Vascular Specialist

On Thursday afternoon, Karin Elisabeth Schmidt, MD, of the Center of Cardiovascular Surgery, Hospital Floridsdorf, Vienna, Austria, will discuss the guidelines of the European Society of Vascular Surgery (ESVS) for the management of abdominal and iliac aortic aneurysms, which were published in January 2019. “Since the last guideline, this field has experienced a rapid technological devices progress, significantly impacting our clinical practice as well as the care of the affected patients,” according to Dr. Schmidt and her colleagues.

They analyzed the different recommendations of the European, British and American guidelines for the treatment of abdominal aortic aneurysms was performed. The publications used for this literature study include the current and previous guidelines of the ESVS published in the European Journal of Vascular and Endovascular Surgery and the guideline published by the Society for Vascular Surgery (SVS) in January 2018, as well as the draft guideline of the National Institute for Health and Care Excellence (NICE) issued in May 2018.

There is consensus for the preference of endovascular treatment of a ruptured aortic aneurysm if this is anatomically possible, according to Dr. Schmidt. She will discuss how, for the majority of elective cases, endovascular care is favored in the SVS and ESVS guidelines in contrast to the NICE draft.

There are generally still more ambiguities than clear recommendations, especially regarding the preferred procedures for complex aortic pathologies, population screening, and follow-up after open and endovascular aortic intervention.

She recommended a critical analysis of the U.S. and European guidelines, as both partly cover different aspects.

The final version of the guideline for the United Kingdom is eagerly expected, according to Dr. Schmidt and her colleagues, as it currently prefers open surgical care in the elective setting. Many research possibilities exist in the search for biomarkers for better assessment of the progression of small aortic aneurysms coupled with functional imaging or pharmacologic influence on aneurysm growth progression. In addition, global platforms for data collection, in particular for newer devices (low profile) and their long-term performance with jointly defined endpoints, should be established.

Dr. Schmidt will discuss how techniques such as artificial intelligence and machine learning will be used in future for monitoring large amounts of data, finding patterns and thus gain new insights.

On Thursday afternoon, Karin Elisabeth Schmidt, MD, of the Center of Cardiovascular Surgery, Hospital Floridsdorf, Vienna, Austria, will discuss the guidelines of the European Society of Vascular Surgery (ESVS) for the management of abdominal and iliac aortic aneurysms, which were published in January 2019. “Since the last guideline, this field has experienced a rapid technological devices progress, significantly impacting our clinical practice as well as the care of the affected patients,” according to Dr. Schmidt and her colleagues.

They analyzed the different recommendations of the European, British and American guidelines for the treatment of abdominal aortic aneurysms was performed. The publications used for this literature study include the current and previous guidelines of the ESVS published in the European Journal of Vascular and Endovascular Surgery and the guideline published by the Society for Vascular Surgery (SVS) in January 2018, as well as the draft guideline of the National Institute for Health and Care Excellence (NICE) issued in May 2018.

There is consensus for the preference of endovascular treatment of a ruptured aortic aneurysm if this is anatomically possible, according to Dr. Schmidt. She will discuss how, for the majority of elective cases, endovascular care is favored in the SVS and ESVS guidelines in contrast to the NICE draft.

There are generally still more ambiguities than clear recommendations, especially regarding the preferred procedures for complex aortic pathologies, population screening, and follow-up after open and endovascular aortic intervention.

She recommended a critical analysis of the U.S. and European guidelines, as both partly cover different aspects.

The final version of the guideline for the United Kingdom is eagerly expected, according to Dr. Schmidt and her colleagues, as it currently prefers open surgical care in the elective setting. Many research possibilities exist in the search for biomarkers for better assessment of the progression of small aortic aneurysms coupled with functional imaging or pharmacologic influence on aneurysm growth progression. In addition, global platforms for data collection, in particular for newer devices (low profile) and their long-term performance with jointly defined endpoints, should be established.

