Photo by Graham Colm

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Thermo Fisher Scientific’s TaqPath Zika Virus Kit.

This means the TaqPath Zika Virus Kit is authorized for the qualitative detection of RNA from Zika virus and diagnosis of Zika virus infection in human serum and urine (collected alongside a patient-matched serum specimen) from individuals meeting the US Centers for Disease Control and Prevention’s criteria for testing.

The EUA does not mean the TaqPath Zika Virus Kit is FDA cleared or approved.

An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency. The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

The EUA for the TaqPath Zika Virus Kit means the test is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.

Testing using the TaqPath Zika Virus Kit is authorized to be conducted by laboratories in the US that are certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-US laboratories.

More information on the TaqPath Zika Virus Kit and other Zika tests granted EUAs can be found on the FDA’s EUA page.

Photo by Graham Colm

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Thermo Fisher Scientific’s TaqPath Zika Virus Kit.

This means the TaqPath Zika Virus Kit is authorized for the qualitative detection of RNA from Zika virus and diagnosis of Zika virus infection in human serum and urine (collected alongside a patient-matched serum specimen) from individuals meeting the US Centers for Disease Control and Prevention’s criteria for testing.

The EUA does not mean the TaqPath Zika Virus Kit is FDA cleared or approved.

An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency. The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

The EUA for the TaqPath Zika Virus Kit means the test is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.

Testing using the TaqPath Zika Virus Kit is authorized to be conducted by laboratories in the US that are certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-US laboratories.

More information on the TaqPath Zika Virus Kit and other Zika tests granted EUAs can be found on the FDA’s EUA page.

Photo by Graham Colm

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Thermo Fisher Scientific’s TaqPath Zika Virus Kit.

This means the TaqPath Zika Virus Kit is authorized for the qualitative detection of RNA from Zika virus and diagnosis of Zika virus infection in human serum and urine (collected alongside a patient-matched serum specimen) from individuals meeting the US Centers for Disease Control and Prevention’s criteria for testing.

The EUA does not mean the TaqPath Zika Virus Kit is FDA cleared or approved.

An EUA allows for the use of unapproved medical products or unapproved uses of approved medical products in an emergency. The products must be used to diagnose, treat, or prevent serious or life-threatening conditions caused by chemical, biological, radiological, or nuclear threat agents, when there are no adequate alternatives.

The EUA for the TaqPath Zika Virus Kit means the test is only authorized as long as circumstances exist to justify the emergency use of in vitro diagnostics for the detection of Zika virus, unless the authorization is terminated or revoked sooner.

Testing using the TaqPath Zika Virus Kit is authorized to be conducted by laboratories in the US that are certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-US laboratories.

More information on the TaqPath Zika Virus Kit and other Zika tests granted EUAs can be found on the FDA’s EUA page.

A device that noninvasively measures intracranial pressure (ICP) had a sensitivity of 75% and a specificity of 89%, compared with standard invasive monitoring, based on the results of an industry-sponsored study of 14 patients with traumatic brain injury or subarachnoid hemorrhage.

“This study provides the first clinical data on the accuracy of the HS-1000 noninvasive ICP monitor, which uses advanced signal analysis algorithms to evaluate properties of acoustic signals traveling through the brain,” wrote Oliver Ganslandt, MD, of Klinikum Stuttgart (Germany) and his associates. The findings were published online Aug. 8 in the Journal of Neurosurgery.

2017 AANS

A device that noninvasively measures intracranial pressure (ICP) had a sensitivity of 75% and a specificity of 89%, compared with standard invasive monitoring, based on the results of an industry-sponsored study of 14 patients with traumatic brain injury or subarachnoid hemorrhage.

“This study provides the first clinical data on the accuracy of the HS-1000 noninvasive ICP monitor, which uses advanced signal analysis algorithms to evaluate properties of acoustic signals traveling through the brain,” wrote Oliver Ganslandt, MD, of Klinikum Stuttgart (Germany) and his associates. The findings were published online Aug. 8 in the Journal of Neurosurgery.

2017 AANS

A device that noninvasively measures intracranial pressure (ICP) had a sensitivity of 75% and a specificity of 89%, compared with standard invasive monitoring, based on the results of an industry-sponsored study of 14 patients with traumatic brain injury or subarachnoid hemorrhage.

“This study provides the first clinical data on the accuracy of the HS-1000 noninvasive ICP monitor, which uses advanced signal analysis algorithms to evaluate properties of acoustic signals traveling through the brain,” wrote Oliver Ganslandt, MD, of Klinikum Stuttgart (Germany) and his associates. The findings were published online Aug. 8 in the Journal of Neurosurgery.

2017 AANS

A 28-year-old woman presents to your office for a routine health maintenance exam. She is currently using an oral contraceptive containing desogestrel and ethinyl estradiol for contraception and is inquiring about a refill for the coming year. What would you recommend?

When choosing a combined oral contraceptive (COC) for a patient, clinicians often have tried-and-true favorites. However, some of them may be placing patients at increased risk for venous thromboembolic events.

In general, when compared with nonusers, women who use COCs have a two- to four-fold increase in risk for venous thromboembolism (VTE) and an increased risk for myocardial infarction (MI) and stroke.^2,3 More specifically, higher doses of estrogen combined with the progesterones gestodene, desogestrel, and levonorgestrel, are associated with a higher risk for VTE.^2-6

In 2012, the European Medicines Agency warned that COCs containing drospirenone were associated with a higher risk for VTE than other preparations, despite similar estrogen content.⁷ The FDA produced a similar statement that same year, recommending that providers carefully consider the risks and benefits before prescribing contraceptives containing drospirenone.⁸

The risks for ischemic stroke and MI have not been clearly established for varying doses of estrogen and different progesterones. This large observational study fills that informational gap by providing risk estimates for the various COC options.

STUDY SUMMARY

One COC comes out ahead

The authors used an observational cohort model to determine the effects of different doses of estrogen combined with different progesterones in COCs on the risks for pulmonary embolism (PE), ischemic stroke, and MI.¹ Data were collected from the French national health insurance database and the French national hospital discharge database.^9,10 The study included nearly 5 million women ages 15 to 49, living in France, who had at least one prescription filled for COCs between July 2010 and September 2012.

The investigators calculated the absolute and relative risks for first PE, ischemic stroke, and MI in women using COC formulations containing either low-dose estrogen (20 µg) or high-dose estrogen (30-40 µg) combined with one of five progesterones (norethisterone, norgestrel, levonorgestrel, desogestrel, gestodene). The relative risk (RR) was adjusted for confounding factors, including age, complimentary universal health insurance, socioeconomic status, hypertension, diabetes, and consultation with a gynecologist in the previous year.

The absolute risk per 100,000 woman-years for all COC use was 33 for PE, 19 for ischemic stroke, and 7 for MI, with a composite risk of 60. The RRs for low-dose estrogen vs high-dose estrogen were 0.75 for PE, 0.82 for ischemic stroke, and 0.56 for MI. The absolute risk reduction (ARR) with low-dose estrogen vs high-dose estrogen was 14/100,000 person-years of use; the number needed to harm (NNH) was 7,143.

Compared with levonorgestrel, desogestrel and gestodene were associated with higher RRs for PE but not arterial events (2.16 for desogestrel and 1.63 for gestodene). For PE, the ARR with levonorgestrel compared to desogestrel and gestodene, respectively, was 19/100,000 and 12/100,000 person-years of use (NNH, 5,263 and 8,333, respectively). The authors concluded that for the same progesterone, using a lower dose of estrogen decreases risk for PE, ischemic stroke, and MI, and that oral contraceptives containing levonorgestrel and low-dose estrogen resulted in the lowest overall risks for PE and arterial thromboembolism.

WHAT’S NEW?

Low-dose estrogen + levonorgestrel confer lowest risk

Prior studies have shown that COCs increase the risk for PE and may also increase the risks for ischemic stroke and MI.^3,11 Studies have also suggested that a higher dose of estrogen in COCs is associated with an increased risk for VTE.^11,12 This study shows that 20 µg of estrogen combined with levonorgestrel is associated with the lowest risks for PE, MI, and ischemic stroke.

CAVEATS

Cohort study, no start date, incomplete tobacco use data

This is an observational cohort study, so it is subject to confounding factors and biases. It does, however, include a very large population, which improves validity. The study did not account for COC start date, which may be confounding because the risk for VTE is highest in the first three months to one year of COC use.¹² Data on tobacco use, a significant independent risk factor for arterial but not venous thromboembolism, was incomplete; however, in other studies, it has only marginally affected outcomes.^3,13

CHALLENGES TO IMPLEMENTATION

Increased vaginal spotting

One potential challenge to implementing this practice changer may be the increased rate of vaginal spotting associated with low-dose estrogen. COCs containing 20 µg of estrogen are associated with spotting in approximately two-thirds of menstrual cycles over the course of a year.¹⁴ That said, women may prefer to endure the spotting in light of the improved safety profile of a lower-dose estrogen pill.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2017. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2017;66[7]:454-456).

A 28-year-old woman presents to your office for a routine health maintenance exam. She is currently using an oral contraceptive containing desogestrel and ethinyl estradiol for contraception and is inquiring about a refill for the coming year. What would you recommend?

When choosing a combined oral contraceptive (COC) for a patient, clinicians often have tried-and-true favorites. However, some of them may be placing patients at increased risk for venous thromboembolic events.

In general, when compared with nonusers, women who use COCs have a two- to four-fold increase in risk for venous thromboembolism (VTE) and an increased risk for myocardial infarction (MI) and stroke.^2,3 More specifically, higher doses of estrogen combined with the progesterones gestodene, desogestrel, and levonorgestrel, are associated with a higher risk for VTE.^2-6

In 2012, the European Medicines Agency warned that COCs containing drospirenone were associated with a higher risk for VTE than other preparations, despite similar estrogen content.⁷ The FDA produced a similar statement that same year, recommending that providers carefully consider the risks and benefits before prescribing contraceptives containing drospirenone.⁸

The risks for ischemic stroke and MI have not been clearly established for varying doses of estrogen and different progesterones. This large observational study fills that informational gap by providing risk estimates for the various COC options.

