User login
Case series shows benefit of nonthermal atmospheric pressure plasma for actinic keratoses
Nonthermal atmospheric pressure plasma (NTAP) may serve as an effective, well-tolerated treatment for actinic keratoses, according to findings of a small study published in the February issue of Journal of the American Academy of Dermatology.
Dr. Peter C. Friedman and his associates at the Skin Center Dermatology Group, New York, wrote that prior studies suggest that NTAP – applied with a hand-held electrode – could selectively induce apoptosis in cancer cells in vitro, and may also up-regulate local and tumor-specific systemic immune response.
In this study, five patients with 5 biopsy-proven and 12 clinically diagnosed actinic keratoses (AKs) were treated with a single dose of NTAP on the target lesion. The procedure involved nanosecond pulses that were applied to the treatment area for 1-2 minutes, an approach designed to provide sufficient dose while avoiding tissue damage (J Am Acad Dermatol. 2017 Feb. doi: 10.1016/j.jaad.2016.09.004).
At the 1-month follow-up – in which photographs were used to compare before and after treatment – 9 of the 17 AK lesions showed full clinical resolution, with no visible or palpable lesions and only minimal site erythema. Three lesions showed significant improvement, with at least a 50% improvement, and five lesions should minor or no improvement.
Dr. Friedman and his associates noted that current treatment options for AKs all have significant downsides including side effects such as pain and inflammation, and frequent recurrences. There were no adverse effects, such as pain, inflammation, or site reaction, reported during treatment with NTAP or 1 month after treatment.
“Given its very impressive tolerability, NTAP may be an excellent alternative for our current treatment options for AKs, especially if its efficacy and treatment procedure time can be improved and if further, long-term studies demonstrate lasting effects,” the authors wrote. “Further studies are needed to optimize treatment parameters, provide histologic confirmation of treatment effect, and evaluate the long-term benefits of this modality.”
No conflicts of interest were declared.
Nonthermal atmospheric pressure plasma (NTAP) may serve as an effective, well-tolerated treatment for actinic keratoses, according to findings of a small study published in the February issue of Journal of the American Academy of Dermatology.
Dr. Peter C. Friedman and his associates at the Skin Center Dermatology Group, New York, wrote that prior studies suggest that NTAP – applied with a hand-held electrode – could selectively induce apoptosis in cancer cells in vitro, and may also up-regulate local and tumor-specific systemic immune response.
In this study, five patients with 5 biopsy-proven and 12 clinically diagnosed actinic keratoses (AKs) were treated with a single dose of NTAP on the target lesion. The procedure involved nanosecond pulses that were applied to the treatment area for 1-2 minutes, an approach designed to provide sufficient dose while avoiding tissue damage (J Am Acad Dermatol. 2017 Feb. doi: 10.1016/j.jaad.2016.09.004).
At the 1-month follow-up – in which photographs were used to compare before and after treatment – 9 of the 17 AK lesions showed full clinical resolution, with no visible or palpable lesions and only minimal site erythema. Three lesions showed significant improvement, with at least a 50% improvement, and five lesions should minor or no improvement.
Dr. Friedman and his associates noted that current treatment options for AKs all have significant downsides including side effects such as pain and inflammation, and frequent recurrences. There were no adverse effects, such as pain, inflammation, or site reaction, reported during treatment with NTAP or 1 month after treatment.
“Given its very impressive tolerability, NTAP may be an excellent alternative for our current treatment options for AKs, especially if its efficacy and treatment procedure time can be improved and if further, long-term studies demonstrate lasting effects,” the authors wrote. “Further studies are needed to optimize treatment parameters, provide histologic confirmation of treatment effect, and evaluate the long-term benefits of this modality.”
No conflicts of interest were declared.
Nonthermal atmospheric pressure plasma (NTAP) may serve as an effective, well-tolerated treatment for actinic keratoses, according to findings of a small study published in the February issue of Journal of the American Academy of Dermatology.
Dr. Peter C. Friedman and his associates at the Skin Center Dermatology Group, New York, wrote that prior studies suggest that NTAP – applied with a hand-held electrode – could selectively induce apoptosis in cancer cells in vitro, and may also up-regulate local and tumor-specific systemic immune response.
In this study, five patients with 5 biopsy-proven and 12 clinically diagnosed actinic keratoses (AKs) were treated with a single dose of NTAP on the target lesion. The procedure involved nanosecond pulses that were applied to the treatment area for 1-2 minutes, an approach designed to provide sufficient dose while avoiding tissue damage (J Am Acad Dermatol. 2017 Feb. doi: 10.1016/j.jaad.2016.09.004).
At the 1-month follow-up – in which photographs were used to compare before and after treatment – 9 of the 17 AK lesions showed full clinical resolution, with no visible or palpable lesions and only minimal site erythema. Three lesions showed significant improvement, with at least a 50% improvement, and five lesions should minor or no improvement.
Dr. Friedman and his associates noted that current treatment options for AKs all have significant downsides including side effects such as pain and inflammation, and frequent recurrences. There were no adverse effects, such as pain, inflammation, or site reaction, reported during treatment with NTAP or 1 month after treatment.
“Given its very impressive tolerability, NTAP may be an excellent alternative for our current treatment options for AKs, especially if its efficacy and treatment procedure time can be improved and if further, long-term studies demonstrate lasting effects,” the authors wrote. “Further studies are needed to optimize treatment parameters, provide histologic confirmation of treatment effect, and evaluate the long-term benefits of this modality.”
No conflicts of interest were declared.
FROM JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Key clinical point: Nonthermal atmospheric pressure plasma may be an effective, well-tolerated treatment for actinic keratoses.
Major finding: One month after a single treatment with NTAP, 9 of 17 AK lesions showed full clinical resolution and 3 lesions showed significant improvement.
Data source: Case series in five patients with actinic keratoses.
Disclosures: No conflicts of interest were declared.
New Zika-infected pregnancies down for most of United States
New cases of Zika infection in pregnant women were down again for the 50 states over the 2-week reporting period ending Jan. 24, but U.S. territories saw a big increase, according to the Centers for Disease Control and Prevention.
It is important to note, however, that Puerto Rico, where most U.S. Zika cases are occurring, has been retroactively reporting cases for months, which can result in larger-than-normal increases.
The territories had 186 new cases of pregnant women with laboratory evidence of Zika virus infection for the 2 weeks ending Jan. 24, compared with 43 for the previous 2-week period. The corresponding numbers for the 50 states and the District of Columbia were 47 (Jan. 24) and 55 (Jan. 10), the CDC data show.
So far for 2016-2017, there have been 4,465 pregnant women reported to have Zika virus infection in the United States: 3,071 in the territories and 1,394 in the 50 states and D.C., according to the U.S. Zika Pregnancy Registry (states, territories, and the District of Columbia) and the U.S. Zika Active Pregnancy Surveillance System (Puerto Rico).
Of the nearly 1,400 state/D.C. Zika-infected pregnancies, 999 have been completed, with 38 infants born with birth defects and 5 defect-related pregnancy losses, the CDC said. There have been no Zika-related pregnancy losses reported in the states/D.C. since late June. The CDC is no longer reporting adverse pregnancy outcomes for the territories because Puerto Rico is not using the same inclusion criteria.
Among all Americans in 2015-2017, there have been 41,387 cases of Zika infection as of Feb. 1. Of that total, 35,334 cases, which is more than 85%, have occurred in Puerto Rico, according to data from the CDC’s Arboviral Disease Branch.
Zika-related birth defects reported by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.
New cases of Zika infection in pregnant women were down again for the 50 states over the 2-week reporting period ending Jan. 24, but U.S. territories saw a big increase, according to the Centers for Disease Control and Prevention.
It is important to note, however, that Puerto Rico, where most U.S. Zika cases are occurring, has been retroactively reporting cases for months, which can result in larger-than-normal increases.
The territories had 186 new cases of pregnant women with laboratory evidence of Zika virus infection for the 2 weeks ending Jan. 24, compared with 43 for the previous 2-week period. The corresponding numbers for the 50 states and the District of Columbia were 47 (Jan. 24) and 55 (Jan. 10), the CDC data show.
So far for 2016-2017, there have been 4,465 pregnant women reported to have Zika virus infection in the United States: 3,071 in the territories and 1,394 in the 50 states and D.C., according to the U.S. Zika Pregnancy Registry (states, territories, and the District of Columbia) and the U.S. Zika Active Pregnancy Surveillance System (Puerto Rico).
Of the nearly 1,400 state/D.C. Zika-infected pregnancies, 999 have been completed, with 38 infants born with birth defects and 5 defect-related pregnancy losses, the CDC said. There have been no Zika-related pregnancy losses reported in the states/D.C. since late June. The CDC is no longer reporting adverse pregnancy outcomes for the territories because Puerto Rico is not using the same inclusion criteria.
Among all Americans in 2015-2017, there have been 41,387 cases of Zika infection as of Feb. 1. Of that total, 35,334 cases, which is more than 85%, have occurred in Puerto Rico, according to data from the CDC’s Arboviral Disease Branch.
Zika-related birth defects reported by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.
New cases of Zika infection in pregnant women were down again for the 50 states over the 2-week reporting period ending Jan. 24, but U.S. territories saw a big increase, according to the Centers for Disease Control and Prevention.
It is important to note, however, that Puerto Rico, where most U.S. Zika cases are occurring, has been retroactively reporting cases for months, which can result in larger-than-normal increases.
The territories had 186 new cases of pregnant women with laboratory evidence of Zika virus infection for the 2 weeks ending Jan. 24, compared with 43 for the previous 2-week period. The corresponding numbers for the 50 states and the District of Columbia were 47 (Jan. 24) and 55 (Jan. 10), the CDC data show.
So far for 2016-2017, there have been 4,465 pregnant women reported to have Zika virus infection in the United States: 3,071 in the territories and 1,394 in the 50 states and D.C., according to the U.S. Zika Pregnancy Registry (states, territories, and the District of Columbia) and the U.S. Zika Active Pregnancy Surveillance System (Puerto Rico).
Of the nearly 1,400 state/D.C. Zika-infected pregnancies, 999 have been completed, with 38 infants born with birth defects and 5 defect-related pregnancy losses, the CDC said. There have been no Zika-related pregnancy losses reported in the states/D.C. since late June. The CDC is no longer reporting adverse pregnancy outcomes for the territories because Puerto Rico is not using the same inclusion criteria.
Among all Americans in 2015-2017, there have been 41,387 cases of Zika infection as of Feb. 1. Of that total, 35,334 cases, which is more than 85%, have occurred in Puerto Rico, according to data from the CDC’s Arboviral Disease Branch.
Zika-related birth defects reported by the CDC could include microcephaly, calcium deposits in the brain indicating possible brain damage, excess fluid in the brain cavities and surrounding the brain, absent or poorly formed brain structures, abnormal eye development, or other problems resulting from brain damage that affect nerves, muscles, and bones. The pregnancy losses encompass any miscarriage, stillbirth, and termination with evidence of birth defects.
VIDEO: Pediatric psoriasis patients prepare for biologics
WAILEA, Hawaii – The first approval of a biologic for pediatric psoriasis, and ongoing clinical trials of other biologics in children with psoriasis, are among the encouraging therapeutic developments for this patient population, Wynnis Tom, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“We are incredibly excited ... as pediatric dermatologists that we’re finally seeing breakthroughs” in terms of Food and Drug Administration activity regarding the use of biologics for treating psoriasis in children, Dr. Tom said in a video interview at the seminar.
Etanercept (Enbrel) is now approved for children with psoriasis, the first biologic indicated for pediatric psoriasis, and clinical trials of other biologics that have been available for adults and nonbiologic products for pediatric psoriasis are underway, she said.
However, getting insurance coverage can still be a challenge, although having long-term efficacy and safety data helps, noted Dr. Tom of the department of dermatology and pediatrics, University of California, San Diego, and Rady Children’s Hospital, San Diego. Also helpful is sending letters to insurers on behalf of the patient, describing the patient’s quality of life, descriptions of treatments that have been unsuccessful, and even photos documenting the disease in the child, she added.
Dr. Tom disclosed ties with Promius, Celgene, and Janssen.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, Hawaii – The first approval of a biologic for pediatric psoriasis, and ongoing clinical trials of other biologics in children with psoriasis, are among the encouraging therapeutic developments for this patient population, Wynnis Tom, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“We are incredibly excited ... as pediatric dermatologists that we’re finally seeing breakthroughs” in terms of Food and Drug Administration activity regarding the use of biologics for treating psoriasis in children, Dr. Tom said in a video interview at the seminar.
Etanercept (Enbrel) is now approved for children with psoriasis, the first biologic indicated for pediatric psoriasis, and clinical trials of other biologics that have been available for adults and nonbiologic products for pediatric psoriasis are underway, she said.
However, getting insurance coverage can still be a challenge, although having long-term efficacy and safety data helps, noted Dr. Tom of the department of dermatology and pediatrics, University of California, San Diego, and Rady Children’s Hospital, San Diego. Also helpful is sending letters to insurers on behalf of the patient, describing the patient’s quality of life, descriptions of treatments that have been unsuccessful, and even photos documenting the disease in the child, she added.
Dr. Tom disclosed ties with Promius, Celgene, and Janssen.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
WAILEA, Hawaii – The first approval of a biologic for pediatric psoriasis, and ongoing clinical trials of other biologics in children with psoriasis, are among the encouraging therapeutic developments for this patient population, Wynnis Tom, MD, said at the Hawaii Dermatology Seminar provided by Global Academy for Medical Education/Skin Disease Education Foundation.
“We are incredibly excited ... as pediatric dermatologists that we’re finally seeing breakthroughs” in terms of Food and Drug Administration activity regarding the use of biologics for treating psoriasis in children, Dr. Tom said in a video interview at the seminar.
Etanercept (Enbrel) is now approved for children with psoriasis, the first biologic indicated for pediatric psoriasis, and clinical trials of other biologics that have been available for adults and nonbiologic products for pediatric psoriasis are underway, she said.
However, getting insurance coverage can still be a challenge, although having long-term efficacy and safety data helps, noted Dr. Tom of the department of dermatology and pediatrics, University of California, San Diego, and Rady Children’s Hospital, San Diego. Also helpful is sending letters to insurers on behalf of the patient, describing the patient’s quality of life, descriptions of treatments that have been unsuccessful, and even photos documenting the disease in the child, she added.
Dr. Tom disclosed ties with Promius, Celgene, and Janssen.
SDEF and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT SDEF HAWAII DERMATOLOGY SEMINAR
Coding Changes for 2017
All physicians will see changes in reimbursement in 2017. A new president with a new agenda makes for an interesting time ahead for health care in the United States. However, in this time of flux, there is one constant: the Final Rule, an informal term for the annual update on how the Medicare system will function and how much you will get paid for what you do.1 The document is 393 pages and outlines what is new in the Medicare system, with lots of supplements giving granular details about physician work, overhead, and supply and labor costs. In this column, I have taken the liberty of dissecting the Final Rule for you and to bring attention to its high and low points for dermatologists.
Changes in Relative Value Units
The conversion factor has gone up, meaning you will be paid a bit more this year for what you do; it is not enough to account for inflation or the increasing cost of unfunded mandates, but it is better than nothing. Although the conversion factor was $35.8043 in 2016, it increased by more than 0.2% on January 1, 2017, to $35.8887.1 How is this conversion factor calculated? We go up 0.5% due to MACRA (Medicare Access and CHIP Reauthorization Act), down 0.013% due to budget neutrality, down 0.07% due to multiple procedure payment reduction changes, and down another 0.18% due to the misvalued code target.1 The misvalued code target is related to targets established by statute for 2016 to 2018 and payment rates are reduced across the board if they are not met.
If payments suffer from reductions in work value, they may not happen all at once. If the Centers for Medicare & Medicaid Services (CMS) reduce total relative value units (RVUs) by more than 20%, reductions will take place over at least 2 years with a single year drop maximum of 19%.1 Unfortunately, such limits do not apply to revised codes, which can take as big a hit as the CMS cares to make.
Changes to Global Periods
In 2015, we learned that 10- and 90-day global periods would be eliminated in 2017 and 2018, respectively, with great concern on the part of the government about the number and level of evaluation and management services embedded in these codes. The implementation of global policy elimination was prohibited by MACRA and the CMS was required to develop and implement a process to gather data on services furnished in the global period from a representative sample of physicians, which they will use to value surgical services beginningin 2019.1 The CMS decided to capture this data with a new set of time-based G codes (which would be onerous for all practicing physicians), not just the unlucky folks who were to be the sample mandated under MACRA.2 During the comment period, it became obvious to the CMS that this concept was flawed for many reasons and it decided to hold a town hall meeting at the CMS headquarters on August 25, 2016, on data collection on resources used in furnishing global services in which 90 minutes of live testimony in the morning was followed by another 90 minutes by telephone in the afternoon.3 This meeting, which I attended, resulted in the CMS changing the all-practitioner reporting program to a specified sample with others allowed to opt in. Practitioners in groups of less than 10 are exempt, and only physicians in Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island must capture data beginning in July 2017.1 These data only have to be captured on codes that are used by more than 100 practitioners and are furnished at least 10,000 times or have allowed charges of greater than $10,000,000 annually. If you are lucky enough to live in one of the testing states, you must start on July 1 but can start before July 1 if you wish. Practitioners in smaller practices or in other geographic areas are encouraged to report data if feasible but are not required to do so. Current Procedural Terminology (CPT) code 99024 will be used for reporting postoperative services rather than the proposed onerous set of G codes, and reporting will not be required for preoperative visits included in the global package or for services not related to the patient’s visit.
Changes to Chronic Care Management
There are new and modified chronic care management codes that are not of use to you unless you are the primary provider for the patient and you and the patient meet multiple stringent requirements.4 The patient must have multiple illnesses, use multiple medications, be unable to perform activities of daily living, require a caregiver, and/or have repeat admissions or emergency department visits. Typical adult patients who receive complex chronic care management services are treated with 3 or more prescription medications and may be receiving other types of therapeutic interventions (eg, physical therapy, occupational therapy). Typical pediatric patients receive 3 or more therapeutic interventions (eg, medications, nutritional support, respiratory therapy). All patients have 2 or more chronic continuous or episodic health conditions that are expected to last at least 12 months or until the death of the patient and place the patient at serious risk for death, acute exacerbation/decompensation, or functional decline.4
Changes to Moderate Sedation Codes
The economic value of providing moderate sedation (eg, drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation) used to be embedded in a variety of CPT codes, which is no longer the case in 2017. Diazepam or similar drugs swallowed or dissolved under the tongue are not included. The new CPT codes 99151, 99152, 99153, 99155, 99156, and 99157 are not to be used to report administration of medications for pain control or minimal sedation (anxiolysis). An independent trained observer, an individual who is qualified to monitor the patient during the procedure and who has no other duties (eg, assisting at surgery) during the procedure, must be present. If you are thinking of using these codes, read the entire section in the CPT manual,4 check your state laws, and consult your malpractice carrier and perhaps even your health care attorney.
Changes to Nail Procedure Codes
Current Procedural Terminology code 11752 (excision of nail and nail matrix, partial or complete [eg, ingrown or deformed nail], for permanent removal; with amputation of tuft of distal phalanx) is now gone, while base code 11750 remains. If you are doing nail surgery and removing underlying bone, instead use code 26236 (partial excision [craterization, saucerization, or diaphysectomy] bone [eg, osteomyelitis]; distal phalanx of finger), 28124 (partial excision [craterization, saucerization, sequestrectomy, or diaphysectomy] bone [eg, osteomyelitis or bossing]; phalanx of toe), or other codes in the same section of the CPT manual if they more precisely describe the procedure performed.
Changes to Slide Consultation Codes
The slide consultation codes 88321 (consultation and report on referred slides prepared elsewhere), 88323 (consultation and report on referred material requiring preparation of slides), and 88325 (consultation, comprehensive, with review of records and specimens, with report on referred material) were revalued this year, with the first 2 showing no change but the latter showing an increase in value from 2.50 to 2.85 RVUs.1 None are meant to be routine. If you have every slide looked at by someone else for “quality assurance reasons,” the consultation is not reportable. If you use these consultation codes too often, the CMS might have concerns about fraud and abuse. Visit http://data.cms.gov to see how you compare to your peers.
Changes to Reflectance Confocal Microscopy Codes
Reflectance confocal microscopy had new codes for 2016, which were carrier priced, and in 2017 they have real RVUs per the CMS. The payments for these codes have a national average reimbursement of $161.85 for 96931 (reflectance confocal microscopy for cellular and subcellular imaging of skin; image acquisition and interpretation and report, first lesion), $104.80 for 96932 (image acquisition only, first lesion), and $45.94 for 96933 (interpretation and report only, first lesion).5 The respective add-on codes have values of $83.26 for 96934 (image acquisition and interpretation and report, each additional lesion [list separately in addition to code for primary procedure]), $35.17 for 96935 (image acquisition only, each additional lesion [list separately in addition to code for primary procedure]), and $43.78 for 96936 (interpretation and report only, each additional lesion [list separately in addition to code for primary procedure]).
