Click Here to Read Supplement. 

In a new supplement to Neurology Reviews, expert Richard J. Nowak, MD, MS, discusses the burden of myasthenia gravis and challenges in treating the disease.

Topics in this supplement include:

• Pathophysiology of Myasthenia Gravis
• Treatment Resistant Myasthenia Gravis
• Burden and Cost

Click Here to Read Supplement.

_{US/UNB-gMG/18/0033}

Click Here to Read Supplement. 

In a new supplement to Neurology Reviews, expert Richard J. Nowak, MD, MS, discusses the burden of myasthenia gravis and challenges in treating the disease.

Topics in this supplement include:

• Pathophysiology of Myasthenia Gravis
• Treatment Resistant Myasthenia Gravis
• Burden and Cost

Click Here to Read Supplement.

_{US/UNB-gMG/18/0033}

Click Here to Read Supplement. 

In a new supplement to Neurology Reviews, expert Richard J. Nowak, MD, MS, discusses the burden of myasthenia gravis and challenges in treating the disease.

Topics in this supplement include:

• Pathophysiology of Myasthenia Gravis
• Treatment Resistant Myasthenia Gravis
• Burden and Cost

Click Here to Read Supplement.

_{US/UNB-gMG/18/0033}

Pelvic inflammatory disease caused by chlamydia appears to significantly increase the risk of ovarian cancer, according to research to be presented at the annual meeting of the American Association for Cancer Research.

The finding, replicated in two large databases, suggests that promptly treating the infection might reduce the lifetime risk of developing ovarian cancer, Britton Trabert, PhD, said during a press briefing held in advance of the meeting.

“Ovarian cancer is typically diagnosed at a late stage and therefore has a poor prognosis,” said Dr. Mardis of The Nationwide Hospital, Columbus, Ohio. “Chlamydia will be an important point of study here, both because of the frequency of this infection, and because it is quite difficult to detect, due to its asymptomatic nature. But the most important take-home point is that we might be able to go a long way in terms of preventing ovarian cancer by routinely screening for infective agents.”

Pelvic inflammatory disease is known to be associated with ovarian cancer, and chlamydia is a leading cause of the disease, noted Dr. Trabert. “But chlamydia infections can be asymptomatic and persist for months or even years, so ascertainment of past chlamydia infections is challenging.”

To investigate the potential link between these infections and ovarian cancer, Dr. Trabert and her colleagues examined associations between antibodies to several infectious agents, including chlamydia, in two large ovarian cancer databases: a population-based case/control study in Poland and a case-control study nested into the U.S. Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial.

The researchers screened for antibodies to chlamydia, Mycoplasma genitalium, Epstein-Barre virus, human papillomavirus, herpes simplex virus-1 and -2, polyomavirus, hepatitis B and C, and cytomegalovirus. The chlamydia antibody selected was plasmid-encoded Pgp3 protein, considered the gold standard measurement for prior or existing chlamydia infections.

The patient cohorts comprised 278 cases vs. 556 controls from the Polish study, and 160 cases vs. 159 controls from the PLCO study. Serum samples were collected at the time of ovarian cancer diagnosis in the Polish cohort, and before diagnosis in the PLCO cohort.

Dr. Trabert presented odds ratios for a Pgp3 antibody titer cut point indicative of past chlamydia infection, and a “more stringent” higher cut point indicative of current or chronic infection. She and her colleagues found statistically significant associations for each cut point in both studies.

In the Polish cohort, the lower Pgp3 cut point was associated with a 63% increased risk of ovarian cancer (odds ratio, 1.63). The higher cut point was associated with a doubling of risk (OR, 2.0).

In the PLCO cohort, the lower cut point was associated with a 43% increased risk (OR, 1.43). The higher cut point more than doubled the risk of ovarian cancer (OR, 2.25).

Neither cohort showed any significant association of ovarian cancer with any of the other antibodies, Dr. Trabert said.

The NCI Intramural Research Program supported the study. Dr. Trabert and her colleagues declared no conflicts of interest.

[email protected]

SOURCE: Trabert et al. Abstract 4942.

Pelvic inflammatory disease caused by chlamydia appears to significantly increase the risk of ovarian cancer, according to research to be presented at the annual meeting of the American Association for Cancer Research.

The finding, replicated in two large databases, suggests that promptly treating the infection might reduce the lifetime risk of developing ovarian cancer, Britton Trabert, PhD, said during a press briefing held in advance of the meeting.

“Ovarian cancer is typically diagnosed at a late stage and therefore has a poor prognosis,” said Dr. Mardis of The Nationwide Hospital, Columbus, Ohio. “Chlamydia will be an important point of study here, both because of the frequency of this infection, and because it is quite difficult to detect, due to its asymptomatic nature. But the most important take-home point is that we might be able to go a long way in terms of preventing ovarian cancer by routinely screening for infective agents.”

Pelvic inflammatory disease is known to be associated with ovarian cancer, and chlamydia is a leading cause of the disease, noted Dr. Trabert. “But chlamydia infections can be asymptomatic and persist for months or even years, so ascertainment of past chlamydia infections is challenging.”

To investigate the potential link between these infections and ovarian cancer, Dr. Trabert and her colleagues examined associations between antibodies to several infectious agents, including chlamydia, in two large ovarian cancer databases: a population-based case/control study in Poland and a case-control study nested into the U.S. Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial.

The researchers screened for antibodies to chlamydia, Mycoplasma genitalium, Epstein-Barre virus, human papillomavirus, herpes simplex virus-1 and -2, polyomavirus, hepatitis B and C, and cytomegalovirus. The chlamydia antibody selected was plasmid-encoded Pgp3 protein, considered the gold standard measurement for prior or existing chlamydia infections.

The patient cohorts comprised 278 cases vs. 556 controls from the Polish study, and 160 cases vs. 159 controls from the PLCO study. Serum samples were collected at the time of ovarian cancer diagnosis in the Polish cohort, and before diagnosis in the PLCO cohort.

Dr. Trabert presented odds ratios for a Pgp3 antibody titer cut point indicative of past chlamydia infection, and a “more stringent” higher cut point indicative of current or chronic infection. She and her colleagues found statistically significant associations for each cut point in both studies.

In the Polish cohort, the lower Pgp3 cut point was associated with a 63% increased risk of ovarian cancer (odds ratio, 1.63). The higher cut point was associated with a doubling of risk (OR, 2.0).

In the PLCO cohort, the lower cut point was associated with a 43% increased risk (OR, 1.43). The higher cut point more than doubled the risk of ovarian cancer (OR, 2.25).

Neither cohort showed any significant association of ovarian cancer with any of the other antibodies, Dr. Trabert said.

The NCI Intramural Research Program supported the study. Dr. Trabert and her colleagues declared no conflicts of interest.

[email protected]

SOURCE: Trabert et al. Abstract 4942.

Pelvic inflammatory disease caused by chlamydia appears to significantly increase the risk of ovarian cancer, according to research to be presented at the annual meeting of the American Association for Cancer Research.

The finding, replicated in two large databases, suggests that promptly treating the infection might reduce the lifetime risk of developing ovarian cancer, Britton Trabert, PhD, said during a press briefing held in advance of the meeting.

“Ovarian cancer is typically diagnosed at a late stage and therefore has a poor prognosis,” said Dr. Mardis of The Nationwide Hospital, Columbus, Ohio. “Chlamydia will be an important point of study here, both because of the frequency of this infection, and because it is quite difficult to detect, due to its asymptomatic nature. But the most important take-home point is that we might be able to go a long way in terms of preventing ovarian cancer by routinely screening for infective agents.”

Pelvic inflammatory disease is known to be associated with ovarian cancer, and chlamydia is a leading cause of the disease, noted Dr. Trabert. “But chlamydia infections can be asymptomatic and persist for months or even years, so ascertainment of past chlamydia infections is challenging.”

To investigate the potential link between these infections and ovarian cancer, Dr. Trabert and her colleagues examined associations between antibodies to several infectious agents, including chlamydia, in two large ovarian cancer databases: a population-based case/control study in Poland and a case-control study nested into the U.S. Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial.