STUDY SUMMARY

One COC comes out ahead

The authors used an observational cohort model to determine the effects of different doses of estrogen combined with different progesterones in COCs on the risks for pulmonary embolism (PE), ischemic stroke, and MI.¹ Data were collected from the French national health insurance database and the French national hospital discharge database.^9,10 The study included nearly 5 million women ages 15 to 49, living in France, who had at least one prescription filled for COCs between July 2010 and September 2012.

The investigators calculated the absolute and relative risks for first PE, ischemic stroke, and MI in women using COC formulations containing either low-dose estrogen (20 µg) or high-dose estrogen (30-40 µg) combined with one of five progesterones (norethisterone, norgestrel, levonorgestrel, desogestrel, gestodene). The relative risk (RR) was adjusted for confounding factors, including age, complimentary universal health insurance, socioeconomic status, hypertension, diabetes, and consultation with a gynecologist in the previous year.

The absolute risk per 100,000 woman-years for all COC use was 33 for PE, 19 for ischemic stroke, and 7 for MI, with a composite risk of 60. The RRs for low-dose estrogen vs high-dose estrogen were 0.75 for PE, 0.82 for ischemic stroke, and 0.56 for MI. The absolute risk reduction (ARR) with low-dose estrogen vs high-dose estrogen was 14/100,000 person-years of use; the number needed to harm (NNH) was 7,143.

Compared with levonorgestrel, desogestrel and gestodene were associated with higher RRs for PE but not arterial events (2.16 for desogestrel and 1.63 for gestodene). For PE, the ARR with levonorgestrel compared to desogestrel and gestodene, respectively, was 19/100,000 and 12/100,000 person-years of use (NNH, 5,263 and 8,333, respectively). The authors concluded that for the same progesterone, using a lower dose of estrogen decreases risk for PE, ischemic stroke, and MI, and that oral contraceptives containing levonorgestrel and low-dose estrogen resulted in the lowest overall risks for PE and arterial thromboembolism.

WHAT’S NEW?

Low-dose estrogen + levonorgestrel confer lowest risk

Prior studies have shown that COCs increase the risk for PE and may also increase the risks for ischemic stroke and MI.^3,11 Studies have also suggested that a higher dose of estrogen in COCs is associated with an increased risk for VTE.^11,12 This study shows that 20 µg of estrogen combined with levonorgestrel is associated with the lowest risks for PE, MI, and ischemic stroke.

CAVEATS

Cohort study, no start date, incomplete tobacco use data

This is an observational cohort study, so it is subject to confounding factors and biases. It does, however, include a very large population, which improves validity. The study did not account for COC start date, which may be confounding because the risk for VTE is highest in the first three months to one year of COC use.¹² Data on tobacco use, a significant independent risk factor for arterial but not venous thromboembolism, was incomplete; however, in other studies, it has only marginally affected outcomes.^3,13

CHALLENGES TO IMPLEMENTATION

Increased vaginal spotting

One potential challenge to implementing this practice changer may be the increased rate of vaginal spotting associated with low-dose estrogen. COCs containing 20 µg of estrogen are associated with spotting in approximately two-thirds of menstrual cycles over the course of a year.¹⁴ That said, women may prefer to endure the spotting in light of the improved safety profile of a lower-dose estrogen pill.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2017. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2017;66[7]:454-456).

A 28-year-old woman presents to your office for a routine health maintenance exam. She is currently using an oral contraceptive containing desogestrel and ethinyl estradiol for contraception and is inquiring about a refill for the coming year. What would you recommend?

When choosing a combined oral contraceptive (COC) for a patient, clinicians often have tried-and-true favorites. However, some of them may be placing patients at increased risk for venous thromboembolic events.

In general, when compared with nonusers, women who use COCs have a two- to four-fold increase in risk for venous thromboembolism (VTE) and an increased risk for myocardial infarction (MI) and stroke.^2,3 More specifically, higher doses of estrogen combined with the progesterones gestodene, desogestrel, and levonorgestrel, are associated with a higher risk for VTE.^2-6

In 2012, the European Medicines Agency warned that COCs containing drospirenone were associated with a higher risk for VTE than other preparations, despite similar estrogen content.⁷ The FDA produced a similar statement that same year, recommending that providers carefully consider the risks and benefits before prescribing contraceptives containing drospirenone.⁸

The risks for ischemic stroke and MI have not been clearly established for varying doses of estrogen and different progesterones. This large observational study fills that informational gap by providing risk estimates for the various COC options.

STUDY SUMMARY

One COC comes out ahead

The authors used an observational cohort model to determine the effects of different doses of estrogen combined with different progesterones in COCs on the risks for pulmonary embolism (PE), ischemic stroke, and MI.¹ Data were collected from the French national health insurance database and the French national hospital discharge database.^9,10 The study included nearly 5 million women ages 15 to 49, living in France, who had at least one prescription filled for COCs between July 2010 and September 2012.

The investigators calculated the absolute and relative risks for first PE, ischemic stroke, and MI in women using COC formulations containing either low-dose estrogen (20 µg) or high-dose estrogen (30-40 µg) combined with one of five progesterones (norethisterone, norgestrel, levonorgestrel, desogestrel, gestodene). The relative risk (RR) was adjusted for confounding factors, including age, complimentary universal health insurance, socioeconomic status, hypertension, diabetes, and consultation with a gynecologist in the previous year.

The absolute risk per 100,000 woman-years for all COC use was 33 for PE, 19 for ischemic stroke, and 7 for MI, with a composite risk of 60. The RRs for low-dose estrogen vs high-dose estrogen were 0.75 for PE, 0.82 for ischemic stroke, and 0.56 for MI. The absolute risk reduction (ARR) with low-dose estrogen vs high-dose estrogen was 14/100,000 person-years of use; the number needed to harm (NNH) was 7,143.

Compared with levonorgestrel, desogestrel and gestodene were associated with higher RRs for PE but not arterial events (2.16 for desogestrel and 1.63 for gestodene). For PE, the ARR with levonorgestrel compared to desogestrel and gestodene, respectively, was 19/100,000 and 12/100,000 person-years of use (NNH, 5,263 and 8,333, respectively). The authors concluded that for the same progesterone, using a lower dose of estrogen decreases risk for PE, ischemic stroke, and MI, and that oral contraceptives containing levonorgestrel and low-dose estrogen resulted in the lowest overall risks for PE and arterial thromboembolism.

WHAT’S NEW?

Low-dose estrogen + levonorgestrel confer lowest risk

Prior studies have shown that COCs increase the risk for PE and may also increase the risks for ischemic stroke and MI.^3,11 Studies have also suggested that a higher dose of estrogen in COCs is associated with an increased risk for VTE.^11,12 This study shows that 20 µg of estrogen combined with levonorgestrel is associated with the lowest risks for PE, MI, and ischemic stroke.

CAVEATS

Cohort study, no start date, incomplete tobacco use data

This is an observational cohort study, so it is subject to confounding factors and biases. It does, however, include a very large population, which improves validity. The study did not account for COC start date, which may be confounding because the risk for VTE is highest in the first three months to one year of COC use.¹² Data on tobacco use, a significant independent risk factor for arterial but not venous thromboembolism, was incomplete; however, in other studies, it has only marginally affected outcomes.^3,13

CHALLENGES TO IMPLEMENTATION

Increased vaginal spotting

One potential challenge to implementing this practice changer may be the increased rate of vaginal spotting associated with low-dose estrogen. COCs containing 20 µg of estrogen are associated with spotting in approximately two-thirds of menstrual cycles over the course of a year.¹⁴ That said, women may prefer to endure the spotting in light of the improved safety profile of a lower-dose estrogen pill.

ACKNOWLEDGEMENT

The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Copyright © 2017. The Family Physicians Inquiries Network. All rights reserved.

Reprinted with permission from the Family Physicians Inquiries Network and The Journal of Family Practice (2017;66[7]:454-456).

A 73-year-old man is transported to the emergency department (ED) by ambulance for nausea, vomiting, diarrhea, and weakness of three days’ duration. Earlier today, he presented to his primary care provider with these symptoms and was found to be hypotensive; he was advised to go to the ED but instead went home against medical advice.

The patient’s medical history is significant for type 2 diabetes, stage 3b chronic kidney disease, dyslipidemia, hypertension, coronary artery disease, and benign prostatic hyperplasia. He has undergone stent placement and triple coronary artery bypass graft surgery. His medication list includes insulin glargine, glimepir­ide, liraglutide, atorvastatin, benazepril, carvedilol, amlodipine, clopidogrel, and tamsulosin.

Upon admission, the patient has a pulse of 98 beats/min; temperature, 98.2°F; respiratory rate, 18 breaths/min^-1; and PO₂, 98 mm Hg. An ECG, chest radiograph, and CT (without contrast) of the head, chest, and abdomen are all within normal limits. Lab evaluation is significant for severe thyrotoxicosis (see Table 1).

Endocrinology consult is requested. Further testing yields the following findings

• Thyroid-stimulating immunoglobulin: 309% (reference range, < 30%)
• Nuclear medicine thyroid scan with uptake: 6-hour uptake of 70.3% (10%-25%) and 24-hour uptake, 81.8% (15%-35%)
• Homogeneous radiotracer uptake within the thyroid gland: no evidence of hot or cold nodules
• Thyroid ultrasound: bilateral enlarged heterogeneous gland and multiple subcentimeter nodules (largest measuring 6 × 7 mm)

These results confirm a diagnosis of Graves’ disease. Treatment options, including antithyroid medications, radioactive iodine ablation (RAI), and surgery, are discussed. The patient is treated with RAI therapy (10 mCi) and discharged from the hospital.

Six days later, however, he returns to the ED with severe intermittent dizziness and lightheadedness of two hours’ duration, new-onset atrial fibrillation (A-fib), and mild shortness of breath. His vital signs include a pulse of 116 beats/min; temperature, 98.1°F; respiratory rate, 18 breaths/min^-1, blood pressure, 154/88 mm Hg; and PO₂, 100 mm Hg.

His lab values include

• TSH < 0.005 uIU/mL
• Free T4, 8.01 ng/dL
• Free T3, 3,701 pg/dL
• eGFR, 60 mL/min/1.73 m²

Cardiology consult is requested. A pacemaker is placed for bradycardia-tachycardia syndrome, and the patient is put on rivaroxaban for stroke prevention.