Other Coding Changes
There are a whole bunch of new codes in the “Genomic Sequencing Procedures and Other Molecular Multianalyte Assays” (MMAAs) section of CPT. The important thing for you to remember is these codes are for the laboratory performing the assay to report, not the physician ordering it. There is a new Appendix O for proprietary laboratory analysis MMAAs, including those that do not have a Category I code. These MMAAs are identified in Appendix O by a 4-digit number followed by the letter M.4
There are some revisions to psychotherapy codes 90832 to 90847. These codes are outside our scope of practice and should only be used by psychiatrists, social workers, psychologists, or other appropriate mental health workers.
Final Thoughts
It has not been a breakout year for telehealth and we still do not have payment for store-and-forward teledermatology, except in a few designated rural areas. With the advent of the rhetoric we have heard after the presidential election, any speculation on what will happen to the brave new world of the merit-based incentive payment system, alternative payment models, and other regulations are anyone’s guess.
- Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Fed Regist. 2016;81(220):80170-80562. To be codified at 42 CFR § 405, 410, 411, 414, 417, 422, 423, 424, 425, and 460.
- Siegel DM. The Proposed Rule and payments for 2017: the good, the bad, and the ugly. Cutis. 2016;98:245-248.
- Data collection on resources used in furnishing global services town hall CY 2017 Medicare physician fee schedule Proposed Rule. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2017-PFS-FR-Townhall.pdf. Published August 25, 2016. Accessed January 4, 2017.
- Current Procedural Terminology 2017, Professional Edition. Chicago, IL: American Medical Association; 2016.
- Addendum B—relative value units and related information used in CY 2017 final rule. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2017-PFS-FR-Addenda.zip. Accessed January 23, 2017.
All physicians will see changes in reimbursement in 2017. A new president with a new agenda makes for an interesting time ahead for health care in the United States. However, in this time of flux, there is one constant: the Final Rule, an informal term for the annual update on how the Medicare system will function and how much you will get paid for what you do.1 The document is 393 pages and outlines what is new in the Medicare system, with lots of supplements giving granular details about physician work, overhead, and supply and labor costs. In this column, I have taken the liberty of dissecting the Final Rule for you and to bring attention to its high and low points for dermatologists.
Changes in Relative Value Units
The conversion factor has gone up, meaning you will be paid a bit more this year for what you do; it is not enough to account for inflation or the increasing cost of unfunded mandates, but it is better than nothing. Although the conversion factor was $35.8043 in 2016, it increased by more than 0.2% on January 1, 2017, to $35.8887.1 How is this conversion factor calculated? We go up 0.5% due to MACRA (Medicare Access and CHIP Reauthorization Act), down 0.013% due to budget neutrality, down 0.07% due to multiple procedure payment reduction changes, and down another 0.18% due to the misvalued code target.1 The misvalued code target is related to targets established by statute for 2016 to 2018 and payment rates are reduced across the board if they are not met.
If payments suffer from reductions in work value, they may not happen all at once. If the Centers for Medicare & Medicaid Services (CMS) reduce total relative value units (RVUs) by more than 20%, reductions will take place over at least 2 years with a single year drop maximum of 19%.1 Unfortunately, such limits do not apply to revised codes, which can take as big a hit as the CMS cares to make.
Changes to Global Periods
In 2015, we learned that 10- and 90-day global periods would be eliminated in 2017 and 2018, respectively, with great concern on the part of the government about the number and level of evaluation and management services embedded in these codes. The implementation of global policy elimination was prohibited by MACRA and the CMS was required to develop and implement a process to gather data on services furnished in the global period from a representative sample of physicians, which they will use to value surgical services beginningin 2019.1 The CMS decided to capture this data with a new set of time-based G codes (which would be onerous for all practicing physicians), not just the unlucky folks who were to be the sample mandated under MACRA.2 During the comment period, it became obvious to the CMS that this concept was flawed for many reasons and it decided to hold a town hall meeting at the CMS headquarters on August 25, 2016, on data collection on resources used in furnishing global services in which 90 minutes of live testimony in the morning was followed by another 90 minutes by telephone in the afternoon.3 This meeting, which I attended, resulted in the CMS changing the all-practitioner reporting program to a specified sample with others allowed to opt in. Practitioners in groups of less than 10 are exempt, and only physicians in Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island must capture data beginning in July 2017.1 These data only have to be captured on codes that are used by more than 100 practitioners and are furnished at least 10,000 times or have allowed charges of greater than $10,000,000 annually. If you are lucky enough to live in one of the testing states, you must start on July 1 but can start before July 1 if you wish. Practitioners in smaller practices or in other geographic areas are encouraged to report data if feasible but are not required to do so. Current Procedural Terminology (CPT) code 99024 will be used for reporting postoperative services rather than the proposed onerous set of G codes, and reporting will not be required for preoperative visits included in the global package or for services not related to the patient’s visit.
Changes to Chronic Care Management
There are new and modified chronic care management codes that are not of use to you unless you are the primary provider for the patient and you and the patient meet multiple stringent requirements.4 The patient must have multiple illnesses, use multiple medications, be unable to perform activities of daily living, require a caregiver, and/or have repeat admissions or emergency department visits. Typical adult patients who receive complex chronic care management services are treated with 3 or more prescription medications and may be receiving other types of therapeutic interventions (eg, physical therapy, occupational therapy). Typical pediatric patients receive 3 or more therapeutic interventions (eg, medications, nutritional support, respiratory therapy). All patients have 2 or more chronic continuous or episodic health conditions that are expected to last at least 12 months or until the death of the patient and place the patient at serious risk for death, acute exacerbation/decompensation, or functional decline.4
Changes to Moderate Sedation Codes
The economic value of providing moderate sedation (eg, drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation) used to be embedded in a variety of CPT codes, which is no longer the case in 2017. Diazepam or similar drugs swallowed or dissolved under the tongue are not included. The new CPT codes 99151, 99152, 99153, 99155, 99156, and 99157 are not to be used to report administration of medications for pain control or minimal sedation (anxiolysis). An independent trained observer, an individual who is qualified to monitor the patient during the procedure and who has no other duties (eg, assisting at surgery) during the procedure, must be present. If you are thinking of using these codes, read the entire section in the CPT manual,4 check your state laws, and consult your malpractice carrier and perhaps even your health care attorney.
Changes to Nail Procedure Codes
Current Procedural Terminology code 11752 (excision of nail and nail matrix, partial or complete [eg, ingrown or deformed nail], for permanent removal; with amputation of tuft of distal phalanx) is now gone, while base code 11750 remains. If you are doing nail surgery and removing underlying bone, instead use code 26236 (partial excision [craterization, saucerization, or diaphysectomy] bone [eg, osteomyelitis]; distal phalanx of finger), 28124 (partial excision [craterization, saucerization, sequestrectomy, or diaphysectomy] bone [eg, osteomyelitis or bossing]; phalanx of toe), or other codes in the same section of the CPT manual if they more precisely describe the procedure performed.
Changes to Slide Consultation Codes
The slide consultation codes 88321 (consultation and report on referred slides prepared elsewhere), 88323 (consultation and report on referred material requiring preparation of slides), and 88325 (consultation, comprehensive, with review of records and specimens, with report on referred material) were revalued this year, with the first 2 showing no change but the latter showing an increase in value from 2.50 to 2.85 RVUs.1 None are meant to be routine. If you have every slide looked at by someone else for “quality assurance reasons,” the consultation is not reportable. If you use these consultation codes too often, the CMS might have concerns about fraud and abuse. Visit http://data.cms.gov to see how you compare to your peers.
Changes to Reflectance Confocal Microscopy Codes
Reflectance confocal microscopy had new codes for 2016, which were carrier priced, and in 2017 they have real RVUs per the CMS. The payments for these codes have a national average reimbursement of $161.85 for 96931 (reflectance confocal microscopy for cellular and subcellular imaging of skin; image acquisition and interpretation and report, first lesion), $104.80 for 96932 (image acquisition only, first lesion), and $45.94 for 96933 (interpretation and report only, first lesion).5 The respective add-on codes have values of $83.26 for 96934 (image acquisition and interpretation and report, each additional lesion [list separately in addition to code for primary procedure]), $35.17 for 96935 (image acquisition only, each additional lesion [list separately in addition to code for primary procedure]), and $43.78 for 96936 (interpretation and report only, each additional lesion [list separately in addition to code for primary procedure]).
Other Coding Changes
There are a whole bunch of new codes in the “Genomic Sequencing Procedures and Other Molecular Multianalyte Assays” (MMAAs) section of CPT. The important thing for you to remember is these codes are for the laboratory performing the assay to report, not the physician ordering it. There is a new Appendix O for proprietary laboratory analysis MMAAs, including those that do not have a Category I code. These MMAAs are identified in Appendix O by a 4-digit number followed by the letter M.4
There are some revisions to psychotherapy codes 90832 to 90847. These codes are outside our scope of practice and should only be used by psychiatrists, social workers, psychologists, or other appropriate mental health workers.
Final Thoughts
It has not been a breakout year for telehealth and we still do not have payment for store-and-forward teledermatology, except in a few designated rural areas. With the advent of the rhetoric we have heard after the presidential election, any speculation on what will happen to the brave new world of the merit-based incentive payment system, alternative payment models, and other regulations are anyone’s guess.
All physicians will see changes in reimbursement in 2017. A new president with a new agenda makes for an interesting time ahead for health care in the United States. However, in this time of flux, there is one constant: the Final Rule, an informal term for the annual update on how the Medicare system will function and how much you will get paid for what you do.1 The document is 393 pages and outlines what is new in the Medicare system, with lots of supplements giving granular details about physician work, overhead, and supply and labor costs. In this column, I have taken the liberty of dissecting the Final Rule for you and to bring attention to its high and low points for dermatologists.
Changes in Relative Value Units
The conversion factor has gone up, meaning you will be paid a bit more this year for what you do; it is not enough to account for inflation or the increasing cost of unfunded mandates, but it is better than nothing. Although the conversion factor was $35.8043 in 2016, it increased by more than 0.2% on January 1, 2017, to $35.8887.1 How is this conversion factor calculated? We go up 0.5% due to MACRA (Medicare Access and CHIP Reauthorization Act), down 0.013% due to budget neutrality, down 0.07% due to multiple procedure payment reduction changes, and down another 0.18% due to the misvalued code target.1 The misvalued code target is related to targets established by statute for 2016 to 2018 and payment rates are reduced across the board if they are not met.
If payments suffer from reductions in work value, they may not happen all at once. If the Centers for Medicare & Medicaid Services (CMS) reduce total relative value units (RVUs) by more than 20%, reductions will take place over at least 2 years with a single year drop maximum of 19%.1 Unfortunately, such limits do not apply to revised codes, which can take as big a hit as the CMS cares to make.
Changes to Global Periods
In 2015, we learned that 10- and 90-day global periods would be eliminated in 2017 and 2018, respectively, with great concern on the part of the government about the number and level of evaluation and management services embedded in these codes. The implementation of global policy elimination was prohibited by MACRA and the CMS was required to develop and implement a process to gather data on services furnished in the global period from a representative sample of physicians, which they will use to value surgical services beginningin 2019.1 The CMS decided to capture this data with a new set of time-based G codes (which would be onerous for all practicing physicians), not just the unlucky folks who were to be the sample mandated under MACRA.2 During the comment period, it became obvious to the CMS that this concept was flawed for many reasons and it decided to hold a town hall meeting at the CMS headquarters on August 25, 2016, on data collection on resources used in furnishing global services in which 90 minutes of live testimony in the morning was followed by another 90 minutes by telephone in the afternoon.3 This meeting, which I attended, resulted in the CMS changing the all-practitioner reporting program to a specified sample with others allowed to opt in. Practitioners in groups of less than 10 are exempt, and only physicians in Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio, Oregon, and Rhode Island must capture data beginning in July 2017.1 These data only have to be captured on codes that are used by more than 100 practitioners and are furnished at least 10,000 times or have allowed charges of greater than $10,000,000 annually. If you are lucky enough to live in one of the testing states, you must start on July 1 but can start before July 1 if you wish. Practitioners in smaller practices or in other geographic areas are encouraged to report data if feasible but are not required to do so. Current Procedural Terminology (CPT) code 99024 will be used for reporting postoperative services rather than the proposed onerous set of G codes, and reporting will not be required for preoperative visits included in the global package or for services not related to the patient’s visit.
Changes to Chronic Care Management
There are new and modified chronic care management codes that are not of use to you unless you are the primary provider for the patient and you and the patient meet multiple stringent requirements.4 The patient must have multiple illnesses, use multiple medications, be unable to perform activities of daily living, require a caregiver, and/or have repeat admissions or emergency department visits. Typical adult patients who receive complex chronic care management services are treated with 3 or more prescription medications and may be receiving other types of therapeutic interventions (eg, physical therapy, occupational therapy). Typical pediatric patients receive 3 or more therapeutic interventions (eg, medications, nutritional support, respiratory therapy). All patients have 2 or more chronic continuous or episodic health conditions that are expected to last at least 12 months or until the death of the patient and place the patient at serious risk for death, acute exacerbation/decompensation, or functional decline.4
Changes to Moderate Sedation Codes
The economic value of providing moderate sedation (eg, drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation) used to be embedded in a variety of CPT codes, which is no longer the case in 2017. Diazepam or similar drugs swallowed or dissolved under the tongue are not included. The new CPT codes 99151, 99152, 99153, 99155, 99156, and 99157 are not to be used to report administration of medications for pain control or minimal sedation (anxiolysis). An independent trained observer, an individual who is qualified to monitor the patient during the procedure and who has no other duties (eg, assisting at surgery) during the procedure, must be present. If you are thinking of using these codes, read the entire section in the CPT manual,4 check your state laws, and consult your malpractice carrier and perhaps even your health care attorney.
Changes to Nail Procedure Codes
Current Procedural Terminology code 11752 (excision of nail and nail matrix, partial or complete [eg, ingrown or deformed nail], for permanent removal; with amputation of tuft of distal phalanx) is now gone, while base code 11750 remains. If you are doing nail surgery and removing underlying bone, instead use code 26236 (partial excision [craterization, saucerization, or diaphysectomy] bone [eg, osteomyelitis]; distal phalanx of finger), 28124 (partial excision [craterization, saucerization, sequestrectomy, or diaphysectomy] bone [eg, osteomyelitis or bossing]; phalanx of toe), or other codes in the same section of the CPT manual if they more precisely describe the procedure performed.
Changes to Slide Consultation Codes
The slide consultation codes 88321 (consultation and report on referred slides prepared elsewhere), 88323 (consultation and report on referred material requiring preparation of slides), and 88325 (consultation, comprehensive, with review of records and specimens, with report on referred material) were revalued this year, with the first 2 showing no change but the latter showing an increase in value from 2.50 to 2.85 RVUs.1 None are meant to be routine. If you have every slide looked at by someone else for “quality assurance reasons,” the consultation is not reportable. If you use these consultation codes too often, the CMS might have concerns about fraud and abuse. Visit http://data.cms.gov to see how you compare to your peers.
Changes to Reflectance Confocal Microscopy Codes
Reflectance confocal microscopy had new codes for 2016, which were carrier priced, and in 2017 they have real RVUs per the CMS. The payments for these codes have a national average reimbursement of $161.85 for 96931 (reflectance confocal microscopy for cellular and subcellular imaging of skin; image acquisition and interpretation and report, first lesion), $104.80 for 96932 (image acquisition only, first lesion), and $45.94 for 96933 (interpretation and report only, first lesion).5 The respective add-on codes have values of $83.26 for 96934 (image acquisition and interpretation and report, each additional lesion [list separately in addition to code for primary procedure]), $35.17 for 96935 (image acquisition only, each additional lesion [list separately in addition to code for primary procedure]), and $43.78 for 96936 (interpretation and report only, each additional lesion [list separately in addition to code for primary procedure]).
Other Coding Changes
There are a whole bunch of new codes in the “Genomic Sequencing Procedures and Other Molecular Multianalyte Assays” (MMAAs) section of CPT. The important thing for you to remember is these codes are for the laboratory performing the assay to report, not the physician ordering it. There is a new Appendix O for proprietary laboratory analysis MMAAs, including those that do not have a Category I code. These MMAAs are identified in Appendix O by a 4-digit number followed by the letter M.4
There are some revisions to psychotherapy codes 90832 to 90847. These codes are outside our scope of practice and should only be used by psychiatrists, social workers, psychologists, or other appropriate mental health workers.
Final Thoughts
It has not been a breakout year for telehealth and we still do not have payment for store-and-forward teledermatology, except in a few designated rural areas. With the advent of the rhetoric we have heard after the presidential election, any speculation on what will happen to the brave new world of the merit-based incentive payment system, alternative payment models, and other regulations are anyone’s guess.
- Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Fed Regist. 2016;81(220):80170-80562. To be codified at 42 CFR § 405, 410, 411, 414, 417, 422, 423, 424, 425, and 460.
- Siegel DM. The Proposed Rule and payments for 2017: the good, the bad, and the ugly. Cutis. 2016;98:245-248.
- Data collection on resources used in furnishing global services town hall CY 2017 Medicare physician fee schedule Proposed Rule. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2017-PFS-FR-Townhall.pdf. Published August 25, 2016. Accessed January 4, 2017.
- Current Procedural Terminology 2017, Professional Edition. Chicago, IL: American Medical Association; 2016.
- Addendum B—relative value units and related information used in CY 2017 final rule. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2017-PFS-FR-Addenda.zip. Accessed January 23, 2017.
- Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements. Fed Regist. 2016;81(220):80170-80562. To be codified at 42 CFR § 405, 410, 411, 414, 417, 422, 423, 424, 425, and 460.
- Siegel DM. The Proposed Rule and payments for 2017: the good, the bad, and the ugly. Cutis. 2016;98:245-248.
- Data collection on resources used in furnishing global services town hall CY 2017 Medicare physician fee schedule Proposed Rule. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2017-PFS-FR-Townhall.pdf. Published August 25, 2016. Accessed January 4, 2017.
- Current Procedural Terminology 2017, Professional Edition. Chicago, IL: American Medical Association; 2016.
- Addendum B—relative value units and related information used in CY 2017 final rule. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/CY2017-PFS-FR-Addenda.zip. Accessed January 23, 2017.
Practice Points
- The conversion factor has increased more than 0.2%, which means you will be paid a bit more this year.
- Review Current Procedural Terminology codes carefully for pain control or moderate sedation as well as nail surgery and slide consultation.
- Reflectance confocal microscopy now has relative value units assigned by the Centers for Medicare & Medicaid Services.
Photoprotection Prevents Skin Cancer: Let’s Make It Fashionable to Wear Sun-Protective Clothing
Photoprotection is the foundation of all skin cancer prevention, as UV radiation (UVR) exposure is the only known modifiable risk factor for skin cancer. With the majority of UVR exposure–induced skin cancers found on the scalp, ears, face, and neck, public health initiatives call for wise choices in personal fashion that emphasize the importance of covering these areas.1-3 From a science of fashion perspective, research has shown that wide-brimmed hats provide better means of ensuring the largest area of coverage compared to standard baseball-style hats.4 Thus, for maximum protection, wide-brimmed hats should be favored. However, in academic and military settings, individual style is not optional and is instead influenced or directed by policy, which may not be aligned with the goal of providing photoprotection and raises additional concern for individuals working in environments with longer periods of peak daylight UVR exposure.
