mean score was 80.82, with the highest impairments seen in the domain of “endurance” (mean, 72.21), and the Paediatric Haemophilia Activities List (PedHAL) mean score was 85.13, with the highest impairments seen in the domains of “leisure activities and sports” and “lying/sitting/kneeling/standing” (mean, 82.04 and 82.97, respectively).

Health-related quality of life as assessed by the Haemo-QoL Short Form was also generally good (mean, 23.07), with the highest impairments seen in the domains of “friends” and “family” (mean, 27.08 and 26.59, respectively).

In the 27% of participants with pain, a high correlation was seen between the HEP-Test-Q and Haemo-QoL, and moderate correlation was seen between the PedHAL and Haemo-QoL, which implies that good physical functioning is related to good health-related quality of life, Dr. Khair explained.

In fact, patients who said they often or always had pain reported significantly worse subjective physical functioning in all HEP-Test-Q and PedHAL domains, as well as higher impairments in their HRQoL vs. those who said they sometimes, rarely, or never experienced pain, she said.

Interestingly, data completion by study participants was improved with use of an iPad vs. “paper and pencil” for questionnaire completion, Dr. Khair said in an interview.

“They preferred this method – it was more in keeping with how they communicate and learn at school,” she said, noting that the iPad database was set up to give real time scores, which could then be used to tailor assessments.

This is an approach that could be undertaken at home pre-clinic visits, she said.

“Gaining the views of children and young adults in patient-reported outcomes is complex, but reveals their views of their care and their lives – an area we should address more,” she added.

Dr. Khair received grant or research support from Pfizer ASPIRE.

[email protected]

Children with severe hemophilia in a U.K. study had generally good self-reported health-related quality of life and physical functioning, but impairment on both measures was greater in those who reported pain.

Of 123 boys with a mean age of 12 years who were included in the multicenter SO-FIT study, 110 had hemophilia A, 25 had a past inhibitor, and 9 had a current inhibitor. Prophylactic treatment was given in 120 of the boys, Kate Khair, PhD of Great Ormond Street Hospital for Children, London, reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.

In the preceding 6 months, participants experienced a median of 0 joint bleeds (range of 0-8), and a median Hemophilia Joint Health Score (HJHS) of 1 (range, 0-37). Physical function scores were good; the Haemophilia & Exercise Project questionnaire (HEP-Test-Q) mean score was 80.82, with the highest impairments seen in the domain of “endurance” (mean, 72.21), and the Paediatric Haemophilia Activities List (PedHAL) mean score was 85.13, with the highest impairments seen in the domains of “leisure activities and sports” and “lying/sitting/kneeling/standing” (mean, 82.04 and 82.97, respectively).

Health-related quality of life as assessed by the Haemo-QoL Short Form was also generally good (mean, 23.07), with the highest impairments seen in the domains of “friends” and “family” (mean, 27.08 and 26.59, respectively).

In the 27% of participants with pain, a high correlation was seen between the HEP-Test-Q and Haemo-QoL, and moderate correlation was seen between the PedHAL and Haemo-QoL, which implies that good physical functioning is related to good health-related quality of life, Dr. Khair explained.

In fact, patients who said they often or always had pain reported significantly worse subjective physical functioning in all HEP-Test-Q and PedHAL domains, as well as higher impairments in their HRQoL vs. those who said they sometimes, rarely, or never experienced pain, she said.

Interestingly, data completion by study participants was improved with use of an iPad vs. “paper and pencil” for questionnaire completion, Dr. Khair said in an interview.

“They preferred this method – it was more in keeping with how they communicate and learn at school,” she said, noting that the iPad database was set up to give real time scores, which could then be used to tailor assessments.

This is an approach that could be undertaken at home pre-clinic visits, she said.

“Gaining the views of children and young adults in patient-reported outcomes is complex, but reveals their views of their care and their lives – an area we should address more,” she added.

Dr. Khair received grant or research support from Pfizer ASPIRE.

[email protected]

Children with severe hemophilia in a U.K. study had generally good self-reported health-related quality of life and physical functioning, but impairment on both measures was greater in those who reported pain.

Of 123 boys with a mean age of 12 years who were included in the multicenter SO-FIT study, 110 had hemophilia A, 25 had a past inhibitor, and 9 had a current inhibitor. Prophylactic treatment was given in 120 of the boys, Kate Khair, PhD of Great Ormond Street Hospital for Children, London, reported at the annual meeting of the European Association for Haemophilia and Allied Disorders.

