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Convalescent plasma not beneficial for critically ill COVID-19 patients
Key clinical point: Critically ill patients with COVID-19 fail to benefit from convalescent plasma.
Major finding: The trial was stopped early after the probability of futility was calculated at 99.4%. Convalescent plasma vs. no plasma groups had 0 vs 3 organ support-free days, 37.3% vs 38.4% in-hospital mortality rates, and 14 vs 14 median days alive and free of organ support.
Study details: The data come from an open-label, randomized component of the ongoing REMAP-CAP trial (n=2,011). Critically ill adults with COVID-19 were randomly assigned to receive convalescent plasma or not.
Disclosures: The study was funded by nonprofits in multiple countries. Several authors reported relationships with pharmaceutical companies and/or research organizations.
Source: Estcourt LJ et al. JAMA. 2021 Oct 4. doi: 10.1001/jama.2021.18178.
Key clinical point: Critically ill patients with COVID-19 fail to benefit from convalescent plasma.
Major finding: The trial was stopped early after the probability of futility was calculated at 99.4%. Convalescent plasma vs. no plasma groups had 0 vs 3 organ support-free days, 37.3% vs 38.4% in-hospital mortality rates, and 14 vs 14 median days alive and free of organ support.
Study details: The data come from an open-label, randomized component of the ongoing REMAP-CAP trial (n=2,011). Critically ill adults with COVID-19 were randomly assigned to receive convalescent plasma or not.
Disclosures: The study was funded by nonprofits in multiple countries. Several authors reported relationships with pharmaceutical companies and/or research organizations.
Source: Estcourt LJ et al. JAMA. 2021 Oct 4. doi: 10.1001/jama.2021.18178.
Key clinical point: Critically ill patients with COVID-19 fail to benefit from convalescent plasma.
Major finding: The trial was stopped early after the probability of futility was calculated at 99.4%. Convalescent plasma vs. no plasma groups had 0 vs 3 organ support-free days, 37.3% vs 38.4% in-hospital mortality rates, and 14 vs 14 median days alive and free of organ support.
Study details: The data come from an open-label, randomized component of the ongoing REMAP-CAP trial (n=2,011). Critically ill adults with COVID-19 were randomly assigned to receive convalescent plasma or not.
Disclosures: The study was funded by nonprofits in multiple countries. Several authors reported relationships with pharmaceutical companies and/or research organizations.
Source: Estcourt LJ et al. JAMA. 2021 Oct 4. doi: 10.1001/jama.2021.18178.
FDA proposes new rule for over-the-counter hearing aids
The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.
Those with severe hearing loss or people under 18 years old would still need to see a doctor or specialist for a hearing device.
In the United States, access to hearing aids can be difficult and expensive. Usually, patients have to go see their health care providers for a prescription. Then, they go to an audiologist, or a hearing aid specialist, to get the devices fitted.
With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.
“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.
The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.
For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.
The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Mr. Becerra with concerns about over-the-counter sales of hearing aids.
“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.
“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.
This new category would apply to certain air conduction hearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear canal.
The FDA is proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.
The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.
There are a number of reasons for hearing loss, including exposure to extremely loud noises, aging, and various medical conditions. Approximately 38 million Americans 18 years old and older report having hearing trouble, said Janet Woodcock, MD, acting commissioner of the FDA.
About 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor, she added.
“Hearing loss can have a profound impact on daily communication, social interaction, and overall health and quality of life for millions of Americans,” Dr. Woodcock said.
The FDA has updated its guidance on hearing devices and personal sound amplification products.
Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.
Amplification devices are not regulated by the FDA.
A version of this article first appeared on WebMD.com.
The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.
Those with severe hearing loss or people under 18 years old would still need to see a doctor or specialist for a hearing device.
In the United States, access to hearing aids can be difficult and expensive. Usually, patients have to go see their health care providers for a prescription. Then, they go to an audiologist, or a hearing aid specialist, to get the devices fitted.
With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.
“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.
The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.
For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.
The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Mr. Becerra with concerns about over-the-counter sales of hearing aids.
“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.
“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.
This new category would apply to certain air conduction hearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear canal.
The FDA is proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.
The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.
There are a number of reasons for hearing loss, including exposure to extremely loud noises, aging, and various medical conditions. Approximately 38 million Americans 18 years old and older report having hearing trouble, said Janet Woodcock, MD, acting commissioner of the FDA.
About 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor, she added.
“Hearing loss can have a profound impact on daily communication, social interaction, and overall health and quality of life for millions of Americans,” Dr. Woodcock said.
The FDA has updated its guidance on hearing devices and personal sound amplification products.
Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.
Amplification devices are not regulated by the FDA.
A version of this article first appeared on WebMD.com.
The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.
Those with severe hearing loss or people under 18 years old would still need to see a doctor or specialist for a hearing device.
In the United States, access to hearing aids can be difficult and expensive. Usually, patients have to go see their health care providers for a prescription. Then, they go to an audiologist, or a hearing aid specialist, to get the devices fitted.
With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.
“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.
The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.
For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.
The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Mr. Becerra with concerns about over-the-counter sales of hearing aids.
“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.
“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.
This new category would apply to certain air conduction hearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear canal.
The FDA is proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.
The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.
There are a number of reasons for hearing loss, including exposure to extremely loud noises, aging, and various medical conditions. Approximately 38 million Americans 18 years old and older report having hearing trouble, said Janet Woodcock, MD, acting commissioner of the FDA.
About 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor, she added.
“Hearing loss can have a profound impact on daily communication, social interaction, and overall health and quality of life for millions of Americans,” Dr. Woodcock said.
The FDA has updated its guidance on hearing devices and personal sound amplification products.
Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.
Amplification devices are not regulated by the FDA.
A version of this article first appeared on WebMD.com.
CAR T for ALL: Areas that need optimizing
The success of chimeric antigen receptor T (CAR T)-cell therapy for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) has garnered much attention, but the field is still in its infancy – with toxicity and relapse rates remaining unacceptably high.
in the use of the therapy in this setting, according to review authors Vanessa A. Fabrizio, MD, a fellow at Duke University, Durham, N.C., and Kevin J. Curran, MD, a pediatric oncologist at Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York.
Based on their review of early pivotal clinical trials, relapse data, toxicities, and mechanisms to optimize CAR T-cell therapy, Dr. Fabrizio and Dr. Curran outlined several “practice points” and proposed a research agenda aimed at optimizing the use of CAR T-cell therapy for B-ALL (Best Pract Res Clin Haematol. 2021 Aug 27. doi: 10.1016/j.beha.2021.101305).