In all military branches, service members don uniforms that include head coverage when operating outdoors; however, the choice of headgear is not always aimed at reducing UVR exposure. Similarly, in our counterpart civilian populations, wearing hats that provide the best photoprotection may be influenced by school policies, which frequently mandate clothing choices for children, or by the press or fashion industry in the general public, which might portray sun-protective garments as unfashionable or in some cases threatening if perceived as demonstrating gang affiliation.5 This article serves to encourage health care providers to not only discuss the use of sunscreen when educating patients on sun protection but also to emphasize the benefits of wearing photoprotective garments, particularly wide-brimmed hats given their simplicity, reusability, and affordability. Hat use is particularly important for men with comorbid androgenetic alopecia.6
Skin Cancer Risk
Unfortunately, the incidence of most common types of skin cancer, specifically nonmelanoma skin cancers such basal cell carcinomas and squamous cell carcinomas (ie, keratinocyte carcinomas [KCs]), is difficult to estimate properly, as these cases are not required to be reported to worldwide cancer registries. However, more than 5.4 million cases of skin cancers were diagnosed among 3.3 million Americans in 2016, with an estimated 13,650 deaths associated with skin cancers (not including KCs).3 Tracking and data analyses of cases diagnosed in the active and reserve component populations of the US Armed Forces reflect parallel findings.7 Keratinocyte carcinomas could be considered largely preventable, as most are the result of UVR exposure.1 Additionally, it has been suggested that the vast majority of mutations in melanoma skin cancers (up to 86%) are caused by UVR exposure.8
Prevention
United States–based national public health services such as the American Cancer Society, the Centers for Disease Control and Prevention, and the American Academy of Dermatology embrace photoprotection as the central practice in reducing risk factors for skin cancers. Guidelines put forth by these and other national preventive medical institutions specifically recommend the use of wide-brimmed hats as the best option for protection of the face, head, ears, and neck, in addition to more common recommendations such as seeking shade, avoiding sunlight during peak hours of the day, and using sunscreen.1-3 At state and local levels, policies should be adapted from these recommendations to support protective practices and skin cancer education that begins early for school-aged children. Unfortunately, in some school districts, wearing hats of any kind may be perceived as disruptive or in some cases baseball hats may be a sign of gang affiliation and are therefore banned in the schoolyard.5 The opposite is true in certain parts of the world where sun protection is embraced by the population as a whole, such as Australia where the widely accepted “slip, slop and slap, seek and slide” campaign has extended to some school policymakers who have considered adopting a “no hat, no play” policy.9,10
Sunscreen use as a primary component of photoprotection has its disadvantages in comparison to wearing protective clothing, as sunscreen cannot be reused and proper usage requires reapplication after swimming, when sweating, and following 2 hours of application.1-3 The need for reapplication of sunscreen can lead to considerable expense as well as time spent in application and reapplication. Additionally, for individuals who are physically active (eg, operationally engaged service members, outdoor athletes), sunscreen applied to the face may become a hindrance to function, as it may drip or enter the eyes with excessive sweating, possibly impairing vision. Some individuals may be averse to applying lotions or creams to the skin in general, as they do not prefer the textural changes or appearance of the skin after application. The application of sunscreen also could impair use of lifesaving military gear (eg, gas masks, helmets) from fitting or securing appropriately.
Patient Education
From a military perspective, a review of a recent targeted pilot study in which skin cancer patients at a US Veterans Administration hospital were surveyed on personal knowledge of UVR protection showed that respondents who had a history of skin cancer diagnosis did not feel that they had ever been at an increased risk for skin cancers and did not receive skin cancer prevention education during their tours of service. The overwhelming majority of all participants in this study agreed that the military should issue sun-protective clothing and sunscreen to active-duty personnel.11 Another 2015 survey of 356 current US Air Force flight line personnel noted that active-duty service members tend not to use sunscreen when at work or while at home, and 43% of participants reported using no sun-protective methods while working outdoors.12 Although these studies focused on military personal, the data mirror findings within the general public, as it was shown in a survey by the Centers for Disease Control and Prevention that Americans do not fully take advantage of the benefits of UVR protection, specifically with regard to sunscreen use. Little to no usage was correlated with low socioeconomic status, suggesting that a reusable form of protection could be preferred.13
Public health initiatives typically promote education on the use of sunscreen in populations that spend a considerable amount of time working outdoors (eg, construction workers, farmers, military personnel); however, we feel emphasis should be placed on the benefits of wearing hats, as the UVR exposure protection they provide does not wear off, is cost effective, does not require reapplication, and has the advantage of being a recyclable and affordable form of photoprotection.
History of the Military-Grade Wide-Brimmed Hat
One military-specific example of a sun-protective hat is the boonie hat, known at the time of its inception as the tropical or hot-weather hat, which first became popular during the Vietnam War. This hat option was initially proposed on April 7, 1966, when it was realized that a full-brimmed field hat was needed to protect soldiers’ faces and necks from rain and sun in harsh tropical climates.14 Unfortunately, despite the protective advantages of this style of head covering and favorable support from service members themselves, the boonie hat was not widely accepted, as commanders disliked its “unmilitary appearance.” Fervent protests by units throughout Vietnam eventually led to a compromise in policy that allowed unit-level commanders to authorize the use of boonie hats for units in combat or combat support field operations.14 Today, the boonie hat continues to garnish mixed emotions from unit commanders, as wearing this garment often is interpreted as not being in line with an appropriate military appearance, which is similar to the public fashion zeitgeist that also does not openly endorse the use of sun-protective garments. A change in fashion culture and policy (both military and civilian) that promotes sun-protective measures is needed.
Wide-Brimmed Hats Are Superior to Baseball Hats
The distribution of skin cancers across anatomic sites is consistent and proportional with the level and frequency of chronic UVR exposure, with the occurrence of most skin cancers being greatest on the nose, forehead/temples, cheeks/perioral areas, and ears.15 Additionally, higher incidences of skin cancers have been noted in chronically sun-exposed areas of the head and neck in men versus women. It is thought that hair distribution in these areas may be the causal factor.6
Baseball-style hats are worn by all branches of the US military as part of standard training and work duty uniform requirements, primarily for the sake of tradition by maintaining a standard appearance and uniform dress code but also to provide photoprotection to these vulnerable areas of the body. Standard, nonmilitary, baseball-style hats have been shown to provide UV protection factor (UPF) equivalents ranging from 2 to 10 on sites known for the highest levels of exposure.16 Military “patrol caps,” fashioned similar to the baseball-style hat but constructed from military-grade textiles, provide greater levels of photoprotection with UPF ratings from 35 to 50 and higher depending on the fabric color.17 Although patrol caps have a favorable UPF rating and are advantageous compared to former military headgear styles (eg, berets), wide-brimmed hats would provide greater overall coverage.4,6 Studies in school environments also revealed that wide-brimmed hats come out ahead in side-by-side testing against baseball hats and are shown to provide greater photoprotection for the cheeks, chin, ears, and neck.16
Final Thoughts
The battle to educate the public about adequate photoprotection to prevent skin cancers caused by UVR exposure applies to all providers, both military and civilian. Our ongoing initiatives should not only sustain current practices but should further stress the importance of wearing wide-brimmed hats as a vital part of coverage of the skin and protection from UVR. We must combat the public perception that wearing wide-brimmed hats is a detractor of personal fashion and that instead it is desirable to reduce the risk for skin cancer. The wide-brimmed hat is a simple, reusable, and easily executed recommendation that should be made to all patients, both military and civilian, young and old. In conclusion, by improving patients’ perceptions and acknowledgment of the importance of photoprotection as well as making a concerted effort to integrate our knowledge in the fashion industry, in policies at schools, in the military, and in popular culture, we will undoubtedly come to agree that it is not unfashionable to wear a wide-brimmed hat, but it is unfashionable to risk developing skin cancer.
- Prevent skin cancer. American Academy of Dermatology website. https://www.aad.org/public/spot-skin-cancer/learn-about-skin-cancer/prevent. Accessed January 4, 2017.
- What can I do to reduce my risk of skin cancer? Centers for Disease Control and Prevention website. http://www.cdc.gov/cancer/skin/basic_info/prevention.htm. Accessed January 4, 2017.
- Cancer facts & figures 2016. American Cancer Society website. http://www.cancer.org/acs/groups/content/@research/documents/document/acspc-047079.pdf. Accessed January 4, 2017.
- Diffey BL, Cheeseman J. Sun protection with hats. Br J Dermatol. 1992;127:10-12.
- Bray FN. Florida school boards restrict access to outdoor sun protection: an observational study. J Am Acad Dermatol. 2016;75:642-644.
- Yeung H, Luk KM, Chen SC. Focal photodamage on the occipital scalp. JAMA Dermatol. 2016;152:1060-1062.
- Lee T, Williams VF, Clark LL. Incident diagnoses of cancers in the active component and cancer-related deaths in the active and reserve components, U.S. Armed Forces, 2005-2014. MSMR. 2016;23:23-31.
- Parkin DM, Mesher D, Sasieni P. Cancers attributable to solar (ultraviolet) radiation exposure in the UK in 2010. Br J Cancer. 2011;105(suppl 2):S66-S69.
- Casper K. Elementary schools consider “no hat no play policy.” Coolibar website. http://blog.coolibar.com/elementary-schools-consider-no-hat-no-play-policy/. Published March 27, 2012. Accessed January 4, 2017.
- Slip, slop, slap, seek & slide: Sid Seagull. SunSmart Victoria website. http://www.sunsmart.com.au/tools/videos/current-tv-campaigns/slip-slop-slap-seek-slide-sid-seagull.html. Accessed January 4, 2017.
- McGrath JM, Fisher V, Krejci-Manwaring J. Skin cancer warnings and the need for new preventive campaigns - a pilot study. Am J Prev Med. 2016;50:E62-E63.
- Parker G, Williams B, Driggers P. Sun exposure knowledge and practices survey of maintenance squadrons at Travis AFB. Mil Med. 2015;180:26-31.
- Holman DM, Berkowitz Z, Guy GP Jr, et al. Patterns of sunscreen use on the face and other exposed skin among US adults [published online May 19, 2015]. J Am Acad Dermatol. 2015;73:83-92.e1.
- Stanton SL. Headgear. In: Stanton SL. U.S. Army Uniforms of the Vietnam War. Harrisburg, PA: Stackpole Books; 1992:26-61.
- Richmond-Sinclair NM, Pandeya N, Ware RS, et al. Incidence of basal cell carcinoma multiplicity and detailed anatomic distribution: longitudinal study of an Australian population [published online July 31, 2008]. J Invest Dermatol. 2009;129:323-328.
- Gies P, Javorniczky J, Roy C, et al. Measurements of the UVR protection provided by hats used at school. Photochem Photobiol. 2006;82:750-754.
- Winterhalter C, DiLuna K, Bide M. Characterization of the Ultraviolet Protection of Combat Uniform Fabrics. Natick, MA: US Army Solider and Biological Chemical Command; 2002. Technical report 02/006.
Photoprotection is the foundation of all skin cancer prevention, as UV radiation (UVR) exposure is the only known modifiable risk factor for skin cancer. With the majority of UVR exposure–induced skin cancers found on the scalp, ears, face, and neck, public health initiatives call for wise choices in personal fashion that emphasize the importance of covering these areas.1-3 From a science of fashion perspective, research has shown that wide-brimmed hats provide better means of ensuring the largest area of coverage compared to standard baseball-style hats.4 Thus, for maximum protection, wide-brimmed hats should be favored. However, in academic and military settings, individual style is not optional and is instead influenced or directed by policy, which may not be aligned with the goal of providing photoprotection and raises additional concern for individuals working in environments with longer periods of peak daylight UVR exposure.
In all military branches, service members don uniforms that include head coverage when operating outdoors; however, the choice of headgear is not always aimed at reducing UVR exposure. Similarly, in our counterpart civilian populations, wearing hats that provide the best photoprotection may be influenced by school policies, which frequently mandate clothing choices for children, or by the press or fashion industry in the general public, which might portray sun-protective garments as unfashionable or in some cases threatening if perceived as demonstrating gang affiliation.5 This article serves to encourage health care providers to not only discuss the use of sunscreen when educating patients on sun protection but also to emphasize the benefits of wearing photoprotective garments, particularly wide-brimmed hats given their simplicity, reusability, and affordability. Hat use is particularly important for men with comorbid androgenetic alopecia.6
Skin Cancer Risk
Unfortunately, the incidence of most common types of skin cancer, specifically nonmelanoma skin cancers such basal cell carcinomas and squamous cell carcinomas (ie, keratinocyte carcinomas [KCs]), is difficult to estimate properly, as these cases are not required to be reported to worldwide cancer registries. However, more than 5.4 million cases of skin cancers were diagnosed among 3.3 million Americans in 2016, with an estimated 13,650 deaths associated with skin cancers (not including KCs).3 Tracking and data analyses of cases diagnosed in the active and reserve component populations of the US Armed Forces reflect parallel findings.7 Keratinocyte carcinomas could be considered largely preventable, as most are the result of UVR exposure.1 Additionally, it has been suggested that the vast majority of mutations in melanoma skin cancers (up to 86%) are caused by UVR exposure.8
Prevention
United States–based national public health services such as the American Cancer Society, the Centers for Disease Control and Prevention, and the American Academy of Dermatology embrace photoprotection as the central practice in reducing risk factors for skin cancers. Guidelines put forth by these and other national preventive medical institutions specifically recommend the use of wide-brimmed hats as the best option for protection of the face, head, ears, and neck, in addition to more common recommendations such as seeking shade, avoiding sunlight during peak hours of the day, and using sunscreen.1-3 At state and local levels, policies should be adapted from these recommendations to support protective practices and skin cancer education that begins early for school-aged children. Unfortunately, in some school districts, wearing hats of any kind may be perceived as disruptive or in some cases baseball hats may be a sign of gang affiliation and are therefore banned in the schoolyard.5 The opposite is true in certain parts of the world where sun protection is embraced by the population as a whole, such as Australia where the widely accepted “slip, slop and slap, seek and slide” campaign has extended to some school policymakers who have considered adopting a “no hat, no play” policy.9,10
Sunscreen use as a primary component of photoprotection has its disadvantages in comparison to wearing protective clothing, as sunscreen cannot be reused and proper usage requires reapplication after swimming, when sweating, and following 2 hours of application.1-3 The need for reapplication of sunscreen can lead to considerable expense as well as time spent in application and reapplication. Additionally, for individuals who are physically active (eg, operationally engaged service members, outdoor athletes), sunscreen applied to the face may become a hindrance to function, as it may drip or enter the eyes with excessive sweating, possibly impairing vision. Some individuals may be averse to applying lotions or creams to the skin in general, as they do not prefer the textural changes or appearance of the skin after application. The application of sunscreen also could impair use of lifesaving military gear (eg, gas masks, helmets) from fitting or securing appropriately.
Patient Education
From a military perspective, a review of a recent targeted pilot study in which skin cancer patients at a US Veterans Administration hospital were surveyed on personal knowledge of UVR protection showed that respondents who had a history of skin cancer diagnosis did not feel that they had ever been at an increased risk for skin cancers and did not receive skin cancer prevention education during their tours of service. The overwhelming majority of all participants in this study agreed that the military should issue sun-protective clothing and sunscreen to active-duty personnel.11 Another 2015 survey of 356 current US Air Force flight line personnel noted that active-duty service members tend not to use sunscreen when at work or while at home, and 43% of participants reported using no sun-protective methods while working outdoors.12 Although these studies focused on military personal, the data mirror findings within the general public, as it was shown in a survey by the Centers for Disease Control and Prevention that Americans do not fully take advantage of the benefits of UVR protection, specifically with regard to sunscreen use. Little to no usage was correlated with low socioeconomic status, suggesting that a reusable form of protection could be preferred.13
Public health initiatives typically promote education on the use of sunscreen in populations that spend a considerable amount of time working outdoors (eg, construction workers, farmers, military personnel); however, we feel emphasis should be placed on the benefits of wearing hats, as the UVR exposure protection they provide does not wear off, is cost effective, does not require reapplication, and has the advantage of being a recyclable and affordable form of photoprotection.
History of the Military-Grade Wide-Brimmed Hat
One military-specific example of a sun-protective hat is the boonie hat, known at the time of its inception as the tropical or hot-weather hat, which first became popular during the Vietnam War. This hat option was initially proposed on April 7, 1966, when it was realized that a full-brimmed field hat was needed to protect soldiers’ faces and necks from rain and sun in harsh tropical climates.14 Unfortunately, despite the protective advantages of this style of head covering and favorable support from service members themselves, the boonie hat was not widely accepted, as commanders disliked its “unmilitary appearance.” Fervent protests by units throughout Vietnam eventually led to a compromise in policy that allowed unit-level commanders to authorize the use of boonie hats for units in combat or combat support field operations.14 Today, the boonie hat continues to garnish mixed emotions from unit commanders, as wearing this garment often is interpreted as not being in line with an appropriate military appearance, which is similar to the public fashion zeitgeist that also does not openly endorse the use of sun-protective garments. A change in fashion culture and policy (both military and civilian) that promotes sun-protective measures is needed.
Wide-Brimmed Hats Are Superior to Baseball Hats
The distribution of skin cancers across anatomic sites is consistent and proportional with the level and frequency of chronic UVR exposure, with the occurrence of most skin cancers being greatest on the nose, forehead/temples, cheeks/perioral areas, and ears.15 Additionally, higher incidences of skin cancers have been noted in chronically sun-exposed areas of the head and neck in men versus women. It is thought that hair distribution in these areas may be the causal factor.6
Baseball-style hats are worn by all branches of the US military as part of standard training and work duty uniform requirements, primarily for the sake of tradition by maintaining a standard appearance and uniform dress code but also to provide photoprotection to these vulnerable areas of the body. Standard, nonmilitary, baseball-style hats have been shown to provide UV protection factor (UPF) equivalents ranging from 2 to 10 on sites known for the highest levels of exposure.16 Military “patrol caps,” fashioned similar to the baseball-style hat but constructed from military-grade textiles, provide greater levels of photoprotection with UPF ratings from 35 to 50 and higher depending on the fabric color.17 Although patrol caps have a favorable UPF rating and are advantageous compared to former military headgear styles (eg, berets), wide-brimmed hats would provide greater overall coverage.4,6 Studies in school environments also revealed that wide-brimmed hats come out ahead in side-by-side testing against baseball hats and are shown to provide greater photoprotection for the cheeks, chin, ears, and neck.16
Final Thoughts
The battle to educate the public about adequate photoprotection to prevent skin cancers caused by UVR exposure applies to all providers, both military and civilian. Our ongoing initiatives should not only sustain current practices but should further stress the importance of wearing wide-brimmed hats as a vital part of coverage of the skin and protection from UVR. We must combat the public perception that wearing wide-brimmed hats is a detractor of personal fashion and that instead it is desirable to reduce the risk for skin cancer. The wide-brimmed hat is a simple, reusable, and easily executed recommendation that should be made to all patients, both military and civilian, young and old. In conclusion, by improving patients’ perceptions and acknowledgment of the importance of photoprotection as well as making a concerted effort to integrate our knowledge in the fashion industry, in policies at schools, in the military, and in popular culture, we will undoubtedly come to agree that it is not unfashionable to wear a wide-brimmed hat, but it is unfashionable to risk developing skin cancer.
Photoprotection is the foundation of all skin cancer prevention, as UV radiation (UVR) exposure is the only known modifiable risk factor for skin cancer. With the majority of UVR exposure–induced skin cancers found on the scalp, ears, face, and neck, public health initiatives call for wise choices in personal fashion that emphasize the importance of covering these areas.1-3 From a science of fashion perspective, research has shown that wide-brimmed hats provide better means of ensuring the largest area of coverage compared to standard baseball-style hats.4 Thus, for maximum protection, wide-brimmed hats should be favored. However, in academic and military settings, individual style is not optional and is instead influenced or directed by policy, which may not be aligned with the goal of providing photoprotection and raises additional concern for individuals working in environments with longer periods of peak daylight UVR exposure.
In all military branches, service members don uniforms that include head coverage when operating outdoors; however, the choice of headgear is not always aimed at reducing UVR exposure. Similarly, in our counterpart civilian populations, wearing hats that provide the best photoprotection may be influenced by school policies, which frequently mandate clothing choices for children, or by the press or fashion industry in the general public, which might portray sun-protective garments as unfashionable or in some cases threatening if perceived as demonstrating gang affiliation.5 This article serves to encourage health care providers to not only discuss the use of sunscreen when educating patients on sun protection but also to emphasize the benefits of wearing photoprotective garments, particularly wide-brimmed hats given their simplicity, reusability, and affordability. Hat use is particularly important for men with comorbid androgenetic alopecia.6
Skin Cancer Risk
Unfortunately, the incidence of most common types of skin cancer, specifically nonmelanoma skin cancers such basal cell carcinomas and squamous cell carcinomas (ie, keratinocyte carcinomas [KCs]), is difficult to estimate properly, as these cases are not required to be reported to worldwide cancer registries. However, more than 5.4 million cases of skin cancers were diagnosed among 3.3 million Americans in 2016, with an estimated 13,650 deaths associated with skin cancers (not including KCs).3 Tracking and data analyses of cases diagnosed in the active and reserve component populations of the US Armed Forces reflect parallel findings.7 Keratinocyte carcinomas could be considered largely preventable, as most are the result of UVR exposure.1 Additionally, it has been suggested that the vast majority of mutations in melanoma skin cancers (up to 86%) are caused by UVR exposure.8
Prevention
United States–based national public health services such as the American Cancer Society, the Centers for Disease Control and Prevention, and the American Academy of Dermatology embrace photoprotection as the central practice in reducing risk factors for skin cancers. Guidelines put forth by these and other national preventive medical institutions specifically recommend the use of wide-brimmed hats as the best option for protection of the face, head, ears, and neck, in addition to more common recommendations such as seeking shade, avoiding sunlight during peak hours of the day, and using sunscreen.1-3 At state and local levels, policies should be adapted from these recommendations to support protective practices and skin cancer education that begins early for school-aged children. Unfortunately, in some school districts, wearing hats of any kind may be perceived as disruptive or in some cases baseball hats may be a sign of gang affiliation and are therefore banned in the schoolyard.5 The opposite is true in certain parts of the world where sun protection is embraced by the population as a whole, such as Australia where the widely accepted “slip, slop and slap, seek and slide” campaign has extended to some school policymakers who have considered adopting a “no hat, no play” policy.9,10
Sunscreen use as a primary component of photoprotection has its disadvantages in comparison to wearing protective clothing, as sunscreen cannot be reused and proper usage requires reapplication after swimming, when sweating, and following 2 hours of application.1-3 The need for reapplication of sunscreen can lead to considerable expense as well as time spent in application and reapplication. Additionally, for individuals who are physically active (eg, operationally engaged service members, outdoor athletes), sunscreen applied to the face may become a hindrance to function, as it may drip or enter the eyes with excessive sweating, possibly impairing vision. Some individuals may be averse to applying lotions or creams to the skin in general, as they do not prefer the textural changes or appearance of the skin after application. The application of sunscreen also could impair use of lifesaving military gear (eg, gas masks, helmets) from fitting or securing appropriately.