The researchers screened for antibodies to chlamydia, Mycoplasma genitalium, Epstein-Barre virus, human papillomavirus, herpes simplex virus-1 and -2, polyomavirus, hepatitis B and C, and cytomegalovirus. The chlamydia antibody selected was plasmid-encoded Pgp3 protein, considered the gold standard measurement for prior or existing chlamydia infections.

The patient cohorts comprised 278 cases vs. 556 controls from the Polish study, and 160 cases vs. 159 controls from the PLCO study. Serum samples were collected at the time of ovarian cancer diagnosis in the Polish cohort, and before diagnosis in the PLCO cohort.

Dr. Trabert presented odds ratios for a Pgp3 antibody titer cut point indicative of past chlamydia infection, and a “more stringent” higher cut point indicative of current or chronic infection. She and her colleagues found statistically significant associations for each cut point in both studies.

In the Polish cohort, the lower Pgp3 cut point was associated with a 63% increased risk of ovarian cancer (odds ratio, 1.63). The higher cut point was associated with a doubling of risk (OR, 2.0).

In the PLCO cohort, the lower cut point was associated with a 43% increased risk (OR, 1.43). The higher cut point more than doubled the risk of ovarian cancer (OR, 2.25).

Neither cohort showed any significant association of ovarian cancer with any of the other antibodies, Dr. Trabert said.

The NCI Intramural Research Program supported the study. Dr. Trabert and her colleagues declared no conflicts of interest.

[email protected]

SOURCE: Trabert et al. Abstract 4942.

Look, I am not a burnout expert. And neither are you (presumably). None of us know much, but that won’t stop the regulations from coming. Program directors are already being asked to provide “wellness plans.” Through the SVS, experts have been enlisted to help, but it is now clear that what works for others won’t necessarily work for vascular surgeons. The next step is up to us. We are the only ones with detailed knowledge of our lives. I believe we are moving closer to answers but still face a few significant hurdles. Don’t worry, there are solutions. Hear me out …

Previously, I shared three studies with you, which found that vascular surgeons had the highest rates of suicidal ideation and career dissatisfaction among surgeons while spending more hours in the hospital than any other specialty. So what has been done to address these horrific numbers? Very little. We need answers now, but most of the data are over 10 years old. Much has changed in our specialty. The endovascular revolution created an entirely new working paradigm. A busy vascular surgeon used to perform 300 cases annually; now this number approaches 1,000. More procedures means more clerical work. Lead aprons and radiation exposure have added new ergonomic and medical concerns. Reimbursement dynamics now favor shorter, more frequent patient interactions over longer, more complex cases. We are benchmarked against old work standards while CPT bundling continuously lowers current RVU designations. EMR was supposed to make our lives better; it has done the opposite. Patient-centered health care has become a mantra, but the measures taken often backfire. Practicing medicine where the desired outcome is a high score on patient satisfaction surveys will likely lead to unnecessary tests, poor cost allocation, and low physician fulfillment. Quality of care is now measured scrupulously while the quality of our lives remains undocumented.

In the absence of organized reform, burnout appears to be increasing. A recent Mayo Clinic–AMA study found the current prevalence to be 54% among physicians. All of this has not happened overnight. I believe practicing vascular surgeons are resilient by default. The majority of us trained prior to the enforcement of duty hour restrictions. Out of high school, I enrolled in a 6-year BA/MD program (skipping 2 years of college seemed like a great idea in high school, less so when I got there). Half of my class never finished. In my intern year, six of the eight categorical residents dropped out. My odds of reaching PGY 2 were 12.5%. Fuzzy math aside, all of your stories are similar. We have proved our resilience over and over again. What is happening here is different.

Burnout is described as emotional exhaustion, low self-esteem, and depersonalization/cynicism. It develops slowly, progressively as stressors increase. A common thread seems to be the feeling that you alone are not enough. Examine your daily life. What are your most common stressors? For me, they relate to time management, clinical documentation, and whatever fresh hell my kids’ teachers have cooked up for “school projects.”

*****Scene*****

Wife: Can you help Luke (kindergarten) finish his diorama? It needs to be a scale depiction of his 3 favorite scenes from Wagner’s Ring cycle.

Me: Sure, I just need to complete the wind tunnel testing on Jack’s (3rd grade) carbon-neutral peanut-free alternative fuel source rocket booster.

Off stage – 7th Grade Son: The genetically modified spiders got loose again!

*****End Scene*****

We want to do a good job, but more hurdles are placed in our way. A recent AMA/Dartmouth Hitchcock study found that 50% of physicians’ time is spent performing data entry and other administrative work. Only 27% of time was spent on patient care. Every hour of face-to-face patient time requires 2 hours of EMR/clerical work. We are trapped in a bureaucratic prison. For years, every quality initiative was solved with a new form. To enter a simple note today, we must first “establish our relationship” with the patient, then ably click through a minefield of “warning boxes” signifying impending DVT prophylaxis catastrophes and antibiotic crimes and misdemeanors, next we scroll through a pre-populated postapocalyptic hellscape of minute- by-minute vital sign entries and lab values dating back to inception. Then, and only then, finally, ON PAGE 11, we can meagerly type: Patient at wound care, will come back on evening rounds.

Dr. Sheahan is the Claude C. Craighead Jr. Professor and Chair, Division of Vascular and Endovascular Surgery, Louisiana State University Health Sciences Center, New Orleans.

Look, I am not a burnout expert. And neither are you (presumably). None of us know much, but that won’t stop the regulations from coming. Program directors are already being asked to provide “wellness plans.” Through the SVS, experts have been enlisted to help, but it is now clear that what works for others won’t necessarily work for vascular surgeons. The next step is up to us. We are the only ones with detailed knowledge of our lives. I believe we are moving closer to answers but still face a few significant hurdles. Don’t worry, there are solutions. Hear me out …

Previously, I shared three studies with you, which found that vascular surgeons had the highest rates of suicidal ideation and career dissatisfaction among surgeons while spending more hours in the hospital than any other specialty. So what has been done to address these horrific numbers? Very little. We need answers now, but most of the data are over 10 years old. Much has changed in our specialty. The endovascular revolution created an entirely new working paradigm. A busy vascular surgeon used to perform 300 cases annually; now this number approaches 1,000. More procedures means more clerical work. Lead aprons and radiation exposure have added new ergonomic and medical concerns. Reimbursement dynamics now favor shorter, more frequent patient interactions over longer, more complex cases. We are benchmarked against old work standards while CPT bundling continuously lowers current RVU designations. EMR was supposed to make our lives better; it has done the opposite. Patient-centered health care has become a mantra, but the measures taken often backfire. Practicing medicine where the desired outcome is a high score on patient satisfaction surveys will likely lead to unnecessary tests, poor cost allocation, and low physician fulfillment. Quality of care is now measured scrupulously while the quality of our lives remains undocumented.

In the absence of organized reform, burnout appears to be increasing. A recent Mayo Clinic–AMA study found the current prevalence to be 54% among physicians. All of this has not happened overnight. I believe practicing vascular surgeons are resilient by default. The majority of us trained prior to the enforcement of duty hour restrictions. Out of high school, I enrolled in a 6-year BA/MD program (skipping 2 years of college seemed like a great idea in high school, less so when I got there). Half of my class never finished. In my intern year, six of the eight categorical residents dropped out. My odds of reaching PGY 2 were 12.5%. Fuzzy math aside, all of your stories are similar. We have proved our resilience over and over again. What is happening here is different.

Burnout is described as emotional exhaustion, low self-esteem, and depersonalization/cynicism. It develops slowly, progressively as stressors increase. A common thread seems to be the feeling that you alone are not enough. Examine your daily life. What are your most common stressors? For me, they relate to time management, clinical documentation, and whatever fresh hell my kids’ teachers have cooked up for “school projects.”

*****Scene*****

Wife: Can you help Luke (kindergarten) finish his diorama? It needs to be a scale depiction of his 3 favorite scenes from Wagner’s Ring cycle.