Practice points
CAR T-cell therapy has transformed the treatment of both pediatric and adult patients with relapsed/refractory (R/R) B-ALL, the authors said, adding that “[c]linical trial results across multiple institutions with different CAR constructs report significant response rates in treated patients.”
Dr. Fabrizio and Dr. Curran specifically note that only one product (tisagenlecleucel) is currently approved for the treatment of R/R B-ALL in patients under age 26 years. Further, the successful application of this therapy is limited by high relapse rates, significant toxicity in some cases, and challenges related to collection and production issues.
They contend that areas in which optimization of CAR T-cell therapy can occur include apheresis, production, chemotherapy bridging, pretreatment disease burden management, toxicity management, disease monitoring after therapy, and use of consolidative allogeneic hematopoietic stem cell transplantation.
Research agenda
Key ways to heighten the success of CAR T-cell therapy for B-ALL are the development of off-the-shelf CAR T-cell products and the selection of optimal T cells to enhance apheresis and production, they said, adding that research is needed on the use of bridging chemotherapy to reduce tumor burden.
Bridging chemotherapy has been shown to impact outcomes while minimizing toxicity, but it remains undefined.
“Prospective trials are required to determine if the optimization of lymphodepleting chemotherapy can improve outcomes, and if consolidative therapy with transplantation should be considered in select patients,” they wrote. “Continued efforts to improve this technology for patients is ongoing while remaining questions are being investigated.”
The authors acknowledge that CAR T-cell therapy has transformed the treatment landscape for both pediatric and adult patients with R/R B-ALL, but this extensive review of all published data on the subject shows that “the incidence of relapse among responders is unacceptably high, demonstrating the need to improve this therapy.”
In conclusion, they wrote: “To be effective following infusion, CAR T cells must expand, persist, exhibit enduring anti-tumor cytotoxicity, withstand and/or counteract an immunosuppressive tumor microenvironment, and overcome targeted tumor antigen escape. In designing CAR T cells for cancer immunotherapy, all of these factors must be harmonized to generate the optimal therapy,” noting that “[t]oxicity management and, ideally the prediction of toxicity in individualized patients, should continue to be a focus of ongoing efforts.”
Dr. Curran has received research support from Juno Therapeutics and Novartis, and has consulted, participated in advisory boards, or taken part in educational seminars for Juno Therapeutics, Novartis, and Mesoblast. Dr. Fabrizio reported having no conflict of interests.
The success of chimeric antigen receptor T (CAR T)-cell therapy for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) has garnered much attention, but the field is still in its infancy – with toxicity and relapse rates remaining unacceptably high.
in the use of the therapy in this setting, according to review authors Vanessa A. Fabrizio, MD, a fellow at Duke University, Durham, N.C., and Kevin J. Curran, MD, a pediatric oncologist at Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York.
Based on their review of early pivotal clinical trials, relapse data, toxicities, and mechanisms to optimize CAR T-cell therapy, Dr. Fabrizio and Dr. Curran outlined several “practice points” and proposed a research agenda aimed at optimizing the use of CAR T-cell therapy for B-ALL (Best Pract Res Clin Haematol. 2021 Aug 27. doi: 10.1016/j.beha.2021.101305).
Practice points
CAR T-cell therapy has transformed the treatment of both pediatric and adult patients with relapsed/refractory (R/R) B-ALL, the authors said, adding that “[c]linical trial results across multiple institutions with different CAR constructs report significant response rates in treated patients.”
Dr. Fabrizio and Dr. Curran specifically note that only one product (tisagenlecleucel) is currently approved for the treatment of R/R B-ALL in patients under age 26 years. Further, the successful application of this therapy is limited by high relapse rates, significant toxicity in some cases, and challenges related to collection and production issues.
They contend that areas in which optimization of CAR T-cell therapy can occur include apheresis, production, chemotherapy bridging, pretreatment disease burden management, toxicity management, disease monitoring after therapy, and use of consolidative allogeneic hematopoietic stem cell transplantation.
Research agenda
Key ways to heighten the success of CAR T-cell therapy for B-ALL are the development of off-the-shelf CAR T-cell products and the selection of optimal T cells to enhance apheresis and production, they said, adding that research is needed on the use of bridging chemotherapy to reduce tumor burden.
Bridging chemotherapy has been shown to impact outcomes while minimizing toxicity, but it remains undefined.
“Prospective trials are required to determine if the optimization of lymphodepleting chemotherapy can improve outcomes, and if consolidative therapy with transplantation should be considered in select patients,” they wrote. “Continued efforts to improve this technology for patients is ongoing while remaining questions are being investigated.”
The authors acknowledge that CAR T-cell therapy has transformed the treatment landscape for both pediatric and adult patients with R/R B-ALL, but this extensive review of all published data on the subject shows that “the incidence of relapse among responders is unacceptably high, demonstrating the need to improve this therapy.”
In conclusion, they wrote: “To be effective following infusion, CAR T cells must expand, persist, exhibit enduring anti-tumor cytotoxicity, withstand and/or counteract an immunosuppressive tumor microenvironment, and overcome targeted tumor antigen escape. In designing CAR T cells for cancer immunotherapy, all of these factors must be harmonized to generate the optimal therapy,” noting that “[t]oxicity management and, ideally the prediction of toxicity in individualized patients, should continue to be a focus of ongoing efforts.”
Dr. Curran has received research support from Juno Therapeutics and Novartis, and has consulted, participated in advisory boards, or taken part in educational seminars for Juno Therapeutics, Novartis, and Mesoblast. Dr. Fabrizio reported having no conflict of interests.
The success of chimeric antigen receptor T (CAR T)-cell therapy for patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) has garnered much attention, but the field is still in its infancy – with toxicity and relapse rates remaining unacceptably high.
in the use of the therapy in this setting, according to review authors Vanessa A. Fabrizio, MD, a fellow at Duke University, Durham, N.C., and Kevin J. Curran, MD, a pediatric oncologist at Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York.
Based on their review of early pivotal clinical trials, relapse data, toxicities, and mechanisms to optimize CAR T-cell therapy, Dr. Fabrizio and Dr. Curran outlined several “practice points” and proposed a research agenda aimed at optimizing the use of CAR T-cell therapy for B-ALL (Best Pract Res Clin Haematol. 2021 Aug 27. doi: 10.1016/j.beha.2021.101305).