Patient Education
From a military perspective, a review of a recent targeted pilot study in which skin cancer patients at a US Veterans Administration hospital were surveyed on personal knowledge of UVR protection showed that respondents who had a history of skin cancer diagnosis did not feel that they had ever been at an increased risk for skin cancers and did not receive skin cancer prevention education during their tours of service. The overwhelming majority of all participants in this study agreed that the military should issue sun-protective clothing and sunscreen to active-duty personnel.11 Another 2015 survey of 356 current US Air Force flight line personnel noted that active-duty service members tend not to use sunscreen when at work or while at home, and 43% of participants reported using no sun-protective methods while working outdoors.12 Although these studies focused on military personal, the data mirror findings within the general public, as it was shown in a survey by the Centers for Disease Control and Prevention that Americans do not fully take advantage of the benefits of UVR protection, specifically with regard to sunscreen use. Little to no usage was correlated with low socioeconomic status, suggesting that a reusable form of protection could be preferred.13
Public health initiatives typically promote education on the use of sunscreen in populations that spend a considerable amount of time working outdoors (eg, construction workers, farmers, military personnel); however, we feel emphasis should be placed on the benefits of wearing hats, as the UVR exposure protection they provide does not wear off, is cost effective, does not require reapplication, and has the advantage of being a recyclable and affordable form of photoprotection.
History of the Military-Grade Wide-Brimmed Hat
One military-specific example of a sun-protective hat is the boonie hat, known at the time of its inception as the tropical or hot-weather hat, which first became popular during the Vietnam War. This hat option was initially proposed on April 7, 1966, when it was realized that a full-brimmed field hat was needed to protect soldiers’ faces and necks from rain and sun in harsh tropical climates.14 Unfortunately, despite the protective advantages of this style of head covering and favorable support from service members themselves, the boonie hat was not widely accepted, as commanders disliked its “unmilitary appearance.” Fervent protests by units throughout Vietnam eventually led to a compromise in policy that allowed unit-level commanders to authorize the use of boonie hats for units in combat or combat support field operations.14 Today, the boonie hat continues to garnish mixed emotions from unit commanders, as wearing this garment often is interpreted as not being in line with an appropriate military appearance, which is similar to the public fashion zeitgeist that also does not openly endorse the use of sun-protective garments. A change in fashion culture and policy (both military and civilian) that promotes sun-protective measures is needed.
Wide-Brimmed Hats Are Superior to Baseball Hats
The distribution of skin cancers across anatomic sites is consistent and proportional with the level and frequency of chronic UVR exposure, with the occurrence of most skin cancers being greatest on the nose, forehead/temples, cheeks/perioral areas, and ears.15 Additionally, higher incidences of skin cancers have been noted in chronically sun-exposed areas of the head and neck in men versus women. It is thought that hair distribution in these areas may be the causal factor.6
Baseball-style hats are worn by all branches of the US military as part of standard training and work duty uniform requirements, primarily for the sake of tradition by maintaining a standard appearance and uniform dress code but also to provide photoprotection to these vulnerable areas of the body. Standard, nonmilitary, baseball-style hats have been shown to provide UV protection factor (UPF) equivalents ranging from 2 to 10 on sites known for the highest levels of exposure.16 Military “patrol caps,” fashioned similar to the baseball-style hat but constructed from military-grade textiles, provide greater levels of photoprotection with UPF ratings from 35 to 50 and higher depending on the fabric color.17 Although patrol caps have a favorable UPF rating and are advantageous compared to former military headgear styles (eg, berets), wide-brimmed hats would provide greater overall coverage.4,6 Studies in school environments also revealed that wide-brimmed hats come out ahead in side-by-side testing against baseball hats and are shown to provide greater photoprotection for the cheeks, chin, ears, and neck.16
Final Thoughts
The battle to educate the public about adequate photoprotection to prevent skin cancers caused by UVR exposure applies to all providers, both military and civilian. Our ongoing initiatives should not only sustain current practices but should further stress the importance of wearing wide-brimmed hats as a vital part of coverage of the skin and protection from UVR. We must combat the public perception that wearing wide-brimmed hats is a detractor of personal fashion and that instead it is desirable to reduce the risk for skin cancer. The wide-brimmed hat is a simple, reusable, and easily executed recommendation that should be made to all patients, both military and civilian, young and old. In conclusion, by improving patients’ perceptions and acknowledgment of the importance of photoprotection as well as making a concerted effort to integrate our knowledge in the fashion industry, in policies at schools, in the military, and in popular culture, we will undoubtedly come to agree that it is not unfashionable to wear a wide-brimmed hat, but it is unfashionable to risk developing skin cancer.
- Prevent skin cancer. American Academy of Dermatology website. https://www.aad.org/public/spot-skin-cancer/learn-about-skin-cancer/prevent. Accessed January 4, 2017.
- What can I do to reduce my risk of skin cancer? Centers for Disease Control and Prevention website. http://www.cdc.gov/cancer/skin/basic_info/prevention.htm. Accessed January 4, 2017.
- Cancer facts & figures 2016. American Cancer Society website. http://www.cancer.org/acs/groups/content/@research/documents/document/acspc-047079.pdf. Accessed January 4, 2017.
- Diffey BL, Cheeseman J. Sun protection with hats. Br J Dermatol. 1992;127:10-12.
- Bray FN. Florida school boards restrict access to outdoor sun protection: an observational study. J Am Acad Dermatol. 2016;75:642-644.
- Yeung H, Luk KM, Chen SC. Focal photodamage on the occipital scalp. JAMA Dermatol. 2016;152:1060-1062.
- Lee T, Williams VF, Clark LL. Incident diagnoses of cancers in the active component and cancer-related deaths in the active and reserve components, U.S. Armed Forces, 2005-2014. MSMR. 2016;23:23-31.
- Parkin DM, Mesher D, Sasieni P. Cancers attributable to solar (ultraviolet) radiation exposure in the UK in 2010. Br J Cancer. 2011;105(suppl 2):S66-S69.
- Casper K. Elementary schools consider “no hat no play policy.” Coolibar website. http://blog.coolibar.com/elementary-schools-consider-no-hat-no-play-policy/. Published March 27, 2012. Accessed January 4, 2017.
- Slip, slop, slap, seek & slide: Sid Seagull. SunSmart Victoria website. http://www.sunsmart.com.au/tools/videos/current-tv-campaigns/slip-slop-slap-seek-slide-sid-seagull.html. Accessed January 4, 2017.
- McGrath JM, Fisher V, Krejci-Manwaring J. Skin cancer warnings and the need for new preventive campaigns - a pilot study. Am J Prev Med. 2016;50:E62-E63.
- Parker G, Williams B, Driggers P. Sun exposure knowledge and practices survey of maintenance squadrons at Travis AFB. Mil Med. 2015;180:26-31.
- Holman DM, Berkowitz Z, Guy GP Jr, et al. Patterns of sunscreen use on the face and other exposed skin among US adults [published online May 19, 2015]. J Am Acad Dermatol. 2015;73:83-92.e1.
- Stanton SL. Headgear. In: Stanton SL. U.S. Army Uniforms of the Vietnam War. Harrisburg, PA: Stackpole Books; 1992:26-61.
- Richmond-Sinclair NM, Pandeya N, Ware RS, et al. Incidence of basal cell carcinoma multiplicity and detailed anatomic distribution: longitudinal study of an Australian population [published online July 31, 2008]. J Invest Dermatol. 2009;129:323-328.
- Gies P, Javorniczky J, Roy C, et al. Measurements of the UVR protection provided by hats used at school. Photochem Photobiol. 2006;82:750-754.
- Winterhalter C, DiLuna K, Bide M. Characterization of the Ultraviolet Protection of Combat Uniform Fabrics. Natick, MA: US Army Solider and Biological Chemical Command; 2002. Technical report 02/006.
- Prevent skin cancer. American Academy of Dermatology website. https://www.aad.org/public/spot-skin-cancer/learn-about-skin-cancer/prevent. Accessed January 4, 2017.
- What can I do to reduce my risk of skin cancer? Centers for Disease Control and Prevention website. http://www.cdc.gov/cancer/skin/basic_info/prevention.htm. Accessed January 4, 2017.
- Cancer facts & figures 2016. American Cancer Society website. http://www.cancer.org/acs/groups/content/@research/documents/document/acspc-047079.pdf. Accessed January 4, 2017.
- Diffey BL, Cheeseman J. Sun protection with hats. Br J Dermatol. 1992;127:10-12.
- Bray FN. Florida school boards restrict access to outdoor sun protection: an observational study. J Am Acad Dermatol. 2016;75:642-644.
- Yeung H, Luk KM, Chen SC. Focal photodamage on the occipital scalp. JAMA Dermatol. 2016;152:1060-1062.
- Lee T, Williams VF, Clark LL. Incident diagnoses of cancers in the active component and cancer-related deaths in the active and reserve components, U.S. Armed Forces, 2005-2014. MSMR. 2016;23:23-31.
- Parkin DM, Mesher D, Sasieni P. Cancers attributable to solar (ultraviolet) radiation exposure in the UK in 2010. Br J Cancer. 2011;105(suppl 2):S66-S69.
- Casper K. Elementary schools consider “no hat no play policy.” Coolibar website. http://blog.coolibar.com/elementary-schools-consider-no-hat-no-play-policy/. Published March 27, 2012. Accessed January 4, 2017.
- Slip, slop, slap, seek & slide: Sid Seagull. SunSmart Victoria website. http://www.sunsmart.com.au/tools/videos/current-tv-campaigns/slip-slop-slap-seek-slide-sid-seagull.html. Accessed January 4, 2017.
- McGrath JM, Fisher V, Krejci-Manwaring J. Skin cancer warnings and the need for new preventive campaigns - a pilot study. Am J Prev Med. 2016;50:E62-E63.
- Parker G, Williams B, Driggers P. Sun exposure knowledge and practices survey of maintenance squadrons at Travis AFB. Mil Med. 2015;180:26-31.
- Holman DM, Berkowitz Z, Guy GP Jr, et al. Patterns of sunscreen use on the face and other exposed skin among US adults [published online May 19, 2015]. J Am Acad Dermatol. 2015;73:83-92.e1.
- Stanton SL. Headgear. In: Stanton SL. U.S. Army Uniforms of the Vietnam War. Harrisburg, PA: Stackpole Books; 1992:26-61.
- Richmond-Sinclair NM, Pandeya N, Ware RS, et al. Incidence of basal cell carcinoma multiplicity and detailed anatomic distribution: longitudinal study of an Australian population [published online July 31, 2008]. J Invest Dermatol. 2009;129:323-328.
- Gies P, Javorniczky J, Roy C, et al. Measurements of the UVR protection provided by hats used at school. Photochem Photobiol. 2006;82:750-754.
- Winterhalter C, DiLuna K, Bide M. Characterization of the Ultraviolet Protection of Combat Uniform Fabrics. Natick, MA: US Army Solider and Biological Chemical Command; 2002. Technical report 02/006.
Practice Points
- Routine wear of wide-brimmed hats is the simplest, most inexpensive, and only reusable form of photoprotection for the head and neck and should be an everyday practice for reducing the risk for preventable skin cancers.
- The regular wear of clothing and head cover with adequate UV protection factor is equally as important to utilize in the prevention of UV-induced skin cancers as the application of topical sunscreens and sunblocks.
- The medical community should make a concerted effort to dispel any public policy or fashion trend that does not promote personal protection from sun-induced skin cancers. Policies that restrict wearing photoprotective garments, such as in schools and in the military, need to be changed.
The Role of Biologic Therapy for Psoriasis in Cardiovascular Risk Reduction
The cardiovascular comorbidities associated with psoriasis have been well documented; however, the mechanism by which psoriasis increases the risk for cardiovascular disease (CVD) remains unclear. Elevated systemic inflammatory cytokines and mediators may play a key role in their association, which prompts the questions: Do systemic medications have a protective effect? Do patients on systemic antipsoriatic treatment have a decreased risk for major adverse cardiovascular events (MACEs) compared with untreated patients?
We believe the shared inflammatory processes involved in psoriasis and atherosclerosis formation are potential targets for therapy in reducing the incidence of CVD and its associated complications. A growing amount of evidence suggests cardioprotective effects associated with antipsoriatic treatments such as tumor necrosis factor (TNF) inhibitors and methotrexate. Gkalpakiotis et al1 demonstrated a reduction in serum E-selectin (mean [standard deviation], 53.04 [23.54] ng/mL vs 35.32 [8.70] ng/mL; P<.001) and IL-22 (25.11 [19.9] pg/mL vs 12.83 [8.42] pg/mL; P<.001) after 3 months of adalimumab administration in patients with moderate to severe psoriasis. Both E-selectin and IL-22 are associated with the development of atherosclerosis, endothelial dysfunction, and an increased incidence of CVD. Similarly, Wu et al2 demonstrated a statistically significant reduction (–5.04 mg/dL [95% confidence interval [CI], –8.24 to –2.12; P<.01) in C-reactive protein in patients with psoriasis, psoriatic arthritis, and rheumatoid arthritis after concurrent use of methotrexate and TNF inhibitors.
Solomon et al3 compared the rate of newly diagnosed diabetes mellitus among psoriasis and rheumatoid arthritis patients treated with TNF inhibitors, methotrexate, hydroxychloroquine, and other nonbiologic disease-modifying antirheumatic drugs. The authors’ findings suggest that those who take a TNF inhibitor (hazard ratio [HR], 0.62; 95% CI, 0.42-0.91) and hydroxychloroquine (HR, 0.54; 95% CI, 0.36-0.80) are at lower risk for diabetes mellitus compared to those treated with nonbiologic disease-modifying antirheumatic drugs. Conversely, the methotrexate (HR, 0.77; 95% CI, 0.53-1.13) cohort did not show a statistically significant reduction in diabetes risk.3
Pina et al4 revealed improvement in endothelial function after 6 months of adalimumab use in patients with moderate to severe psoriasis. To evaluate the presence of subclinical endothelial dysfunction, the authors assessed brachial artery reactivity by measuring flow-mediated dilation and carotid artery stiffness by pulse wave velocity. Patients showed an increase in flow-mediated dilation (mean [SD], 6.19% [2.44%] vs 7.46% [2.43%]; P=.008) and reduction in pulse wave velocity (6.28 [1.04] m/s vs 5.69 [1.31] m/s; P=.03) compared to baseline measurements, indicating an improvement of endothelial function.4
Ahlehoff et al5 observed for improvements in subclinical left ventricular dysfunction in psoriasis patients after treatment with biologics. Using echocardiography, they assessed for changes in diastolic function and left ventricular systolic deformation (defined by global longitudinal strain). Of patients who received 3 months of biologic therapy (TNF inhibitor orIL-12/23 inhibitor) and maintained at minimum a psoriasis area and severity index 50 response, all demonstrated an improvement in diastolic function (mean [SD], 8.1 [2.1] vs 6.7 [1.9]; P<.001) and global longitudinal strain (mean [SD], –16.8% [2.1%] vs –18.3% [2.3%]; P<.001). Of note, patients who did not achieve a psoriasis area and severity index 50 response at follow-up did not exhibit an improvement in subclinical myocardial function.5
Moreover, a Danish nationwide study with up to 5-year follow-up evaluated the risk for MACE (ie, cardiovascular death, myocardial infarction, stroke) in patients with severe psoriasis receiving systemic anti-inflammatory medications and nonsystemic therapies including topical treatments, phototherapy, and climate therapy.6 Compared to nonsystemic therapies, methotrexate use (HR, 0.53; 95% CI, 0.34-0.83) was associated with a decreased risk for cardiovascular events. However, a protective decreased risk was not found among patients who used systemic cyclosporine (HR, 1.06; 95% CI, 0.26-4.27) or retinoids (HR, 1.80; 95% CI, 1.03-2.96). Any biological drug use had a comparable but nonsignificant reduction of cardiovascular events (HR, 0.58; 95% CI, 0.30-1.10). After multivariable adjustment, TNF inhibitors were associated with a statistically significant decreased risk for cardiovascular events (HR, 0.46; 95% CI, 0.22-0.98; P=.04) compared to nonsystemic therapies. The IL-12/23 inhibitor did not demonstrate this relationship (HR, 1.52; 95% CI, 0.47-4.94).6
Lastly, Wu et al7 compared the risk for MACE (ie, myocardial infarction, stroke, unstable angina, transient ischemic attack) between patients with psoriasis who received TNF inhibitors or methotrexate. The TNF inhibitor and methotrexate cohorts were observed for a median of 12 months and 9 months, respectively. After adjusting for potential confounding factors, they found a 45% reduction (HR, 0.55; 95% CI, 0.45-0.67) in cardiovascular event risk in the TNF inhibitor cohort compared with the methotrexate cohort. Notably, analyses also showed comparatively fewer cardiovascular events in the TNF inhibitor cohort throughout all time points—6, 12, 18, 24, 60 months—in the observation period. Regression analysis revealed an 11% reduction in cardiovascular events (HR, 0.89; 95% CI, 0.80-0.98) with each additional 6 months of cumulative TNF inhibitor exposure.
The current sum of evidence suggests cardioprotective effects of TNF inhibitor and methotrexate use. However, given the cumulative systemic toxicity and inferior cutaneous efficacy of methotrexate, TNF inhibitors will likely play a more significant role going forward. The role of methotrexate may be for its simultaneous use with biologic therapies to limit immunogenicity. Newer biologic agents such as IL-12/23 and IL-17 inhibitors have not yet been as extensively studied for their effects on cardiovascular risk as their TNF inhibitor counterparts. However, because of their shared ability to target specific immunological pathways, it is plausible that IL-12/23 and IL-17 agents may exhibit cardioprotective effects.8
Patients with psoriasis should be counseled and educated about the increased risk for CVD and its associated morbidity and mortality risk. Screening for modifiable risk factors and recommending therapeutic lifestyle changes also is appropriate. Future studies should help define the role of specific systemic drugs in reducing the risk for CVD in patients with psoriasis.
- Gkalpakiotis S, Arenbergerova M, Gkalpakioti P, et al. Impact of adalimumab treatment on cardiovascular risk biomarkers in psoriasis: results of a pilot study [published online October 24, 2016]. J Dermatol. doi:10.1111/1346-8138.13661.
- Wu JJ, Rowan CG, Bebchuk JD, et al. Association between tumor necrosis factor inhibitor (TNFi) therapy and changes in C-reactive protein (CRP), blood pressure, and alanine aminotransferase (ALT) among patients with psoriasis, psoriatic arthritis, or rheumatoid arthritis [published online March 5, 2015]. J Am Acad Dermatol. 2015;72:917-919.
- Solomon DH, Massarotti E, Garg R, et al. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011;305:2525-2531.
- Pina T, Corrales A, Lopez-Mejias R, et al. Anti-tumor necrosis factor-alpha therapy improves endothelial function and arterial stiffness in patients with moderate to severe psoriasis: a 6-month prospective study. J Dermatol. 2016;43:1267-1272.
- Ahlehoff O, Hansen PR, Gislason GH, et al. Myocardial function and effects of biologic therapy in patients with severe psoriasis: a prospective echocardiographic study [published online April 6, 2015]. J Eur Acad Dermatol Venereol. 2016;30:819-823.
- Ahlehoff O, Skov L, Gislason G, et al. Cardiovascular outcomes and systemic anti-inflammatory drugs in patients with severe psoriasis: 5-year follow-up of a Danish nationwide cohort [published online October 10, 2014]. J Eur Acad Dermatol Venereol. 2015;29:1128-1134.