Me: Sure, I just need to complete the wind tunnel testing on Jack’s (3rd grade) carbon-neutral peanut-free alternative fuel source rocket booster.

Off stage – 7th Grade Son: The genetically modified spiders got loose again!

*****End Scene*****

We want to do a good job, but more hurdles are placed in our way. A recent AMA/Dartmouth Hitchcock study found that 50% of physicians’ time is spent performing data entry and other administrative work. Only 27% of time was spent on patient care. Every hour of face-to-face patient time requires 2 hours of EMR/clerical work. We are trapped in a bureaucratic prison. For years, every quality initiative was solved with a new form. To enter a simple note today, we must first “establish our relationship” with the patient, then ably click through a minefield of “warning boxes” signifying impending DVT prophylaxis catastrophes and antibiotic crimes and misdemeanors, next we scroll through a pre-populated postapocalyptic hellscape of minute- by-minute vital sign entries and lab values dating back to inception. Then, and only then, finally, ON PAGE 11, we can meagerly type: Patient at wound care, will come back on evening rounds.

Dr. Sheahan is the Claude C. Craighead Jr. Professor and Chair, Division of Vascular and Endovascular Surgery, Louisiana State University Health Sciences Center, New Orleans.

Look, I am not a burnout expert. And neither are you (presumably). None of us know much, but that won’t stop the regulations from coming. Program directors are already being asked to provide “wellness plans.” Through the SVS, experts have been enlisted to help, but it is now clear that what works for others won’t necessarily work for vascular surgeons. The next step is up to us. We are the only ones with detailed knowledge of our lives. I believe we are moving closer to answers but still face a few significant hurdles. Don’t worry, there are solutions. Hear me out …

Previously, I shared three studies with you, which found that vascular surgeons had the highest rates of suicidal ideation and career dissatisfaction among surgeons while spending more hours in the hospital than any other specialty. So what has been done to address these horrific numbers? Very little. We need answers now, but most of the data are over 10 years old. Much has changed in our specialty. The endovascular revolution created an entirely new working paradigm. A busy vascular surgeon used to perform 300 cases annually; now this number approaches 1,000. More procedures means more clerical work. Lead aprons and radiation exposure have added new ergonomic and medical concerns. Reimbursement dynamics now favor shorter, more frequent patient interactions over longer, more complex cases. We are benchmarked against old work standards while CPT bundling continuously lowers current RVU designations. EMR was supposed to make our lives better; it has done the opposite. Patient-centered health care has become a mantra, but the measures taken often backfire. Practicing medicine where the desired outcome is a high score on patient satisfaction surveys will likely lead to unnecessary tests, poor cost allocation, and low physician fulfillment. Quality of care is now measured scrupulously while the quality of our lives remains undocumented.

In the absence of organized reform, burnout appears to be increasing. A recent Mayo Clinic–AMA study found the current prevalence to be 54% among physicians. All of this has not happened overnight. I believe practicing vascular surgeons are resilient by default. The majority of us trained prior to the enforcement of duty hour restrictions. Out of high school, I enrolled in a 6-year BA/MD program (skipping 2 years of college seemed like a great idea in high school, less so when I got there). Half of my class never finished. In my intern year, six of the eight categorical residents dropped out. My odds of reaching PGY 2 were 12.5%. Fuzzy math aside, all of your stories are similar. We have proved our resilience over and over again. What is happening here is different.

Burnout is described as emotional exhaustion, low self-esteem, and depersonalization/cynicism. It develops slowly, progressively as stressors increase. A common thread seems to be the feeling that you alone are not enough. Examine your daily life. What are your most common stressors? For me, they relate to time management, clinical documentation, and whatever fresh hell my kids’ teachers have cooked up for “school projects.”

*****Scene*****

Wife: Can you help Luke (kindergarten) finish his diorama? It needs to be a scale depiction of his 3 favorite scenes from Wagner’s Ring cycle.

Me: Sure, I just need to complete the wind tunnel testing on Jack’s (3rd grade) carbon-neutral peanut-free alternative fuel source rocket booster.

Off stage – 7th Grade Son: The genetically modified spiders got loose again!

*****End Scene*****

We want to do a good job, but more hurdles are placed in our way. A recent AMA/Dartmouth Hitchcock study found that 50% of physicians’ time is spent performing data entry and other administrative work. Only 27% of time was spent on patient care. Every hour of face-to-face patient time requires 2 hours of EMR/clerical work. We are trapped in a bureaucratic prison. For years, every quality initiative was solved with a new form. To enter a simple note today, we must first “establish our relationship” with the patient, then ably click through a minefield of “warning boxes” signifying impending DVT prophylaxis catastrophes and antibiotic crimes and misdemeanors, next we scroll through a pre-populated postapocalyptic hellscape of minute- by-minute vital sign entries and lab values dating back to inception. Then, and only then, finally, ON PAGE 11, we can meagerly type: Patient at wound care, will come back on evening rounds.

Dr. Sheahan is the Claude C. Craighead Jr. Professor and Chair, Division of Vascular and Endovascular Surgery, Louisiana State University Health Sciences Center, New Orleans.

Closure of a patent foramen ovale (PFO) with an atrial septal aneurysm, hypermobility, or size of 2 mm or greater reduces the risk of stroke recurrence in patients with cryptogenic stroke, according to research published online ahead of print March 12 in the Journal of the American College of Cardiology.

“Considering the high prevalence of PFO in the general population and cryptogenic stroke patients, the key to appropriate use of this medical device is determining how to select optimal candidates for the procedure,” said Jae-Kwan Song, MD, PhD, a Professor in the Department of Medicine at Asan Medical Center, University of Ulsan College of Medicine, in Seoul, South Korea. “With our study and other recent trials, the criteria for selecting patients for the procedure are becoming clearer; in particular, the results suggest that closure is beneficial for those with high-risk PFO.”

A Multisite Superiority Trial

Previous research has not offered a definitive answer to the question of whether physicians can determine the potential benefit of PFO closure according to the PFO’s morphologic characteristics. In an earlier study, Dr. Song and colleagues found that high-risk PFO, as defined by transesophageal echocardiography (TEE), helped to predict stroke recurrence. The investigators then initiated the DEFENSE-PFO trial to evaluate whether restricting treatment to patients with cryptogenic stroke and PFO morphology associated with a higher rate of recurrent stroke would enhance the benefits of PFO closure.

Dr. Song and colleagues conducted DEFENSE-PFO, an open-label superiority trial, at two sites in South Korea from June 2011 through October 2017. Eligible patients had an ischemic stroke within the previous six months with no identifiable cause other than a high-risk PFO with left-to-right shunting. The researchers performed a standardized evaluation to rule out other identifiable mechanisms of stroke. The exclusion criteria were at least 50% stenosis of a major vessel, occlusion of a major vessel, and stroke resulting from small-vessel occlusive disease. Dr. Song and colleagues performed Holter monitoring or prolonged monitoring of cardiac rhythm to rule out paroxysmal atrial fibrillation.

A high-risk PFO was defined as one with an atrial septal aneurysm (ie, protrusion of the dilated segment of the septum at least 15 mm beyond the level surface of the atrial septum), hypermobility (ie, phasic septal excursion of 10 mm or more into either atrium), or size (ie, maximum separation of the septum primum from the secundum during the Valsalva maneuver) of 2 mm or greater on TEE.

Patients were randomized in equal groups to transcatheter PFO closure with the Amplatzer PFO Occluder plus medical therapy or medical therapy alone. All participants received antiplatelet therapy or anticoagulation chosen by the local investigator. During follow-up visits at one, three, six, 12, and 24 months, investigators recorded clinical data.

The primary end point was a composite of stroke, vascular death, or Thrombolysis in Myocardial Infarction (TIMI)-defined major bleeding during two years of follow-up. The secondary end point was asymptomatic ischemic stroke on follow-up MRI.