In the preceding 6 months, participants experienced a median of 0 joint bleeds (range of 0-8), and a median Hemophilia Joint Health Score (HJHS) of 1 (range, 0-37). Physical function scores were good; the Haemophilia & Exercise Project questionnaire (HEP-Test-Q) mean score was 80.82, with the highest impairments seen in the domain of “endurance” (mean, 72.21), and the Paediatric Haemophilia Activities List (PedHAL) mean score was 85.13, with the highest impairments seen in the domains of “leisure activities and sports” and “lying/sitting/kneeling/standing” (mean, 82.04 and 82.97, respectively).

Health-related quality of life as assessed by the Haemo-QoL Short Form was also generally good (mean, 23.07), with the highest impairments seen in the domains of “friends” and “family” (mean, 27.08 and 26.59, respectively).

In the 27% of participants with pain, a high correlation was seen between the HEP-Test-Q and Haemo-QoL, and moderate correlation was seen between the PedHAL and Haemo-QoL, which implies that good physical functioning is related to good health-related quality of life, Dr. Khair explained.

In fact, patients who said they often or always had pain reported significantly worse subjective physical functioning in all HEP-Test-Q and PedHAL domains, as well as higher impairments in their HRQoL vs. those who said they sometimes, rarely, or never experienced pain, she said.

Interestingly, data completion by study participants was improved with use of an iPad vs. “paper and pencil” for questionnaire completion, Dr. Khair said in an interview.

“They preferred this method – it was more in keeping with how they communicate and learn at school,” she said, noting that the iPad database was set up to give real time scores, which could then be used to tailor assessments.

This is an approach that could be undertaken at home pre-clinic visits, she said.

“Gaining the views of children and young adults in patient-reported outcomes is complex, but reveals their views of their care and their lives – an area we should address more,” she added.

Dr. Khair received grant or research support from Pfizer ASPIRE.

[email protected]

AML cells

CRISPR-based genetic screens have revealed essential genes—those required for cellular proliferation and survival—in 14 acute myeloid leukemia (AML) cell lines, according to investigators.

By combining this information with the existing genomic information on these cell lines, the investigators believe they have identified vulnerabilities that could potentially be exploited with new therapies.

The group described their research in Cell.

A major aspect of their study focused on the genes and protein pathways connected to the Ras oncogene, which is the most commonly mutated oncogene in human cancers and plays a role in AML.

“For the most part, the mutant Ras protein itself has been considered to be ‘undruggable,’” said study author Tim Wang, a doctoral student at the Massachusetts Institute of Technology in Cambridge.

“An alternative approach has been to find other genes that Ras-mutant cancers rely on with the hope that one of them may be druggable. Unfortunately, such ‘Ras-synthetic-lethal’ genes have been difficult to identify.”

Using CRISPR-based screens, the investigators were able to gauge the impact of individually knocking out each of the 18,000 protein-coding genes in the human genome.

“This process rapidly enabled us to identify the short list of genes that were selectively required in only the Ras-mutant cells,” explained study author David Sabatini, MD, PhD, of the Massachusetts Institute of Technology.

He and his colleagues found that the enzymes catalyzing the latter steps of the Ras processing pathway, Rce1 and Icmt, displayed synthetic lethality with oncogenic Ras, which suggests they might be therapeutic targets in AML and other cancers driven by oncogenic Ras.

The investigators also said their findings provide further support for the central role of MAPK signaling in Ras-driven cancers, suggest PREX1 and the Rac pathway are critical regulators of MAPK pathway activation, and indicate that c-Raf could be a therapeutic target in cancers driven by oncogenic Ras.

In addition to defining the Ras-specific gene essentiality network, the investigators said they were able to determine the function of previously unstudied genes.

The team started by focusing on genes that were essential in some of the AML cell lines but dispensable for others. For each of these genes, the investigators sifted through their data to find others that showed a matching pattern of essentiality, with the idea that all of them had similar functions.

Indeed, this analysis revealed gene groups that were already known to act together and uncovered novel associations between genes that were not known to be related or had been previously unstudied.

“What’s particularly exciting about this work is that we have just begun to scratch the surface with our method,” Wang concluded. “By applying it broadly, we could reveal a huge amount of information about the functional organization of human genes and their roles in many diseases.”

AML cells

CRISPR-based genetic screens have revealed essential genes—those required for cellular proliferation and survival—in 14 acute myeloid leukemia (AML) cell lines, according to investigators.

By combining this information with the existing genomic information on these cell lines, the investigators believe they have identified vulnerabilities that could potentially be exploited with new therapies.

The group described their research in Cell.

A major aspect of their study focused on the genes and protein pathways connected to the Ras oncogene, which is the most commonly mutated oncogene in human cancers and plays a role in AML.