The endocrinologist suspects post-RAI thyroiditis or ineffective RAI treatment. The patient is started on methimazole (10 mg bid), and his carvedilol is replaced with metoprolol (50 mg bid).

Two weeks postdischarge, the patient returns to the office. Although he says he’s doing better, he seems uneasy and agitated and has a pulse of 120 beats/min. His meth­imazole and metoprolol are increased (to 10 mg tid and 50 mg tid, respectively).

Another two weeks later, lab results still show elevated thyroid levels—now with increased enzyme levels on liver function testing. The patient reports worsening dizziness and shortness of breath. He is sent back to hospital and admitted for inpatient management, with urgent surgical consult for thyroidectomy. Total thyroidectomy is successfully performed, and the final pathology report shows a benign goiter.

DISCUSSION

Thyroid storm is an extreme form of thyrotoxicosis with an associated mortality rate of 8% to 25%.¹ When thyroid hormone levels are elevated, adrenaline receptors are upregulated—but, while it is possible for persistent thyrotoxicosis to progress to thyroid storm on its own, a surge of adrenaline is usually needed. Most cases are triggered by acute stressors (ie, myocardial infarction, surgery, anesthesia, labor and delivery) in the context of underlying thyrotoxicosis.¹

Diagnosis of thyroid storm is made clinically in patients who are thyrotoxic and present with systemic decompensation (ie, altered mental status, cardiovascular dysfunction, hyperpyrexia). Although no universally accepted criteria currently exist, the Burch-Wartofsky Point Scale (BWPS; see Table 2) can be used to assess disease severity and guide the extent of treatment and monitoring.² However, this measure should not replace clinical judgment—the distinction between compensated thyrotoxicosis and decompensating thyrotoxicosis (thyroid storm) should be made by sound but prompt clinical assessment.

Once thyroid storm is suspected, aggressive treatment should be implemented to improve the systemic thyrotoxic state. Propylthiouracil (PTU) is preferred over methimazole, as it blocks T4 to T3 conversion in addition to blocking new hormone synthesis. Propranolol is the best choice of ß-blocker because it also blocks T4 to T3 conversion and controls cardiac rhythm.

Iodine can rapidly block new hormone synthesis and release; it is often used to reduce thyroid hormone levels prior to emergency thyroid surgery. However, it should be given at least one hour after a dose of PTU. Hydrocortisone is given prophylactically for relative adrenal insufficiency (due to rapid cortisol clearance during thyrotoxic state); it may block T4 to T3 conversion as well. Volume resuscitation, respiratory care, temperature control (eg, antipyretics, cooling blankets), and nutritional support should also be incorporated, ideally in the intensive care unit (ICU). During or after thyroid storm management, treatment of the precipitating event/illness and of hyperthyroidism should be initiated to prevent recurrence.¹

The patient’s initial BWPS was 30 (gastrointestinal [GI] score 10 + central nervous system [CNS] score 10 + without precipitating factor 10), which put him in the “impending storm” category. At his second ED visit, his BWPS was 40 (cardiovascular score 10 + A-fib 10 + GI score 10 + CNS score 10 + precipitating factor [RAI ablation] score 0)—still in the “impending storm” category but certainly indicating a worsened state.

RAI for hyperthyroidism can transiently increase thyroid hormone levels due to inflammation of the gland. To prevent exacerbation of the thyrotoxic state, pretreatment with meth­imazole should be considered in patients with risk factors (eg, older age, cardiovascular complications, cerebrovascular disease, pulmonary disease, renal failure, infection, trauma, and poorly controlled diabetes). Patients should also be placed on ß-blockers prior to treatment, in anticipation of a transient rise in thyroid hormone levels.

Due to this patient’s age, severity of thyrotoxicosis, and multiple risk factors, strong consideration should have been given to pretreating him with antithyroid medication and a ß-blocker before definitive treatment was given. This would have potentially averted his subsequent hospital visits and urgent need for thyroidectomy.

CONCLUSION

Thyroid storm is an uncommon but serious medical condition with a high mortality rate. Prompt recognition and an aggressive multimodal treatment approach, ideally in the ICU, are paramount to stabilize patients and seek definitive treatment.

A 73-year-old man is transported to the emergency department (ED) by ambulance for nausea, vomiting, diarrhea, and weakness of three days’ duration. Earlier today, he presented to his primary care provider with these symptoms and was found to be hypotensive; he was advised to go to the ED but instead went home against medical advice.

The patient’s medical history is significant for type 2 diabetes, stage 3b chronic kidney disease, dyslipidemia, hypertension, coronary artery disease, and benign prostatic hyperplasia. He has undergone stent placement and triple coronary artery bypass graft surgery. His medication list includes insulin glargine, glimepir­ide, liraglutide, atorvastatin, benazepril, carvedilol, amlodipine, clopidogrel, and tamsulosin.

Upon admission, the patient has a pulse of 98 beats/min; temperature, 98.2°F; respiratory rate, 18 breaths/min^-1; and PO₂, 98 mm Hg. An ECG, chest radiograph, and CT (without contrast) of the head, chest, and abdomen are all within normal limits. Lab evaluation is significant for severe thyrotoxicosis (see Table 1).

Endocrinology consult is requested. Further testing yields the following findings

• Thyroid-stimulating immunoglobulin: 309% (reference range, < 30%)
• Nuclear medicine thyroid scan with uptake: 6-hour uptake of 70.3% (10%-25%) and 24-hour uptake, 81.8% (15%-35%)
• Homogeneous radiotracer uptake within the thyroid gland: no evidence of hot or cold nodules
• Thyroid ultrasound: bilateral enlarged heterogeneous gland and multiple subcentimeter nodules (largest measuring 6 × 7 mm)

These results confirm a diagnosis of Graves’ disease. Treatment options, including antithyroid medications, radioactive iodine ablation (RAI), and surgery, are discussed. The patient is treated with RAI therapy (10 mCi) and discharged from the hospital.

Six days later, however, he returns to the ED with severe intermittent dizziness and lightheadedness of two hours’ duration, new-onset atrial fibrillation (A-fib), and mild shortness of breath. His vital signs include a pulse of 116 beats/min; temperature, 98.1°F; respiratory rate, 18 breaths/min^-1, blood pressure, 154/88 mm Hg; and PO₂, 100 mm Hg.

His lab values include

• TSH < 0.005 uIU/mL
• Free T4, 8.01 ng/dL
• Free T3, 3,701 pg/dL
• eGFR, 60 mL/min/1.73 m²

Cardiology consult is requested. A pacemaker is placed for bradycardia-tachycardia syndrome, and the patient is put on rivaroxaban for stroke prevention.

The endocrinologist suspects post-RAI thyroiditis or ineffective RAI treatment. The patient is started on methimazole (10 mg bid), and his carvedilol is replaced with metoprolol (50 mg bid).

Two weeks postdischarge, the patient returns to the office. Although he says he’s doing better, he seems uneasy and agitated and has a pulse of 120 beats/min. His meth­imazole and metoprolol are increased (to 10 mg tid and 50 mg tid, respectively).

Another two weeks later, lab results still show elevated thyroid levels—now with increased enzyme levels on liver function testing. The patient reports worsening dizziness and shortness of breath. He is sent back to hospital and admitted for inpatient management, with urgent surgical consult for thyroidectomy. Total thyroidectomy is successfully performed, and the final pathology report shows a benign goiter.

DISCUSSION

Thyroid storm is an extreme form of thyrotoxicosis with an associated mortality rate of 8% to 25%.¹ When thyroid hormone levels are elevated, adrenaline receptors are upregulated—but, while it is possible for persistent thyrotoxicosis to progress to thyroid storm on its own, a surge of adrenaline is usually needed. Most cases are triggered by acute stressors (ie, myocardial infarction, surgery, anesthesia, labor and delivery) in the context of underlying thyrotoxicosis.¹

Diagnosis of thyroid storm is made clinically in patients who are thyrotoxic and present with systemic decompensation (ie, altered mental status, cardiovascular dysfunction, hyperpyrexia). Although no universally accepted criteria currently exist, the Burch-Wartofsky Point Scale (BWPS; see Table 2) can be used to assess disease severity and guide the extent of treatment and monitoring.² However, this measure should not replace clinical judgment—the distinction between compensated thyrotoxicosis and decompensating thyrotoxicosis (thyroid storm) should be made by sound but prompt clinical assessment.

Once thyroid storm is suspected, aggressive treatment should be implemented to improve the systemic thyrotoxic state. Propylthiouracil (PTU) is preferred over methimazole, as it blocks T4 to T3 conversion in addition to blocking new hormone synthesis. Propranolol is the best choice of ß-blocker because it also blocks T4 to T3 conversion and controls cardiac rhythm.

Iodine can rapidly block new hormone synthesis and release; it is often used to reduce thyroid hormone levels prior to emergency thyroid surgery. However, it should be given at least one hour after a dose of PTU. Hydrocortisone is given prophylactically for relative adrenal insufficiency (due to rapid cortisol clearance during thyrotoxic state); it may block T4 to T3 conversion as well. Volume resuscitation, respiratory care, temperature control (eg, antipyretics, cooling blankets), and nutritional support should also be incorporated, ideally in the intensive care unit (ICU). During or after thyroid storm management, treatment of the precipitating event/illness and of hyperthyroidism should be initiated to prevent recurrence.¹

The patient’s initial BWPS was 30 (gastrointestinal [GI] score 10 + central nervous system [CNS] score 10 + without precipitating factor 10), which put him in the “impending storm” category. At his second ED visit, his BWPS was 40 (cardiovascular score 10 + A-fib 10 + GI score 10 + CNS score 10 + precipitating factor [RAI ablation] score 0)—still in the “impending storm” category but certainly indicating a worsened state.

RAI for hyperthyroidism can transiently increase thyroid hormone levels due to inflammation of the gland. To prevent exacerbation of the thyrotoxic state, pretreatment with meth­imazole should be considered in patients with risk factors (eg, older age, cardiovascular complications, cerebrovascular disease, pulmonary disease, renal failure, infection, trauma, and poorly controlled diabetes). Patients should also be placed on ß-blockers prior to treatment, in anticipation of a transient rise in thyroid hormone levels.