No End-Point Events After PFO Closure

Dr. Song and colleagues identified 450 patients with cryptogenic stoke and PFO, of whom 175 had high-risk PFO. They randomized 60 patients to each study arm. Participants’ mean age was 51.8. The groups were well balanced in terms of age, sex, medical history, qualifying event, modified Rankin scale score at discharge, and the anatomic characteristics of the PFO and atrial septum.

Seven patients randomized to PFO closure declined the treatment. Dual antiplatelet therapy was the most common medication in both groups at 30 days after randomization. This trend continued for as long as 12 months in the medication-only group, but single antiplatelet therapy became the most common strategy after six months in the PFO-closure group. About 17% of patients in the PFO-closure group stopped medication after the intervention. The median duration of follow-up was 2.8 years.

In the intention-to-treat analysis, no patient in the PFO-closure group had a primary end point event, compared with six patients in the medication-only group. Events recorded in the latter group included five ischemic strokes, one cerebral hemorrhage, two TIMI-defined major bleeding events, and one transient ischemic attack. The Kaplan-Meier two-year cumulative estimate of the probability of stroke was 10.5% in the medication-only group. The number of patients needed to treat with PFO closure to avoid one stroke at two years thus was 10.

Implications for Selection Criteria

The DEFENSE-PFO study differs from two previous trials that found benefits of PFO closure, but did not consider the anatomic features of the atrial septum or PFO. “The only trial with stringent entry criteria similar to ours is the CLOSE trial, which required that patients have a large interatrial right-to-left shunt (more than 30 microbubbles in the left atrium within three cardiac cycles after opacification of the right atrium) or an atrial septal aneurysm (a septum primum excursion greater than 10 mm),” said Dr. Song and colleagues. “Both the CLOSE trial and our trial showed no occurrence of stroke in patients who underwent PFO closure, suggesting that the beneficial effect of percutaneous device closure of PFO can be maximized by adding the morphologic characteristics of PFO, as evaluated by TEE, to the selection criteria for the procedure.”

Because the DEFENSE-PFO study was terminated early for patient safety, it was underpowered to provide a hazard ratio for its primary end point. In addition, selection bias may have affected the study, since it was conducted at a small number of centers.

—Erik Greb

Suggested Reading

Lee PH, Song J-K, Kim JS, et al. Cryptogenic stroke and high-risk patent foramen ovale: The DEFENSE-PFO trial. J Am Coll Cardiol. 2018 Mar 12 [Epub ahead of print].

Mas JL, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377(11):1011-1021.

Closure of a patent foramen ovale (PFO) with an atrial septal aneurysm, hypermobility, or size of 2 mm or greater reduces the risk of stroke recurrence in patients with cryptogenic stroke, according to research published online ahead of print March 12 in the Journal of the American College of Cardiology.

“Considering the high prevalence of PFO in the general population and cryptogenic stroke patients, the key to appropriate use of this medical device is determining how to select optimal candidates for the procedure,” said Jae-Kwan Song, MD, PhD, a Professor in the Department of Medicine at Asan Medical Center, University of Ulsan College of Medicine, in Seoul, South Korea. “With our study and other recent trials, the criteria for selecting patients for the procedure are becoming clearer; in particular, the results suggest that closure is beneficial for those with high-risk PFO.”

A Multisite Superiority Trial

Previous research has not offered a definitive answer to the question of whether physicians can determine the potential benefit of PFO closure according to the PFO’s morphologic characteristics. In an earlier study, Dr. Song and colleagues found that high-risk PFO, as defined by transesophageal echocardiography (TEE), helped to predict stroke recurrence. The investigators then initiated the DEFENSE-PFO trial to evaluate whether restricting treatment to patients with cryptogenic stroke and PFO morphology associated with a higher rate of recurrent stroke would enhance the benefits of PFO closure.

Dr. Song and colleagues conducted DEFENSE-PFO, an open-label superiority trial, at two sites in South Korea from June 2011 through October 2017. Eligible patients had an ischemic stroke within the previous six months with no identifiable cause other than a high-risk PFO with left-to-right shunting. The researchers performed a standardized evaluation to rule out other identifiable mechanisms of stroke. The exclusion criteria were at least 50% stenosis of a major vessel, occlusion of a major vessel, and stroke resulting from small-vessel occlusive disease. Dr. Song and colleagues performed Holter monitoring or prolonged monitoring of cardiac rhythm to rule out paroxysmal atrial fibrillation.

A high-risk PFO was defined as one with an atrial septal aneurysm (ie, protrusion of the dilated segment of the septum at least 15 mm beyond the level surface of the atrial septum), hypermobility (ie, phasic septal excursion of 10 mm or more into either atrium), or size (ie, maximum separation of the septum primum from the secundum during the Valsalva maneuver) of 2 mm or greater on TEE.

Patients were randomized in equal groups to transcatheter PFO closure with the Amplatzer PFO Occluder plus medical therapy or medical therapy alone. All participants received antiplatelet therapy or anticoagulation chosen by the local investigator. During follow-up visits at one, three, six, 12, and 24 months, investigators recorded clinical data.

The primary end point was a composite of stroke, vascular death, or Thrombolysis in Myocardial Infarction (TIMI)-defined major bleeding during two years of follow-up. The secondary end point was asymptomatic ischemic stroke on follow-up MRI.

No End-Point Events After PFO Closure

Dr. Song and colleagues identified 450 patients with cryptogenic stoke and PFO, of whom 175 had high-risk PFO. They randomized 60 patients to each study arm. Participants’ mean age was 51.8. The groups were well balanced in terms of age, sex, medical history, qualifying event, modified Rankin scale score at discharge, and the anatomic characteristics of the PFO and atrial septum.

Seven patients randomized to PFO closure declined the treatment. Dual antiplatelet therapy was the most common medication in both groups at 30 days after randomization. This trend continued for as long as 12 months in the medication-only group, but single antiplatelet therapy became the most common strategy after six months in the PFO-closure group. About 17% of patients in the PFO-closure group stopped medication after the intervention. The median duration of follow-up was 2.8 years.

In the intention-to-treat analysis, no patient in the PFO-closure group had a primary end point event, compared with six patients in the medication-only group. Events recorded in the latter group included five ischemic strokes, one cerebral hemorrhage, two TIMI-defined major bleeding events, and one transient ischemic attack. The Kaplan-Meier two-year cumulative estimate of the probability of stroke was 10.5% in the medication-only group. The number of patients needed to treat with PFO closure to avoid one stroke at two years thus was 10.

Implications for Selection Criteria

The DEFENSE-PFO study differs from two previous trials that found benefits of PFO closure, but did not consider the anatomic features of the atrial septum or PFO. “The only trial with stringent entry criteria similar to ours is the CLOSE trial, which required that patients have a large interatrial right-to-left shunt (more than 30 microbubbles in the left atrium within three cardiac cycles after opacification of the right atrium) or an atrial septal aneurysm (a septum primum excursion greater than 10 mm),” said Dr. Song and colleagues. “Both the CLOSE trial and our trial showed no occurrence of stroke in patients who underwent PFO closure, suggesting that the beneficial effect of percutaneous device closure of PFO can be maximized by adding the morphologic characteristics of PFO, as evaluated by TEE, to the selection criteria for the procedure.”

Because the DEFENSE-PFO study was terminated early for patient safety, it was underpowered to provide a hazard ratio for its primary end point. In addition, selection bias may have affected the study, since it was conducted at a small number of centers.

—Erik Greb

Suggested Reading

Lee PH, Song J-K, Kim JS, et al. Cryptogenic stroke and high-risk patent foramen ovale: The DEFENSE-PFO trial. J Am Coll Cardiol. 2018 Mar 12 [Epub ahead of print].

Mas JL, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377(11):1011-1021.

Closure of a patent foramen ovale (PFO) with an atrial septal aneurysm, hypermobility, or size of 2 mm or greater reduces the risk of stroke recurrence in patients with cryptogenic stroke, according to research published online ahead of print March 12 in the Journal of the American College of Cardiology.