Practice points
CAR T-cell therapy has transformed the treatment of both pediatric and adult patients with relapsed/refractory (R/R) B-ALL, the authors said, adding that “[c]linical trial results across multiple institutions with different CAR constructs report significant response rates in treated patients.”
Dr. Fabrizio and Dr. Curran specifically note that only one product (tisagenlecleucel) is currently approved for the treatment of R/R B-ALL in patients under age 26 years. Further, the successful application of this therapy is limited by high relapse rates, significant toxicity in some cases, and challenges related to collection and production issues.
They contend that areas in which optimization of CAR T-cell therapy can occur include apheresis, production, chemotherapy bridging, pretreatment disease burden management, toxicity management, disease monitoring after therapy, and use of consolidative allogeneic hematopoietic stem cell transplantation.
Research agenda
Key ways to heighten the success of CAR T-cell therapy for B-ALL are the development of off-the-shelf CAR T-cell products and the selection of optimal T cells to enhance apheresis and production, they said, adding that research is needed on the use of bridging chemotherapy to reduce tumor burden.
Bridging chemotherapy has been shown to impact outcomes while minimizing toxicity, but it remains undefined.
“Prospective trials are required to determine if the optimization of lymphodepleting chemotherapy can improve outcomes, and if consolidative therapy with transplantation should be considered in select patients,” they wrote. “Continued efforts to improve this technology for patients is ongoing while remaining questions are being investigated.”
The authors acknowledge that CAR T-cell therapy has transformed the treatment landscape for both pediatric and adult patients with R/R B-ALL, but this extensive review of all published data on the subject shows that “the incidence of relapse among responders is unacceptably high, demonstrating the need to improve this therapy.”
In conclusion, they wrote: “To be effective following infusion, CAR T cells must expand, persist, exhibit enduring anti-tumor cytotoxicity, withstand and/or counteract an immunosuppressive tumor microenvironment, and overcome targeted tumor antigen escape. In designing CAR T cells for cancer immunotherapy, all of these factors must be harmonized to generate the optimal therapy,” noting that “[t]oxicity management and, ideally the prediction of toxicity in individualized patients, should continue to be a focus of ongoing efforts.”
Dr. Curran has received research support from Juno Therapeutics and Novartis, and has consulted, participated in advisory boards, or taken part in educational seminars for Juno Therapeutics, Novartis, and Mesoblast. Dr. Fabrizio reported having no conflict of interests.
FROM BEST PRACTICE & RESEARCH CLINICAL HAEMATOLOGY
COVID-19-related pulmonary sequelae common in patients with diabetes
Key clinical point: Pulmonary sequelae at 6 months after COVID-19 infection are more common in patients with diabetes or hyperglycemia compared with normoglycemic individuals.
Major finding: At 6 months, residual lung abnormalities on computed tomography were seen in 65.4%, 58.3%, and 36.6% of patients with preexisting diabetes, secondary hyperglycemia, and normoglycemia, respectively.
Study details: The data come from a retrospective study of 141 patients with COVID-19 at 2 hospitals in Wuhan, China.
Disclosures: The research was supported by the National Natural Science Foundation of China, National Key Research and Development Project of China, and Zhejiang University. The authors declared no competing interests.
Source: Li Y et al. Eur J Radiol. 2021 Oct 5. doi: 10.1016/j.ejrad.2021.109997.
Key clinical point: Pulmonary sequelae at 6 months after COVID-19 infection are more common in patients with diabetes or hyperglycemia compared with normoglycemic individuals.
Major finding: At 6 months, residual lung abnormalities on computed tomography were seen in 65.4%, 58.3%, and 36.6% of patients with preexisting diabetes, secondary hyperglycemia, and normoglycemia, respectively.
Study details: The data come from a retrospective study of 141 patients with COVID-19 at 2 hospitals in Wuhan, China.
Disclosures: The research was supported by the National Natural Science Foundation of China, National Key Research and Development Project of China, and Zhejiang University. The authors declared no competing interests.
Source: Li Y et al. Eur J Radiol. 2021 Oct 5. doi: 10.1016/j.ejrad.2021.109997.
Key clinical point: Pulmonary sequelae at 6 months after COVID-19 infection are more common in patients with diabetes or hyperglycemia compared with normoglycemic individuals.
Major finding: At 6 months, residual lung abnormalities on computed tomography were seen in 65.4%, 58.3%, and 36.6% of patients with preexisting diabetes, secondary hyperglycemia, and normoglycemia, respectively.
Study details: The data come from a retrospective study of 141 patients with COVID-19 at 2 hospitals in Wuhan, China.
Disclosures: The research was supported by the National Natural Science Foundation of China, National Key Research and Development Project of China, and Zhejiang University. The authors declared no competing interests.
Source: Li Y et al. Eur J Radiol. 2021 Oct 5. doi: 10.1016/j.ejrad.2021.109997.
Lipiodol retention patterns show no impact on overall survival in HCC
Key clinical point: The primary outcome of local recurrence-free survival was significantly longer for lesions showing complete retention than for those showing incomplete retention, but overall survival was no different based on lipidiol retention.
Major finding: After propensity score matching of 121 pairs of lesions with complete/incomplete retention, the median local recurrence-free survival for lesions exhibiting complete retention was 1,279 days, compared to a median of 819 days in the incomplete retention group (P = 0.030).
Study details: The data come from 198 adult patients with a total of 280 HCC lesions who underwent transarterial lipiodol injection and thermal ablation at three centers between June 2014 and September 2020.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Tan J et al. Abdom Radiol. 2021 Oct 12. doi: 10.1007/s00261-021-03305-3.
Key clinical point: The primary outcome of local recurrence-free survival was significantly longer for lesions showing complete retention than for those showing incomplete retention, but overall survival was no different based on lipidiol retention.
Major finding: After propensity score matching of 121 pairs of lesions with complete/incomplete retention, the median local recurrence-free survival for lesions exhibiting complete retention was 1,279 days, compared to a median of 819 days in the incomplete retention group (P = 0.030).
Study details: The data come from 198 adult patients with a total of 280 HCC lesions who underwent transarterial lipiodol injection and thermal ablation at three centers between June 2014 and September 2020.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Tan J et al. Abdom Radiol. 2021 Oct 12. doi: 10.1007/s00261-021-03305-3.
Key clinical point: The primary outcome of local recurrence-free survival was significantly longer for lesions showing complete retention than for those showing incomplete retention, but overall survival was no different based on lipidiol retention.