Dr. Schmidt will discuss how techniques such as artificial intelligence and machine learning will be used in future for monitoring large amounts of data, finding patterns and thus gain new insights.

On Thursday afternoon, Karin Elisabeth Schmidt, MD, of the Center of Cardiovascular Surgery, Hospital Floridsdorf, Vienna, Austria, will discuss the guidelines of the European Society of Vascular Surgery (ESVS) for the management of abdominal and iliac aortic aneurysms, which were published in January 2019. “Since the last guideline, this field has experienced a rapid technological devices progress, significantly impacting our clinical practice as well as the care of the affected patients,” according to Dr. Schmidt and her colleagues.

They analyzed the different recommendations of the European, British and American guidelines for the treatment of abdominal aortic aneurysms was performed. The publications used for this literature study include the current and previous guidelines of the ESVS published in the European Journal of Vascular and Endovascular Surgery and the guideline published by the Society for Vascular Surgery (SVS) in January 2018, as well as the draft guideline of the National Institute for Health and Care Excellence (NICE) issued in May 2018.

There is consensus for the preference of endovascular treatment of a ruptured aortic aneurysm if this is anatomically possible, according to Dr. Schmidt. She will discuss how, for the majority of elective cases, endovascular care is favored in the SVS and ESVS guidelines in contrast to the NICE draft.

There are generally still more ambiguities than clear recommendations, especially regarding the preferred procedures for complex aortic pathologies, population screening, and follow-up after open and endovascular aortic intervention.

She recommended a critical analysis of the U.S. and European guidelines, as both partly cover different aspects.

The final version of the guideline for the United Kingdom is eagerly expected, according to Dr. Schmidt and her colleagues, as it currently prefers open surgical care in the elective setting. Many research possibilities exist in the search for biomarkers for better assessment of the progression of small aortic aneurysms coupled with functional imaging or pharmacologic influence on aneurysm growth progression. In addition, global platforms for data collection, in particular for newer devices (low profile) and their long-term performance with jointly defined endpoints, should be established.

Dr. Schmidt will discuss how techniques such as artificial intelligence and machine learning will be used in future for monitoring large amounts of data, finding patterns and thus gain new insights.

On Thursday morning, John T. Loree, a medical student at SUNY Upstate Medical School, Syracuse, will present a study that he and his colleagues performed to assess the risks and complications associated with the use of central venous access (CVA) catheters over the long term. They attempted to identify high-risk subgroups based upon patient characteristics and line type. The research is warranted so that modified follow-up regimens can be implemented to reduce risk and improve patient outcomes. In his presentation, Mr. Loree will discuss selected therapies for specific complications.

The researchers performed a PubMed data base search, which located 21 papers published between 2012 and 2018. In this sample, 6,781 catheters were placed in 6,183 patients, with a total dwell time of 2,538,323 days. Patients characteristics varied from children to adults. Various line types were used (peripherally inserted central catheter [PICC], central line, mediport, tunneled central venous catheter). Indications for catheterization included (chemotherapy, dialysis, total parenteral nutrition (TPN), and other medication infusion.

Mr. Loree will discuss the primary outcomes – overall complication rate and the infectious and mechanical complication rates per 1,000 catheter-days.

He and his colleagues found that port purpose was significantly predictive of infection rate, while port type was selectively predictive of overall and mechanical complication rate. Subgroup analysis demonstrated significantly increased overall complication rates in peripherally inserted catheters and patients receiving medications, and increased mechanical complication rates with central lines.

Shorter dwell time was significantly associated with an increased infection rate and overall complication rate.

Mr. Loree will discuss how the complication rates associated with long-term use of CVA catheters were associated with factors easily identifiable at the initial patient visit.

Their data will show how, overall, PICC lines used for TPN/medication administration were associated with the highest complication rate, while mediports used for chemotherapy were associated with the lowest complication rate. Based on these patient characteristics, stricter follow-up to monitor for complications can be used in select patients to improve patient outcomes, according to Mr. Loree.