Due to this patient’s age, severity of thyrotoxicosis, and multiple risk factors, strong consideration should have been given to pretreating him with antithyroid medication and a ß-blocker before definitive treatment was given. This would have potentially averted his subsequent hospital visits and urgent need for thyroidectomy.

CONCLUSION

Thyroid storm is an uncommon but serious medical condition with a high mortality rate. Prompt recognition and an aggressive multimodal treatment approach, ideally in the ICU, are paramount to stabilize patients and seek definitive treatment.

A 73-year-old man is transported to the emergency department (ED) by ambulance for nausea, vomiting, diarrhea, and weakness of three days’ duration. Earlier today, he presented to his primary care provider with these symptoms and was found to be hypotensive; he was advised to go to the ED but instead went home against medical advice.

The patient’s medical history is significant for type 2 diabetes, stage 3b chronic kidney disease, dyslipidemia, hypertension, coronary artery disease, and benign prostatic hyperplasia. He has undergone stent placement and triple coronary artery bypass graft surgery. His medication list includes insulin glargine, glimepir­ide, liraglutide, atorvastatin, benazepril, carvedilol, amlodipine, clopidogrel, and tamsulosin.

Upon admission, the patient has a pulse of 98 beats/min; temperature, 98.2°F; respiratory rate, 18 breaths/min^-1; and PO₂, 98 mm Hg. An ECG, chest radiograph, and CT (without contrast) of the head, chest, and abdomen are all within normal limits. Lab evaluation is significant for severe thyrotoxicosis (see Table 1).

Endocrinology consult is requested. Further testing yields the following findings

• Thyroid-stimulating immunoglobulin: 309% (reference range, < 30%)
• Nuclear medicine thyroid scan with uptake: 6-hour uptake of 70.3% (10%-25%) and 24-hour uptake, 81.8% (15%-35%)
• Homogeneous radiotracer uptake within the thyroid gland: no evidence of hot or cold nodules
• Thyroid ultrasound: bilateral enlarged heterogeneous gland and multiple subcentimeter nodules (largest measuring 6 × 7 mm)

These results confirm a diagnosis of Graves’ disease. Treatment options, including antithyroid medications, radioactive iodine ablation (RAI), and surgery, are discussed. The patient is treated with RAI therapy (10 mCi) and discharged from the hospital.

Six days later, however, he returns to the ED with severe intermittent dizziness and lightheadedness of two hours’ duration, new-onset atrial fibrillation (A-fib), and mild shortness of breath. His vital signs include a pulse of 116 beats/min; temperature, 98.1°F; respiratory rate, 18 breaths/min^-1, blood pressure, 154/88 mm Hg; and PO₂, 100 mm Hg.

His lab values include

• TSH < 0.005 uIU/mL
• Free T4, 8.01 ng/dL
• Free T3, 3,701 pg/dL
• eGFR, 60 mL/min/1.73 m²

Cardiology consult is requested. A pacemaker is placed for bradycardia-tachycardia syndrome, and the patient is put on rivaroxaban for stroke prevention.

The endocrinologist suspects post-RAI thyroiditis or ineffective RAI treatment. The patient is started on methimazole (10 mg bid), and his carvedilol is replaced with metoprolol (50 mg bid).

Two weeks postdischarge, the patient returns to the office. Although he says he’s doing better, he seems uneasy and agitated and has a pulse of 120 beats/min. His meth­imazole and metoprolol are increased (to 10 mg tid and 50 mg tid, respectively).

Another two weeks later, lab results still show elevated thyroid levels—now with increased enzyme levels on liver function testing. The patient reports worsening dizziness and shortness of breath. He is sent back to hospital and admitted for inpatient management, with urgent surgical consult for thyroidectomy. Total thyroidectomy is successfully performed, and the final pathology report shows a benign goiter.

DISCUSSION

Thyroid storm is an extreme form of thyrotoxicosis with an associated mortality rate of 8% to 25%.¹ When thyroid hormone levels are elevated, adrenaline receptors are upregulated—but, while it is possible for persistent thyrotoxicosis to progress to thyroid storm on its own, a surge of adrenaline is usually needed. Most cases are triggered by acute stressors (ie, myocardial infarction, surgery, anesthesia, labor and delivery) in the context of underlying thyrotoxicosis.¹

Diagnosis of thyroid storm is made clinically in patients who are thyrotoxic and present with systemic decompensation (ie, altered mental status, cardiovascular dysfunction, hyperpyrexia). Although no universally accepted criteria currently exist, the Burch-Wartofsky Point Scale (BWPS; see Table 2) can be used to assess disease severity and guide the extent of treatment and monitoring.² However, this measure should not replace clinical judgment—the distinction between compensated thyrotoxicosis and decompensating thyrotoxicosis (thyroid storm) should be made by sound but prompt clinical assessment.

Once thyroid storm is suspected, aggressive treatment should be implemented to improve the systemic thyrotoxic state. Propylthiouracil (PTU) is preferred over methimazole, as it blocks T4 to T3 conversion in addition to blocking new hormone synthesis. Propranolol is the best choice of ß-blocker because it also blocks T4 to T3 conversion and controls cardiac rhythm.

Iodine can rapidly block new hormone synthesis and release; it is often used to reduce thyroid hormone levels prior to emergency thyroid surgery. However, it should be given at least one hour after a dose of PTU. Hydrocortisone is given prophylactically for relative adrenal insufficiency (due to rapid cortisol clearance during thyrotoxic state); it may block T4 to T3 conversion as well. Volume resuscitation, respiratory care, temperature control (eg, antipyretics, cooling blankets), and nutritional support should also be incorporated, ideally in the intensive care unit (ICU). During or after thyroid storm management, treatment of the precipitating event/illness and of hyperthyroidism should be initiated to prevent recurrence.¹

The patient’s initial BWPS was 30 (gastrointestinal [GI] score 10 + central nervous system [CNS] score 10 + without precipitating factor 10), which put him in the “impending storm” category. At his second ED visit, his BWPS was 40 (cardiovascular score 10 + A-fib 10 + GI score 10 + CNS score 10 + precipitating factor [RAI ablation] score 0)—still in the “impending storm” category but certainly indicating a worsened state.

RAI for hyperthyroidism can transiently increase thyroid hormone levels due to inflammation of the gland. To prevent exacerbation of the thyrotoxic state, pretreatment with meth­imazole should be considered in patients with risk factors (eg, older age, cardiovascular complications, cerebrovascular disease, pulmonary disease, renal failure, infection, trauma, and poorly controlled diabetes). Patients should also be placed on ß-blockers prior to treatment, in anticipation of a transient rise in thyroid hormone levels.

Due to this patient’s age, severity of thyrotoxicosis, and multiple risk factors, strong consideration should have been given to pretreating him with antithyroid medication and a ß-blocker before definitive treatment was given. This would have potentially averted his subsequent hospital visits and urgent need for thyroidectomy.

CONCLUSION

Thyroid storm is an uncommon but serious medical condition with a high mortality rate. Prompt recognition and an aggressive multimodal treatment approach, ideally in the ICU, are paramount to stabilize patients and seek definitive treatment.

The Senate has confirmed Elinore F. McCance-Katz, MD, PhD, as the nation’s first mental health czar.

Dr. McCance-Katz, a psychiatrist, has focused her career largely on addiction treatment, particularly opioid abuse. This expertise has helped her receive the backing of several mental health organizations, including the American Psychiatric Association, the National Alliance on Mental Illness, and the American Society of Addiction Medicine.

As leader of the Substance Abuse and Mental Health Services Administration, Dr. McCance-Katz is expected to streamline more than 100 federal mental health agencies into a more effective system and to oversee a more than $3.5 billion budget annually. Having previously served as SAMHSA’s chief medical officer, Dr. McCance-Katz once again enters the fray surrounding the agency’s historically poor record of serving people with serious mental illnesses such as schizophrenia and bipolar disorder. Dr. McCance-Katz stepped down from her chief medical officer role in 2015 after serving 2 years, later penning a piece criticizing the agency’s lack of commitment to understanding – much less implementing – psychiatric treatments based on a medical approach. Instead, she argued, SAMHSA favored non–evidence-based psychosocial interventions.

Despite this, Rep. Tim Murphy (R.-Penn.) – a clinical psychologist and the congressman most responsible for drafting the legislation that created the position – issued a highly critical statement when her nomination was announced earlier this year. He called into question Dr. McCance-Katz’s commitment to the medical model and blamed her in part for the agency’s previous failures.

Dr. McCance-Katz currently serves as the chief medical officer at the Rhode Island Department of Behavioral Healthcare, Developmental Disabilities, and Hospitals. She also is a professor of psychiatry and human behavior, and professor of behavioral and social sciences at Brown University, Providence, R.I. She is expected to take up her new post as U.S. assistant secretary for mental health and substance use by the fall, according to a SAMHSA spokeperson.

[email protected]

On Twitter @whitneymcknight

The Senate has confirmed Elinore F. McCance-Katz, MD, PhD, as the nation’s first mental health czar.

Dr. McCance-Katz, a psychiatrist, has focused her career largely on addiction treatment, particularly opioid abuse. This expertise has helped her receive the backing of several mental health organizations, including the American Psychiatric Association, the National Alliance on Mental Illness, and the American Society of Addiction Medicine.

As leader of the Substance Abuse and Mental Health Services Administration, Dr. McCance-Katz is expected to streamline more than 100 federal mental health agencies into a more effective system and to oversee a more than $3.5 billion budget annually. Having previously served as SAMHSA’s chief medical officer, Dr. McCance-Katz once again enters the fray surrounding the agency’s historically poor record of serving people with serious mental illnesses such as schizophrenia and bipolar disorder. Dr. McCance-Katz stepped down from her chief medical officer role in 2015 after serving 2 years, later penning a piece criticizing the agency’s lack of commitment to understanding – much less implementing – psychiatric treatments based on a medical approach. Instead, she argued, SAMHSA favored non–evidence-based psychosocial interventions.

Despite this, Rep. Tim Murphy (R.-Penn.) – a clinical psychologist and the congressman most responsible for drafting the legislation that created the position – issued a highly critical statement when her nomination was announced earlier this year. He called into question Dr. McCance-Katz’s commitment to the medical model and blamed her in part for the agency’s previous failures.