“For the most part, the mutant Ras protein itself has been considered to be ‘undruggable,’” said study author Tim Wang, a doctoral student at the Massachusetts Institute of Technology in Cambridge.

“An alternative approach has been to find other genes that Ras-mutant cancers rely on with the hope that one of them may be druggable. Unfortunately, such ‘Ras-synthetic-lethal’ genes have been difficult to identify.”

Using CRISPR-based screens, the investigators were able to gauge the impact of individually knocking out each of the 18,000 protein-coding genes in the human genome.

“This process rapidly enabled us to identify the short list of genes that were selectively required in only the Ras-mutant cells,” explained study author David Sabatini, MD, PhD, of the Massachusetts Institute of Technology.

He and his colleagues found that the enzymes catalyzing the latter steps of the Ras processing pathway, Rce1 and Icmt, displayed synthetic lethality with oncogenic Ras, which suggests they might be therapeutic targets in AML and other cancers driven by oncogenic Ras.

The investigators also said their findings provide further support for the central role of MAPK signaling in Ras-driven cancers, suggest PREX1 and the Rac pathway are critical regulators of MAPK pathway activation, and indicate that c-Raf could be a therapeutic target in cancers driven by oncogenic Ras.

In addition to defining the Ras-specific gene essentiality network, the investigators said they were able to determine the function of previously unstudied genes.

The team started by focusing on genes that were essential in some of the AML cell lines but dispensable for others. For each of these genes, the investigators sifted through their data to find others that showed a matching pattern of essentiality, with the idea that all of them had similar functions.

Indeed, this analysis revealed gene groups that were already known to act together and uncovered novel associations between genes that were not known to be related or had been previously unstudied.

“What’s particularly exciting about this work is that we have just begun to scratch the surface with our method,” Wang concluded. “By applying it broadly, we could reveal a huge amount of information about the functional organization of human genes and their roles in many diseases.”

AML cells

CRISPR-based genetic screens have revealed essential genes—those required for cellular proliferation and survival—in 14 acute myeloid leukemia (AML) cell lines, according to investigators.

By combining this information with the existing genomic information on these cell lines, the investigators believe they have identified vulnerabilities that could potentially be exploited with new therapies.

The group described their research in Cell.

A major aspect of their study focused on the genes and protein pathways connected to the Ras oncogene, which is the most commonly mutated oncogene in human cancers and plays a role in AML.

“For the most part, the mutant Ras protein itself has been considered to be ‘undruggable,’” said study author Tim Wang, a doctoral student at the Massachusetts Institute of Technology in Cambridge.

“An alternative approach has been to find other genes that Ras-mutant cancers rely on with the hope that one of them may be druggable. Unfortunately, such ‘Ras-synthetic-lethal’ genes have been difficult to identify.”

Using CRISPR-based screens, the investigators were able to gauge the impact of individually knocking out each of the 18,000 protein-coding genes in the human genome.

“This process rapidly enabled us to identify the short list of genes that were selectively required in only the Ras-mutant cells,” explained study author David Sabatini, MD, PhD, of the Massachusetts Institute of Technology.

He and his colleagues found that the enzymes catalyzing the latter steps of the Ras processing pathway, Rce1 and Icmt, displayed synthetic lethality with oncogenic Ras, which suggests they might be therapeutic targets in AML and other cancers driven by oncogenic Ras.

The investigators also said their findings provide further support for the central role of MAPK signaling in Ras-driven cancers, suggest PREX1 and the Rac pathway are critical regulators of MAPK pathway activation, and indicate that c-Raf could be a therapeutic target in cancers driven by oncogenic Ras.

In addition to defining the Ras-specific gene essentiality network, the investigators said they were able to determine the function of previously unstudied genes.

The team started by focusing on genes that were essential in some of the AML cell lines but dispensable for others. For each of these genes, the investigators sifted through their data to find others that showed a matching pattern of essentiality, with the idea that all of them had similar functions.

Indeed, this analysis revealed gene groups that were already known to act together and uncovered novel associations between genes that were not known to be related or had been previously unstudied.

“What’s particularly exciting about this work is that we have just begun to scratch the surface with our method,” Wang concluded. “By applying it broadly, we could reveal a huge amount of information about the functional organization of human genes and their roles in many diseases.”

When used in intensive care units, video laryngoscopy did not improve the chances of successful intubation on the first try, compared with direct laryngoscopy, and was associated with a significantly higher risk of severe life-threatening complications, researchers reported.