Major finding: After propensity score matching of 121 pairs of lesions with complete/incomplete retention, the median local recurrence-free survival for lesions exhibiting complete retention was 1,279 days, compared to a median of 819 days in the incomplete retention group (P = 0.030).
Study details: The data come from 198 adult patients with a total of 280 HCC lesions who underwent transarterial lipiodol injection and thermal ablation at three centers between June 2014 and September 2020.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Tan J et al. Abdom Radiol. 2021 Oct 12. doi: 10.1007/s00261-021-03305-3.
TACE combination therapy improved outcomes in intermediate and advanced HCC
Key clinical point: Time to progression and progression-free survival significantly improved among adults with HCC who received a combination of trans-arterial chemoembolization (TACE) and sorafenib compared to those who received TACE alone or with placebo; both objective response rate and disease control rate also improved in combination therapy patients.
Major finding: The combination therapy of trans-arterial chemoembolization (TACE) and sorafenib significantly improved time to progression (hazard ratio 0.73; P = 0.03) and progression-free survival (HR 0.62; P < 0.00001) compared to TACE alone or with placebo; however, the combination did not improve overall survival compared to the other groups.
Study details: The data come from a meta-analysis of 7 randomized, controlled trials with a total of 1,464 patients; of these, 734 had TACE plus sorafenib and 730 had TACE plus placebo or TACE only.
Disclosures: The study was supported by the National Key Research and Development Program of China and the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
Source: Dai Y et al. Transl Oncol. 2021 Oct 7. doi: 10.1016/j.tranon.2021.101238.
Key clinical point: Time to progression and progression-free survival significantly improved among adults with HCC who received a combination of trans-arterial chemoembolization (TACE) and sorafenib compared to those who received TACE alone or with placebo; both objective response rate and disease control rate also improved in combination therapy patients.
Major finding: The combination therapy of trans-arterial chemoembolization (TACE) and sorafenib significantly improved time to progression (hazard ratio 0.73; P = 0.03) and progression-free survival (HR 0.62; P < 0.00001) compared to TACE alone or with placebo; however, the combination did not improve overall survival compared to the other groups.
Study details: The data come from a meta-analysis of 7 randomized, controlled trials with a total of 1,464 patients; of these, 734 had TACE plus sorafenib and 730 had TACE plus placebo or TACE only.
Disclosures: The study was supported by the National Key Research and Development Program of China and the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
Source: Dai Y et al. Transl Oncol. 2021 Oct 7. doi: 10.1016/j.tranon.2021.101238.
Key clinical point: Time to progression and progression-free survival significantly improved among adults with HCC who received a combination of trans-arterial chemoembolization (TACE) and sorafenib compared to those who received TACE alone or with placebo; both objective response rate and disease control rate also improved in combination therapy patients.
Major finding: The combination therapy of trans-arterial chemoembolization (TACE) and sorafenib significantly improved time to progression (hazard ratio 0.73; P = 0.03) and progression-free survival (HR 0.62; P < 0.00001) compared to TACE alone or with placebo; however, the combination did not improve overall survival compared to the other groups.
Study details: The data come from a meta-analysis of 7 randomized, controlled trials with a total of 1,464 patients; of these, 734 had TACE plus sorafenib and 730 had TACE plus placebo or TACE only.
Disclosures: The study was supported by the National Key Research and Development Program of China and the National Natural Science Foundation of China. The researchers had no financial conflicts to disclose.
Source: Dai Y et al. Transl Oncol. 2021 Oct 7. doi: 10.1016/j.tranon.2021.101238.
Nucleotide analog treatment shows promise in hepatitis B-related HCC
Key clinical point: Nucleotide analog therapy (NtA) significantly reduced risk of HCC recurrence and increased overall survival compared to nucleoside analog therapy (NsA) in patients who underwent curative hepatectomy.
Major finding: Compared to NsA therapy, NtA therapy significantly decreased the risk of HCC recurrence (hazard ratio 0.64; P < 0.001) and HCC-related death (HR 0.52; P = 0.001) in patients after surgical resection.
Study details: The data come from a retrospective study of 1,303 adults with hepatitis B-related HCC who received curative hepatectomy at five centers between April 2014 and April 2019.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Qi W et al. Cancer Med. 2021 Oct 13. doi: 10.1002/cam4.4348.
Key clinical point: Nucleotide analog therapy (NtA) significantly reduced risk of HCC recurrence and increased overall survival compared to nucleoside analog therapy (NsA) in patients who underwent curative hepatectomy.
Major finding: Compared to NsA therapy, NtA therapy significantly decreased the risk of HCC recurrence (hazard ratio 0.64; P < 0.001) and HCC-related death (HR 0.52; P = 0.001) in patients after surgical resection.
Study details: The data come from a retrospective study of 1,303 adults with hepatitis B-related HCC who received curative hepatectomy at five centers between April 2014 and April 2019.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Qi W et al. Cancer Med. 2021 Oct 13. doi: 10.1002/cam4.4348.
Key clinical point: Nucleotide analog therapy (NtA) significantly reduced risk of HCC recurrence and increased overall survival compared to nucleoside analog therapy (NsA) in patients who underwent curative hepatectomy.
Major finding: Compared to NsA therapy, NtA therapy significantly decreased the risk of HCC recurrence (hazard ratio 0.64; P < 0.001) and HCC-related death (HR 0.52; P = 0.001) in patients after surgical resection.
Study details: The data come from a retrospective study of 1,303 adults with hepatitis B-related HCC who received curative hepatectomy at five centers between April 2014 and April 2019.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Qi W et al. Cancer Med. 2021 Oct 13. doi: 10.1002/cam4.4348.
Repeat hepatic resection extends recurrence-free survival in recurrent HCC
Key clinical point: Patients with recurrent hepatocellular carcinoma had increased recurrence-free survival after rHR compared to RFA, but significantly lower morbidity and shorter hospital stays with RFA compared to rHR; overall survival rates were not significantly different between groups.
Major finding: The median recurrence-free survival was longer in recurrent HCC patients treated with rHR compared to RFA (23.6 months vs 15.2 months, hazard ratio 0.76). However, RFA was significantly association with lower morbidity of grade 3 and above (0.6% vs 6.2%) and with a shorter hospital stay (8.0 days vs 3.0 days) compared to rHR.