Dr. McCance-Katz currently serves as the chief medical officer at the Rhode Island Department of Behavioral Healthcare, Developmental Disabilities, and Hospitals. She also is a professor of psychiatry and human behavior, and professor of behavioral and social sciences at Brown University, Providence, R.I. She is expected to take up her new post as U.S. assistant secretary for mental health and substance use by the fall, according to a SAMHSA spokeperson.

[email protected]

On Twitter @whitneymcknight

The Senate has confirmed Elinore F. McCance-Katz, MD, PhD, as the nation’s first mental health czar.

Dr. McCance-Katz, a psychiatrist, has focused her career largely on addiction treatment, particularly opioid abuse. This expertise has helped her receive the backing of several mental health organizations, including the American Psychiatric Association, the National Alliance on Mental Illness, and the American Society of Addiction Medicine.

As leader of the Substance Abuse and Mental Health Services Administration, Dr. McCance-Katz is expected to streamline more than 100 federal mental health agencies into a more effective system and to oversee a more than $3.5 billion budget annually. Having previously served as SAMHSA’s chief medical officer, Dr. McCance-Katz once again enters the fray surrounding the agency’s historically poor record of serving people with serious mental illnesses such as schizophrenia and bipolar disorder. Dr. McCance-Katz stepped down from her chief medical officer role in 2015 after serving 2 years, later penning a piece criticizing the agency’s lack of commitment to understanding – much less implementing – psychiatric treatments based on a medical approach. Instead, she argued, SAMHSA favored non–evidence-based psychosocial interventions.

Despite this, Rep. Tim Murphy (R.-Penn.) – a clinical psychologist and the congressman most responsible for drafting the legislation that created the position – issued a highly critical statement when her nomination was announced earlier this year. He called into question Dr. McCance-Katz’s commitment to the medical model and blamed her in part for the agency’s previous failures.

Dr. McCance-Katz currently serves as the chief medical officer at the Rhode Island Department of Behavioral Healthcare, Developmental Disabilities, and Hospitals. She also is a professor of psychiatry and human behavior, and professor of behavioral and social sciences at Brown University, Providence, R.I. She is expected to take up her new post as U.S. assistant secretary for mental health and substance use by the fall, according to a SAMHSA spokeperson.

[email protected]

On Twitter @whitneymcknight

Vemurafenib (Zelboraf) has been granted a supplemental new drug application and priority review by the Food and Drug Administration for the treatment of Erdheim-Chester disease with BRAF V600 mutation, according to a press release issued by Genentech.

The FDA is expected to make a decision on the indication by Dec. 7, 2017. Vemurafenib is approved for the treatment of unresectable or metastatic melanoma with BRAF V600E mutation.

[email protected]

Vemurafenib (Zelboraf) has been granted a supplemental new drug application and priority review by the Food and Drug Administration for the treatment of Erdheim-Chester disease with BRAF V600 mutation, according to a press release issued by Genentech.

The FDA is expected to make a decision on the indication by Dec. 7, 2017. Vemurafenib is approved for the treatment of unresectable or metastatic melanoma with BRAF V600E mutation.

[email protected]

Vemurafenib (Zelboraf) has been granted a supplemental new drug application and priority review by the Food and Drug Administration for the treatment of Erdheim-Chester disease with BRAF V600 mutation, according to a press release issued by Genentech.

The FDA is expected to make a decision on the indication by Dec. 7, 2017. Vemurafenib is approved for the treatment of unresectable or metastatic melanoma with BRAF V600E mutation.

[email protected]

Question: Congressional proposals on medical tort reform can be expected to include the following, except:

A. A no-fault system akin to automobile no-fault insurance.

B. A cap on noneconomic damages.

C. “Safe-harbor” immunity against medical negligence.

D. Health courts in place of the judge/jury system to adjudicate claims.

E. Promotion of laws that encourage apologies and error disclosures.

Answer: A. Under the current Republican administration, one can expect legislative efforts at federal tort reform, especially given that Thomas E. Price, MD, the new secretary of the Department of Health & Human Services, is an orthopedic surgeon who has spoken passionately about defensive medicine, damage caps, health tribunals, and practice guidelines. As a former House representative for Georgia, Dr. Price has introduced several tort reform bills, so it is likely that any omnibus federal law will incorporate some of his proposals.¹

Over the decades, many states have gone ahead in enacting their own statutes while awaiting federal action. Iowa is the latest example. It recently passed legislation that included a noneconomic damages cap of $250,000, stronger expert witness standards, a certificate of merit in all medical liability lawsuits, and an expansion of its “candor” protections.² Additional reforms in other states include pretrial screening panels; arbitration; structured periodic payments in lieu of lump sum payments; penalties for frivolous suits; shortened statutes of limitations; making the loser bear all litigation costs; abolishing the collateral source rule, as well as joint and several liability; and limiting attorney contingency fees.

The best-known reform is a cap on noneconomic losses, such as pain and suffering, that doesn’t abridge compensation for economic losses, i.e., medical expenses and lost wages. This provides some predictability because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments.

Interestingly, Dr. Price himself has not pushed for a federal cap on noneconomic damages, but other Republican bills have proposed a cap of $250,000. Many states, such as California, Kansas, and Texas, have seen their cap statutes withstand constitutional challenge. However, other jurisdictions, notably Georgia, Illinois, and Missouri, have ruled them unconstitutional.

California’s law, popularly known as MICRA (Medical Injury Compensation Reform Act), came under renewed attack in 2015 with a wrongful death suit from hemorrhagic complications related to Coumadin (warfarin) use following heart surgery.³ The plaintiff’s constitutional challenges included violation of equal protection, due process, and the right to a jury trial, but these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000, as required under MICRA. A California court of appeal rejected her claim as being “contrary to many well-established legal principles.”

On the other hand, Florida’s Supreme Court recently held in a closely divided decision of 4-3 that the state’s caps were unconstitutional.⁴ The law limited noneconomic damages in malpractice cases to either $500,000 or $1 million if the injuries were catastrophic. The court ruled that the caps were arbitrary and unfairly hurt the most severely injured. It was unconvinced that they would reduce malpractice insurance rates; at any rate, there was no present crisis to justify the caps. The decision came 3 years after the court had struck down caps in a case of wrongful death.⁵

Three relative newcomers to the legal landscape – health courts, apology laws, and safe harbors – appear to be taking center stage in any forthcoming federal reform measures.
 

Health courts

Under this proposal, so-called health panels and tribunals would now adjudicate malpractice claims. Such health courts would dispense with the jury; further, regular judges would be replaced with specialized judges who would make binding determinations. In one version, a panel of medical experts would initially screen the complaint, followed by an administrative health care tribunal that would feature judges with medical expertise. These tribunals would issue binding rulings, but either party could appeal to a state court for a reversal.

In countries such as Scandinavia and New Zealand, these administrative compensation approaches are coupled to a no-fault system and appear to work well. However, unlike auto no-fault and workers’ compensation, the notion of medical no-fault has never caught on in the United States.

As currently construed, health courts evince dramatic departures from traditional rules of civil procedure. For one, the panels may render decisions before discovery has occurred, which would substantially limit a patient’s ability to learn the facts of what had happened to cause the injury. The panel may rely on a standard of “gross negligence” instead of “ordinary negligence,” requiring evidence not merely of substandard care but of recklessness. This would be a heavier burden on the victim, and could be expected to generate stiff opposition from the plaintiff’s bar. In addition, evidentiary rules may be modified, requiring that an appeal show with clear and convincing proof that the tribunal had erred.
 

Apology law

Disclosure of medical errors to the injured patient is believed to serve as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called apology laws that disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician.

For example, the Ohio Supreme Court ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute.⁶ Apology laws vary from state to state, and some do not shield admissions regarding causation of error or fault.

However, it is unclear if apology laws work. A recent study from Vanderbilt University reported that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit.⁷ And for surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
 

Safe harbors

A proposal released by U.S. House Speaker Paul Ryan (R-Wis.) in June 2016 made reference to “safe harbors” from liability for those adhering to clinical practice guidelines. The Institute of Medicine defines practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”

There are thousands of guidelines that have been developed by medical organizations and governmental agencies, as well as by insurance carriers, managed care organizations, and others. They purport to define the best evidence-based medicine, and if they were arrived at by the consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards.

Theoretically, adherence to guidelines could reduce the practice of defensive medicine and improve the quality of care. However, the available evidence does not indicate that guideline-based safe harbors will prove very effective in reducing malpractice claims: They are inapplicable in 85% of cases, and they have been estimated to eliminate defendants’ payments in less than 1% of claims.

Whether any form of tort reform emerges from the current Congress is as much about politics as it is about justice. It comes at an inopportune time, given the impasse over the health care debate. Still, on June 29, 2017, the U.S. House passed a medical liability reform bill with a vote of 218-210 along party lines that would cap noneconomic damages at $250,000, shorten the statute of limitations to 3 years after the date of injury, and abolish joint and several liability.⁸ The outlook in the U.S. Senate, however, is anything but certain.
 

References

1. N Engl J Med. 2017 May 11;376(19):1806-8.

2. “Sweeping new tort reforms will protect Iowa physicians” AMA Wire. June 1, 2017.

3. Chan v. Curran, 237 CA 4th 601 (2015).

4. N. Broward Hospital District v. Kalitan, (Florida Supreme Court, decided June 8, 2017).

5. Estate of Michelle Evette McCall v. U.S., 2014 Fla LEXIS 933 (No. SC 11-1148; March 13, 2014).

6. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).

7. “Sorry is Never Enough: The Effect of State Apology Laws on Medical Malpractice Liability Risk” SSRN. 2016 Dec 10.

8. Protecting Access to Care Act of 2017 (H.R. 1215).

Question: Congressional proposals on medical tort reform can be expected to include the following, except:

A. A no-fault system akin to automobile no-fault insurance.

B. A cap on noneconomic damages.

C. “Safe-harbor” immunity against medical negligence.

D. Health courts in place of the judge/jury system to adjudicate claims.

E. Promotion of laws that encourage apologies and error disclosures.

Answer: A. Under the current Republican administration, one can expect legislative efforts at federal tort reform, especially given that Thomas E. Price, MD, the new secretary of the Department of Health & Human Services, is an orthopedic surgeon who has spoken passionately about defensive medicine, damage caps, health tribunals, and practice guidelines. As a former House representative for Georgia, Dr. Price has introduced several tort reform bills, so it is likely that any omnibus federal law will incorporate some of his proposals.¹

Over the decades, many states have gone ahead in enacting their own statutes while awaiting federal action. Iowa is the latest example. It recently passed legislation that included a noneconomic damages cap of $250,000, stronger expert witness standards, a certificate of merit in all medical liability lawsuits, and an expansion of its “candor” protections.² Additional reforms in other states include pretrial screening panels; arbitration; structured periodic payments in lieu of lump sum payments; penalties for frivolous suits; shortened statutes of limitations; making the loser bear all litigation costs; abolishing the collateral source rule, as well as joint and several liability; and limiting attorney contingency fees.