In a multicenter, randomized trial of 371 patients, first-pass intubation rates did not differ significantly whether video or direct laryngoscopy was used, at 67.7% and 70.3%, respectively, Jean Baptiste Lascarrou, MD, of District Hospital Centre, La Roche-sur-Yon, France, and his associates wrote. Meanwhile, the combined rate of death, cardiac arrest, severe cardiovascular collapse, and hypoxemia was 9.5% with video laryngoscopy and just 2.8% with direct laryngoscopy, a significant difference (JAMA. 2017 Jan 24;317[5]:483-93).

“Improved glottis visualization with video laryngoscopy did not translate into a higher success rate for first-pass intubation, because tracheal catheterization under indirect vision was more difficult, in keeping with earlier data,” the researchers concluded. “Further studies are needed to assess the comparative effectiveness of these two strategies in different clinical settings and among operators with diverse skill levels.”

Intubation in the ICU carries an inherently high risk because patients are often acutely unstable, and the intubating clinician is usually a nonexpert, the investigators noted. At the same time, the procedure must be done quickly to prevent aspiration because patients usually have not fasted. Care bundles and training on simulators have improved safety, but ICU intubations remain riskier than those done in the operating room.

Observational studies and smaller trials in ICUs seemed to support video laryngoscopy over the Macintosh laryngoscope, but raised questions about intubation time and mortality, the investigators noted. To help resolve these issues, they randomly assigned adults needing orotracheal intubation at seven ICUs in France to either video or direct Macintosh laryngoscopy, and followed them for 28 days. Patients averaged 63 years of age, and 37% were women.

For both arms, residents performed the initial intubation attempt in about 80% of cases, and successful intubation usually took 3 minutes. Video laryngoscopy did not significantly increase the combined risk of esophageal intubation, aspiration, arrhythmia, or dental injury (5.4% versus 7.7% for direct laryngoscopy). But the only death in the study occurred after video laryngoscopy, and there were four cardiac arrests after video laryngoscopy and none after direct laryngoscopy, the researchers said. Furthermore, the rate of severe hypoxemia was nearly six times higher after video laryngoscopy than with direct laryngoscopy, and the rate of hypotension was twice as high.

The researchers did not identify predictors of life-threatening complications with video laryngoscopy, but hypothesized that being able to clearly visualize the glottis might create “a false impression of safety,” especially among nonexperts. “In addition, poorer alignment of the pharyngeal axis, laryngeal axis, and mouth opening despite good glottis visualization by video laryngoscopy can lead to mechanical upper airway obstruction and faster progression to hypoxemia,” they wrote.

Centre Hospitalier Département de la Vendée sponsored the study. Dr. Lascarrou reported having no relevant conflicts of interest. Four coinvestigators disclosed ties to Fisher & Paykel, LFB, Merck Sharp & Dohme, Astellas, Basilea Pharmaceutica. Gilead, Alexion, and Cubist. The remaining coinvestigators had no disclosures.

When used in intensive care units, video laryngoscopy did not improve the chances of successful intubation on the first try, compared with direct laryngoscopy, and was associated with a significantly higher risk of severe life-threatening complications, researchers reported.

In a multicenter, randomized trial of 371 patients, first-pass intubation rates did not differ significantly whether video or direct laryngoscopy was used, at 67.7% and 70.3%, respectively, Jean Baptiste Lascarrou, MD, of District Hospital Centre, La Roche-sur-Yon, France, and his associates wrote. Meanwhile, the combined rate of death, cardiac arrest, severe cardiovascular collapse, and hypoxemia was 9.5% with video laryngoscopy and just 2.8% with direct laryngoscopy, a significant difference (JAMA. 2017 Jan 24;317[5]:483-93).

“Improved glottis visualization with video laryngoscopy did not translate into a higher success rate for first-pass intubation, because tracheal catheterization under indirect vision was more difficult, in keeping with earlier data,” the researchers concluded. “Further studies are needed to assess the comparative effectiveness of these two strategies in different clinical settings and among operators with diverse skill levels.”

Intubation in the ICU carries an inherently high risk because patients are often acutely unstable, and the intubating clinician is usually a nonexpert, the investigators noted. At the same time, the procedure must be done quickly to prevent aspiration because patients usually have not fasted. Care bundles and training on simulators have improved safety, but ICU intubations remain riskier than those done in the operating room.

Observational studies and smaller trials in ICUs seemed to support video laryngoscopy over the Macintosh laryngoscope, but raised questions about intubation time and mortality, the investigators noted. To help resolve these issues, they randomly assigned adults needing orotracheal intubation at seven ICUs in France to either video or direct Macintosh laryngoscopy, and followed them for 28 days. Patients averaged 63 years of age, and 37% were women.