Study details: The data come from a retrospective, multicenter study including 847 HCC patients; of these, 307 underwent repeat hepatic resection (rHR) and 540 underwent radiofrequency ablation (RFA) between January 2003 and January 2018.
Disclosures: The study was supported by the Natural Science Foundation of China, the China Postdoctoral Science Foundation, the Guangxi BaGui Scholars’ Special Fund, the Gunagxi Natural Science Foundation, and the Science Research and Technology Development Programme of Guangxi. The researchers had no financial conflicts to disclose.
Source: Zhong J-H et al. Br J Surg. 2021 Oct 13. doi: 10.1093/bjs/znab340.
Key clinical point: Patients with recurrent hepatocellular carcinoma had increased recurrence-free survival after rHR compared to RFA, but significantly lower morbidity and shorter hospital stays with RFA compared to rHR; overall survival rates were not significantly different between groups.
Major finding: The median recurrence-free survival was longer in recurrent HCC patients treated with rHR compared to RFA (23.6 months vs 15.2 months, hazard ratio 0.76). However, RFA was significantly association with lower morbidity of grade 3 and above (0.6% vs 6.2%) and with a shorter hospital stay (8.0 days vs 3.0 days) compared to rHR.
Study details: The data come from a retrospective, multicenter study including 847 HCC patients; of these, 307 underwent repeat hepatic resection (rHR) and 540 underwent radiofrequency ablation (RFA) between January 2003 and January 2018.
Disclosures: The study was supported by the Natural Science Foundation of China, the China Postdoctoral Science Foundation, the Guangxi BaGui Scholars’ Special Fund, the Gunagxi Natural Science Foundation, and the Science Research and Technology Development Programme of Guangxi. The researchers had no financial conflicts to disclose.
Source: Zhong J-H et al. Br J Surg. 2021 Oct 13. doi: 10.1093/bjs/znab340.
Key clinical point: Patients with recurrent hepatocellular carcinoma had increased recurrence-free survival after rHR compared to RFA, but significantly lower morbidity and shorter hospital stays with RFA compared to rHR; overall survival rates were not significantly different between groups.
Major finding: The median recurrence-free survival was longer in recurrent HCC patients treated with rHR compared to RFA (23.6 months vs 15.2 months, hazard ratio 0.76). However, RFA was significantly association with lower morbidity of grade 3 and above (0.6% vs 6.2%) and with a shorter hospital stay (8.0 days vs 3.0 days) compared to rHR.
Study details: The data come from a retrospective, multicenter study including 847 HCC patients; of these, 307 underwent repeat hepatic resection (rHR) and 540 underwent radiofrequency ablation (RFA) between January 2003 and January 2018.
Disclosures: The study was supported by the Natural Science Foundation of China, the China Postdoctoral Science Foundation, the Guangxi BaGui Scholars’ Special Fund, the Gunagxi Natural Science Foundation, and the Science Research and Technology Development Programme of Guangxi. The researchers had no financial conflicts to disclose.
Source: Zhong J-H et al. Br J Surg. 2021 Oct 13. doi: 10.1093/bjs/znab340.
Liver imaging algorithm predicts success of SBRT in hepatocellular carcinoma
Key clinical point: The Liver Imaging Reporting and Data System (LI-RADS) treatment response algorithm (TRA) effectively predicted tumor necrosis in patients treated for HCC with SBRT.
Major finding: The sensitivity was 71%-86% and specificity was 85%-96% for incomplete tumor necrosis of lesions treated with SBRT when the LR-TR Equivocal category was nonviable. When the LR-TR Equivocal category was viable, sensitivity was 88%-96% and specificity was
Study details: The data come from a retrospective study of 40 lesions treated with Stereotactic Body Radiation Therapy (SBRT) in 26 adult patients with HCC.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Mendiratta-Lala M et al. Int J Radiat Oncol Biol Phys. 2021 Oct 10. doi: 10.1016/j.ijrobp.2021.10.006.
Key clinical point: The Liver Imaging Reporting and Data System (LI-RADS) treatment response algorithm (TRA) effectively predicted tumor necrosis in patients treated for HCC with SBRT.
Major finding: The sensitivity was 71%-86% and specificity was 85%-96% for incomplete tumor necrosis of lesions treated with SBRT when the LR-TR Equivocal category was nonviable. When the LR-TR Equivocal category was viable, sensitivity was 88%-96% and specificity was
Study details: The data come from a retrospective study of 40 lesions treated with Stereotactic Body Radiation Therapy (SBRT) in 26 adult patients with HCC.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Mendiratta-Lala M et al. Int J Radiat Oncol Biol Phys. 2021 Oct 10. doi: 10.1016/j.ijrobp.2021.10.006.
Key clinical point: The Liver Imaging Reporting and Data System (LI-RADS) treatment response algorithm (TRA) effectively predicted tumor necrosis in patients treated for HCC with SBRT.
Major finding: The sensitivity was 71%-86% and specificity was 85%-96% for incomplete tumor necrosis of lesions treated with SBRT when the LR-TR Equivocal category was nonviable. When the LR-TR Equivocal category was viable, sensitivity was 88%-96% and specificity was
Study details: The data come from a retrospective study of 40 lesions treated with Stereotactic Body Radiation Therapy (SBRT) in 26 adult patients with HCC.
Disclosures: The study received no outside funding. The researchers had no financial conflicts to disclose.
Source: Mendiratta-Lala M et al. Int J Radiat Oncol Biol Phys. 2021 Oct 10. doi: 10.1016/j.ijrobp.2021.10.006.
Study finds plume generated during laser tattoo removal generally viewed as safe
Results of a new .
While tattoo removal plume has not been previously studied, an analysis from 2016 found that laser hair removal plume contains toxic compounds, including carcinogens and environmental toxins, underscoring the importance of using smoke evacuators, good ventilation, and respiratory protection. “Ultrafine particles can become lodged in human alveoli in the lungs,” the study’s senior author, Mathew M. Avram, MD, JD, said during a virtual course on laser and aesthetic skin therapy. “This travels over distances, so it is potentially affecting people in your waiting room and others in areas within the clinic.”
For the study of laser tattoo removal plume, Yakir S. Levin, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston; Dr. Avram, director of laser, cosmetics, and dermatologic surgery at MGH; and coinvestigators from NIOSH, conducted air sampling to determine the gaseous, particulate, and microbiological content of laser tattoo removal plume. They performed the study in ex vivo pig skin and in humans undergoing routine laser tattoo removal, and measured ultrafine particulate concentrations, metals, volatile organic compounds, and airborne bacteria.