On Thursday morning, John T. Loree, a medical student at SUNY Upstate Medical School, Syracuse, will present a study that he and his colleagues performed to assess the risks and complications associated with the use of central venous access (CVA) catheters over the long term. They attempted to identify high-risk subgroups based upon patient characteristics and line type. The research is warranted so that modified follow-up regimens can be implemented to reduce risk and improve patient outcomes. In his presentation, Mr. Loree will discuss selected therapies for specific complications.

The researchers performed a PubMed data base search, which located 21 papers published between 2012 and 2018. In this sample, 6,781 catheters were placed in 6,183 patients, with a total dwell time of 2,538,323 days. Patients characteristics varied from children to adults. Various line types were used (peripherally inserted central catheter [PICC], central line, mediport, tunneled central venous catheter). Indications for catheterization included (chemotherapy, dialysis, total parenteral nutrition (TPN), and other medication infusion.

Mr. Loree will discuss the primary outcomes – overall complication rate and the infectious and mechanical complication rates per 1,000 catheter-days.

He and his colleagues found that port purpose was significantly predictive of infection rate, while port type was selectively predictive of overall and mechanical complication rate. Subgroup analysis demonstrated significantly increased overall complication rates in peripherally inserted catheters and patients receiving medications, and increased mechanical complication rates with central lines.

Shorter dwell time was significantly associated with an increased infection rate and overall complication rate.

Mr. Loree will discuss how the complication rates associated with long-term use of CVA catheters were associated with factors easily identifiable at the initial patient visit.

Their data will show how, overall, PICC lines used for TPN/medication administration were associated with the highest complication rate, while mediports used for chemotherapy were associated with the lowest complication rate. Based on these patient characteristics, stricter follow-up to monitor for complications can be used in select patients to improve patient outcomes, according to Mr. Loree.

On Thursday morning, John T. Loree, a medical student at SUNY Upstate Medical School, Syracuse, will present a study that he and his colleagues performed to assess the risks and complications associated with the use of central venous access (CVA) catheters over the long term. They attempted to identify high-risk subgroups based upon patient characteristics and line type. The research is warranted so that modified follow-up regimens can be implemented to reduce risk and improve patient outcomes. In his presentation, Mr. Loree will discuss selected therapies for specific complications.

The researchers performed a PubMed data base search, which located 21 papers published between 2012 and 2018. In this sample, 6,781 catheters were placed in 6,183 patients, with a total dwell time of 2,538,323 days. Patients characteristics varied from children to adults. Various line types were used (peripherally inserted central catheter [PICC], central line, mediport, tunneled central venous catheter). Indications for catheterization included (chemotherapy, dialysis, total parenteral nutrition (TPN), and other medication infusion.

Mr. Loree will discuss the primary outcomes – overall complication rate and the infectious and mechanical complication rates per 1,000 catheter-days.

He and his colleagues found that port purpose was significantly predictive of infection rate, while port type was selectively predictive of overall and mechanical complication rate. Subgroup analysis demonstrated significantly increased overall complication rates in peripherally inserted catheters and patients receiving medications, and increased mechanical complication rates with central lines.

Shorter dwell time was significantly associated with an increased infection rate and overall complication rate.

Mr. Loree will discuss how the complication rates associated with long-term use of CVA catheters were associated with factors easily identifiable at the initial patient visit.

Their data will show how, overall, PICC lines used for TPN/medication administration were associated with the highest complication rate, while mediports used for chemotherapy were associated with the lowest complication rate. Based on these patient characteristics, stricter follow-up to monitor for complications can be used in select patients to improve patient outcomes, according to Mr. Loree.

November is National Diabetes Month, which gives SVS members the perfect opportunity to further educate their patients and loved ones with the SVS Foundation Patient flier on diabetes and vascular disease. These are available in both English and Spanish and can be downloaded instantly. You may also send patients and referrers to our Diabetes and Vascular Disease page. This holds several resources that might be useful for education purposes. Spread awareness and education using the many resources the SVS has to offer.