“Considering the high prevalence of PFO in the general population and cryptogenic stroke patients, the key to appropriate use of this medical device is determining how to select optimal candidates for the procedure,” said Jae-Kwan Song, MD, PhD, a Professor in the Department of Medicine at Asan Medical Center, University of Ulsan College of Medicine, in Seoul, South Korea. “With our study and other recent trials, the criteria for selecting patients for the procedure are becoming clearer; in particular, the results suggest that closure is beneficial for those with high-risk PFO.”

A Multisite Superiority Trial

Previous research has not offered a definitive answer to the question of whether physicians can determine the potential benefit of PFO closure according to the PFO’s morphologic characteristics. In an earlier study, Dr. Song and colleagues found that high-risk PFO, as defined by transesophageal echocardiography (TEE), helped to predict stroke recurrence. The investigators then initiated the DEFENSE-PFO trial to evaluate whether restricting treatment to patients with cryptogenic stroke and PFO morphology associated with a higher rate of recurrent stroke would enhance the benefits of PFO closure.

Dr. Song and colleagues conducted DEFENSE-PFO, an open-label superiority trial, at two sites in South Korea from June 2011 through October 2017. Eligible patients had an ischemic stroke within the previous six months with no identifiable cause other than a high-risk PFO with left-to-right shunting. The researchers performed a standardized evaluation to rule out other identifiable mechanisms of stroke. The exclusion criteria were at least 50% stenosis of a major vessel, occlusion of a major vessel, and stroke resulting from small-vessel occlusive disease. Dr. Song and colleagues performed Holter monitoring or prolonged monitoring of cardiac rhythm to rule out paroxysmal atrial fibrillation.

A high-risk PFO was defined as one with an atrial septal aneurysm (ie, protrusion of the dilated segment of the septum at least 15 mm beyond the level surface of the atrial septum), hypermobility (ie, phasic septal excursion of 10 mm or more into either atrium), or size (ie, maximum separation of the septum primum from the secundum during the Valsalva maneuver) of 2 mm or greater on TEE.

Patients were randomized in equal groups to transcatheter PFO closure with the Amplatzer PFO Occluder plus medical therapy or medical therapy alone. All participants received antiplatelet therapy or anticoagulation chosen by the local investigator. During follow-up visits at one, three, six, 12, and 24 months, investigators recorded clinical data.

The primary end point was a composite of stroke, vascular death, or Thrombolysis in Myocardial Infarction (TIMI)-defined major bleeding during two years of follow-up. The secondary end point was asymptomatic ischemic stroke on follow-up MRI.

No End-Point Events After PFO Closure

Dr. Song and colleagues identified 450 patients with cryptogenic stoke and PFO, of whom 175 had high-risk PFO. They randomized 60 patients to each study arm. Participants’ mean age was 51.8. The groups were well balanced in terms of age, sex, medical history, qualifying event, modified Rankin scale score at discharge, and the anatomic characteristics of the PFO and atrial septum.

Seven patients randomized to PFO closure declined the treatment. Dual antiplatelet therapy was the most common medication in both groups at 30 days after randomization. This trend continued for as long as 12 months in the medication-only group, but single antiplatelet therapy became the most common strategy after six months in the PFO-closure group. About 17% of patients in the PFO-closure group stopped medication after the intervention. The median duration of follow-up was 2.8 years.

In the intention-to-treat analysis, no patient in the PFO-closure group had a primary end point event, compared with six patients in the medication-only group. Events recorded in the latter group included five ischemic strokes, one cerebral hemorrhage, two TIMI-defined major bleeding events, and one transient ischemic attack. The Kaplan-Meier two-year cumulative estimate of the probability of stroke was 10.5% in the medication-only group. The number of patients needed to treat with PFO closure to avoid one stroke at two years thus was 10.

Implications for Selection Criteria

The DEFENSE-PFO study differs from two previous trials that found benefits of PFO closure, but did not consider the anatomic features of the atrial septum or PFO. “The only trial with stringent entry criteria similar to ours is the CLOSE trial, which required that patients have a large interatrial right-to-left shunt (more than 30 microbubbles in the left atrium within three cardiac cycles after opacification of the right atrium) or an atrial septal aneurysm (a septum primum excursion greater than 10 mm),” said Dr. Song and colleagues. “Both the CLOSE trial and our trial showed no occurrence of stroke in patients who underwent PFO closure, suggesting that the beneficial effect of percutaneous device closure of PFO can be maximized by adding the morphologic characteristics of PFO, as evaluated by TEE, to the selection criteria for the procedure.”

Because the DEFENSE-PFO study was terminated early for patient safety, it was underpowered to provide a hazard ratio for its primary end point. In addition, selection bias may have affected the study, since it was conducted at a small number of centers.

—Erik Greb

Suggested Reading

Lee PH, Song J-K, Kim JS, et al. Cryptogenic stroke and high-risk patent foramen ovale: The DEFENSE-PFO trial. J Am Coll Cardiol. 2018 Mar 12 [Epub ahead of print].

Mas JL, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377(11):1011-1021.

Jeffrey Glasheen, MD, had not considered focusing on quality improvement (QI) while studying at the University of Wisconsin, Madison. It was not until a medical error led to the death of a family member that his eyes were opened to the potential consequences of a system not invested in care quality.

“I couldn’t square with it because I had spent the last two to three years of my life working with some of the most dedicated, passionate, hard working people who all were trying to improve lives, and the fact that what I was seeing could result in a family member dying just didn’t make sense,” said Dr. Glasheen. “At the time I thought ‘This must be one of those unfortunate things that happens once in a lifetime,’ and I put it on the back burner.”

As more research on medical errors emerged, however, Dr. Glasheen realized his family’s experience was not as unique as he had thought.

It was after reading the now famous Institute of Medicine report, “To err is human,” which found that medical errors were responsible for 44,000-98,000 deaths a year, that Dr. Glasheen resolved to pursue a career in quality improvement.

[email protected]

Jeffrey Glasheen, MD, had not considered focusing on quality improvement (QI) while studying at the University of Wisconsin, Madison. It was not until a medical error led to the death of a family member that his eyes were opened to the potential consequences of a system not invested in care quality.

“I couldn’t square with it because I had spent the last two to three years of my life working with some of the most dedicated, passionate, hard working people who all were trying to improve lives, and the fact that what I was seeing could result in a family member dying just didn’t make sense,” said Dr. Glasheen. “At the time I thought ‘This must be one of those unfortunate things that happens once in a lifetime,’ and I put it on the back burner.”

As more research on medical errors emerged, however, Dr. Glasheen realized his family’s experience was not as unique as he had thought.

It was after reading the now famous Institute of Medicine report, “To err is human,” which found that medical errors were responsible for 44,000-98,000 deaths a year, that Dr. Glasheen resolved to pursue a career in quality improvement.

[email protected]

Jeffrey Glasheen, MD, had not considered focusing on quality improvement (QI) while studying at the University of Wisconsin, Madison. It was not until a medical error led to the death of a family member that his eyes were opened to the potential consequences of a system not invested in care quality.

“I couldn’t square with it because I had spent the last two to three years of my life working with some of the most dedicated, passionate, hard working people who all were trying to improve lives, and the fact that what I was seeing could result in a family member dying just didn’t make sense,” said Dr. Glasheen. “At the time I thought ‘This must be one of those unfortunate things that happens once in a lifetime,’ and I put it on the back burner.”

As more research on medical errors emerged, however, Dr. Glasheen realized his family’s experience was not as unique as he had thought.

It was after reading the now famous Institute of Medicine report, “To err is human,” which found that medical errors were responsible for 44,000-98,000 deaths a year, that Dr. Glasheen resolved to pursue a career in quality improvement.

[email protected]

Herpes zoster, also known as shingles, is caused by a reactivation of varicella-zoster virus. Once an individual has been exposed to varicella-zoster virus, either from primary infection (chickenpox) or vaccination, the virus remains dormant in dorsal root ganglion cells. It may become reactivated at a later time, which results in herpes zoster. Typically, immunosuppression (hematologic malignancy and HIV infection) and age are factors that play a role in reactivation, although young people may develop shingles as well. Older age increases the incidence of herpes zoster.