- Wu JJ, Guérin A, Sundaram M, et al. Cardiovascular event risk assessment in psoriasis patients treated with tumor necrosis factor-α inhibitors versus methotrexate [published online October 26, 2016]. J Am Acad Dermatol. 2017;76:81-90.
- Egeberg A, Skov L. Management of cardiovascular disease in patients with psoriasis. Expert Opin Pharmacother. 2016;17:1509-1516.
The cardiovascular comorbidities associated with psoriasis have been well documented; however, the mechanism by which psoriasis increases the risk for cardiovascular disease (CVD) remains unclear. Elevated systemic inflammatory cytokines and mediators may play a key role in their association, which prompts the questions: Do systemic medications have a protective effect? Do patients on systemic antipsoriatic treatment have a decreased risk for major adverse cardiovascular events (MACEs) compared with untreated patients?
We believe the shared inflammatory processes involved in psoriasis and atherosclerosis formation are potential targets for therapy in reducing the incidence of CVD and its associated complications. A growing amount of evidence suggests cardioprotective effects associated with antipsoriatic treatments such as tumor necrosis factor (TNF) inhibitors and methotrexate. Gkalpakiotis et al1 demonstrated a reduction in serum E-selectin (mean [standard deviation], 53.04 [23.54] ng/mL vs 35.32 [8.70] ng/mL; P<.001) and IL-22 (25.11 [19.9] pg/mL vs 12.83 [8.42] pg/mL; P<.001) after 3 months of adalimumab administration in patients with moderate to severe psoriasis. Both E-selectin and IL-22 are associated with the development of atherosclerosis, endothelial dysfunction, and an increased incidence of CVD. Similarly, Wu et al2 demonstrated a statistically significant reduction (–5.04 mg/dL [95% confidence interval [CI], –8.24 to –2.12; P<.01) in C-reactive protein in patients with psoriasis, psoriatic arthritis, and rheumatoid arthritis after concurrent use of methotrexate and TNF inhibitors.
Solomon et al3 compared the rate of newly diagnosed diabetes mellitus among psoriasis and rheumatoid arthritis patients treated with TNF inhibitors, methotrexate, hydroxychloroquine, and other nonbiologic disease-modifying antirheumatic drugs. The authors’ findings suggest that those who take a TNF inhibitor (hazard ratio [HR], 0.62; 95% CI, 0.42-0.91) and hydroxychloroquine (HR, 0.54; 95% CI, 0.36-0.80) are at lower risk for diabetes mellitus compared to those treated with nonbiologic disease-modifying antirheumatic drugs. Conversely, the methotrexate (HR, 0.77; 95% CI, 0.53-1.13) cohort did not show a statistically significant reduction in diabetes risk.3
Pina et al4 revealed improvement in endothelial function after 6 months of adalimumab use in patients with moderate to severe psoriasis. To evaluate the presence of subclinical endothelial dysfunction, the authors assessed brachial artery reactivity by measuring flow-mediated dilation and carotid artery stiffness by pulse wave velocity. Patients showed an increase in flow-mediated dilation (mean [SD], 6.19% [2.44%] vs 7.46% [2.43%]; P=.008) and reduction in pulse wave velocity (6.28 [1.04] m/s vs 5.69 [1.31] m/s; P=.03) compared to baseline measurements, indicating an improvement of endothelial function.4
Ahlehoff et al5 observed for improvements in subclinical left ventricular dysfunction in psoriasis patients after treatment with biologics. Using echocardiography, they assessed for changes in diastolic function and left ventricular systolic deformation (defined by global longitudinal strain). Of patients who received 3 months of biologic therapy (TNF inhibitor orIL-12/23 inhibitor) and maintained at minimum a psoriasis area and severity index 50 response, all demonstrated an improvement in diastolic function (mean [SD], 8.1 [2.1] vs 6.7 [1.9]; P<.001) and global longitudinal strain (mean [SD], –16.8% [2.1%] vs –18.3% [2.3%]; P<.001). Of note, patients who did not achieve a psoriasis area and severity index 50 response at follow-up did not exhibit an improvement in subclinical myocardial function.5
Moreover, a Danish nationwide study with up to 5-year follow-up evaluated the risk for MACE (ie, cardiovascular death, myocardial infarction, stroke) in patients with severe psoriasis receiving systemic anti-inflammatory medications and nonsystemic therapies including topical treatments, phototherapy, and climate therapy.6 Compared to nonsystemic therapies, methotrexate use (HR, 0.53; 95% CI, 0.34-0.83) was associated with a decreased risk for cardiovascular events. However, a protective decreased risk was not found among patients who used systemic cyclosporine (HR, 1.06; 95% CI, 0.26-4.27) or retinoids (HR, 1.80; 95% CI, 1.03-2.96). Any biological drug use had a comparable but nonsignificant reduction of cardiovascular events (HR, 0.58; 95% CI, 0.30-1.10). After multivariable adjustment, TNF inhibitors were associated with a statistically significant decreased risk for cardiovascular events (HR, 0.46; 95% CI, 0.22-0.98; P=.04) compared to nonsystemic therapies. The IL-12/23 inhibitor did not demonstrate this relationship (HR, 1.52; 95% CI, 0.47-4.94).6
Lastly, Wu et al7 compared the risk for MACE (ie, myocardial infarction, stroke, unstable angina, transient ischemic attack) between patients with psoriasis who received TNF inhibitors or methotrexate. The TNF inhibitor and methotrexate cohorts were observed for a median of 12 months and 9 months, respectively. After adjusting for potential confounding factors, they found a 45% reduction (HR, 0.55; 95% CI, 0.45-0.67) in cardiovascular event risk in the TNF inhibitor cohort compared with the methotrexate cohort. Notably, analyses also showed comparatively fewer cardiovascular events in the TNF inhibitor cohort throughout all time points—6, 12, 18, 24, 60 months—in the observation period. Regression analysis revealed an 11% reduction in cardiovascular events (HR, 0.89; 95% CI, 0.80-0.98) with each additional 6 months of cumulative TNF inhibitor exposure.
The current sum of evidence suggests cardioprotective effects of TNF inhibitor and methotrexate use. However, given the cumulative systemic toxicity and inferior cutaneous efficacy of methotrexate, TNF inhibitors will likely play a more significant role going forward. The role of methotrexate may be for its simultaneous use with biologic therapies to limit immunogenicity. Newer biologic agents such as IL-12/23 and IL-17 inhibitors have not yet been as extensively studied for their effects on cardiovascular risk as their TNF inhibitor counterparts. However, because of their shared ability to target specific immunological pathways, it is plausible that IL-12/23 and IL-17 agents may exhibit cardioprotective effects.8
Patients with psoriasis should be counseled and educated about the increased risk for CVD and its associated morbidity and mortality risk. Screening for modifiable risk factors and recommending therapeutic lifestyle changes also is appropriate. Future studies should help define the role of specific systemic drugs in reducing the risk for CVD in patients with psoriasis.
The cardiovascular comorbidities associated with psoriasis have been well documented; however, the mechanism by which psoriasis increases the risk for cardiovascular disease (CVD) remains unclear. Elevated systemic inflammatory cytokines and mediators may play a key role in their association, which prompts the questions: Do systemic medications have a protective effect? Do patients on systemic antipsoriatic treatment have a decreased risk for major adverse cardiovascular events (MACEs) compared with untreated patients?
We believe the shared inflammatory processes involved in psoriasis and atherosclerosis formation are potential targets for therapy in reducing the incidence of CVD and its associated complications. A growing amount of evidence suggests cardioprotective effects associated with antipsoriatic treatments such as tumor necrosis factor (TNF) inhibitors and methotrexate. Gkalpakiotis et al1 demonstrated a reduction in serum E-selectin (mean [standard deviation], 53.04 [23.54] ng/mL vs 35.32 [8.70] ng/mL; P<.001) and IL-22 (25.11 [19.9] pg/mL vs 12.83 [8.42] pg/mL; P<.001) after 3 months of adalimumab administration in patients with moderate to severe psoriasis. Both E-selectin and IL-22 are associated with the development of atherosclerosis, endothelial dysfunction, and an increased incidence of CVD. Similarly, Wu et al2 demonstrated a statistically significant reduction (–5.04 mg/dL [95% confidence interval [CI], –8.24 to –2.12; P<.01) in C-reactive protein in patients with psoriasis, psoriatic arthritis, and rheumatoid arthritis after concurrent use of methotrexate and TNF inhibitors.
Solomon et al3 compared the rate of newly diagnosed diabetes mellitus among psoriasis and rheumatoid arthritis patients treated with TNF inhibitors, methotrexate, hydroxychloroquine, and other nonbiologic disease-modifying antirheumatic drugs. The authors’ findings suggest that those who take a TNF inhibitor (hazard ratio [HR], 0.62; 95% CI, 0.42-0.91) and hydroxychloroquine (HR, 0.54; 95% CI, 0.36-0.80) are at lower risk for diabetes mellitus compared to those treated with nonbiologic disease-modifying antirheumatic drugs. Conversely, the methotrexate (HR, 0.77; 95% CI, 0.53-1.13) cohort did not show a statistically significant reduction in diabetes risk.3
Pina et al4 revealed improvement in endothelial function after 6 months of adalimumab use in patients with moderate to severe psoriasis. To evaluate the presence of subclinical endothelial dysfunction, the authors assessed brachial artery reactivity by measuring flow-mediated dilation and carotid artery stiffness by pulse wave velocity. Patients showed an increase in flow-mediated dilation (mean [SD], 6.19% [2.44%] vs 7.46% [2.43%]; P=.008) and reduction in pulse wave velocity (6.28 [1.04] m/s vs 5.69 [1.31] m/s; P=.03) compared to baseline measurements, indicating an improvement of endothelial function.4
Ahlehoff et al5 observed for improvements in subclinical left ventricular dysfunction in psoriasis patients after treatment with biologics. Using echocardiography, they assessed for changes in diastolic function and left ventricular systolic deformation (defined by global longitudinal strain). Of patients who received 3 months of biologic therapy (TNF inhibitor orIL-12/23 inhibitor) and maintained at minimum a psoriasis area and severity index 50 response, all demonstrated an improvement in diastolic function (mean [SD], 8.1 [2.1] vs 6.7 [1.9]; P<.001) and global longitudinal strain (mean [SD], –16.8% [2.1%] vs –18.3% [2.3%]; P<.001). Of note, patients who did not achieve a psoriasis area and severity index 50 response at follow-up did not exhibit an improvement in subclinical myocardial function.5
Moreover, a Danish nationwide study with up to 5-year follow-up evaluated the risk for MACE (ie, cardiovascular death, myocardial infarction, stroke) in patients with severe psoriasis receiving systemic anti-inflammatory medications and nonsystemic therapies including topical treatments, phototherapy, and climate therapy.6 Compared to nonsystemic therapies, methotrexate use (HR, 0.53; 95% CI, 0.34-0.83) was associated with a decreased risk for cardiovascular events. However, a protective decreased risk was not found among patients who used systemic cyclosporine (HR, 1.06; 95% CI, 0.26-4.27) or retinoids (HR, 1.80; 95% CI, 1.03-2.96). Any biological drug use had a comparable but nonsignificant reduction of cardiovascular events (HR, 0.58; 95% CI, 0.30-1.10). After multivariable adjustment, TNF inhibitors were associated with a statistically significant decreased risk for cardiovascular events (HR, 0.46; 95% CI, 0.22-0.98; P=.04) compared to nonsystemic therapies. The IL-12/23 inhibitor did not demonstrate this relationship (HR, 1.52; 95% CI, 0.47-4.94).6
Lastly, Wu et al7 compared the risk for MACE (ie, myocardial infarction, stroke, unstable angina, transient ischemic attack) between patients with psoriasis who received TNF inhibitors or methotrexate. The TNF inhibitor and methotrexate cohorts were observed for a median of 12 months and 9 months, respectively. After adjusting for potential confounding factors, they found a 45% reduction (HR, 0.55; 95% CI, 0.45-0.67) in cardiovascular event risk in the TNF inhibitor cohort compared with the methotrexate cohort. Notably, analyses also showed comparatively fewer cardiovascular events in the TNF inhibitor cohort throughout all time points—6, 12, 18, 24, 60 months—in the observation period. Regression analysis revealed an 11% reduction in cardiovascular events (HR, 0.89; 95% CI, 0.80-0.98) with each additional 6 months of cumulative TNF inhibitor exposure.
The current sum of evidence suggests cardioprotective effects of TNF inhibitor and methotrexate use. However, given the cumulative systemic toxicity and inferior cutaneous efficacy of methotrexate, TNF inhibitors will likely play a more significant role going forward. The role of methotrexate may be for its simultaneous use with biologic therapies to limit immunogenicity. Newer biologic agents such as IL-12/23 and IL-17 inhibitors have not yet been as extensively studied for their effects on cardiovascular risk as their TNF inhibitor counterparts. However, because of their shared ability to target specific immunological pathways, it is plausible that IL-12/23 and IL-17 agents may exhibit cardioprotective effects.8
Patients with psoriasis should be counseled and educated about the increased risk for CVD and its associated morbidity and mortality risk. Screening for modifiable risk factors and recommending therapeutic lifestyle changes also is appropriate. Future studies should help define the role of specific systemic drugs in reducing the risk for CVD in patients with psoriasis.
- Gkalpakiotis S, Arenbergerova M, Gkalpakioti P, et al. Impact of adalimumab treatment on cardiovascular risk biomarkers in psoriasis: results of a pilot study [published online October 24, 2016]. J Dermatol. doi:10.1111/1346-8138.13661.
- Wu JJ, Rowan CG, Bebchuk JD, et al. Association between tumor necrosis factor inhibitor (TNFi) therapy and changes in C-reactive protein (CRP), blood pressure, and alanine aminotransferase (ALT) among patients with psoriasis, psoriatic arthritis, or rheumatoid arthritis [published online March 5, 2015]. J Am Acad Dermatol. 2015;72:917-919.
- Solomon DH, Massarotti E, Garg R, et al. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011;305:2525-2531.
- Pina T, Corrales A, Lopez-Mejias R, et al. Anti-tumor necrosis factor-alpha therapy improves endothelial function and arterial stiffness in patients with moderate to severe psoriasis: a 6-month prospective study. J Dermatol. 2016;43:1267-1272.
- Ahlehoff O, Hansen PR, Gislason GH, et al. Myocardial function and effects of biologic therapy in patients with severe psoriasis: a prospective echocardiographic study [published online April 6, 2015]. J Eur Acad Dermatol Venereol. 2016;30:819-823.
- Ahlehoff O, Skov L, Gislason G, et al. Cardiovascular outcomes and systemic anti-inflammatory drugs in patients with severe psoriasis: 5-year follow-up of a Danish nationwide cohort [published online October 10, 2014]. J Eur Acad Dermatol Venereol. 2015;29:1128-1134.
- Wu JJ, Guérin A, Sundaram M, et al. Cardiovascular event risk assessment in psoriasis patients treated with tumor necrosis factor-α inhibitors versus methotrexate [published online October 26, 2016]. J Am Acad Dermatol. 2017;76:81-90.
- Egeberg A, Skov L. Management of cardiovascular disease in patients with psoriasis. Expert Opin Pharmacother. 2016;17:1509-1516.
- Gkalpakiotis S, Arenbergerova M, Gkalpakioti P, et al. Impact of adalimumab treatment on cardiovascular risk biomarkers in psoriasis: results of a pilot study [published online October 24, 2016]. J Dermatol. doi:10.1111/1346-8138.13661.
- Wu JJ, Rowan CG, Bebchuk JD, et al. Association between tumor necrosis factor inhibitor (TNFi) therapy and changes in C-reactive protein (CRP), blood pressure, and alanine aminotransferase (ALT) among patients with psoriasis, psoriatic arthritis, or rheumatoid arthritis [published online March 5, 2015]. J Am Acad Dermatol. 2015;72:917-919.
- Solomon DH, Massarotti E, Garg R, et al. Association between disease-modifying antirheumatic drugs and diabetes risk in patients with rheumatoid arthritis and psoriasis. JAMA. 2011;305:2525-2531.
- Pina T, Corrales A, Lopez-Mejias R, et al. Anti-tumor necrosis factor-alpha therapy improves endothelial function and arterial stiffness in patients with moderate to severe psoriasis: a 6-month prospective study. J Dermatol. 2016;43:1267-1272.
- Ahlehoff O, Hansen PR, Gislason GH, et al. Myocardial function and effects of biologic therapy in patients with severe psoriasis: a prospective echocardiographic study [published online April 6, 2015]. J Eur Acad Dermatol Venereol. 2016;30:819-823.
- Ahlehoff O, Skov L, Gislason G, et al. Cardiovascular outcomes and systemic anti-inflammatory drugs in patients with severe psoriasis: 5-year follow-up of a Danish nationwide cohort [published online October 10, 2014]. J Eur Acad Dermatol Venereol. 2015;29:1128-1134.
- Wu JJ, Guérin A, Sundaram M, et al. Cardiovascular event risk assessment in psoriasis patients treated with tumor necrosis factor-α inhibitors versus methotrexate [published online October 26, 2016]. J Am Acad Dermatol. 2017;76:81-90.
- Egeberg A, Skov L. Management of cardiovascular disease in patients with psoriasis. Expert Opin Pharmacother. 2016;17:1509-1516.
Tips to maximize minimally invasive lower facial lift procedure
MIAMI – Lifting the lower face using minimally invasive barbed sutures can yield rejuvenation results that last 12-18 months, providing an option for patients who do not wish to undergo full facelift surgery, according to a presentation at ODAC 2017.
“We have something new in our toolbox. The Silhouette InstaLift is a “good new thing to consider adding to your practice. It works really nice for me in combination with other facial rejuvenation strategies,” said Susan Weinkle, MD, a private practice Mohs surgeon and aesthetic dermatologist in Bradenton, Fla.
“Now we can reposition the skin. It works quite nicely in skin of color also,” Dr. Weinkle said during a lecture and live demonstration at the Orlando Dermatology Aesthetic and Clinical Conference.
Procedure tips
Begin by marking where on the patient’s face you intend to place the sutures. The proper vector is a straight lift back toward the upper ear in many cases. Also, take a photo before you start, so you know the location of the sutures in case the patient comes back for more, Dr. Weinkle recommended.
“What I like to do next is to sit the patient up and look at them head-on,” Dr. Weinkle said. “It helps to tweak the placement of the suture markings.” If a patient’s face appears asymmetrical, the dermatologist can place more sutures on one side than the other. Also, when there are neck issues, you can put an exit point for the sutures 1.5 cm below the mandible, she added.
Be patient after you anesthetize the entry and exit points because the epinephrine does not work immediately, Dr. Weinkle advised.
She does not anesthetize along the entire suture tract because the aim is to thread the sutures through the subcutaneous tissue. “You do not want to anesthetize the tract area between entry and exit points. If the patient feels it, you’re probably too superficial and you’re in the dermis.”
The next step is using an 18G needle to form an entry point for the 23G needle. “Pinch the skin, insert and stretch the skin just a bit. If you don’t pinch at the entry point, the cones can be difficult to pop in.” Dr. Weinkle said. Also, if you establish all entry points before inserting the sutures, it can save time.
Dr. Weinkle generally uses a number 8 InstaLift suture, but it also comes in sizes 12 and 16. After you open the package, gently pull the suture to tighten the knots between the cones. “Don’t pull hard from both ends – you can break the suture.”
When inserting the long needle to place the suture, it’s “almost like playing the violin with a bow.” As the clinician advances along tract line, he or she should run the needle between thumb and forefinger to check the positioning. Once the suture is placed and the needle removed, pull medially on the suture until the cones audibly “pop” – they are self anchoring. “I’ve seen some people break the sutures. You can pull them out and start again,” she noted.
“InstaLift is a bit of a misnomer,” Dr. Weinkle said. “Fibroblast stimulation and collagen improves final result over the next 2-3 months.” Improvements can last 12-18 months – it’s not permanent. “I think I would make a great candidate,” she joked. “Unfortunately, this is one thing I cannot do myself.”
There is minimal bruising after the procedure in Dr. Weinkle’s experience. Potential complications include swelling, dimpling at entry points, misplacement, and ecchymosis.
Dr. Weinkle is a consultant and principal investigator for Sinclair Pharma, manufacturer of InstaLift.
MIAMI – Lifting the lower face using minimally invasive barbed sutures can yield rejuvenation results that last 12-18 months, providing an option for patients who do not wish to undergo full facelift surgery, according to a presentation at ODAC 2017.
“We have something new in our toolbox. The Silhouette InstaLift is a “good new thing to consider adding to your practice. It works really nice for me in combination with other facial rejuvenation strategies,” said Susan Weinkle, MD, a private practice Mohs surgeon and aesthetic dermatologist in Bradenton, Fla.