November is National Diabetes Month, which gives SVS members the perfect opportunity to further educate their patients and loved ones with the SVS Foundation Patient flier on diabetes and vascular disease. These are available in both English and Spanish and can be downloaded instantly. You may also send patients and referrers to our Diabetes and Vascular Disease page. This holds several resources that might be useful for education purposes. Spread awareness and education using the many resources the SVS has to offer.

November is National Diabetes Month, which gives SVS members the perfect opportunity to further educate their patients and loved ones with the SVS Foundation Patient flier on diabetes and vascular disease. These are available in both English and Spanish and can be downloaded instantly. You may also send patients and referrers to our Diabetes and Vascular Disease page. This holds several resources that might be useful for education purposes. Spread awareness and education using the many resources the SVS has to offer.

SVSConnect gives members an opportunity to share tough cases, discuss new breakthroughs in the industry and/or seek trusty advice from other professionals. Currently a post about Peer Support through the new SVS Member Support Program is one of the many discussions that users are engaging in. This post kicks off a series of discussion posts by the SVS Wellness Task Force, in collaboration with SurgeonMasters, that will focus on improving surgeons’ well-being, practice performance and patient outcomes. It is recommended that all who access SVSConnect on their mobile device download the app. This is the most user-friendly way to access the community and is an easy download. Follow the steps on this PDF to download the app. Reach out to [email protected] with any questions.

SVSConnect gives members an opportunity to share tough cases, discuss new breakthroughs in the industry and/or seek trusty advice from other professionals. Currently a post about Peer Support through the new SVS Member Support Program is one of the many discussions that users are engaging in. This post kicks off a series of discussion posts by the SVS Wellness Task Force, in collaboration with SurgeonMasters, that will focus on improving surgeons’ well-being, practice performance and patient outcomes. It is recommended that all who access SVSConnect on their mobile device download the app. This is the most user-friendly way to access the community and is an easy download. Follow the steps on this PDF to download the app. Reach out to [email protected] with any questions.

SVSConnect gives members an opportunity to share tough cases, discuss new breakthroughs in the industry and/or seek trusty advice from other professionals. Currently a post about Peer Support through the new SVS Member Support Program is one of the many discussions that users are engaging in. This post kicks off a series of discussion posts by the SVS Wellness Task Force, in collaboration with SurgeonMasters, that will focus on improving surgeons’ well-being, practice performance and patient outcomes. It is recommended that all who access SVSConnect on their mobile device download the app. This is the most user-friendly way to access the community and is an easy download. Follow the steps on this PDF to download the app. Reach out to [email protected] with any questions.

Abstracts and videos for the 2020 Vascular Annual Meeting will be accepted now through January 15. The submission process may be completed on a smartphone or tablet computer. The Video Committee encourages submissions in areas such as dialysis access, lower extremity revascularization, surgical bypass procedures, venous interventions, management of adverse events and more. Read more and begin the submission process here.

Abstracts and videos for the 2020 Vascular Annual Meeting will be accepted now through January 15. The submission process may be completed on a smartphone or tablet computer. The Video Committee encourages submissions in areas such as dialysis access, lower extremity revascularization, surgical bypass procedures, venous interventions, management of adverse events and more. Read more and begin the submission process here.

Abstracts and videos for the 2020 Vascular Annual Meeting will be accepted now through January 15. The submission process may be completed on a smartphone or tablet computer. The Video Committee encourages submissions in areas such as dialysis access, lower extremity revascularization, surgical bypass procedures, venous interventions, management of adverse events and more. Read more and begin the submission process here.

Almost all of the patient assistance programs funded by independent charities for subsidizing prescription medications exclude patients without insurance, a cross-sectional analysis has shown.

Of 274 patient assistance programs analyzed from six independent charities, 267 (97%) listed insurance coverage as an eligibility requirement for their program, according to So-Yeon Kang, MPH, MBA, a PhD student at Johns Hopkins University, Baltimore, and colleagues.