Courtesy Dr. Donna Bilu Martin

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected]. This case and photo were submitted by Dr. Bilu Martin.

Herpes zoster, also known as shingles, is caused by a reactivation of varicella-zoster virus. Once an individual has been exposed to varicella-zoster virus, either from primary infection (chickenpox) or vaccination, the virus remains dormant in dorsal root ganglion cells. It may become reactivated at a later time, which results in herpes zoster. Typically, immunosuppression (hematologic malignancy and HIV infection) and age are factors that play a role in reactivation, although young people may develop shingles as well. Older age increases the incidence of herpes zoster.

Courtesy Dr. Donna Bilu Martin

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected]. This case and photo were submitted by Dr. Bilu Martin.

Herpes zoster, also known as shingles, is caused by a reactivation of varicella-zoster virus. Once an individual has been exposed to varicella-zoster virus, either from primary infection (chickenpox) or vaccination, the virus remains dormant in dorsal root ganglion cells. It may become reactivated at a later time, which results in herpes zoster. Typically, immunosuppression (hematologic malignancy and HIV infection) and age are factors that play a role in reactivation, although young people may develop shingles as well. Older age increases the incidence of herpes zoster.

Courtesy Dr. Donna Bilu Martin

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at edermatologynews.com. To submit a case for possible publication, send an email to [email protected]. This case and photo were submitted by Dr. Bilu Martin.

Counseling alone is unlikely to combat tanning addiction in adolescents; treatment that addresses the comorbid substance abuse and psychiatric issues is necessary, said Kimberly A. Miller, PhD, of the University of Southern California, Los Angeles, and her associates.

©Vidmantas Goldbergas/iStockphoto.com

Of a multiethnic sample of 2,637 high school students aged 16-17 years from Los Angeles, 7% met the modified CAGE criteria for tanning addiction, a compulsive drive to use indoor tanning beds frequently. The rate was similar in Hispanic teens and non-Hispanic white adolescents (7.6% versus 7.9%, respectively). Asian and Asian American teens had the lowest prevalence of tanning addiction (4.3%), while Native Hawaiian/Pacific Islanders had the highest (10.5%). Slightly more females than males met the criteria (9% vs. 5%), Dr. Miller and her associates reported in the Journal of Investigative Dermatology.

Past 30-day tobacco and marijuana use was significantly associated with tanning addiction, and teens with problem drinking were 3.4 times as likely to meet tanning addiction criteria as were those without problem drinking. Adolescents with panic disorder symptoms were two times more likely to meet tanning addiction criteria than were those without symptoms, and those with obsessive-compulsive disorder symptoms were three times more likely, Dr. Miller and associates said.

“With each additional problem use of substances, the likelihood of tanning addiction was increased by 67% for adolescents; for each additional psychological symptom, this figure was 30%,” the researchers said.

Dr. Miller and her associates cited several limitations. One was the cross-sectional design of the study. Another was the study’s focus on adolescents from Los Angeles, which limits the generalizability of the findings.

The authors declared no conflicts of interest.

SOURCE: Miller KA et al. J Investig Dermatol. 2018. doi: 10.1016/j.jid.2018.02.018.

Counseling alone is unlikely to combat tanning addiction in adolescents; treatment that addresses the comorbid substance abuse and psychiatric issues is necessary, said Kimberly A. Miller, PhD, of the University of Southern California, Los Angeles, and her associates.

©Vidmantas Goldbergas/iStockphoto.com

Of a multiethnic sample of 2,637 high school students aged 16-17 years from Los Angeles, 7% met the modified CAGE criteria for tanning addiction, a compulsive drive to use indoor tanning beds frequently. The rate was similar in Hispanic teens and non-Hispanic white adolescents (7.6% versus 7.9%, respectively). Asian and Asian American teens had the lowest prevalence of tanning addiction (4.3%), while Native Hawaiian/Pacific Islanders had the highest (10.5%). Slightly more females than males met the criteria (9% vs. 5%), Dr. Miller and her associates reported in the Journal of Investigative Dermatology.

Past 30-day tobacco and marijuana use was significantly associated with tanning addiction, and teens with problem drinking were 3.4 times as likely to meet tanning addiction criteria as were those without problem drinking. Adolescents with panic disorder symptoms were two times more likely to meet tanning addiction criteria than were those without symptoms, and those with obsessive-compulsive disorder symptoms were three times more likely, Dr. Miller and associates said.

“With each additional problem use of substances, the likelihood of tanning addiction was increased by 67% for adolescents; for each additional psychological symptom, this figure was 30%,” the researchers said.

Dr. Miller and her associates cited several limitations. One was the cross-sectional design of the study. Another was the study’s focus on adolescents from Los Angeles, which limits the generalizability of the findings.

The authors declared no conflicts of interest.

SOURCE: Miller KA et al. J Investig Dermatol. 2018. doi: 10.1016/j.jid.2018.02.018.

Counseling alone is unlikely to combat tanning addiction in adolescents; treatment that addresses the comorbid substance abuse and psychiatric issues is necessary, said Kimberly A. Miller, PhD, of the University of Southern California, Los Angeles, and her associates.

©Vidmantas Goldbergas/iStockphoto.com

Of a multiethnic sample of 2,637 high school students aged 16-17 years from Los Angeles, 7% met the modified CAGE criteria for tanning addiction, a compulsive drive to use indoor tanning beds frequently. The rate was similar in Hispanic teens and non-Hispanic white adolescents (7.6% versus 7.9%, respectively). Asian and Asian American teens had the lowest prevalence of tanning addiction (4.3%), while Native Hawaiian/Pacific Islanders had the highest (10.5%). Slightly more females than males met the criteria (9% vs. 5%), Dr. Miller and her associates reported in the Journal of Investigative Dermatology.

Past 30-day tobacco and marijuana use was significantly associated with tanning addiction, and teens with problem drinking were 3.4 times as likely to meet tanning addiction criteria as were those without problem drinking. Adolescents with panic disorder symptoms were two times more likely to meet tanning addiction criteria than were those without symptoms, and those with obsessive-compulsive disorder symptoms were three times more likely, Dr. Miller and associates said.

“With each additional problem use of substances, the likelihood of tanning addiction was increased by 67% for adolescents; for each additional psychological symptom, this figure was 30%,” the researchers said.

Dr. Miller and her associates cited several limitations. One was the cross-sectional design of the study. Another was the study’s focus on adolescents from Los Angeles, which limits the generalizability of the findings.

The authors declared no conflicts of interest.

SOURCE: Miller KA et al. J Investig Dermatol. 2018. doi: 10.1016/j.jid.2018.02.018.

Alcohol dependence ages your brain. Artificial intelligence comes to glucose monitoring. There’s a promising combo treatment for allergic rhinitis. And evidence mounts for the importance of thrombectomy in stroke.

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

Alcohol dependence ages your brain. Artificial intelligence comes to glucose monitoring. There’s a promising combo treatment for allergic rhinitis. And evidence mounts for the importance of thrombectomy in stroke.

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

Alcohol dependence ages your brain. Artificial intelligence comes to glucose monitoring. There’s a promising combo treatment for allergic rhinitis. And evidence mounts for the importance of thrombectomy in stroke.

Listen to the MDedge Daily News podcast for all the details on today’s top news.


 

Photo by Rhoda Baer

New research suggests patients with acute myeloid leukemia (AML) may have a lower risk of early mortality if they receive treatment at a National Cancer Institute (NCI) cancer center.

In a study of AML patients in California, the risk of 60-day mortality was 53% lower among patients treated at NCI cancer centers than among those treated at other centers.

These findings were reported in Cancer.

“We found the early mortality, deaths less than 60 days after diagnosis, was significantly lower at the NCI-designated cancer centers compared to non-NCI-designated cancer centers in California,” said study author Brian Jonas, MD, PhD, of the University of California at Davis School of Medicine in Sacramento, California.

To conduct this study, Dr Jonas and his colleagues analyzed data from the California Cancer Registry and the California Office of Statewide Health Planning and Development Patient Discharge Database.