For the swine portion of the study, they found that levels of metals including aluminum, copper, manganese, phosphorus, potassium, titanium, and zirconium were all below occupational exposure limits. All organic compounds including acetone and benzene were also below occupational exposure limits. “This is different than what we found in the study of laser plume generated during hair removal,” Dr. Avram said. “In laser hair removal, these were all elevated to a concerning extent.”
For the human part of the study, particle concentrations for ultrafine particulates were higher in the dermatologist’s breathing zone and near the tattoo removal site than in the rest of the treatment room or outside of the room. Concentrations were 30 times lower for human skin than for pig skin. “We’re not sure why, but there were higher levels of ultrafine particulates right around the area we treated,” Dr. Avram said. “Still, they were all below exposure limits that would be concerning in terms of NIOSH. So, although they were elevated, they were still considered safe. That was the case for organic compounds as well.”
He pointed out that the study, which was supported by a grant from the American Society for Dermatologic Surgery (ASDS), did not include an analysis of viral particles generated during later tattoo removal “so there is a question about that,” and it is something worth studying, he said.
Dr. Avram, the current president of ASDS, noted that 17% of the estimated 40 million-plus Americans with tattoos have “tattoo regret,” and many turn to dermatologic surgeons for removal, which requires multiple treatments, and is painful and expensive.
Picosecond lasers
“One thing that’s changed in the past several years is the development of picosecond lasers, which produce extraordinarily high energy for an extraordinarily short period of time,” he said at the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. The desired endpoint is dermal whitening with cavitation and rupture. “You don’t want to see splatter with the epidermis flying off,” he said.
Several devices are commercially available with wavelengths of 532, 680, 755, 785, and 1064 nm, and pulse durations ranging from 300 to 750 picoseconds. Nd:Yag lasers target red and black ink, while alexandrite and ruby wavelengths target green and blue ink.
“After the treatment, we use simple Vaseline on top of the tattoo and a nonadherent Telfa dressing with paper tape over it,” Dr. Avram said. For patients with skin of color, he said, “occasionally I will add a steroid. Inflammation and redness can lead to hyperpigmentation. The steroid decreases some of that inflammation and therefore decreases the risk of hyperpigmentation.”
In his clinical experience, picosecond lasers are more effective at tattoo removal than Q-switched nanosecond lasers overall. With a picosecond laser, “you get some nonselective targeting of other pigments such as yellow to improve, even though you really don’t have the correct wavelength. I also think they are more effective for faded tattoos than the Q-switched nanosecond lasers, but they are significantly more expensive, so you need to think about that, and to what extent you are doing tattoo removal. In any event, it’s a multi-treatment process. You do it for multiple weeks between treatments and it takes time and patience. During the consultation, it is crucial to let patients know that.”
In 2012, R. Rox Anderson, MD, director of the Wellman Center for Photomedicine, and colleagues first described the R20 method for tattoo removal, which consists of four consecutive treatment passes with a Q-switched alexandrite laser separated by 20 minutes. “On the first treatment pass, there was an immediate whitening reaction “with little or no whitening on subsequent passes,” said Dr. Avram, who was not involved with the study. “Three months later, treatment with the R20 method was much more effective than conventional single-pass laser treatment. Light microscopy showed greater dispersion of the ink with the R20 method.” A follow-up study conducted at the Wellman Center did not completely support these findings, but a subsequent study led by Suzanne L. Kilmer, MD, was more supportive.
This concept has led to new treatment paradigms for tattoo removal, including the Food and Drug Administration–cleared perfluorodecalin patch, a transparent PFD-infused silicone patch that helps reduce scatter and improves efficacy. “It also allows for performing of repeat laser treatments at the same visit without waiting 20 minutes as you would with the R20 method,” Dr. Avram said. In a pilot study, 11 of the 17 patients showed more rapid clearance with the PFD patch than the control side versus one pass without the PFD patch. “It’s important to note that they used only one wavelength, and some of the tattoos weren’t appropriate for that wavelength, so 11 out of 17 is actually better than it might seem,” he said.
Ablative fractional resurfacing can play a role with tattoo removal, but Dr. Avram typically limits this option to recalcitrant tattoos. “Remember: You’re creating a zone of ablation with a cuff of coagulation, so you’re going to remove some of the tattoo just by creating those areas of clearance and vaporization,” he said. “You can do that in combination with the Q-switched or picosecond laser, which has better efficacy. The best way to do this is to start with the pigment laser – the picosecond or nanosecond laser – and then do the ablative fractional resurfacing afterward. You should never use IPL or laser hair removal lasers to remove tattoos, though. I see that occasionally. You’re going to burn your patients.”
Another approach is to use an Nd:Yag picosecond laser followed by microneedling. “What we’re trying to do here is get an egress of the tattoo pigments,” he explained. “We’re trying to mobilize the ink, get it out of the skin, and get it out of the macrophages to get improvement.”
In 2019, Soliton’s Rapid Acoustic Pulse (RAP) device was cleared by the FDA for tattoo removal. The device is indicated as an accessory to the 1064-nm Q-switched laser for black ink tattoo removal on the arms, legs, and torso in Fitzpatrick skin type I-III individuals. “It’s an application for 1 minute and that allows for additional laser passes,” Dr. Avram said. “You do the laser treatment, you do the acoustic shock wave device, and you do this as multiple passes. This is getting back to the R20 method, the idea that you are going to treat repeatedly. The rapid acoustic pulses result in dispersion and destruction of dermal vacuoles, which enables multiple laser passes in a single treatment session. If you can see the ink, you can ablate the ink.”
Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.
Results of a new .
While tattoo removal plume has not been previously studied, an analysis from 2016 found that laser hair removal plume contains toxic compounds, including carcinogens and environmental toxins, underscoring the importance of using smoke evacuators, good ventilation, and respiratory protection. “Ultrafine particles can become lodged in human alveoli in the lungs,” the study’s senior author, Mathew M. Avram, MD, JD, said during a virtual course on laser and aesthetic skin therapy. “This travels over distances, so it is potentially affecting people in your waiting room and others in areas within the clinic.”
For the study of laser tattoo removal plume, Yakir S. Levin, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston; Dr. Avram, director of laser, cosmetics, and dermatologic surgery at MGH; and coinvestigators from NIOSH, conducted air sampling to determine the gaseous, particulate, and microbiological content of laser tattoo removal plume. They performed the study in ex vivo pig skin and in humans undergoing routine laser tattoo removal, and measured ultrafine particulate concentrations, metals, volatile organic compounds, and airborne bacteria.