Out-of-pocket prescription costs for Medicare Part D plans can cost “thousands of dollars” because of higher coinsurance rates and no catastrophic cap on the program, the researchers noted in JAMA.

“For this reason, independent charity foundations offering patient assistance programs to these patients are entitled to receive tax-deductible donations from pharmaceutical companies,” they wrote. “However, the findings from this study suggest that several features of the programs may limit their usefulness to financially needy patients and bolster the use of expensive drugs.”

The researchers examined the 274 patient assistance programs funded by the CancerCare Co-Payment Assistance Foundation, Good Days, the HealthWell Foundation, the Patient Access Network Foundation, Patient Advocate Foundation Co-Pay Relief, and Patient Services Incorporated. Copayment assistance alone was provided by 168 programs, 90 programs offered assistance with copayments and health insurance premiums, and 9 programs provided assistance to subsidize health insurance premiums only.

Cancer or cancer-related treatments were covered by 41% of programs, and 34% provided assistance for genetic or rare diseases.

In 2017, the six charities spent an average of 86% of their revenue on patient expenditures: They had a total revenue of between $24 million and $532 million, while the expenditures for patient assistance ranged from $24 million and $353 million. With regard to eligibility, the income limit that was most common was 500% of the federal poverty level.

The researchers also studied which of 18 drugs were covered by assistance programs. They found that brand-name prescriptions were covered by a mean of 3.1 assistance programs, compared with a mean of 1.2 programs that covered a generic version of each drug. Of the 18 drugs studied, 12 drugs (67%) were in protected classes and therefore covered by Medicare Part D. Prescription drugs that were covered were more likely to be expensive, compared with drugs that were not covered (median annual cost of $1,157, versus $367).

The researchers noted several limitations of the study, such the inability to correlate the programs with drug spending, assuming that generic substitution was always possible. In addition, the analysis of drug use was limited to two charity foundations.

In a related editorial, Katherine L. Kraschel and Gregory D. Curfman, MD, wrote that some patient assistance programs might be violating federal law.

“Coupled with recent enforcement activity by the Department of Justice, the data reported by Kang et al. suggest that some programs may warrant continued regulatory scrutiny and enforcement,” wrote Ms. Kraschel, executive director of the Solomon Center for Health Law & Policy at Yale University Law School, New Haven, Conn., and Dr. Curfman, deputy editor of JAMA in Chicago (JAMA. 2019;322[5]:405-6).

In addition, the Office of Inspector General created a special advisory bulletin in 2014 that clarifies how pharmaceutical companies should comply with the Anti-Kickback Statute within a patient assistance program. This guidance states that pharmaceutical companies should make assistance available to all products, rather than simply high-cost or specialty drugs, which pharmaceutical companies have not consistently followed, Ms. Kraschel and Dr. Curfman explained.

To help patients and the health care system, the authors recommended the Office of the Inspector General implement stronger restrictions for pharmaceutical companies contributing to patient assistance programs and develop reporting requirements for transparency purposes.

“The extent to which patient assistance programs violate tax exemption standards that prohibit private benefit that does not further its charitable purpose and is intentionally aimed to benefit the pharmaceutical companies warrants further scrutiny,” Ms. Kraschel and Dr. Curfman wrote. “It is particularly egregious that the payments made from pharmaceutical companies to patient assistance programs may be illegal yet simultaneously tax deductible.”

The study was funded by Arnold Ventures. The authors of the study and the editorial reported no relevant conflicts of interest.

SOURCE: Kang S-Y et al. JAMA. 2019;322(5):422-9.

Almost all of the patient assistance programs funded by independent charities for subsidizing prescription medications exclude patients without insurance, a cross-sectional analysis has shown.

Of 274 patient assistance programs analyzed from six independent charities, 267 (97%) listed insurance coverage as an eligibility requirement for their program, according to So-Yeon Kang, MPH, MBA, a PhD student at Johns Hopkins University, Baltimore, and colleagues.