The best-known reform is a cap on noneconomic losses, such as pain and suffering, that doesn’t abridge compensation for economic losses, i.e., medical expenses and lost wages. This provides some predictability because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments.

Interestingly, Dr. Price himself has not pushed for a federal cap on noneconomic damages, but other Republican bills have proposed a cap of $250,000. Many states, such as California, Kansas, and Texas, have seen their cap statutes withstand constitutional challenge. However, other jurisdictions, notably Georgia, Illinois, and Missouri, have ruled them unconstitutional.

California’s law, popularly known as MICRA (Medical Injury Compensation Reform Act), came under renewed attack in 2015 with a wrongful death suit from hemorrhagic complications related to Coumadin (warfarin) use following heart surgery.³ The plaintiff’s constitutional challenges included violation of equal protection, due process, and the right to a jury trial, but these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000, as required under MICRA. A California court of appeal rejected her claim as being “contrary to many well-established legal principles.”

On the other hand, Florida’s Supreme Court recently held in a closely divided decision of 4-3 that the state’s caps were unconstitutional.⁴ The law limited noneconomic damages in malpractice cases to either $500,000 or $1 million if the injuries were catastrophic. The court ruled that the caps were arbitrary and unfairly hurt the most severely injured. It was unconvinced that they would reduce malpractice insurance rates; at any rate, there was no present crisis to justify the caps. The decision came 3 years after the court had struck down caps in a case of wrongful death.⁵

Three relative newcomers to the legal landscape – health courts, apology laws, and safe harbors – appear to be taking center stage in any forthcoming federal reform measures.
 

Health courts

Under this proposal, so-called health panels and tribunals would now adjudicate malpractice claims. Such health courts would dispense with the jury; further, regular judges would be replaced with specialized judges who would make binding determinations. In one version, a panel of medical experts would initially screen the complaint, followed by an administrative health care tribunal that would feature judges with medical expertise. These tribunals would issue binding rulings, but either party could appeal to a state court for a reversal.

In countries such as Scandinavia and New Zealand, these administrative compensation approaches are coupled to a no-fault system and appear to work well. However, unlike auto no-fault and workers’ compensation, the notion of medical no-fault has never caught on in the United States.

As currently construed, health courts evince dramatic departures from traditional rules of civil procedure. For one, the panels may render decisions before discovery has occurred, which would substantially limit a patient’s ability to learn the facts of what had happened to cause the injury. The panel may rely on a standard of “gross negligence” instead of “ordinary negligence,” requiring evidence not merely of substandard care but of recklessness. This would be a heavier burden on the victim, and could be expected to generate stiff opposition from the plaintiff’s bar. In addition, evidentiary rules may be modified, requiring that an appeal show with clear and convincing proof that the tribunal had erred.
 

Apology law

Disclosure of medical errors to the injured patient is believed to serve as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called apology laws that disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician.

For example, the Ohio Supreme Court ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute.⁶ Apology laws vary from state to state, and some do not shield admissions regarding causation of error or fault.

However, it is unclear if apology laws work. A recent study from Vanderbilt University reported that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit.⁷ And for surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
 

Safe harbors

A proposal released by U.S. House Speaker Paul Ryan (R-Wis.) in June 2016 made reference to “safe harbors” from liability for those adhering to clinical practice guidelines. The Institute of Medicine defines practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”

There are thousands of guidelines that have been developed by medical organizations and governmental agencies, as well as by insurance carriers, managed care organizations, and others. They purport to define the best evidence-based medicine, and if they were arrived at by the consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards.

Theoretically, adherence to guidelines could reduce the practice of defensive medicine and improve the quality of care. However, the available evidence does not indicate that guideline-based safe harbors will prove very effective in reducing malpractice claims: They are inapplicable in 85% of cases, and they have been estimated to eliminate defendants’ payments in less than 1% of claims.

Whether any form of tort reform emerges from the current Congress is as much about politics as it is about justice. It comes at an inopportune time, given the impasse over the health care debate. Still, on June 29, 2017, the U.S. House passed a medical liability reform bill with a vote of 218-210 along party lines that would cap noneconomic damages at $250,000, shorten the statute of limitations to 3 years after the date of injury, and abolish joint and several liability.⁸ The outlook in the U.S. Senate, however, is anything but certain.
 

References

1. N Engl J Med. 2017 May 11;376(19):1806-8.

2. “Sweeping new tort reforms will protect Iowa physicians” AMA Wire. June 1, 2017.

3. Chan v. Curran, 237 CA 4th 601 (2015).

4. N. Broward Hospital District v. Kalitan, (Florida Supreme Court, decided June 8, 2017).

5. Estate of Michelle Evette McCall v. U.S., 2014 Fla LEXIS 933 (No. SC 11-1148; March 13, 2014).

6. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).

7. “Sorry is Never Enough: The Effect of State Apology Laws on Medical Malpractice Liability Risk” SSRN. 2016 Dec 10.

8. Protecting Access to Care Act of 2017 (H.R. 1215).

Question: Congressional proposals on medical tort reform can be expected to include the following, except:

A. A no-fault system akin to automobile no-fault insurance.

B. A cap on noneconomic damages.

C. “Safe-harbor” immunity against medical negligence.

D. Health courts in place of the judge/jury system to adjudicate claims.

E. Promotion of laws that encourage apologies and error disclosures.

Answer: A. Under the current Republican administration, one can expect legislative efforts at federal tort reform, especially given that Thomas E. Price, MD, the new secretary of the Department of Health & Human Services, is an orthopedic surgeon who has spoken passionately about defensive medicine, damage caps, health tribunals, and practice guidelines. As a former House representative for Georgia, Dr. Price has introduced several tort reform bills, so it is likely that any omnibus federal law will incorporate some of his proposals.¹

Over the decades, many states have gone ahead in enacting their own statutes while awaiting federal action. Iowa is the latest example. It recently passed legislation that included a noneconomic damages cap of $250,000, stronger expert witness standards, a certificate of merit in all medical liability lawsuits, and an expansion of its “candor” protections.² Additional reforms in other states include pretrial screening panels; arbitration; structured periodic payments in lieu of lump sum payments; penalties for frivolous suits; shortened statutes of limitations; making the loser bear all litigation costs; abolishing the collateral source rule, as well as joint and several liability; and limiting attorney contingency fees.

The best-known reform is a cap on noneconomic losses, such as pain and suffering, that doesn’t abridge compensation for economic losses, i.e., medical expenses and lost wages. This provides some predictability because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments.

Interestingly, Dr. Price himself has not pushed for a federal cap on noneconomic damages, but other Republican bills have proposed a cap of $250,000. Many states, such as California, Kansas, and Texas, have seen their cap statutes withstand constitutional challenge. However, other jurisdictions, notably Georgia, Illinois, and Missouri, have ruled them unconstitutional.

California’s law, popularly known as MICRA (Medical Injury Compensation Reform Act), came under renewed attack in 2015 with a wrongful death suit from hemorrhagic complications related to Coumadin (warfarin) use following heart surgery.³ The plaintiff’s constitutional challenges included violation of equal protection, due process, and the right to a jury trial, but these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000, as required under MICRA. A California court of appeal rejected her claim as being “contrary to many well-established legal principles.”

On the other hand, Florida’s Supreme Court recently held in a closely divided decision of 4-3 that the state’s caps were unconstitutional.⁴ The law limited noneconomic damages in malpractice cases to either $500,000 or $1 million if the injuries were catastrophic. The court ruled that the caps were arbitrary and unfairly hurt the most severely injured. It was unconvinced that they would reduce malpractice insurance rates; at any rate, there was no present crisis to justify the caps. The decision came 3 years after the court had struck down caps in a case of wrongful death.⁵

Three relative newcomers to the legal landscape – health courts, apology laws, and safe harbors – appear to be taking center stage in any forthcoming federal reform measures.
 

Health courts

Under this proposal, so-called health panels and tribunals would now adjudicate malpractice claims. Such health courts would dispense with the jury; further, regular judges would be replaced with specialized judges who would make binding determinations. In one version, a panel of medical experts would initially screen the complaint, followed by an administrative health care tribunal that would feature judges with medical expertise. These tribunals would issue binding rulings, but either party could appeal to a state court for a reversal.

In countries such as Scandinavia and New Zealand, these administrative compensation approaches are coupled to a no-fault system and appear to work well. However, unlike auto no-fault and workers’ compensation, the notion of medical no-fault has never caught on in the United States.

As currently construed, health courts evince dramatic departures from traditional rules of civil procedure. For one, the panels may render decisions before discovery has occurred, which would substantially limit a patient’s ability to learn the facts of what had happened to cause the injury. The panel may rely on a standard of “gross negligence” instead of “ordinary negligence,” requiring evidence not merely of substandard care but of recklessness. This would be a heavier burden on the victim, and could be expected to generate stiff opposition from the plaintiff’s bar. In addition, evidentiary rules may be modified, requiring that an appeal show with clear and convincing proof that the tribunal had erred.
 

Apology law

Disclosure of medical errors to the injured patient is believed to serve as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called apology laws that disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician.

For example, the Ohio Supreme Court ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute.⁶ Apology laws vary from state to state, and some do not shield admissions regarding causation of error or fault.

However, it is unclear if apology laws work. A recent study from Vanderbilt University reported that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit.⁷ And for surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
 

Safe harbors

A proposal released by U.S. House Speaker Paul Ryan (R-Wis.) in June 2016 made reference to “safe harbors” from liability for those adhering to clinical practice guidelines. The Institute of Medicine defines practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”

There are thousands of guidelines that have been developed by medical organizations and governmental agencies, as well as by insurance carriers, managed care organizations, and others. They purport to define the best evidence-based medicine, and if they were arrived at by the consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards.