For the swine portion of the study, they found that levels of metals including aluminum, copper, manganese, phosphorus, potassium, titanium, and zirconium were all below occupational exposure limits. All organic compounds including acetone and benzene were also below occupational exposure limits. “This is different than what we found in the study of laser plume generated during hair removal,” Dr. Avram said. “In laser hair removal, these were all elevated to a concerning extent.”
For the human part of the study, particle concentrations for ultrafine particulates were higher in the dermatologist’s breathing zone and near the tattoo removal site than in the rest of the treatment room or outside of the room. Concentrations were 30 times lower for human skin than for pig skin. “We’re not sure why, but there were higher levels of ultrafine particulates right around the area we treated,” Dr. Avram said. “Still, they were all below exposure limits that would be concerning in terms of NIOSH. So, although they were elevated, they were still considered safe. That was the case for organic compounds as well.”
He pointed out that the study, which was supported by a grant from the American Society for Dermatologic Surgery (ASDS), did not include an analysis of viral particles generated during later tattoo removal “so there is a question about that,” and it is something worth studying, he said.
Dr. Avram, the current president of ASDS, noted that 17% of the estimated 40 million-plus Americans with tattoos have “tattoo regret,” and many turn to dermatologic surgeons for removal, which requires multiple treatments, and is painful and expensive.
Picosecond lasers
“One thing that’s changed in the past several years is the development of picosecond lasers, which produce extraordinarily high energy for an extraordinarily short period of time,” he said at the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. The desired endpoint is dermal whitening with cavitation and rupture. “You don’t want to see splatter with the epidermis flying off,” he said.
Several devices are commercially available with wavelengths of 532, 680, 755, 785, and 1064 nm, and pulse durations ranging from 300 to 750 picoseconds. Nd:Yag lasers target red and black ink, while alexandrite and ruby wavelengths target green and blue ink.
“After the treatment, we use simple Vaseline on top of the tattoo and a nonadherent Telfa dressing with paper tape over it,” Dr. Avram said. For patients with skin of color, he said, “occasionally I will add a steroid. Inflammation and redness can lead to hyperpigmentation. The steroid decreases some of that inflammation and therefore decreases the risk of hyperpigmentation.”
In his clinical experience, picosecond lasers are more effective at tattoo removal than Q-switched nanosecond lasers overall. With a picosecond laser, “you get some nonselective targeting of other pigments such as yellow to improve, even though you really don’t have the correct wavelength. I also think they are more effective for faded tattoos than the Q-switched nanosecond lasers, but they are significantly more expensive, so you need to think about that, and to what extent you are doing tattoo removal. In any event, it’s a multi-treatment process. You do it for multiple weeks between treatments and it takes time and patience. During the consultation, it is crucial to let patients know that.”
In 2012, R. Rox Anderson, MD, director of the Wellman Center for Photomedicine, and colleagues first described the R20 method for tattoo removal, which consists of four consecutive treatment passes with a Q-switched alexandrite laser separated by 20 minutes. “On the first treatment pass, there was an immediate whitening reaction “with little or no whitening on subsequent passes,” said Dr. Avram, who was not involved with the study. “Three months later, treatment with the R20 method was much more effective than conventional single-pass laser treatment. Light microscopy showed greater dispersion of the ink with the R20 method.” A follow-up study conducted at the Wellman Center did not completely support these findings, but a subsequent study led by Suzanne L. Kilmer, MD, was more supportive.
This concept has led to new treatment paradigms for tattoo removal, including the Food and Drug Administration–cleared perfluorodecalin patch, a transparent PFD-infused silicone patch that helps reduce scatter and improves efficacy. “It also allows for performing of repeat laser treatments at the same visit without waiting 20 minutes as you would with the R20 method,” Dr. Avram said. In a pilot study, 11 of the 17 patients showed more rapid clearance with the PFD patch than the control side versus one pass without the PFD patch. “It’s important to note that they used only one wavelength, and some of the tattoos weren’t appropriate for that wavelength, so 11 out of 17 is actually better than it might seem,” he said.
Ablative fractional resurfacing can play a role with tattoo removal, but Dr. Avram typically limits this option to recalcitrant tattoos. “Remember: You’re creating a zone of ablation with a cuff of coagulation, so you’re going to remove some of the tattoo just by creating those areas of clearance and vaporization,” he said. “You can do that in combination with the Q-switched or picosecond laser, which has better efficacy. The best way to do this is to start with the pigment laser – the picosecond or nanosecond laser – and then do the ablative fractional resurfacing afterward. You should never use IPL or laser hair removal lasers to remove tattoos, though. I see that occasionally. You’re going to burn your patients.”
Another approach is to use an Nd:Yag picosecond laser followed by microneedling. “What we’re trying to do here is get an egress of the tattoo pigments,” he explained. “We’re trying to mobilize the ink, get it out of the skin, and get it out of the macrophages to get improvement.”
In 2019, Soliton’s Rapid Acoustic Pulse (RAP) device was cleared by the FDA for tattoo removal. The device is indicated as an accessory to the 1064-nm Q-switched laser for black ink tattoo removal on the arms, legs, and torso in Fitzpatrick skin type I-III individuals. “It’s an application for 1 minute and that allows for additional laser passes,” Dr. Avram said. “You do the laser treatment, you do the acoustic shock wave device, and you do this as multiple passes. This is getting back to the R20 method, the idea that you are going to treat repeatedly. The rapid acoustic pulses result in dispersion and destruction of dermal vacuoles, which enables multiple laser passes in a single treatment session. If you can see the ink, you can ablate the ink.”
Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.
Results of a new .
While tattoo removal plume has not been previously studied, an analysis from 2016 found that laser hair removal plume contains toxic compounds, including carcinogens and environmental toxins, underscoring the importance of using smoke evacuators, good ventilation, and respiratory protection. “Ultrafine particles can become lodged in human alveoli in the lungs,” the study’s senior author, Mathew M. Avram, MD, JD, said during a virtual course on laser and aesthetic skin therapy. “This travels over distances, so it is potentially affecting people in your waiting room and others in areas within the clinic.”