Out-of-pocket prescription costs for Medicare Part D plans can cost “thousands of dollars” because of higher coinsurance rates and no catastrophic cap on the program, the researchers noted in JAMA.

“For this reason, independent charity foundations offering patient assistance programs to these patients are entitled to receive tax-deductible donations from pharmaceutical companies,” they wrote. “However, the findings from this study suggest that several features of the programs may limit their usefulness to financially needy patients and bolster the use of expensive drugs.”

The researchers examined the 274 patient assistance programs funded by the CancerCare Co-Payment Assistance Foundation, Good Days, the HealthWell Foundation, the Patient Access Network Foundation, Patient Advocate Foundation Co-Pay Relief, and Patient Services Incorporated. Copayment assistance alone was provided by 168 programs, 90 programs offered assistance with copayments and health insurance premiums, and 9 programs provided assistance to subsidize health insurance premiums only.

Cancer or cancer-related treatments were covered by 41% of programs, and 34% provided assistance for genetic or rare diseases.

In 2017, the six charities spent an average of 86% of their revenue on patient expenditures: They had a total revenue of between $24 million and $532 million, while the expenditures for patient assistance ranged from $24 million and $353 million. With regard to eligibility, the income limit that was most common was 500% of the federal poverty level.

The researchers also studied which of 18 drugs were covered by assistance programs. They found that brand-name prescriptions were covered by a mean of 3.1 assistance programs, compared with a mean of 1.2 programs that covered a generic version of each drug. Of the 18 drugs studied, 12 drugs (67%) were in protected classes and therefore covered by Medicare Part D. Prescription drugs that were covered were more likely to be expensive, compared with drugs that were not covered (median annual cost of $1,157, versus $367).

The researchers noted several limitations of the study, such the inability to correlate the programs with drug spending, assuming that generic substitution was always possible. In addition, the analysis of drug use was limited to two charity foundations.

In a related editorial, Katherine L. Kraschel and Gregory D. Curfman, MD, wrote that some patient assistance programs might be violating federal law.

“Coupled with recent enforcement activity by the Department of Justice, the data reported by Kang et al. suggest that some programs may warrant continued regulatory scrutiny and enforcement,” wrote Ms. Kraschel, executive director of the Solomon Center for Health Law & Policy at Yale University Law School, New Haven, Conn., and Dr. Curfman, deputy editor of JAMA in Chicago (JAMA. 2019;322[5]:405-6).

In addition, the Office of Inspector General created a special advisory bulletin in 2014 that clarifies how pharmaceutical companies should comply with the Anti-Kickback Statute within a patient assistance program. This guidance states that pharmaceutical companies should make assistance available to all products, rather than simply high-cost or specialty drugs, which pharmaceutical companies have not consistently followed, Ms. Kraschel and Dr. Curfman explained.

To help patients and the health care system, the authors recommended the Office of the Inspector General implement stronger restrictions for pharmaceutical companies contributing to patient assistance programs and develop reporting requirements for transparency purposes.

“The extent to which patient assistance programs violate tax exemption standards that prohibit private benefit that does not further its charitable purpose and is intentionally aimed to benefit the pharmaceutical companies warrants further scrutiny,” Ms. Kraschel and Dr. Curfman wrote. “It is particularly egregious that the payments made from pharmaceutical companies to patient assistance programs may be illegal yet simultaneously tax deductible.”

The study was funded by Arnold Ventures. The authors of the study and the editorial reported no relevant conflicts of interest.

SOURCE: Kang S-Y et al. JAMA. 2019;322(5):422-9.

Almost all of the patient assistance programs funded by independent charities for subsidizing prescription medications exclude patients without insurance, a cross-sectional analysis has shown.

Of 274 patient assistance programs analyzed from six independent charities, 267 (97%) listed insurance coverage as an eligibility requirement for their program, according to So-Yeon Kang, MPH, MBA, a PhD student at Johns Hopkins University, Baltimore, and colleagues.