Theoretically, adherence to guidelines could reduce the practice of defensive medicine and improve the quality of care. However, the available evidence does not indicate that guideline-based safe harbors will prove very effective in reducing malpractice claims: They are inapplicable in 85% of cases, and they have been estimated to eliminate defendants’ payments in less than 1% of claims.

Whether any form of tort reform emerges from the current Congress is as much about politics as it is about justice. It comes at an inopportune time, given the impasse over the health care debate. Still, on June 29, 2017, the U.S. House passed a medical liability reform bill with a vote of 218-210 along party lines that would cap noneconomic damages at $250,000, shorten the statute of limitations to 3 years after the date of injury, and abolish joint and several liability.⁸ The outlook in the U.S. Senate, however, is anything but certain.
 

References

1. N Engl J Med. 2017 May 11;376(19):1806-8.

2. “Sweeping new tort reforms will protect Iowa physicians” AMA Wire. June 1, 2017.

3. Chan v. Curran, 237 CA 4th 601 (2015).

4. N. Broward Hospital District v. Kalitan, (Florida Supreme Court, decided June 8, 2017).

5. Estate of Michelle Evette McCall v. U.S., 2014 Fla LEXIS 933 (No. SC 11-1148; March 13, 2014).

6. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).

7. “Sorry is Never Enough: The Effect of State Apology Laws on Medical Malpractice Liability Risk” SSRN. 2016 Dec 10.

8. Protecting Access to Care Act of 2017 (H.R. 1215).

CHICAGO – Screening infants with a port-wine stain for Sturge-Weber syndrome (SWS) with a magnetic resonance imaging brain scan had a 23% false-negative rate and actually delayed seizure detection, according to a recent study.

When infants with port-wine stains receive a dermatology consult, they may also be screened for SWS by means of MRI and by electroencephalography, particularly if their lesion phenotype puts them at higher risk for SWS. But the accuracy and benefit of the screenings has not been well established, said Michaela Zallmann, MD, the study’s first author. Hemifacial lesions that involve both the forehead and cheek and median lesions that are centered around the facial midline are both considered high-risk lesions.

Dr. Zallmann, a dermatologist at Monash University and the Royal Children’s Hospital, Melbourne, and her coinvestigators examined data on 126 patients with facial port-wine stains who came to a laser clinic over a 12-month period. Of these, 32 (25.4%) had a high-risk port-wine stain, and 9 of those 32 (28.1%) had a capillary-venous malformation characteristic of SWS. Of the high-risk patients, 14 received a screening MRI or EEG before having had a first seizure. Of those 14 scans, 1 resulted in a diagnosis of SWS; of the 13 patients with a negative MRI screen, 3 (23.1%) were later found to have SWS when their parents or caregivers detected seizures. Thus, a total of four of the high-risk infants who were screened eventually were diagnosed with SWS.

Of the 18 high-risk patients who did not receive a screening MRI, 3 (16.7%) developed seizures, while 2 (11.1%) were seizure free but developed glaucoma severe enough to require treatment. One patient who was also seizure free developed an autism spectrum disorder.

Two patients who were in the high-risk group received screening EEGs that detected abnormalities that were not yet clinically evident. These included sub-clinical seizures and posterior-quadrant focal slowing. Both of these patients had initial negative screening MRIs.

Scanning early in life, using inappropriate imaging protocols, and having an inexperienced radiologist were all factors associated with a higher probability of false negative screening MRI, according to the researchers’ analysis, which was presented in a poster session at the World Congress of Pediatric Dermatology.

All of the false negative MRIs in the study cohort were conducted in infants younger than 9 weeks old. But whether it is useful to reserve imaging for later in infancy is debatable. “While later imaging may have improved sensitivity, 75% of infants with SWS will have already had their first seizure by 12 months of age,” wrote Dr. Zallmann and her colleagues.

Of the infants involved in the study, two of the three patients with false negative scans did not receive a referral to a neurologist, nor did their parents receive seizure education. “False reassurance may delay seizure detection,” Dr. Zallmann said.

For infants with positive MRIs who went on to develop seizures, the mean age of when they experienced their first documented seizure was 10 weeks. For those who did not receive an MRI, the mean age was 14 months, compared with 28 months for patients who had received a false negative MRI.

In discussing the findings, Dr. Zallmann and her colleagues made the point that early referral to a pediatric neurologist is important, especially for infants with the higher-risk port-wine stain patterns of hemifacial and median lesions. Seizure education can help parents detect the often subtle signs of seizures in infants with SWS, which can include staring spells, subtle limb twitching, and lip smacking.

The fact that seizures were detected an average of 14 months later in patients with negative screening MRIs may mean that such subtle signs were missed. “False reassurance may delay the recognition and treatment of seizures and impact neurodevelopmental outcomes,” Dr. Zallmann and her colleagues wrote in the abstract that accompanied the poster.

The study, while small, helps fill in some knowledge gaps, the researchers pointed out; they noted that there is no consensus on what level or type of facial involvement warrants screening, which protocols are best for MRI and EEG, or even whether the screening will improve seizure detection or outcomes.

“Currently there is no evidence that screening improves neurodevelopmental outcomes,” they said. “Conversely, there is a role for early neurological referral, symptom education, and potentially of EEGs in the prevention of complications related to SWS.”

Dr. Zallmann reported no conflicts of interest.
 

[email protected]

On Twitter @karioakes

CHICAGO – Screening infants with a port-wine stain for Sturge-Weber syndrome (SWS) with a magnetic resonance imaging brain scan had a 23% false-negative rate and actually delayed seizure detection, according to a recent study.

When infants with port-wine stains receive a dermatology consult, they may also be screened for SWS by means of MRI and by electroencephalography, particularly if their lesion phenotype puts them at higher risk for SWS. But the accuracy and benefit of the screenings has not been well established, said Michaela Zallmann, MD, the study’s first author. Hemifacial lesions that involve both the forehead and cheek and median lesions that are centered around the facial midline are both considered high-risk lesions.

Dr. Zallmann, a dermatologist at Monash University and the Royal Children’s Hospital, Melbourne, and her coinvestigators examined data on 126 patients with facial port-wine stains who came to a laser clinic over a 12-month period. Of these, 32 (25.4%) had a high-risk port-wine stain, and 9 of those 32 (28.1%) had a capillary-venous malformation characteristic of SWS. Of the high-risk patients, 14 received a screening MRI or EEG before having had a first seizure. Of those 14 scans, 1 resulted in a diagnosis of SWS; of the 13 patients with a negative MRI screen, 3 (23.1%) were later found to have SWS when their parents or caregivers detected seizures. Thus, a total of four of the high-risk infants who were screened eventually were diagnosed with SWS.

Of the 18 high-risk patients who did not receive a screening MRI, 3 (16.7%) developed seizures, while 2 (11.1%) were seizure free but developed glaucoma severe enough to require treatment. One patient who was also seizure free developed an autism spectrum disorder.

Two patients who were in the high-risk group received screening EEGs that detected abnormalities that were not yet clinically evident. These included sub-clinical seizures and posterior-quadrant focal slowing. Both of these patients had initial negative screening MRIs.

Scanning early in life, using inappropriate imaging protocols, and having an inexperienced radiologist were all factors associated with a higher probability of false negative screening MRI, according to the researchers’ analysis, which was presented in a poster session at the World Congress of Pediatric Dermatology.

All of the false negative MRIs in the study cohort were conducted in infants younger than 9 weeks old. But whether it is useful to reserve imaging for later in infancy is debatable. “While later imaging may have improved sensitivity, 75% of infants with SWS will have already had their first seizure by 12 months of age,” wrote Dr. Zallmann and her colleagues.

Of the infants involved in the study, two of the three patients with false negative scans did not receive a referral to a neurologist, nor did their parents receive seizure education. “False reassurance may delay seizure detection,” Dr. Zallmann said.

For infants with positive MRIs who went on to develop seizures, the mean age of when they experienced their first documented seizure was 10 weeks. For those who did not receive an MRI, the mean age was 14 months, compared with 28 months for patients who had received a false negative MRI.

In discussing the findings, Dr. Zallmann and her colleagues made the point that early referral to a pediatric neurologist is important, especially for infants with the higher-risk port-wine stain patterns of hemifacial and median lesions. Seizure education can help parents detect the often subtle signs of seizures in infants with SWS, which can include staring spells, subtle limb twitching, and lip smacking.

The fact that seizures were detected an average of 14 months later in patients with negative screening MRIs may mean that such subtle signs were missed. “False reassurance may delay the recognition and treatment of seizures and impact neurodevelopmental outcomes,” Dr. Zallmann and her colleagues wrote in the abstract that accompanied the poster.

The study, while small, helps fill in some knowledge gaps, the researchers pointed out; they noted that there is no consensus on what level or type of facial involvement warrants screening, which protocols are best for MRI and EEG, or even whether the screening will improve seizure detection or outcomes.

“Currently there is no evidence that screening improves neurodevelopmental outcomes,” they said. “Conversely, there is a role for early neurological referral, symptom education, and potentially of EEGs in the prevention of complications related to SWS.”

Dr. Zallmann reported no conflicts of interest.
 

[email protected]

On Twitter @karioakes

CHICAGO – Screening infants with a port-wine stain for Sturge-Weber syndrome (SWS) with a magnetic resonance imaging brain scan had a 23% false-negative rate and actually delayed seizure detection, according to a recent study.

When infants with port-wine stains receive a dermatology consult, they may also be screened for SWS by means of MRI and by electroencephalography, particularly if their lesion phenotype puts them at higher risk for SWS. But the accuracy and benefit of the screenings has not been well established, said Michaela Zallmann, MD, the study’s first author. Hemifacial lesions that involve both the forehead and cheek and median lesions that are centered around the facial midline are both considered high-risk lesions.