For the study of laser tattoo removal plume, Yakir S. Levin, MD, PhD, a dermatologist at the Wellman Center for Photomedicine at Massachusetts General Hospital, Boston; Dr. Avram, director of laser, cosmetics, and dermatologic surgery at MGH; and coinvestigators from NIOSH, conducted air sampling to determine the gaseous, particulate, and microbiological content of laser tattoo removal plume. They performed the study in ex vivo pig skin and in humans undergoing routine laser tattoo removal, and measured ultrafine particulate concentrations, metals, volatile organic compounds, and airborne bacteria.
For the swine portion of the study, they found that levels of metals including aluminum, copper, manganese, phosphorus, potassium, titanium, and zirconium were all below occupational exposure limits. All organic compounds including acetone and benzene were also below occupational exposure limits. “This is different than what we found in the study of laser plume generated during hair removal,” Dr. Avram said. “In laser hair removal, these were all elevated to a concerning extent.”
For the human part of the study, particle concentrations for ultrafine particulates were higher in the dermatologist’s breathing zone and near the tattoo removal site than in the rest of the treatment room or outside of the room. Concentrations were 30 times lower for human skin than for pig skin. “We’re not sure why, but there were higher levels of ultrafine particulates right around the area we treated,” Dr. Avram said. “Still, they were all below exposure limits that would be concerning in terms of NIOSH. So, although they were elevated, they were still considered safe. That was the case for organic compounds as well.”
He pointed out that the study, which was supported by a grant from the American Society for Dermatologic Surgery (ASDS), did not include an analysis of viral particles generated during later tattoo removal “so there is a question about that,” and it is something worth studying, he said.
Dr. Avram, the current president of ASDS, noted that 17% of the estimated 40 million-plus Americans with tattoos have “tattoo regret,” and many turn to dermatologic surgeons for removal, which requires multiple treatments, and is painful and expensive.
Picosecond lasers
“One thing that’s changed in the past several years is the development of picosecond lasers, which produce extraordinarily high energy for an extraordinarily short period of time,” he said at the meeting, named “Laser & Aesthetic Skin Therapy: What’s the Truth?” and sponsored by Harvard Medical School, Massachusetts General Hospital, and the Wellman Center for Photomedicine. The desired endpoint is dermal whitening with cavitation and rupture. “You don’t want to see splatter with the epidermis flying off,” he said.
Several devices are commercially available with wavelengths of 532, 680, 755, 785, and 1064 nm, and pulse durations ranging from 300 to 750 picoseconds. Nd:Yag lasers target red and black ink, while alexandrite and ruby wavelengths target green and blue ink.
“After the treatment, we use simple Vaseline on top of the tattoo and a nonadherent Telfa dressing with paper tape over it,” Dr. Avram said. For patients with skin of color, he said, “occasionally I will add a steroid. Inflammation and redness can lead to hyperpigmentation. The steroid decreases some of that inflammation and therefore decreases the risk of hyperpigmentation.”
In his clinical experience, picosecond lasers are more effective at tattoo removal than Q-switched nanosecond lasers overall. With a picosecond laser, “you get some nonselective targeting of other pigments such as yellow to improve, even though you really don’t have the correct wavelength. I also think they are more effective for faded tattoos than the Q-switched nanosecond lasers, but they are significantly more expensive, so you need to think about that, and to what extent you are doing tattoo removal. In any event, it’s a multi-treatment process. You do it for multiple weeks between treatments and it takes time and patience. During the consultation, it is crucial to let patients know that.”
In 2012, R. Rox Anderson, MD, director of the Wellman Center for Photomedicine, and colleagues first described the R20 method for tattoo removal, which consists of four consecutive treatment passes with a Q-switched alexandrite laser separated by 20 minutes. “On the first treatment pass, there was an immediate whitening reaction “with little or no whitening on subsequent passes,” said Dr. Avram, who was not involved with the study. “Three months later, treatment with the R20 method was much more effective than conventional single-pass laser treatment. Light microscopy showed greater dispersion of the ink with the R20 method.” A follow-up study conducted at the Wellman Center did not completely support these findings, but a subsequent study led by Suzanne L. Kilmer, MD, was more supportive.
This concept has led to new treatment paradigms for tattoo removal, including the Food and Drug Administration–cleared perfluorodecalin patch, a transparent PFD-infused silicone patch that helps reduce scatter and improves efficacy. “It also allows for performing of repeat laser treatments at the same visit without waiting 20 minutes as you would with the R20 method,” Dr. Avram said. In a pilot study, 11 of the 17 patients showed more rapid clearance with the PFD patch than the control side versus one pass without the PFD patch. “It’s important to note that they used only one wavelength, and some of the tattoos weren’t appropriate for that wavelength, so 11 out of 17 is actually better than it might seem,” he said.
Ablative fractional resurfacing can play a role with tattoo removal, but Dr. Avram typically limits this option to recalcitrant tattoos. “Remember: You’re creating a zone of ablation with a cuff of coagulation, so you’re going to remove some of the tattoo just by creating those areas of clearance and vaporization,” he said. “You can do that in combination with the Q-switched or picosecond laser, which has better efficacy. The best way to do this is to start with the pigment laser – the picosecond or nanosecond laser – and then do the ablative fractional resurfacing afterward. You should never use IPL or laser hair removal lasers to remove tattoos, though. I see that occasionally. You’re going to burn your patients.”
Another approach is to use an Nd:Yag picosecond laser followed by microneedling. “What we’re trying to do here is get an egress of the tattoo pigments,” he explained. “We’re trying to mobilize the ink, get it out of the skin, and get it out of the macrophages to get improvement.”
In 2019, Soliton’s Rapid Acoustic Pulse (RAP) device was cleared by the FDA for tattoo removal. The device is indicated as an accessory to the 1064-nm Q-switched laser for black ink tattoo removal on the arms, legs, and torso in Fitzpatrick skin type I-III individuals. “It’s an application for 1 minute and that allows for additional laser passes,” Dr. Avram said. “You do the laser treatment, you do the acoustic shock wave device, and you do this as multiple passes. This is getting back to the R20 method, the idea that you are going to treat repeatedly. The rapid acoustic pulses result in dispersion and destruction of dermal vacuoles, which enables multiple laser passes in a single treatment session. If you can see the ink, you can ablate the ink.”
Dr. Avram disclosed that he has received consulting fees from Allergan, Merz, and Galderma. He is a member of the scientific advisory board for Allergan and Soliton, is an investigator for Endo, and holds stock options in La Jolla NanoMedical Inc.
FROM A LASER & AESTHETIC SKIN THERAPY COURSE