For both arms, residents performed the initial intubation attempt in about 80% of cases, and successful intubation usually took 3 minutes. Video laryngoscopy did not significantly increase the combined risk of esophageal intubation, aspiration, arrhythmia, or dental injury (5.4% versus 7.7% for direct laryngoscopy). But the only death in the study occurred after video laryngoscopy, and there were four cardiac arrests after video laryngoscopy and none after direct laryngoscopy, the researchers said. Furthermore, the rate of severe hypoxemia was nearly six times higher after video laryngoscopy than with direct laryngoscopy, and the rate of hypotension was twice as high.

The researchers did not identify predictors of life-threatening complications with video laryngoscopy, but hypothesized that being able to clearly visualize the glottis might create “a false impression of safety,” especially among nonexperts. “In addition, poorer alignment of the pharyngeal axis, laryngeal axis, and mouth opening despite good glottis visualization by video laryngoscopy can lead to mechanical upper airway obstruction and faster progression to hypoxemia,” they wrote.

Centre Hospitalier Département de la Vendée sponsored the study. Dr. Lascarrou reported having no relevant conflicts of interest. Four coinvestigators disclosed ties to Fisher & Paykel, LFB, Merck Sharp & Dohme, Astellas, Basilea Pharmaceutica. Gilead, Alexion, and Cubist. The remaining coinvestigators had no disclosures.

When used in intensive care units, video laryngoscopy did not improve the chances of successful intubation on the first try, compared with direct laryngoscopy, and was associated with a significantly higher risk of severe life-threatening complications, researchers reported.

In a multicenter, randomized trial of 371 patients, first-pass intubation rates did not differ significantly whether video or direct laryngoscopy was used, at 67.7% and 70.3%, respectively, Jean Baptiste Lascarrou, MD, of District Hospital Centre, La Roche-sur-Yon, France, and his associates wrote. Meanwhile, the combined rate of death, cardiac arrest, severe cardiovascular collapse, and hypoxemia was 9.5% with video laryngoscopy and just 2.8% with direct laryngoscopy, a significant difference (JAMA. 2017 Jan 24;317[5]:483-93).

“Improved glottis visualization with video laryngoscopy did not translate into a higher success rate for first-pass intubation, because tracheal catheterization under indirect vision was more difficult, in keeping with earlier data,” the researchers concluded. “Further studies are needed to assess the comparative effectiveness of these two strategies in different clinical settings and among operators with diverse skill levels.”

Intubation in the ICU carries an inherently high risk because patients are often acutely unstable, and the intubating clinician is usually a nonexpert, the investigators noted. At the same time, the procedure must be done quickly to prevent aspiration because patients usually have not fasted. Care bundles and training on simulators have improved safety, but ICU intubations remain riskier than those done in the operating room.

Observational studies and smaller trials in ICUs seemed to support video laryngoscopy over the Macintosh laryngoscope, but raised questions about intubation time and mortality, the investigators noted. To help resolve these issues, they randomly assigned adults needing orotracheal intubation at seven ICUs in France to either video or direct Macintosh laryngoscopy, and followed them for 28 days. Patients averaged 63 years of age, and 37% were women.

For both arms, residents performed the initial intubation attempt in about 80% of cases, and successful intubation usually took 3 minutes. Video laryngoscopy did not significantly increase the combined risk of esophageal intubation, aspiration, arrhythmia, or dental injury (5.4% versus 7.7% for direct laryngoscopy). But the only death in the study occurred after video laryngoscopy, and there were four cardiac arrests after video laryngoscopy and none after direct laryngoscopy, the researchers said. Furthermore, the rate of severe hypoxemia was nearly six times higher after video laryngoscopy than with direct laryngoscopy, and the rate of hypotension was twice as high.

The researchers did not identify predictors of life-threatening complications with video laryngoscopy, but hypothesized that being able to clearly visualize the glottis might create “a false impression of safety,” especially among nonexperts. “In addition, poorer alignment of the pharyngeal axis, laryngeal axis, and mouth opening despite good glottis visualization by video laryngoscopy can lead to mechanical upper airway obstruction and faster progression to hypoxemia,” they wrote.

Centre Hospitalier Département de la Vendée sponsored the study. Dr. Lascarrou reported having no relevant conflicts of interest. Four coinvestigators disclosed ties to Fisher & Paykel, LFB, Merck Sharp & Dohme, Astellas, Basilea Pharmaceutica. Gilead, Alexion, and Cubist. The remaining coinvestigators had no disclosures.