“Now we can reposition the skin. It works quite nicely in skin of color also,” Dr. Weinkle said during a lecture and live demonstration at the Orlando Dermatology Aesthetic and Clinical Conference.
Procedure tips
Begin by marking where on the patient’s face you intend to place the sutures. The proper vector is a straight lift back toward the upper ear in many cases. Also, take a photo before you start, so you know the location of the sutures in case the patient comes back for more, Dr. Weinkle recommended.
“What I like to do next is to sit the patient up and look at them head-on,” Dr. Weinkle said. “It helps to tweak the placement of the suture markings.” If a patient’s face appears asymmetrical, the dermatologist can place more sutures on one side than the other. Also, when there are neck issues, you can put an exit point for the sutures 1.5 cm below the mandible, she added.
Be patient after you anesthetize the entry and exit points because the epinephrine does not work immediately, Dr. Weinkle advised.
She does not anesthetize along the entire suture tract because the aim is to thread the sutures through the subcutaneous tissue. “You do not want to anesthetize the tract area between entry and exit points. If the patient feels it, you’re probably too superficial and you’re in the dermis.”
The next step is using an 18G needle to form an entry point for the 23G needle. “Pinch the skin, insert and stretch the skin just a bit. If you don’t pinch at the entry point, the cones can be difficult to pop in.” Dr. Weinkle said. Also, if you establish all entry points before inserting the sutures, it can save time.
Dr. Weinkle generally uses a number 8 InstaLift suture, but it also comes in sizes 12 and 16. After you open the package, gently pull the suture to tighten the knots between the cones. “Don’t pull hard from both ends – you can break the suture.”
When inserting the long needle to place the suture, it’s “almost like playing the violin with a bow.” As the clinician advances along tract line, he or she should run the needle between thumb and forefinger to check the positioning. Once the suture is placed and the needle removed, pull medially on the suture until the cones audibly “pop” – they are self anchoring. “I’ve seen some people break the sutures. You can pull them out and start again,” she noted.
“InstaLift is a bit of a misnomer,” Dr. Weinkle said. “Fibroblast stimulation and collagen improves final result over the next 2-3 months.” Improvements can last 12-18 months – it’s not permanent. “I think I would make a great candidate,” she joked. “Unfortunately, this is one thing I cannot do myself.”
There is minimal bruising after the procedure in Dr. Weinkle’s experience. Potential complications include swelling, dimpling at entry points, misplacement, and ecchymosis.
Dr. Weinkle is a consultant and principal investigator for Sinclair Pharma, manufacturer of InstaLift.
MIAMI – Lifting the lower face using minimally invasive barbed sutures can yield rejuvenation results that last 12-18 months, providing an option for patients who do not wish to undergo full facelift surgery, according to a presentation at ODAC 2017.
“We have something new in our toolbox. The Silhouette InstaLift is a “good new thing to consider adding to your practice. It works really nice for me in combination with other facial rejuvenation strategies,” said Susan Weinkle, MD, a private practice Mohs surgeon and aesthetic dermatologist in Bradenton, Fla.
“Now we can reposition the skin. It works quite nicely in skin of color also,” Dr. Weinkle said during a lecture and live demonstration at the Orlando Dermatology Aesthetic and Clinical Conference.
Procedure tips
Begin by marking where on the patient’s face you intend to place the sutures. The proper vector is a straight lift back toward the upper ear in many cases. Also, take a photo before you start, so you know the location of the sutures in case the patient comes back for more, Dr. Weinkle recommended.
“What I like to do next is to sit the patient up and look at them head-on,” Dr. Weinkle said. “It helps to tweak the placement of the suture markings.” If a patient’s face appears asymmetrical, the dermatologist can place more sutures on one side than the other. Also, when there are neck issues, you can put an exit point for the sutures 1.5 cm below the mandible, she added.
Be patient after you anesthetize the entry and exit points because the epinephrine does not work immediately, Dr. Weinkle advised.
She does not anesthetize along the entire suture tract because the aim is to thread the sutures through the subcutaneous tissue. “You do not want to anesthetize the tract area between entry and exit points. If the patient feels it, you’re probably too superficial and you’re in the dermis.”
The next step is using an 18G needle to form an entry point for the 23G needle. “Pinch the skin, insert and stretch the skin just a bit. If you don’t pinch at the entry point, the cones can be difficult to pop in.” Dr. Weinkle said. Also, if you establish all entry points before inserting the sutures, it can save time.
Dr. Weinkle generally uses a number 8 InstaLift suture, but it also comes in sizes 12 and 16. After you open the package, gently pull the suture to tighten the knots between the cones. “Don’t pull hard from both ends – you can break the suture.”
When inserting the long needle to place the suture, it’s “almost like playing the violin with a bow.” As the clinician advances along tract line, he or she should run the needle between thumb and forefinger to check the positioning. Once the suture is placed and the needle removed, pull medially on the suture until the cones audibly “pop” – they are self anchoring. “I’ve seen some people break the sutures. You can pull them out and start again,” she noted.
“InstaLift is a bit of a misnomer,” Dr. Weinkle said. “Fibroblast stimulation and collagen improves final result over the next 2-3 months.” Improvements can last 12-18 months – it’s not permanent. “I think I would make a great candidate,” she joked. “Unfortunately, this is one thing I cannot do myself.”
There is minimal bruising after the procedure in Dr. Weinkle’s experience. Potential complications include swelling, dimpling at entry points, misplacement, and ecchymosis.
Dr. Weinkle is a consultant and principal investigator for Sinclair Pharma, manufacturer of InstaLift.
EXPERT ANALYSIS AT ODAC 2017
Nivolumab shows promise for pretreated advanced HCC
SAN FRANCISCO – Nivolumab was associated with durable responses in heavily pretreated patients with advanced hepatocellular carcinoma in the dose-escalation and dose-expansion phases of the CheckMate 040 study.
Further, the safety profile of nivolumab, a fully human IgG4 monoclonal antibody inhibitor of programmed death-1 (PD-1), was consistent with that observed in other solid tumors; events were manageable, and no new safety signals were detected, Ignacio Melero, MD, of Clinica Universidad de Navarra, Pamplona, Spain, reported at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and Society of Surgical Oncology.
In all, 262 patients with histologically confirmed advanced disease not amenable to curative resection were treated across the CheckMate 040 dose-escalation phase (phase I), which evaluated 0.1-10 mg/kg of nivolumab given every 2 weeks, and the dose-expansion phase (phase II), which involved nivolumab at a dose of 3 mg/kg every 2 weeks in four cohorts: sorafenib naive/intolerant patients, sorafenib progressors, hepatitis C virus-infected patients, and hepatitis B virus-infected patients.
“Because of the inflammation that often afflicts the liver, we were very afraid of precipitating hyper-acute or fulminant hepatitis in these patients, and that was the reason we undertook a very careful dose escalation,” Dr. Melero said, adding that due to efficacy and safety results in the dose escalation phase, the 3-mg/kg dose used in other clinical trials was expanded to all subjects, including uninfected patients and those with HCV or HBV infection.
In regard to safety and tolerability – the primary endpoint of phase I – grade 3/4 treatment-related adverse events occurred in 20% of patients. No maximum tolerated dose was reached during dose escalation, Dr. Melero said.
The most common reason for treatment discontinuation was disease progression; very few patients discontinued for toxicity, he said, noting that “the safety profile was very consistent with what has been reported in other indications.”
In fact, most grade 3/4 events involved laboratory abnormalities without clinical repercussions, he said.
The safety profile in phase II was consistent with that observed in phase I, and no differences in safety were seen in the three categories of hepatocellular carcinoma patients in the study.
In regard to objective response – the primary endpoint of phase II – the investigator-assessed rates were 16.2% in phase I and 18.6% in phase II, and the rates assessed by blinded independent central review were 18.9% and 14.5% in the phases, respectively. Based on imaging assessed using modified RESIST criteria, the rates were 21.6% and 18.6%, respectively.
The median duration of response was 17.1 months in phase I, and had not yet been reached in phase II, Dr. Melero said, adding that in uninfected patients, an “important number of patients developed stable disease that was durable.”
This also was seen in patients with chronic hepatitis, he noted.
“We believe that stabilization of disease is a driver of survival, because we have seen that in dose escalation, 45% of patients were alive 18 months after treatment onset, and at last data base log [in dose escalation], 71% were alive 9 months after starting treatment,” he said.
Of note, objective response rates were similar in patients treated with sorafenib and in those who received nivolumab as first-line treatment, and they were similar regardless of tumor programmed death-ligand 1 (PD-L1) expression.
Quality of life, as reported by patients via EQ-5D questionnaire, remained stable over time.
Study subjects had a median age of 63 years, and were heavily pretreated – most often by sorafenib.
Hepatocellular carcinoma diagnosed at advanced stages has a poor prognosis, and those who progress on sorafenib – the only systemic therapy option in such patients – have few options, Dr. Melero said.
Nivolumab, which has been shown to restore T-cell–mediated antitumor activity, has demonstrated clinical and survival benefit in a number of tumor types.
The current findings suggest that it also is a promising alternative for advanced hepatocellular carcinoma.
“Nivolumab demonstrated objective responses and long-term survival in both sorafenib-experienced and sorafenib-naive patients. Nivolumab monotherapy provided early, stable and durable responses when they took place, efficacy was observed irrespective of chronic viral infection by hepatitis viruses, and responses were also observed in PD-L1-negative cases upon examination of biopsies,” he concluded, noting that a randomized phase III trial comparing nivolumab with systemic sorafenib is ongoing.
CheckMate 040 was sponsored by Bristol Myers Squibb. Dr. Melero reported receiving honoraria from and serving as a consultant or adviser for AstraZeneca, Bayer, Bristol-Myers Squibb, Incyte, Merck Serono, MSD, and Roche, and reported research funding to his institution from Alligator Bioscience, Pfizer, and Tusk Therapeutics.
SAN FRANCISCO – Nivolumab was associated with durable responses in heavily pretreated patients with advanced hepatocellular carcinoma in the dose-escalation and dose-expansion phases of the CheckMate 040 study.
Further, the safety profile of nivolumab, a fully human IgG4 monoclonal antibody inhibitor of programmed death-1 (PD-1), was consistent with that observed in other solid tumors; events were manageable, and no new safety signals were detected, Ignacio Melero, MD, of Clinica Universidad de Navarra, Pamplona, Spain, reported at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and Society of Surgical Oncology.
In all, 262 patients with histologically confirmed advanced disease not amenable to curative resection were treated across the CheckMate 040 dose-escalation phase (phase I), which evaluated 0.1-10 mg/kg of nivolumab given every 2 weeks, and the dose-expansion phase (phase II), which involved nivolumab at a dose of 3 mg/kg every 2 weeks in four cohorts: sorafenib naive/intolerant patients, sorafenib progressors, hepatitis C virus-infected patients, and hepatitis B virus-infected patients.
“Because of the inflammation that often afflicts the liver, we were very afraid of precipitating hyper-acute or fulminant hepatitis in these patients, and that was the reason we undertook a very careful dose escalation,” Dr. Melero said, adding that due to efficacy and safety results in the dose escalation phase, the 3-mg/kg dose used in other clinical trials was expanded to all subjects, including uninfected patients and those with HCV or HBV infection.
In regard to safety and tolerability – the primary endpoint of phase I – grade 3/4 treatment-related adverse events occurred in 20% of patients. No maximum tolerated dose was reached during dose escalation, Dr. Melero said.
The most common reason for treatment discontinuation was disease progression; very few patients discontinued for toxicity, he said, noting that “the safety profile was very consistent with what has been reported in other indications.”
In fact, most grade 3/4 events involved laboratory abnormalities without clinical repercussions, he said.
The safety profile in phase II was consistent with that observed in phase I, and no differences in safety were seen in the three categories of hepatocellular carcinoma patients in the study.
In regard to objective response – the primary endpoint of phase II – the investigator-assessed rates were 16.2% in phase I and 18.6% in phase II, and the rates assessed by blinded independent central review were 18.9% and 14.5% in the phases, respectively. Based on imaging assessed using modified RESIST criteria, the rates were 21.6% and 18.6%, respectively.
The median duration of response was 17.1 months in phase I, and had not yet been reached in phase II, Dr. Melero said, adding that in uninfected patients, an “important number of patients developed stable disease that was durable.”
This also was seen in patients with chronic hepatitis, he noted.
“We believe that stabilization of disease is a driver of survival, because we have seen that in dose escalation, 45% of patients were alive 18 months after treatment onset, and at last data base log [in dose escalation], 71% were alive 9 months after starting treatment,” he said.
Of note, objective response rates were similar in patients treated with sorafenib and in those who received nivolumab as first-line treatment, and they were similar regardless of tumor programmed death-ligand 1 (PD-L1) expression.
Quality of life, as reported by patients via EQ-5D questionnaire, remained stable over time.
Study subjects had a median age of 63 years, and were heavily pretreated – most often by sorafenib.
Hepatocellular carcinoma diagnosed at advanced stages has a poor prognosis, and those who progress on sorafenib – the only systemic therapy option in such patients – have few options, Dr. Melero said.
Nivolumab, which has been shown to restore T-cell–mediated antitumor activity, has demonstrated clinical and survival benefit in a number of tumor types.
The current findings suggest that it also is a promising alternative for advanced hepatocellular carcinoma.
“Nivolumab demonstrated objective responses and long-term survival in both sorafenib-experienced and sorafenib-naive patients. Nivolumab monotherapy provided early, stable and durable responses when they took place, efficacy was observed irrespective of chronic viral infection by hepatitis viruses, and responses were also observed in PD-L1-negative cases upon examination of biopsies,” he concluded, noting that a randomized phase III trial comparing nivolumab with systemic sorafenib is ongoing.
CheckMate 040 was sponsored by Bristol Myers Squibb. Dr. Melero reported receiving honoraria from and serving as a consultant or adviser for AstraZeneca, Bayer, Bristol-Myers Squibb, Incyte, Merck Serono, MSD, and Roche, and reported research funding to his institution from Alligator Bioscience, Pfizer, and Tusk Therapeutics.
SAN FRANCISCO – Nivolumab was associated with durable responses in heavily pretreated patients with advanced hepatocellular carcinoma in the dose-escalation and dose-expansion phases of the CheckMate 040 study.
Further, the safety profile of nivolumab, a fully human IgG4 monoclonal antibody inhibitor of programmed death-1 (PD-1), was consistent with that observed in other solid tumors; events were manageable, and no new safety signals were detected, Ignacio Melero, MD, of Clinica Universidad de Navarra, Pamplona, Spain, reported at the symposium, sponsored by ASCO, ASTRO, the American Gastroenterological Association, and Society of Surgical Oncology.
In all, 262 patients with histologically confirmed advanced disease not amenable to curative resection were treated across the CheckMate 040 dose-escalation phase (phase I), which evaluated 0.1-10 mg/kg of nivolumab given every 2 weeks, and the dose-expansion phase (phase II), which involved nivolumab at a dose of 3 mg/kg every 2 weeks in four cohorts: sorafenib naive/intolerant patients, sorafenib progressors, hepatitis C virus-infected patients, and hepatitis B virus-infected patients.
“Because of the inflammation that often afflicts the liver, we were very afraid of precipitating hyper-acute or fulminant hepatitis in these patients, and that was the reason we undertook a very careful dose escalation,” Dr. Melero said, adding that due to efficacy and safety results in the dose escalation phase, the 3-mg/kg dose used in other clinical trials was expanded to all subjects, including uninfected patients and those with HCV or HBV infection.
In regard to safety and tolerability – the primary endpoint of phase I – grade 3/4 treatment-related adverse events occurred in 20% of patients. No maximum tolerated dose was reached during dose escalation, Dr. Melero said.
The most common reason for treatment discontinuation was disease progression; very few patients discontinued for toxicity, he said, noting that “the safety profile was very consistent with what has been reported in other indications.”
In fact, most grade 3/4 events involved laboratory abnormalities without clinical repercussions, he said.
The safety profile in phase II was consistent with that observed in phase I, and no differences in safety were seen in the three categories of hepatocellular carcinoma patients in the study.
In regard to objective response – the primary endpoint of phase II – the investigator-assessed rates were 16.2% in phase I and 18.6% in phase II, and the rates assessed by blinded independent central review were 18.9% and 14.5% in the phases, respectively. Based on imaging assessed using modified RESIST criteria, the rates were 21.6% and 18.6%, respectively.
The median duration of response was 17.1 months in phase I, and had not yet been reached in phase II, Dr. Melero said, adding that in uninfected patients, an “important number of patients developed stable disease that was durable.”
This also was seen in patients with chronic hepatitis, he noted.
“We believe that stabilization of disease is a driver of survival, because we have seen that in dose escalation, 45% of patients were alive 18 months after treatment onset, and at last data base log [in dose escalation], 71% were alive 9 months after starting treatment,” he said.
Of note, objective response rates were similar in patients treated with sorafenib and in those who received nivolumab as first-line treatment, and they were similar regardless of tumor programmed death-ligand 1 (PD-L1) expression.
Quality of life, as reported by patients via EQ-5D questionnaire, remained stable over time.
Study subjects had a median age of 63 years, and were heavily pretreated – most often by sorafenib.
Hepatocellular carcinoma diagnosed at advanced stages has a poor prognosis, and those who progress on sorafenib – the only systemic therapy option in such patients – have few options, Dr. Melero said.
Nivolumab, which has been shown to restore T-cell–mediated antitumor activity, has demonstrated clinical and survival benefit in a number of tumor types.
The current findings suggest that it also is a promising alternative for advanced hepatocellular carcinoma.
“Nivolumab demonstrated objective responses and long-term survival in both sorafenib-experienced and sorafenib-naive patients. Nivolumab monotherapy provided early, stable and durable responses when they took place, efficacy was observed irrespective of chronic viral infection by hepatitis viruses, and responses were also observed in PD-L1-negative cases upon examination of biopsies,” he concluded, noting that a randomized phase III trial comparing nivolumab with systemic sorafenib is ongoing.
CheckMate 040 was sponsored by Bristol Myers Squibb. Dr. Melero reported receiving honoraria from and serving as a consultant or adviser for AstraZeneca, Bayer, Bristol-Myers Squibb, Incyte, Merck Serono, MSD, and Roche, and reported research funding to his institution from Alligator Bioscience, Pfizer, and Tusk Therapeutics.
AT THE 2017 GASTROINTESTINAL CANCERS SYMPOSIUM
Key clinical point:
Major finding: Investigator-assessed objective response rates were 16.2% in phase I and 18.6% in phase II.
Data source: The CheckMate 040 phase I and phase II clinical studies involving 262 patients.
Disclosures: CheckMate 040 was sponsored by Bristol Myers Squibb. Dr. Melero reported receiving honoraria from and serving as a consultant or adviser for AstraZeneca, Bayer, Bristol-Myers Squibb, Incyte, Merck Serono, MSD, and Roche, and reported research funding to his institution from Alligator Bioscience, Pfizer, and Tusk Therapeutics.
Detecting and managing monochorionic twin complications
Approximately 20% of all twin pregnancies are monochorionic, with the fetuses sharing a single placenta. Although the majority of these pregnancies are uncomplicated, monochorionic twins are significantly more likely than dichorionic twins to incur complications that can threaten the life and health of one or both fetuses.
The death of one monochorionic twin leaves the other twin with a 15% risk of demise. Survival after the loss of a co-twin is also associated with a 25% incidence of neurologic injury, compared with a 2% incidence in dichorionic pregnancies. Additionally, monochorionic pregnancies carry the risk of unique complications such as twin-to-twin transfusion syndrome, selective fetal growth restriction, twin anemia polycythemia sequence, and twin reversed arterial perfusion.
Increased ultrasonographic surveillance recommended for monochorionic twin pregnancies has been outlined in a recent consensus statement from the North American Fetal Therapy Network (Obstet Gynecol. 2015 Jan;125[1]:118-23). Beginning at 16 weeks’ gestation, monochorionic twins should be assessed every 2 weeks using amniotic fluid balance, presence/absence of fluid within the fetal bladder, and with fetal Doppler (umbilical artery, middle cerebral artery, and ductus venosus) studies. Fetal growth should also be assessed at least every 4 weeks.
Since monochorionic twins are at increased risk for congenital heart disease, echocardiography is also performed between 18 and 22 weeks, with surveillance intervals of 2 weeks or shorter if potential complications are identified. Early detection of these and other complications allows for earlier intervention, earlier referral if necessary, and potentially better outcomes.
Twin-to-twin transfusion syndrome
Twin-to-twin transfusion syndrome (TTTS) is one of the most common and most serious complications, affecting approximately 10% of monochorionic pregnancies. Significant imbalances in blood-flow exchange lead to progressive cardiovascular decompensation that causes one twin to become a “donor” of blood volume, and the other twin to become a “recipient.” Without proper treatment between 16 and 26 weeks’ gestation, the perinatal mortality rate has been estimated to be 70% or higher.