The California Cancer Registry provides sociodemographic and clinical data for all California cancer patients. The California Office of Statewide Health Planning and Development Patient Discharge Database has data on diagnoses and procedures for all hospital patients in California, excluding 14 Veterans Affairs and military hospitals.

Patients

The study included data on AML patients 18 and older who received inpatient chemotherapy between 1999 and 2014. There were 7007 patients, 1762 (25%) of whom were treated at NCI-designated cancer centers.

The median number of new AML patients per year was 13.5 (range, 0-43) at the NCI centers and 2 (range, 1-17) at non-NCI centers that admitted at least 1 patient with AML. More than half of the non-NCI centers had a median of 0 new AML patients per year.

NCI patients were more likely to be younger (≤65) than non-NCI patients (P<0.0001), to live in neighborhoods with higher socioeconomic status (P<0.0001), have fewer comorbidities (P<0.0001), and have public health insurance (P<0.0001).

Results

There were several types of complications that differed significantly between center types.

Patients treated at NCI centers were significantly more likely to have leukapheresis (5.5% vs 2.7%; P<0.001) and renal failure (22.8% vs 19.9%; P=0.010).

But they were significantly less likely to have respiratory failure (11.6% vs 14.3%; P=0.003) and cardiac arrest (1.1% vs 2.0%; P=0.014).

Sixty-day survival was significantly higher among NCI patients (88.0% vs 76.3%; P<0.001).

In an inverse-probability-weighted analysis adjusted for sociodemographic factors and comorbidities, treatment at an NCI center was associated with significantly lower early mortality, with an odds ratio (OR) of 0.46 (P<0.001).

This analysis also revealed a significant association between increased early mortality and major bleeding (OR=1.79, P<0.001), renal failure (OR=2.33, P<0.001), respiratory failure (OR=6.46, P<0.001), and cardiac arrest (OR=13.33, P<0.001).

For the most part, the impact of complications on early mortality did not differ significantly by treatment center.

The exception was respiratory failure. Patients with respiratory failure had a significantly greater risk of early mortality if they were treated at a non-NCI center (OR=9.48) than at an NCI center (OR=4.20).

Potential explanations

The researchers believe the variations in early mortality they observed point to inconsistent supportive care. However, more work must be done to fully understand the differences in care driving these issues.

“This is clearly provocative data that makes you want to understand exactly why,” Dr Jonas said. “We’re going to have to dive into that question in a more significant way.”

In the absence of data that could identify the exact causes, the researchers noted that other studies have shown higher patient volumes may contribute to better care.

“I see 60 or more AML cases per year,” Dr Jonas said. “High volume/low volume must play a role.”

The researchers believe other potential contributing factors could be access to clinical trials, better nursing ratios, and more sophisticated intensive care units.

The team hopes this research will spawn more intensive efforts to identify the causes that underlie variations in early mortality between hospital sites.

“This is a provocative and hopeful paper in terms of improving outcomes,” Dr Jonas said. “It sends a positive message that there are things we could probably do that could help everyone.”

Photo by Rhoda Baer

New research suggests patients with acute myeloid leukemia (AML) may have a lower risk of early mortality if they receive treatment at a National Cancer Institute (NCI) cancer center.

In a study of AML patients in California, the risk of 60-day mortality was 53% lower among patients treated at NCI cancer centers than among those treated at other centers.

These findings were reported in Cancer.

“We found the early mortality, deaths less than 60 days after diagnosis, was significantly lower at the NCI-designated cancer centers compared to non-NCI-designated cancer centers in California,” said study author Brian Jonas, MD, PhD, of the University of California at Davis School of Medicine in Sacramento, California.

To conduct this study, Dr Jonas and his colleagues analyzed data from the California Cancer Registry and the California Office of Statewide Health Planning and Development Patient Discharge Database.

The California Cancer Registry provides sociodemographic and clinical data for all California cancer patients. The California Office of Statewide Health Planning and Development Patient Discharge Database has data on diagnoses and procedures for all hospital patients in California, excluding 14 Veterans Affairs and military hospitals.

Patients

The study included data on AML patients 18 and older who received inpatient chemotherapy between 1999 and 2014. There were 7007 patients, 1762 (25%) of whom were treated at NCI-designated cancer centers.

The median number of new AML patients per year was 13.5 (range, 0-43) at the NCI centers and 2 (range, 1-17) at non-NCI centers that admitted at least 1 patient with AML. More than half of the non-NCI centers had a median of 0 new AML patients per year.

NCI patients were more likely to be younger (≤65) than non-NCI patients (P<0.0001), to live in neighborhoods with higher socioeconomic status (P<0.0001), have fewer comorbidities (P<0.0001), and have public health insurance (P<0.0001).

Results

There were several types of complications that differed significantly between center types.

Patients treated at NCI centers were significantly more likely to have leukapheresis (5.5% vs 2.7%; P<0.001) and renal failure (22.8% vs 19.9%; P=0.010).

But they were significantly less likely to have respiratory failure (11.6% vs 14.3%; P=0.003) and cardiac arrest (1.1% vs 2.0%; P=0.014).

Sixty-day survival was significantly higher among NCI patients (88.0% vs 76.3%; P<0.001).

In an inverse-probability-weighted analysis adjusted for sociodemographic factors and comorbidities, treatment at an NCI center was associated with significantly lower early mortality, with an odds ratio (OR) of 0.46 (P<0.001).

This analysis also revealed a significant association between increased early mortality and major bleeding (OR=1.79, P<0.001), renal failure (OR=2.33, P<0.001), respiratory failure (OR=6.46, P<0.001), and cardiac arrest (OR=13.33, P<0.001).

For the most part, the impact of complications on early mortality did not differ significantly by treatment center.

The exception was respiratory failure. Patients with respiratory failure had a significantly greater risk of early mortality if they were treated at a non-NCI center (OR=9.48) than at an NCI center (OR=4.20).

Potential explanations

The researchers believe the variations in early mortality they observed point to inconsistent supportive care. However, more work must be done to fully understand the differences in care driving these issues.

“This is clearly provocative data that makes you want to understand exactly why,” Dr Jonas said. “We’re going to have to dive into that question in a more significant way.”

In the absence of data that could identify the exact causes, the researchers noted that other studies have shown higher patient volumes may contribute to better care.

“I see 60 or more AML cases per year,” Dr Jonas said. “High volume/low volume must play a role.”

The researchers believe other potential contributing factors could be access to clinical trials, better nursing ratios, and more sophisticated intensive care units.

The team hopes this research will spawn more intensive efforts to identify the causes that underlie variations in early mortality between hospital sites.

“This is a provocative and hopeful paper in terms of improving outcomes,” Dr Jonas said. “It sends a positive message that there are things we could probably do that could help everyone.”

Photo by Rhoda Baer

New research suggests patients with acute myeloid leukemia (AML) may have a lower risk of early mortality if they receive treatment at a National Cancer Institute (NCI) cancer center.

In a study of AML patients in California, the risk of 60-day mortality was 53% lower among patients treated at NCI cancer centers than among those treated at other centers.

These findings were reported in Cancer.

“We found the early mortality, deaths less than 60 days after diagnosis, was significantly lower at the NCI-designated cancer centers compared to non-NCI-designated cancer centers in California,” said study author Brian Jonas, MD, PhD, of the University of California at Davis School of Medicine in Sacramento, California.

To conduct this study, Dr Jonas and his colleagues analyzed data from the California Cancer Registry and the California Office of Statewide Health Planning and Development Patient Discharge Database.

The California Cancer Registry provides sociodemographic and clinical data for all California cancer patients. The California Office of Statewide Health Planning and Development Patient Discharge Database has data on diagnoses and procedures for all hospital patients in California, excluding 14 Veterans Affairs and military hospitals.

Patients

The study included data on AML patients 18 and older who received inpatient chemotherapy between 1999 and 2014. There were 7007 patients, 1762 (25%) of whom were treated at NCI-designated cancer centers.