Dr. Zallmann, a dermatologist at Monash University and the Royal Children’s Hospital, Melbourne, and her coinvestigators examined data on 126 patients with facial port-wine stains who came to a laser clinic over a 12-month period. Of these, 32 (25.4%) had a high-risk port-wine stain, and 9 of those 32 (28.1%) had a capillary-venous malformation characteristic of SWS. Of the high-risk patients, 14 received a screening MRI or EEG before having had a first seizure. Of those 14 scans, 1 resulted in a diagnosis of SWS; of the 13 patients with a negative MRI screen, 3 (23.1%) were later found to have SWS when their parents or caregivers detected seizures. Thus, a total of four of the high-risk infants who were screened eventually were diagnosed with SWS.

Of the 18 high-risk patients who did not receive a screening MRI, 3 (16.7%) developed seizures, while 2 (11.1%) were seizure free but developed glaucoma severe enough to require treatment. One patient who was also seizure free developed an autism spectrum disorder.

Two patients who were in the high-risk group received screening EEGs that detected abnormalities that were not yet clinically evident. These included sub-clinical seizures and posterior-quadrant focal slowing. Both of these patients had initial negative screening MRIs.

Scanning early in life, using inappropriate imaging protocols, and having an inexperienced radiologist were all factors associated with a higher probability of false negative screening MRI, according to the researchers’ analysis, which was presented in a poster session at the World Congress of Pediatric Dermatology.

All of the false negative MRIs in the study cohort were conducted in infants younger than 9 weeks old. But whether it is useful to reserve imaging for later in infancy is debatable. “While later imaging may have improved sensitivity, 75% of infants with SWS will have already had their first seizure by 12 months of age,” wrote Dr. Zallmann and her colleagues.

Of the infants involved in the study, two of the three patients with false negative scans did not receive a referral to a neurologist, nor did their parents receive seizure education. “False reassurance may delay seizure detection,” Dr. Zallmann said.

For infants with positive MRIs who went on to develop seizures, the mean age of when they experienced their first documented seizure was 10 weeks. For those who did not receive an MRI, the mean age was 14 months, compared with 28 months for patients who had received a false negative MRI.

In discussing the findings, Dr. Zallmann and her colleagues made the point that early referral to a pediatric neurologist is important, especially for infants with the higher-risk port-wine stain patterns of hemifacial and median lesions. Seizure education can help parents detect the often subtle signs of seizures in infants with SWS, which can include staring spells, subtle limb twitching, and lip smacking.

The fact that seizures were detected an average of 14 months later in patients with negative screening MRIs may mean that such subtle signs were missed. “False reassurance may delay the recognition and treatment of seizures and impact neurodevelopmental outcomes,” Dr. Zallmann and her colleagues wrote in the abstract that accompanied the poster.

The study, while small, helps fill in some knowledge gaps, the researchers pointed out; they noted that there is no consensus on what level or type of facial involvement warrants screening, which protocols are best for MRI and EEG, or even whether the screening will improve seizure detection or outcomes.

“Currently there is no evidence that screening improves neurodevelopmental outcomes,” they said. “Conversely, there is a role for early neurological referral, symptom education, and potentially of EEGs in the prevention of complications related to SWS.”

Dr. Zallmann reported no conflicts of interest.
 

[email protected]

On Twitter @karioakes

COLORADO SPRINGS – Significant variability exists between hospitals in Washington state in their rates of invasive mediastinal staging for lung cancer, Farhood Farjah, MD, reported at the annual meeting of the Western Thoracic Surgical Association.

“We found evidence of a fivefold variation in hospital-level rates of invasive mediastinal staging not explained by chance or case mix,” according to Dr. Farjah of the University of Washington, Seattle.

[email protected]

COLORADO SPRINGS – Significant variability exists between hospitals in Washington state in their rates of invasive mediastinal staging for lung cancer, Farhood Farjah, MD, reported at the annual meeting of the Western Thoracic Surgical Association.

“We found evidence of a fivefold variation in hospital-level rates of invasive mediastinal staging not explained by chance or case mix,” according to Dr. Farjah of the University of Washington, Seattle.

[email protected]

COLORADO SPRINGS – Significant variability exists between hospitals in Washington state in their rates of invasive mediastinal staging for lung cancer, Farhood Farjah, MD, reported at the annual meeting of the Western Thoracic Surgical Association.

“We found evidence of a fivefold variation in hospital-level rates of invasive mediastinal staging not explained by chance or case mix,” according to Dr. Farjah of the University of Washington, Seattle.

[email protected]

PARIS – Transcatheter aortic valve replacement using the self-expanding Evolut R device in high-surgical-risk patients with failing surgical aortic bioprostheses showed promising 30-day safety and effectiveness results in the ongoing VIVA study, Ran Kornowski, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“We had a lot of patients with small, failing valves in this study. Despite this, our valve gradients postprocedure were very, very low. This means to me that this platform is very well suited to deal with valve-in-valve procedures in general and with small bioprosthetic valves in particular,” observed Dr. Kornowski, chairman of the department of cardiology at Rabin Medical Center in Petah Tikva, Israel, and president of the Israel Heart Society.

Bruce Jancin/Frontline Medical News

• All-cause mortality occurred in 2.5% of patients.

• The 30-day stroke rate was 3%, with no disabling strokes.

• Major vascular complications occurred in 6.5% of the VIVA patients.

• Major bleeding occurred in 7%, minor bleeding in 7.9%. There were no cases of life-threatening bleeding.

• The incidence of Stage I acute kidney injury was rare, at 0.5%.

• Seven percent of patients received a permanent pacemaker.

• Eighty-seven percent of patients had no postprocedure paravalvular regurgitation (PVR), 11.4 had mild PVR, and 1.5% had moderate PVR.

• NYHA classification improved from baseline to 30 days in 81% of patients. At 30 days, 93% of participants were NYHA class I or II.

Turning to echocardiographic findings, the mean gradient improved from a mean baseline of 31.8 mm Hg to 12.6 mm Hg, while the effective orifice area rose from 1.0 to 1.5 cm². The magnitude of both improvements was greater for patients with stenosis as their mode of valve failure.

“With the Evolut R, we aim for higher implantations – not more than about 4 mm below the ring – because going deeper could bring about higher gradients and functional deterioration later on,” the cardiologist explained.

The 1-year primary efficacy endpoint – lack of significant aortic stenosis as defined by a mean gradient less than 40 mm Hg – will be reported soon. The VIVA study is sponsored by Medtronic. Dr. Kornowski reported serving as a consultant to the company.

[email protected]

PARIS – Transcatheter aortic valve replacement using the self-expanding Evolut R device in high-surgical-risk patients with failing surgical aortic bioprostheses showed promising 30-day safety and effectiveness results in the ongoing VIVA study, Ran Kornowski, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“We had a lot of patients with small, failing valves in this study. Despite this, our valve gradients postprocedure were very, very low. This means to me that this platform is very well suited to deal with valve-in-valve procedures in general and with small bioprosthetic valves in particular,” observed Dr. Kornowski, chairman of the department of cardiology at Rabin Medical Center in Petah Tikva, Israel, and president of the Israel Heart Society.

Bruce Jancin/Frontline Medical News

• All-cause mortality occurred in 2.5% of patients.

• The 30-day stroke rate was 3%, with no disabling strokes.

• Major vascular complications occurred in 6.5% of the VIVA patients.

• Major bleeding occurred in 7%, minor bleeding in 7.9%. There were no cases of life-threatening bleeding.

• The incidence of Stage I acute kidney injury was rare, at 0.5%.

• Seven percent of patients received a permanent pacemaker.

• Eighty-seven percent of patients had no postprocedure paravalvular regurgitation (PVR), 11.4 had mild PVR, and 1.5% had moderate PVR.

• NYHA classification improved from baseline to 30 days in 81% of patients. At 30 days, 93% of participants were NYHA class I or II.

Turning to echocardiographic findings, the mean gradient improved from a mean baseline of 31.8 mm Hg to 12.6 mm Hg, while the effective orifice area rose from 1.0 to 1.5 cm². The magnitude of both improvements was greater for patients with stenosis as their mode of valve failure.

“With the Evolut R, we aim for higher implantations – not more than about 4 mm below the ring – because going deeper could bring about higher gradients and functional deterioration later on,” the cardiologist explained.

The 1-year primary efficacy endpoint – lack of significant aortic stenosis as defined by a mean gradient less than 40 mm Hg – will be reported soon. The VIVA study is sponsored by Medtronic. Dr. Kornowski reported serving as a consultant to the company.

[email protected]

PARIS – Transcatheter aortic valve replacement using the self-expanding Evolut R device in high-surgical-risk patients with failing surgical aortic bioprostheses showed promising 30-day safety and effectiveness results in the ongoing VIVA study, Ran Kornowski, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.

“We had a lot of patients with small, failing valves in this study. Despite this, our valve gradients postprocedure were very, very low. This means to me that this platform is very well suited to deal with valve-in-valve procedures in general and with small bioprosthetic valves in particular,” observed Dr. Kornowski, chairman of the department of cardiology at Rabin Medical Center in Petah Tikva, Israel, and president of the Israel Heart Society.

Bruce Jancin/Frontline Medical News

• All-cause mortality occurred in 2.5% of patients.

• The 30-day stroke rate was 3%, with no disabling strokes.

• Major vascular complications occurred in 6.5% of the VIVA patients.

• Major bleeding occurred in 7%, minor bleeding in 7.9%. There were no cases of life-threatening bleeding.

• The incidence of Stage I acute kidney injury was rare, at 0.5%.

• Seven percent of patients received a permanent pacemaker.

• Eighty-seven percent of patients had no postprocedure paravalvular regurgitation (PVR), 11.4 had mild PVR, and 1.5% had moderate PVR.

• NYHA classification improved from baseline to 30 days in 81% of patients. At 30 days, 93% of participants were NYHA class I or II.

Turning to echocardiographic findings, the mean gradient improved from a mean baseline of 31.8 mm Hg to 12.6 mm Hg, while the effective orifice area rose from 1.0 to 1.5 cm². The magnitude of both improvements was greater for patients with stenosis as their mode of valve failure.

“With the Evolut R, we aim for higher implantations – not more than about 4 mm below the ring – because going deeper could bring about higher gradients and functional deterioration later on,” the cardiologist explained.

The 1-year primary efficacy endpoint – lack of significant aortic stenosis as defined by a mean gradient less than 40 mm Hg – will be reported soon. The VIVA study is sponsored by Medtronic. Dr. Kornowski reported serving as a consultant to the company.

[email protected]