Disease severity is classified according to the Quintero staging system. Stage I is characterized by amniotic fluid discordance. In stage II, the bladder of the donor twin is no longer visible sonographically. Stage III is marked by critically abnormal Doppler waveforms in either twin (absent/reverse end-diastolic velocity in the umbilical artery, reverse flow in the ductus venosus, or pulsatile flow in the umbilical vein). In stage IV, one of the twins has developed hydrops, and stage V is characterized by the death of one or both of the twins.
Amnioreduction to decrease intra-amniotic pressure had been the treatment of choice until a randomized controlled trial, published in 2004, demonstrated that fetoscopic laser coagulation of anastomoses was superior as a first-line treatment for severe TTTS that is diagnosed before 26 weeks. Perinatal mortality and morbidity were significantly lower after the laser treatment (N Engl J Med. 2004 Jul 8;351[2]:136-44).
Outcomes were further improved over the next decade as the laser surgery technique was modified to cover the entire vascular equator rather than selective components of the vasculature. In an open-label randomized controlled trial comparing the two approaches for severe TTTS, fetoscopic laser coagulation of the vascular equator (known as the Solomon technique) reduced the risk of twin anemia polycythemia sequence and recurrence of TTTS – the two main postoperative complications associated with residual anastomoses after selective coagulation (Lancet. 2014 Jun 21;383[9935]:2144-51).
The procedure has many challenges and can be impacted by one’s inability to see the entire vascular equator because of poor access, by the patient’s history of other interventions, and by the stage of TTTS.
Laser coagulation is regarded as the standard treatment for Quintero stage II-IV disease, and it is offered in some cases of stage I disease, such as those involving severe polyhydramnios and shortened cervix. Research currently underway is examining the outcomes of treatment for stage I disease, but data thus far suggest that intervening at stage I is generally better than expectant management.
With laser coagulation treatment, the survival rate in pregnancies complicated by TTTS is about 85%-90% for one fetus, and about 70% for both. TTTS sometimes causes one twin, particularly the recipient, to develop pulmonary valve stenosis, but this is generally a functional problem that resolves when the syndrome is treated.
After treatment, it is important to monitor for the development of twin anemia-polycythemia sequence, which may still occur if full visualization of the vascular equator was not possible or if a fine vessel was missed. Such monitoring involves weekly ultrasound surveillance with middle cerebral artery peak systolic velocity measurements.
Patients should also be monitored for abnormal neurologic development, ventriculomegaly, and other signs of abnormal brain development. Even “perfect” laser treatment with seemingly complete placental separation has been associated with abnormal neurologic development in about 10%-15% of cases.
Maternal complications with TTTS include placental abruption and preterm membrane rupture, the latter of which occurs about 15%-20% of the time.
Currently under much discussion is fetoscopic laser coagulation of TTTS placentas that have “proximate cord insertions.” The surgery in these cases – where the cords are less than 4 cm apart – is much more challenging because of technical difficulties in visualizing the vascular equator, and outcomes are being studied. Some centers will not perform laser surgery on placentas with proximate cord insertions, which fortunately are uncommon. However, the surgery is possible; I have completed three cases thus far, each with dual survival.
Selective fetal growth restriction
Selective fetal growth restriction (sFGR) stems from unequal placental sharing and affects approximately 15%-20% of all monochorionic pregnancies, making it a bit more common than TTTS. Diagnostic criteria vary, but the North American Fetal Therapy Network recommends using either an estimated fetal weight below the 10th percentile, with or without significant growth discordance (greater than 25%), or just growth discordance greater than 25%. Either provides an acceptable definition of sFGR.
With sFGR, in general, the normally growing twin has normal fluid and the growth-restricted twin has less fluid. This makes it different from TTTS, in which the twins may have different sizes but fluid discordance is always present. Also in TTTS, there is a finding of polyhydramnios in the recipient.
There are three types of sFGR, based on umbilical artery Doppler findings. In type I there is no cardiovascular imbalance, and management typically involves weekly monitoring with Doppler ultrasound. If Doppler findings remain normal for some time, monitoring every 2-4 weeks will suffice. Elective delivery is generally set for 35 or 36 weeks.
Type II sFGR involves cardiovascular compromise early in pregnancy, with umbilical artery Doppler showing persistent reversed or absent end-diastolic flow. Treatment options include monitoring closely and, in general, delivering by 32 weeks. In these cases, prematurity may jeopardize the life or health of the normally growing twin while saving the life of the growth-restricted twin.
When type II sFGR is diagnosed early, selective termination of the growth-restricted fetus may be another option. This is a relatively safe procedure overall but it carries risks such as ruptured membrane and damage to the normal twin (10%-35% risk).
Type III sFGR is uniquely unpredictable, with intermittently absent or reversed flow stemming from a large artery-artery anastomosis. The direction of blood flow may suddenly change; in fact, the diagnosis is made by placing the Doppler caliper close to the placenta cord insertion and watching the end-diastolic flow. Present, absent, and reverse flow within a minute of observation demonstrates the presence of a large artery-artery anastomosis.
The risk of unexpected fetal death with severe sFGR is estimated to be 15% or higher, and the spontaneous death of the poorly growing twin threatens both the survival and the neurologic health of the co-twin. The risk of a parenchymal lesion for the co-twin is about 20%-40%.
Management decisions can be extremely difficult. As with type II, one could manage expectantly and generally deliver by 32 weeks. Fetoscopic laser coagulation to achieve complete dichorionization, as done with TTTS, could also be discussed; this approach could save the life of one twin in the event that the co-twin dies. Finally, selective termination may again be an option. None is a perfect treatment, and parents must be thoroughly counseled and supported in understanding the options and risks.
Twin anemia polycythemia sequence
Unlike TTTS, twin anemia polycythemia sequence (TAPS) does not involve a fluid shift. Rather, red blood cells shift from one fetus to the other through extremely small-caliber vessels, leading to severe anemia of one fetus and polycythemia of the other. The chronic and unbalanced transfusion occurs in about 5% of monochorionic twins, generally after 26 weeks’ gestation.
TAPS also occurs after laser treatment for TTTS in about 10%-15% of cases (generally within 4 weeks of treatment), though this incidence is significantly reduced when complete dichorionization is achieved using the Solomon technique for fetoscopic laser coagulation. Diagnosis is made when the middle cerebral artery peak systolic velocity of the red blood cell donor is greater than 1.5 MoM and the peak systolic velocity of the recipient is less than 1.0 MoM, without amniotic fluid discordance.
There are no established preferred treatments, but fetoscopic laser coagulation is an option for some patients. Visibility can be extremely poor when TAPS occurs after a laser treatment and vessels can be difficult to identify, but in selected cases it is possible with an experienced team. When performed, treatment can be followed by delivery or by intrauterine transfusion of the anemic fetus. Intrauterine transfusion has been studied as a primary treatment, but it generally is problematic because the small vessels at the root of TAPS continue to exist.
Twin reversed arterial perfusion
In about 1% of monochorionic pregnancies, an arterial incident prevents one of the twins from developing a heart and upper body. Some research has suggested that the condition is associated with trisomies in about 10% of the cases.
The viable, structurally normal co-twin therefore acts like a pump, continually perfusing the nonviable twin through an abnormal vascular circuit that allows arterial blood to flow in a reverse direction. In the process, the normal twin, or “pump twin,” can develop heart failure and hydrops. Mortality appears to be about 55%.
Diagnosis is straightforward, but it has been challenging to determine which pregnancies will require intervention. Some research has suggested that the risk of hydrops and mortality increases significantly – and favors intervention – when the weight difference is greater than 70%. On the other hand, if the difference is less than 50%, survival of the pump twin approaches 80% and continuing surveillance may be most appropriate.
Radiofrequency ablation of the cord of the nonviable twin is one of the treatment methods and has about an 80% success rate. Another option is coagulation of the blood supply in the abnormal twin using a laser fiber via a fine needle during the first trimester. An ongoing European trial of the procedure is showing success rates of approximately 70%.
Dr. Turan is director of fetal therapy and complex obstetric surgery, and an associate professor of obstetrics, gynecology, and reproductive sciences at the University of Maryland School of Medicine, Baltimore. He reported having no relevant financial disclosures.
Approximately 20% of all twin pregnancies are monochorionic, with the fetuses sharing a single placenta. Although the majority of these pregnancies are uncomplicated, monochorionic twins are significantly more likely than dichorionic twins to incur complications that can threaten the life and health of one or both fetuses.
The death of one monochorionic twin leaves the other twin with a 15% risk of demise. Survival after the loss of a co-twin is also associated with a 25% incidence of neurologic injury, compared with a 2% incidence in dichorionic pregnancies. Additionally, monochorionic pregnancies carry the risk of unique complications such as twin-to-twin transfusion syndrome, selective fetal growth restriction, twin anemia polycythemia sequence, and twin reversed arterial perfusion.
Increased ultrasonographic surveillance recommended for monochorionic twin pregnancies has been outlined in a recent consensus statement from the North American Fetal Therapy Network (Obstet Gynecol. 2015 Jan;125[1]:118-23). Beginning at 16 weeks’ gestation, monochorionic twins should be assessed every 2 weeks using amniotic fluid balance, presence/absence of fluid within the fetal bladder, and with fetal Doppler (umbilical artery, middle cerebral artery, and ductus venosus) studies. Fetal growth should also be assessed at least every 4 weeks.
Since monochorionic twins are at increased risk for congenital heart disease, echocardiography is also performed between 18 and 22 weeks, with surveillance intervals of 2 weeks or shorter if potential complications are identified. Early detection of these and other complications allows for earlier intervention, earlier referral if necessary, and potentially better outcomes.
Twin-to-twin transfusion syndrome
Twin-to-twin transfusion syndrome (TTTS) is one of the most common and most serious complications, affecting approximately 10% of monochorionic pregnancies. Significant imbalances in blood-flow exchange lead to progressive cardiovascular decompensation that causes one twin to become a “donor” of blood volume, and the other twin to become a “recipient.” Without proper treatment between 16 and 26 weeks’ gestation, the perinatal mortality rate has been estimated to be 70% or higher.
Disease severity is classified according to the Quintero staging system. Stage I is characterized by amniotic fluid discordance. In stage II, the bladder of the donor twin is no longer visible sonographically. Stage III is marked by critically abnormal Doppler waveforms in either twin (absent/reverse end-diastolic velocity in the umbilical artery, reverse flow in the ductus venosus, or pulsatile flow in the umbilical vein). In stage IV, one of the twins has developed hydrops, and stage V is characterized by the death of one or both of the twins.
Amnioreduction to decrease intra-amniotic pressure had been the treatment of choice until a randomized controlled trial, published in 2004, demonstrated that fetoscopic laser coagulation of anastomoses was superior as a first-line treatment for severe TTTS that is diagnosed before 26 weeks. Perinatal mortality and morbidity were significantly lower after the laser treatment (N Engl J Med. 2004 Jul 8;351[2]:136-44).
Outcomes were further improved over the next decade as the laser surgery technique was modified to cover the entire vascular equator rather than selective components of the vasculature. In an open-label randomized controlled trial comparing the two approaches for severe TTTS, fetoscopic laser coagulation of the vascular equator (known as the Solomon technique) reduced the risk of twin anemia polycythemia sequence and recurrence of TTTS – the two main postoperative complications associated with residual anastomoses after selective coagulation (Lancet. 2014 Jun 21;383[9935]:2144-51).
The procedure has many challenges and can be impacted by one’s inability to see the entire vascular equator because of poor access, by the patient’s history of other interventions, and by the stage of TTTS.
Laser coagulation is regarded as the standard treatment for Quintero stage II-IV disease, and it is offered in some cases of stage I disease, such as those involving severe polyhydramnios and shortened cervix. Research currently underway is examining the outcomes of treatment for stage I disease, but data thus far suggest that intervening at stage I is generally better than expectant management.
With laser coagulation treatment, the survival rate in pregnancies complicated by TTTS is about 85%-90% for one fetus, and about 70% for both. TTTS sometimes causes one twin, particularly the recipient, to develop pulmonary valve stenosis, but this is generally a functional problem that resolves when the syndrome is treated.
After treatment, it is important to monitor for the development of twin anemia-polycythemia sequence, which may still occur if full visualization of the vascular equator was not possible or if a fine vessel was missed. Such monitoring involves weekly ultrasound surveillance with middle cerebral artery peak systolic velocity measurements.
Patients should also be monitored for abnormal neurologic development, ventriculomegaly, and other signs of abnormal brain development. Even “perfect” laser treatment with seemingly complete placental separation has been associated with abnormal neurologic development in about 10%-15% of cases.
Maternal complications with TTTS include placental abruption and preterm membrane rupture, the latter of which occurs about 15%-20% of the time.
Currently under much discussion is fetoscopic laser coagulation of TTTS placentas that have “proximate cord insertions.” The surgery in these cases – where the cords are less than 4 cm apart – is much more challenging because of technical difficulties in visualizing the vascular equator, and outcomes are being studied. Some centers will not perform laser surgery on placentas with proximate cord insertions, which fortunately are uncommon. However, the surgery is possible; I have completed three cases thus far, each with dual survival.
Selective fetal growth restriction
Selective fetal growth restriction (sFGR) stems from unequal placental sharing and affects approximately 15%-20% of all monochorionic pregnancies, making it a bit more common than TTTS. Diagnostic criteria vary, but the North American Fetal Therapy Network recommends using either an estimated fetal weight below the 10th percentile, with or without significant growth discordance (greater than 25%), or just growth discordance greater than 25%. Either provides an acceptable definition of sFGR.
With sFGR, in general, the normally growing twin has normal fluid and the growth-restricted twin has less fluid. This makes it different from TTTS, in which the twins may have different sizes but fluid discordance is always present. Also in TTTS, there is a finding of polyhydramnios in the recipient.
There are three types of sFGR, based on umbilical artery Doppler findings. In type I there is no cardiovascular imbalance, and management typically involves weekly monitoring with Doppler ultrasound. If Doppler findings remain normal for some time, monitoring every 2-4 weeks will suffice. Elective delivery is generally set for 35 or 36 weeks.
Type II sFGR involves cardiovascular compromise early in pregnancy, with umbilical artery Doppler showing persistent reversed or absent end-diastolic flow. Treatment options include monitoring closely and, in general, delivering by 32 weeks. In these cases, prematurity may jeopardize the life or health of the normally growing twin while saving the life of the growth-restricted twin.
When type II sFGR is diagnosed early, selective termination of the growth-restricted fetus may be another option. This is a relatively safe procedure overall but it carries risks such as ruptured membrane and damage to the normal twin (10%-35% risk).
Type III sFGR is uniquely unpredictable, with intermittently absent or reversed flow stemming from a large artery-artery anastomosis. The direction of blood flow may suddenly change; in fact, the diagnosis is made by placing the Doppler caliper close to the placenta cord insertion and watching the end-diastolic flow. Present, absent, and reverse flow within a minute of observation demonstrates the presence of a large artery-artery anastomosis.
The risk of unexpected fetal death with severe sFGR is estimated to be 15% or higher, and the spontaneous death of the poorly growing twin threatens both the survival and the neurologic health of the co-twin. The risk of a parenchymal lesion for the co-twin is about 20%-40%.
Management decisions can be extremely difficult. As with type II, one could manage expectantly and generally deliver by 32 weeks. Fetoscopic laser coagulation to achieve complete dichorionization, as done with TTTS, could also be discussed; this approach could save the life of one twin in the event that the co-twin dies. Finally, selective termination may again be an option. None is a perfect treatment, and parents must be thoroughly counseled and supported in understanding the options and risks.
Twin anemia polycythemia sequence
Unlike TTTS, twin anemia polycythemia sequence (TAPS) does not involve a fluid shift. Rather, red blood cells shift from one fetus to the other through extremely small-caliber vessels, leading to severe anemia of one fetus and polycythemia of the other. The chronic and unbalanced transfusion occurs in about 5% of monochorionic twins, generally after 26 weeks’ gestation.
TAPS also occurs after laser treatment for TTTS in about 10%-15% of cases (generally within 4 weeks of treatment), though this incidence is significantly reduced when complete dichorionization is achieved using the Solomon technique for fetoscopic laser coagulation. Diagnosis is made when the middle cerebral artery peak systolic velocity of the red blood cell donor is greater than 1.5 MoM and the peak systolic velocity of the recipient is less than 1.0 MoM, without amniotic fluid discordance.
There are no established preferred treatments, but fetoscopic laser coagulation is an option for some patients. Visibility can be extremely poor when TAPS occurs after a laser treatment and vessels can be difficult to identify, but in selected cases it is possible with an experienced team. When performed, treatment can be followed by delivery or by intrauterine transfusion of the anemic fetus. Intrauterine transfusion has been studied as a primary treatment, but it generally is problematic because the small vessels at the root of TAPS continue to exist.
Twin reversed arterial perfusion
In about 1% of monochorionic pregnancies, an arterial incident prevents one of the twins from developing a heart and upper body. Some research has suggested that the condition is associated with trisomies in about 10% of the cases.
The viable, structurally normal co-twin therefore acts like a pump, continually perfusing the nonviable twin through an abnormal vascular circuit that allows arterial blood to flow in a reverse direction. In the process, the normal twin, or “pump twin,” can develop heart failure and hydrops. Mortality appears to be about 55%.
Diagnosis is straightforward, but it has been challenging to determine which pregnancies will require intervention. Some research has suggested that the risk of hydrops and mortality increases significantly – and favors intervention – when the weight difference is greater than 70%. On the other hand, if the difference is less than 50%, survival of the pump twin approaches 80% and continuing surveillance may be most appropriate.
Radiofrequency ablation of the cord of the nonviable twin is one of the treatment methods and has about an 80% success rate. Another option is coagulation of the blood supply in the abnormal twin using a laser fiber via a fine needle during the first trimester. An ongoing European trial of the procedure is showing success rates of approximately 70%.
Dr. Turan is director of fetal therapy and complex obstetric surgery, and an associate professor of obstetrics, gynecology, and reproductive sciences at the University of Maryland School of Medicine, Baltimore. He reported having no relevant financial disclosures.
Approximately 20% of all twin pregnancies are monochorionic, with the fetuses sharing a single placenta. Although the majority of these pregnancies are uncomplicated, monochorionic twins are significantly more likely than dichorionic twins to incur complications that can threaten the life and health of one or both fetuses.
The death of one monochorionic twin leaves the other twin with a 15% risk of demise. Survival after the loss of a co-twin is also associated with a 25% incidence of neurologic injury, compared with a 2% incidence in dichorionic pregnancies. Additionally, monochorionic pregnancies carry the risk of unique complications such as twin-to-twin transfusion syndrome, selective fetal growth restriction, twin anemia polycythemia sequence, and twin reversed arterial perfusion.
Increased ultrasonographic surveillance recommended for monochorionic twin pregnancies has been outlined in a recent consensus statement from the North American Fetal Therapy Network (Obstet Gynecol. 2015 Jan;125[1]:118-23). Beginning at 16 weeks’ gestation, monochorionic twins should be assessed every 2 weeks using amniotic fluid balance, presence/absence of fluid within the fetal bladder, and with fetal Doppler (umbilical artery, middle cerebral artery, and ductus venosus) studies. Fetal growth should also be assessed at least every 4 weeks.
Since monochorionic twins are at increased risk for congenital heart disease, echocardiography is also performed between 18 and 22 weeks, with surveillance intervals of 2 weeks or shorter if potential complications are identified. Early detection of these and other complications allows for earlier intervention, earlier referral if necessary, and potentially better outcomes.
Twin-to-twin transfusion syndrome
Twin-to-twin transfusion syndrome (TTTS) is one of the most common and most serious complications, affecting approximately 10% of monochorionic pregnancies. Significant imbalances in blood-flow exchange lead to progressive cardiovascular decompensation that causes one twin to become a “donor” of blood volume, and the other twin to become a “recipient.” Without proper treatment between 16 and 26 weeks’ gestation, the perinatal mortality rate has been estimated to be 70% or higher.
Disease severity is classified according to the Quintero staging system. Stage I is characterized by amniotic fluid discordance. In stage II, the bladder of the donor twin is no longer visible sonographically. Stage III is marked by critically abnormal Doppler waveforms in either twin (absent/reverse end-diastolic velocity in the umbilical artery, reverse flow in the ductus venosus, or pulsatile flow in the umbilical vein). In stage IV, one of the twins has developed hydrops, and stage V is characterized by the death of one or both of the twins.