The median number of new AML patients per year was 13.5 (range, 0-43) at the NCI centers and 2 (range, 1-17) at non-NCI centers that admitted at least 1 patient with AML. More than half of the non-NCI centers had a median of 0 new AML patients per year.

NCI patients were more likely to be younger (≤65) than non-NCI patients (P<0.0001), to live in neighborhoods with higher socioeconomic status (P<0.0001), have fewer comorbidities (P<0.0001), and have public health insurance (P<0.0001).

Results

There were several types of complications that differed significantly between center types.

Patients treated at NCI centers were significantly more likely to have leukapheresis (5.5% vs 2.7%; P<0.001) and renal failure (22.8% vs 19.9%; P=0.010).

But they were significantly less likely to have respiratory failure (11.6% vs 14.3%; P=0.003) and cardiac arrest (1.1% vs 2.0%; P=0.014).

Sixty-day survival was significantly higher among NCI patients (88.0% vs 76.3%; P<0.001).

In an inverse-probability-weighted analysis adjusted for sociodemographic factors and comorbidities, treatment at an NCI center was associated with significantly lower early mortality, with an odds ratio (OR) of 0.46 (P<0.001).

This analysis also revealed a significant association between increased early mortality and major bleeding (OR=1.79, P<0.001), renal failure (OR=2.33, P<0.001), respiratory failure (OR=6.46, P<0.001), and cardiac arrest (OR=13.33, P<0.001).

For the most part, the impact of complications on early mortality did not differ significantly by treatment center.

The exception was respiratory failure. Patients with respiratory failure had a significantly greater risk of early mortality if they were treated at a non-NCI center (OR=9.48) than at an NCI center (OR=4.20).

Potential explanations

The researchers believe the variations in early mortality they observed point to inconsistent supportive care. However, more work must be done to fully understand the differences in care driving these issues.

“This is clearly provocative data that makes you want to understand exactly why,” Dr Jonas said. “We’re going to have to dive into that question in a more significant way.”

In the absence of data that could identify the exact causes, the researchers noted that other studies have shown higher patient volumes may contribute to better care.

“I see 60 or more AML cases per year,” Dr Jonas said. “High volume/low volume must play a role.”

The researchers believe other potential contributing factors could be access to clinical trials, better nursing ratios, and more sophisticated intensive care units.

The team hopes this research will spawn more intensive efforts to identify the causes that underlie variations in early mortality between hospital sites.

“This is a provocative and hopeful paper in terms of improving outcomes,” Dr Jonas said. “It sends a positive message that there are things we could probably do that could help everyone.”

Bhatia, R.S., et al, JAMA Intern Med 177(9):1326, September 1, 2017

BACKGROUND: Both the USPSTF and the Choosing Wisely campaign recommend against routine ECG screening in low-risk patients. A routine ECG at the time of an annual physical in this population is considered to be an example of low-value care.

METHODS: The authors, coordinated at Women’s College Hospital in Toronto, examined the frequency of ECGs after annual health examinations in low-risk adults seen in primary care. Scrutiny of provincial databases identified 3,629,859 patients who had an annual exam in 2010-2015, excluding those with a history of cardiac disease or high-risk criteria. The primary outcomes were receipt of an ECG within 30 days after the annual exam and downstream cardiac care (cardiac testing or consultations) within 90 days.

RESULTS: Just over one-fifth of the patients (21.5%) had an ECG following the annual exam. Rates of ECG ordering varied widely among regions (from 0.7% to 24.4%), among the 679 primary care practices (1.8% to 76.1% of patients), and among the 8036 primary care physicians (1.1% to 94.9%). Receipt of an ECG was significantly more likely for older patients with certain comorbidities (cancer, rheumatologic disease) and less likely for rural residents. Physician traits associated with ECG ordering included male sex, medical school in an international program, and practicing for 30 years or more; in fact, practice-level variation explained 22% of the variation in ECG use. Patients having (versus not having) ECGs had significantly higher rates of cardiac consultations (odds ratio [OR] 5.38; 95% CI 5.24- 5.52) and cardiac tests (transthoracic echocardiogram, OR 7.1; stress test, OR 6.5; and nuclear stress test, OR 4.2). Despite this, one-year follow-up was consistent with low rates of cardiac morbidity and mortality in both groups.

CONCLUSIONS: Routine performance of an ECG appears to be relatively common in low-risk patients and increases the likelihood of unnecessary downstream testing. 37 references ([email protected] – no reprints)

Bhatia, R.S., et al, JAMA Intern Med 177(9):1326, September 1, 2017

BACKGROUND: Both the USPSTF and the Choosing Wisely campaign recommend against routine ECG screening in low-risk patients. A routine ECG at the time of an annual physical in this population is considered to be an example of low-value care.

METHODS: The authors, coordinated at Women’s College Hospital in Toronto, examined the frequency of ECGs after annual health examinations in low-risk adults seen in primary care. Scrutiny of provincial databases identified 3,629,859 patients who had an annual exam in 2010-2015, excluding those with a history of cardiac disease or high-risk criteria. The primary outcomes were receipt of an ECG within 30 days after the annual exam and downstream cardiac care (cardiac testing or consultations) within 90 days.

RESULTS: Just over one-fifth of the patients (21.5%) had an ECG following the annual exam. Rates of ECG ordering varied widely among regions (from 0.7% to 24.4%), among the 679 primary care practices (1.8% to 76.1% of patients), and among the 8036 primary care physicians (1.1% to 94.9%). Receipt of an ECG was significantly more likely for older patients with certain comorbidities (cancer, rheumatologic disease) and less likely for rural residents. Physician traits associated with ECG ordering included male sex, medical school in an international program, and practicing for 30 years or more; in fact, practice-level variation explained 22% of the variation in ECG use. Patients having (versus not having) ECGs had significantly higher rates of cardiac consultations (odds ratio [OR] 5.38; 95% CI 5.24- 5.52) and cardiac tests (transthoracic echocardiogram, OR 7.1; stress test, OR 6.5; and nuclear stress test, OR 4.2). Despite this, one-year follow-up was consistent with low rates of cardiac morbidity and mortality in both groups.

CONCLUSIONS: Routine performance of an ECG appears to be relatively common in low-risk patients and increases the likelihood of unnecessary downstream testing. 37 references ([email protected] – no reprints)

Bhatia, R.S., et al, JAMA Intern Med 177(9):1326, September 1, 2017

BACKGROUND: Both the USPSTF and the Choosing Wisely campaign recommend against routine ECG screening in low-risk patients. A routine ECG at the time of an annual physical in this population is considered to be an example of low-value care.

METHODS: The authors, coordinated at Women’s College Hospital in Toronto, examined the frequency of ECGs after annual health examinations in low-risk adults seen in primary care. Scrutiny of provincial databases identified 3,629,859 patients who had an annual exam in 2010-2015, excluding those with a history of cardiac disease or high-risk criteria. The primary outcomes were receipt of an ECG within 30 days after the annual exam and downstream cardiac care (cardiac testing or consultations) within 90 days.

RESULTS: Just over one-fifth of the patients (21.5%) had an ECG following the annual exam. Rates of ECG ordering varied widely among regions (from 0.7% to 24.4%), among the 679 primary care practices (1.8% to 76.1% of patients), and among the 8036 primary care physicians (1.1% to 94.9%). Receipt of an ECG was significantly more likely for older patients with certain comorbidities (cancer, rheumatologic disease) and less likely for rural residents. Physician traits associated with ECG ordering included male sex, medical school in an international program, and practicing for 30 years or more; in fact, practice-level variation explained 22% of the variation in ECG use. Patients having (versus not having) ECGs had significantly higher rates of cardiac consultations (odds ratio [OR] 5.38; 95% CI 5.24- 5.52) and cardiac tests (transthoracic echocardiogram, OR 7.1; stress test, OR 6.5; and nuclear stress test, OR 4.2). Despite this, one-year follow-up was consistent with low rates of cardiac morbidity and mortality in both groups.

CONCLUSIONS: Routine performance of an ECG appears to be relatively common in low-risk patients and increases the likelihood of unnecessary downstream testing. 37 references ([email protected] – no reprints)