Amnioreduction to decrease intra-amniotic pressure had been the treatment of choice until a randomized controlled trial, published in 2004, demonstrated that fetoscopic laser coagulation of anastomoses was superior as a first-line treatment for severe TTTS that is diagnosed before 26 weeks. Perinatal mortality and morbidity were significantly lower after the laser treatment (N Engl J Med. 2004 Jul 8;351[2]:136-44).
Outcomes were further improved over the next decade as the laser surgery technique was modified to cover the entire vascular equator rather than selective components of the vasculature. In an open-label randomized controlled trial comparing the two approaches for severe TTTS, fetoscopic laser coagulation of the vascular equator (known as the Solomon technique) reduced the risk of twin anemia polycythemia sequence and recurrence of TTTS – the two main postoperative complications associated with residual anastomoses after selective coagulation (Lancet. 2014 Jun 21;383[9935]:2144-51).
The procedure has many challenges and can be impacted by one’s inability to see the entire vascular equator because of poor access, by the patient’s history of other interventions, and by the stage of TTTS.
Laser coagulation is regarded as the standard treatment for Quintero stage II-IV disease, and it is offered in some cases of stage I disease, such as those involving severe polyhydramnios and shortened cervix. Research currently underway is examining the outcomes of treatment for stage I disease, but data thus far suggest that intervening at stage I is generally better than expectant management.
With laser coagulation treatment, the survival rate in pregnancies complicated by TTTS is about 85%-90% for one fetus, and about 70% for both. TTTS sometimes causes one twin, particularly the recipient, to develop pulmonary valve stenosis, but this is generally a functional problem that resolves when the syndrome is treated.
After treatment, it is important to monitor for the development of twin anemia-polycythemia sequence, which may still occur if full visualization of the vascular equator was not possible or if a fine vessel was missed. Such monitoring involves weekly ultrasound surveillance with middle cerebral artery peak systolic velocity measurements.
Patients should also be monitored for abnormal neurologic development, ventriculomegaly, and other signs of abnormal brain development. Even “perfect” laser treatment with seemingly complete placental separation has been associated with abnormal neurologic development in about 10%-15% of cases.
Maternal complications with TTTS include placental abruption and preterm membrane rupture, the latter of which occurs about 15%-20% of the time.
Currently under much discussion is fetoscopic laser coagulation of TTTS placentas that have “proximate cord insertions.” The surgery in these cases – where the cords are less than 4 cm apart – is much more challenging because of technical difficulties in visualizing the vascular equator, and outcomes are being studied. Some centers will not perform laser surgery on placentas with proximate cord insertions, which fortunately are uncommon. However, the surgery is possible; I have completed three cases thus far, each with dual survival.
Selective fetal growth restriction
Selective fetal growth restriction (sFGR) stems from unequal placental sharing and affects approximately 15%-20% of all monochorionic pregnancies, making it a bit more common than TTTS. Diagnostic criteria vary, but the North American Fetal Therapy Network recommends using either an estimated fetal weight below the 10th percentile, with or without significant growth discordance (greater than 25%), or just growth discordance greater than 25%. Either provides an acceptable definition of sFGR.
With sFGR, in general, the normally growing twin has normal fluid and the growth-restricted twin has less fluid. This makes it different from TTTS, in which the twins may have different sizes but fluid discordance is always present. Also in TTTS, there is a finding of polyhydramnios in the recipient.
There are three types of sFGR, based on umbilical artery Doppler findings. In type I there is no cardiovascular imbalance, and management typically involves weekly monitoring with Doppler ultrasound. If Doppler findings remain normal for some time, monitoring every 2-4 weeks will suffice. Elective delivery is generally set for 35 or 36 weeks.
Type II sFGR involves cardiovascular compromise early in pregnancy, with umbilical artery Doppler showing persistent reversed or absent end-diastolic flow. Treatment options include monitoring closely and, in general, delivering by 32 weeks. In these cases, prematurity may jeopardize the life or health of the normally growing twin while saving the life of the growth-restricted twin.
When type II sFGR is diagnosed early, selective termination of the growth-restricted fetus may be another option. This is a relatively safe procedure overall but it carries risks such as ruptured membrane and damage to the normal twin (10%-35% risk).
Type III sFGR is uniquely unpredictable, with intermittently absent or reversed flow stemming from a large artery-artery anastomosis. The direction of blood flow may suddenly change; in fact, the diagnosis is made by placing the Doppler caliper close to the placenta cord insertion and watching the end-diastolic flow. Present, absent, and reverse flow within a minute of observation demonstrates the presence of a large artery-artery anastomosis.
The risk of unexpected fetal death with severe sFGR is estimated to be 15% or higher, and the spontaneous death of the poorly growing twin threatens both the survival and the neurologic health of the co-twin. The risk of a parenchymal lesion for the co-twin is about 20%-40%.
Management decisions can be extremely difficult. As with type II, one could manage expectantly and generally deliver by 32 weeks. Fetoscopic laser coagulation to achieve complete dichorionization, as done with TTTS, could also be discussed; this approach could save the life of one twin in the event that the co-twin dies. Finally, selective termination may again be an option. None is a perfect treatment, and parents must be thoroughly counseled and supported in understanding the options and risks.
Twin anemia polycythemia sequence
Unlike TTTS, twin anemia polycythemia sequence (TAPS) does not involve a fluid shift. Rather, red blood cells shift from one fetus to the other through extremely small-caliber vessels, leading to severe anemia of one fetus and polycythemia of the other. The chronic and unbalanced transfusion occurs in about 5% of monochorionic twins, generally after 26 weeks’ gestation.
TAPS also occurs after laser treatment for TTTS in about 10%-15% of cases (generally within 4 weeks of treatment), though this incidence is significantly reduced when complete dichorionization is achieved using the Solomon technique for fetoscopic laser coagulation. Diagnosis is made when the middle cerebral artery peak systolic velocity of the red blood cell donor is greater than 1.5 MoM and the peak systolic velocity of the recipient is less than 1.0 MoM, without amniotic fluid discordance.
There are no established preferred treatments, but fetoscopic laser coagulation is an option for some patients. Visibility can be extremely poor when TAPS occurs after a laser treatment and vessels can be difficult to identify, but in selected cases it is possible with an experienced team. When performed, treatment can be followed by delivery or by intrauterine transfusion of the anemic fetus. Intrauterine transfusion has been studied as a primary treatment, but it generally is problematic because the small vessels at the root of TAPS continue to exist.
Twin reversed arterial perfusion
In about 1% of monochorionic pregnancies, an arterial incident prevents one of the twins from developing a heart and upper body. Some research has suggested that the condition is associated with trisomies in about 10% of the cases.
The viable, structurally normal co-twin therefore acts like a pump, continually perfusing the nonviable twin through an abnormal vascular circuit that allows arterial blood to flow in a reverse direction. In the process, the normal twin, or “pump twin,” can develop heart failure and hydrops. Mortality appears to be about 55%.
Diagnosis is straightforward, but it has been challenging to determine which pregnancies will require intervention. Some research has suggested that the risk of hydrops and mortality increases significantly – and favors intervention – when the weight difference is greater than 70%. On the other hand, if the difference is less than 50%, survival of the pump twin approaches 80% and continuing surveillance may be most appropriate.
Radiofrequency ablation of the cord of the nonviable twin is one of the treatment methods and has about an 80% success rate. Another option is coagulation of the blood supply in the abnormal twin using a laser fiber via a fine needle during the first trimester. An ongoing European trial of the procedure is showing success rates of approximately 70%.
Dr. Turan is director of fetal therapy and complex obstetric surgery, and an associate professor of obstetrics, gynecology, and reproductive sciences at the University of Maryland School of Medicine, Baltimore. He reported having no relevant financial disclosures.
Zika virus in pregnancy
Editor’s Note: This is the second installment of a six-part series that will review key concepts and articles that ob.gyns. can use to prepare for the American Board of Obstetrics and Gynecology Maintenance of Certification examination. The series is adapted from Ob/Gyn Board Master (obgynboardmaster.com), an online board review course created by Erudyte Inc. The series will cover issues in reproductive endocrinology and infertility, maternal-fetal medicine, gynecologic oncology, and female pelvic medicine, as well as general test-taking and study tips. This month’s edition of the Board Corner focuses on Zika virus.
In 2016, The American Board of Obstetricians and Gynecologists assigned four maintenance of certification (MOC) articles dealing with Zika virus:
Zika Virus and Pregnancy: What Obstetric Health Care Providers Need to Know1
Update: Interim Guidance for Health Care Providers Caring for Women of Reproductive Age with Possible Zika Virus Exposure – United States, 20163
Interim Guidelines for Pregnant Women During a Zika Virus Outbreak – United States, 20164
The diagnosis and management of Zika virus in pregnancy is a hot topic that should be reviewed before any Obstetrics and Gynecology board exam. This month’s Board Corner will review the key elements for ob.gyns.
Let’s begin with a possible medical board question: Which of the following is LEAST LIKELY to be associated with congenital Zika virus infection?
A. Omphalocele
B. Microcephaly
C. Ventriculomegaly
D. Cataract
E. Intracranial calcifications
The correct answer is A.
Omphalocele has not been observed to be associated with Zika virus infection. Answers B-E are incorrect because reported fetal and neonatal abnormalities associated with Zika virus include microcephaly, ventriculomegaly, intracranial calcifications, brain atrophy, and cataracts.
Key points
The key points to remember are:
Transmission of Zika virus to humans most commonly occurs from the bite of an infected mosquito. Other modes of transmission have been reported, such as sexual transmission, maternal-fetal transmission, and transmission through blood transfusion.
Infection with Zika virus and maternal-fetal transmission have been documented in all trimesters of pregnancy. Reported fetal and neonatal sequelae include microcephaly, ventriculomegaly, intracranial calcifications, brain atrophy, and cataracts.
Immunoglobulin M (IgM) can also be detected as early as 4 days after the onset of illness. For those women who have laboratory-confirmed Zika virus infection during pregnancy, amniocentesis should be offered after 15 weeks gestation.
Literature summary
Zika virus is a mosquito-borne virus that is most commonly transmitted by the Aedes aegypti mosquito. This species of mosquito is also known to transmit dengue, yellow fever, and chikungunya viruses. Initial data suggest that the incubation period for Zika virus is a few days up to 2 weeks. Acute onset of fever, maculopapular rash, conjunctivitis, and arthralgia are the most common symptoms of Zika infection. Symptoms generally only last up to 7 days and are typically mild. Only about 20% of people infected with the virus become ill. There is currently no specific antiviral treatment available for Zika virus disease.
Testing for Zika virus can include detection of viral RNA, Zika antigen, or antibodies. Reverse transcription–polymerase chain reaction (RT-PCR) can be performed on serum, amniotic fluid, and tissue (such as placenta). It is recommended that RT-PCR testing of serum be performed within 7 days of the onset of symptoms. Immunoglobulin M (IgM) can also be detected as early as 4 days after the onset of illness.
Though fetal microcephaly can be detected ultrasonographically at 18-20 weeks gestation, the diagnosis can be challenging because there is no standard definition of fetal microcephaly. Because other intracranial abnormalities have been detected in association with congenital Zika infection, a complete ultrasound examination should be performed to assess the fetal neuroanatomy.
For those women who have laboratory-confirmed Zika virus infection during pregnancy, amniocentesis should be offered after 15 weeks gestation. RT-PCR can be used to test for the presence of Zika virus RNA in the amniotic fluid. Patients should be referred to a maternal-fetal medicine specialist for serial ultrasounds to assess fetal anatomy and monitor fetal growth every 3-4 weeks.
References
1. Obstet Gynecol. 2016 Apr;127(4):642-8.
2. Morb Mortal Wkly Rep. 2016;65:311-4.
3. Morb Mortal Wkly Rep. 2016;65:315-22.
4. Morb Mortal Wkly Rep. 2016;65:30-3.
Dr. Siddighi is editor-in-chief of the Ob/Gyn Board Master and director of female pelvic medicine and reconstructive surgery and director of grand rounds at Loma Linda University Health in California. Ob.Gyn. News and Ob/Gyn Board Master are owned by the same parent company, Frontline Medical Communications.
Editor’s Note: This is the second installment of a six-part series that will review key concepts and articles that ob.gyns. can use to prepare for the American Board of Obstetrics and Gynecology Maintenance of Certification examination. The series is adapted from Ob/Gyn Board Master (obgynboardmaster.com), an online board review course created by Erudyte Inc. The series will cover issues in reproductive endocrinology and infertility, maternal-fetal medicine, gynecologic oncology, and female pelvic medicine, as well as general test-taking and study tips. This month’s edition of the Board Corner focuses on Zika virus.
In 2016, The American Board of Obstetricians and Gynecologists assigned four maintenance of certification (MOC) articles dealing with Zika virus:
Zika Virus and Pregnancy: What Obstetric Health Care Providers Need to Know1
Update: Interim Guidance for Health Care Providers Caring for Women of Reproductive Age with Possible Zika Virus Exposure – United States, 20163
Interim Guidelines for Pregnant Women During a Zika Virus Outbreak – United States, 20164
The diagnosis and management of Zika virus in pregnancy is a hot topic that should be reviewed before any Obstetrics and Gynecology board exam. This month’s Board Corner will review the key elements for ob.gyns.
Let’s begin with a possible medical board question: Which of the following is LEAST LIKELY to be associated with congenital Zika virus infection?
A. Omphalocele
B. Microcephaly
C. Ventriculomegaly
D. Cataract
E. Intracranial calcifications
The correct answer is A.
Omphalocele has not been observed to be associated with Zika virus infection. Answers B-E are incorrect because reported fetal and neonatal abnormalities associated with Zika virus include microcephaly, ventriculomegaly, intracranial calcifications, brain atrophy, and cataracts.
Key points
The key points to remember are:
Transmission of Zika virus to humans most commonly occurs from the bite of an infected mosquito. Other modes of transmission have been reported, such as sexual transmission, maternal-fetal transmission, and transmission through blood transfusion.
Infection with Zika virus and maternal-fetal transmission have been documented in all trimesters of pregnancy. Reported fetal and neonatal sequelae include microcephaly, ventriculomegaly, intracranial calcifications, brain atrophy, and cataracts.
Immunoglobulin M (IgM) can also be detected as early as 4 days after the onset of illness. For those women who have laboratory-confirmed Zika virus infection during pregnancy, amniocentesis should be offered after 15 weeks gestation.
Literature summary
Zika virus is a mosquito-borne virus that is most commonly transmitted by the Aedes aegypti mosquito. This species of mosquito is also known to transmit dengue, yellow fever, and chikungunya viruses. Initial data suggest that the incubation period for Zika virus is a few days up to 2 weeks. Acute onset of fever, maculopapular rash, conjunctivitis, and arthralgia are the most common symptoms of Zika infection. Symptoms generally only last up to 7 days and are typically mild. Only about 20% of people infected with the virus become ill. There is currently no specific antiviral treatment available for Zika virus disease.
Testing for Zika virus can include detection of viral RNA, Zika antigen, or antibodies. Reverse transcription–polymerase chain reaction (RT-PCR) can be performed on serum, amniotic fluid, and tissue (such as placenta). It is recommended that RT-PCR testing of serum be performed within 7 days of the onset of symptoms. Immunoglobulin M (IgM) can also be detected as early as 4 days after the onset of illness.
Though fetal microcephaly can be detected ultrasonographically at 18-20 weeks gestation, the diagnosis can be challenging because there is no standard definition of fetal microcephaly. Because other intracranial abnormalities have been detected in association with congenital Zika infection, a complete ultrasound examination should be performed to assess the fetal neuroanatomy.
For those women who have laboratory-confirmed Zika virus infection during pregnancy, amniocentesis should be offered after 15 weeks gestation. RT-PCR can be used to test for the presence of Zika virus RNA in the amniotic fluid. Patients should be referred to a maternal-fetal medicine specialist for serial ultrasounds to assess fetal anatomy and monitor fetal growth every 3-4 weeks.
References
1. Obstet Gynecol. 2016 Apr;127(4):642-8.
2. Morb Mortal Wkly Rep. 2016;65:311-4.
3. Morb Mortal Wkly Rep. 2016;65:315-22.
4. Morb Mortal Wkly Rep. 2016;65:30-3.
Dr. Siddighi is editor-in-chief of the Ob/Gyn Board Master and director of female pelvic medicine and reconstructive surgery and director of grand rounds at Loma Linda University Health in California. Ob.Gyn. News and Ob/Gyn Board Master are owned by the same parent company, Frontline Medical Communications.
Editor’s Note: This is the second installment of a six-part series that will review key concepts and articles that ob.gyns. can use to prepare for the American Board of Obstetrics and Gynecology Maintenance of Certification examination. The series is adapted from Ob/Gyn Board Master (obgynboardmaster.com), an online board review course created by Erudyte Inc. The series will cover issues in reproductive endocrinology and infertility, maternal-fetal medicine, gynecologic oncology, and female pelvic medicine, as well as general test-taking and study tips. This month’s edition of the Board Corner focuses on Zika virus.
In 2016, The American Board of Obstetricians and Gynecologists assigned four maintenance of certification (MOC) articles dealing with Zika virus:
Zika Virus and Pregnancy: What Obstetric Health Care Providers Need to Know1
Update: Interim Guidance for Health Care Providers Caring for Women of Reproductive Age with Possible Zika Virus Exposure – United States, 20163
Interim Guidelines for Pregnant Women During a Zika Virus Outbreak – United States, 20164
The diagnosis and management of Zika virus in pregnancy is a hot topic that should be reviewed before any Obstetrics and Gynecology board exam. This month’s Board Corner will review the key elements for ob.gyns.
Let’s begin with a possible medical board question: Which of the following is LEAST LIKELY to be associated with congenital Zika virus infection?
A. Omphalocele
B. Microcephaly
C. Ventriculomegaly
D. Cataract
E. Intracranial calcifications
The correct answer is A.
Omphalocele has not been observed to be associated with Zika virus infection. Answers B-E are incorrect because reported fetal and neonatal abnormalities associated with Zika virus include microcephaly, ventriculomegaly, intracranial calcifications, brain atrophy, and cataracts.
Key points
The key points to remember are:
Transmission of Zika virus to humans most commonly occurs from the bite of an infected mosquito. Other modes of transmission have been reported, such as sexual transmission, maternal-fetal transmission, and transmission through blood transfusion.
Infection with Zika virus and maternal-fetal transmission have been documented in all trimesters of pregnancy. Reported fetal and neonatal sequelae include microcephaly, ventriculomegaly, intracranial calcifications, brain atrophy, and cataracts.
Immunoglobulin M (IgM) can also be detected as early as 4 days after the onset of illness. For those women who have laboratory-confirmed Zika virus infection during pregnancy, amniocentesis should be offered after 15 weeks gestation.
Literature summary
Zika virus is a mosquito-borne virus that is most commonly transmitted by the Aedes aegypti mosquito. This species of mosquito is also known to transmit dengue, yellow fever, and chikungunya viruses. Initial data suggest that the incubation period for Zika virus is a few days up to 2 weeks. Acute onset of fever, maculopapular rash, conjunctivitis, and arthralgia are the most common symptoms of Zika infection. Symptoms generally only last up to 7 days and are typically mild. Only about 20% of people infected with the virus become ill. There is currently no specific antiviral treatment available for Zika virus disease.
Testing for Zika virus can include detection of viral RNA, Zika antigen, or antibodies. Reverse transcription–polymerase chain reaction (RT-PCR) can be performed on serum, amniotic fluid, and tissue (such as placenta). It is recommended that RT-PCR testing of serum be performed within 7 days of the onset of symptoms. Immunoglobulin M (IgM) can also be detected as early as 4 days after the onset of illness.
Though fetal microcephaly can be detected ultrasonographically at 18-20 weeks gestation, the diagnosis can be challenging because there is no standard definition of fetal microcephaly. Because other intracranial abnormalities have been detected in association with congenital Zika infection, a complete ultrasound examination should be performed to assess the fetal neuroanatomy.
For those women who have laboratory-confirmed Zika virus infection during pregnancy, amniocentesis should be offered after 15 weeks gestation. RT-PCR can be used to test for the presence of Zika virus RNA in the amniotic fluid. Patients should be referred to a maternal-fetal medicine specialist for serial ultrasounds to assess fetal anatomy and monitor fetal growth every 3-4 weeks.
References
1. Obstet Gynecol. 2016 Apr;127(4):642-8.
2. Morb Mortal Wkly Rep. 2016;65:311-4.
3. Morb Mortal Wkly Rep. 2016;65:315-22.
4. Morb Mortal Wkly Rep. 2016;65:30-3.
Dr. Siddighi is editor-in-chief of the Ob/Gyn Board Master and director of female pelvic medicine and reconstructive surgery and director of grand rounds at Loma Linda University Health in California. Ob.Gyn. News and Ob/Gyn Board Master are owned by the same parent company, Frontline Medical Communications.