Out-of-pocket prescription costs for Medicare Part D plans can cost “thousands of dollars” because of higher coinsurance rates and no catastrophic cap on the program, the researchers noted in JAMA.

“For this reason, independent charity foundations offering patient assistance programs to these patients are entitled to receive tax-deductible donations from pharmaceutical companies,” they wrote. “However, the findings from this study suggest that several features of the programs may limit their usefulness to financially needy patients and bolster the use of expensive drugs.”

The researchers examined the 274 patient assistance programs funded by the CancerCare Co-Payment Assistance Foundation, Good Days, the HealthWell Foundation, the Patient Access Network Foundation, Patient Advocate Foundation Co-Pay Relief, and Patient Services Incorporated. Copayment assistance alone was provided by 168 programs, 90 programs offered assistance with copayments and health insurance premiums, and 9 programs provided assistance to subsidize health insurance premiums only.

Cancer or cancer-related treatments were covered by 41% of programs, and 34% provided assistance for genetic or rare diseases.

In 2017, the six charities spent an average of 86% of their revenue on patient expenditures: They had a total revenue of between $24 million and $532 million, while the expenditures for patient assistance ranged from $24 million and $353 million. With regard to eligibility, the income limit that was most common was 500% of the federal poverty level.

The researchers also studied which of 18 drugs were covered by assistance programs. They found that brand-name prescriptions were covered by a mean of 3.1 assistance programs, compared with a mean of 1.2 programs that covered a generic version of each drug. Of the 18 drugs studied, 12 drugs (67%) were in protected classes and therefore covered by Medicare Part D. Prescription drugs that were covered were more likely to be expensive, compared with drugs that were not covered (median annual cost of $1,157, versus $367).

The researchers noted several limitations of the study, such the inability to correlate the programs with drug spending, assuming that generic substitution was always possible. In addition, the analysis of drug use was limited to two charity foundations.

In a related editorial, Katherine L. Kraschel and Gregory D. Curfman, MD, wrote that some patient assistance programs might be violating federal law.

“Coupled with recent enforcement activity by the Department of Justice, the data reported by Kang et al. suggest that some programs may warrant continued regulatory scrutiny and enforcement,” wrote Ms. Kraschel, executive director of the Solomon Center for Health Law & Policy at Yale University Law School, New Haven, Conn., and Dr. Curfman, deputy editor of JAMA in Chicago (JAMA. 2019;322[5]:405-6).

In addition, the Office of Inspector General created a special advisory bulletin in 2014 that clarifies how pharmaceutical companies should comply with the Anti-Kickback Statute within a patient assistance program. This guidance states that pharmaceutical companies should make assistance available to all products, rather than simply high-cost or specialty drugs, which pharmaceutical companies have not consistently followed, Ms. Kraschel and Dr. Curfman explained.

To help patients and the health care system, the authors recommended the Office of the Inspector General implement stronger restrictions for pharmaceutical companies contributing to patient assistance programs and develop reporting requirements for transparency purposes.

“The extent to which patient assistance programs violate tax exemption standards that prohibit private benefit that does not further its charitable purpose and is intentionally aimed to benefit the pharmaceutical companies warrants further scrutiny,” Ms. Kraschel and Dr. Curfman wrote. “It is particularly egregious that the payments made from pharmaceutical companies to patient assistance programs may be illegal yet simultaneously tax deductible.”

The study was funded by Arnold Ventures. The authors of the study and the editorial reported no relevant conflicts of interest.

SOURCE: Kang S-Y et al. JAMA. 2019;322(5):422-9.

Icosapent ethyl, a highly purified form of the ethyl ester of eicosapentaenoic acid, received unanimous backing from a Food and Drug Administration advisory panel for a new indication for reducing cardiovascular event risk.

Icosapent ethyl (Vascepa) received initial agency approval in 2012 for the indication of cutting triglyceride levels once they reached at least 500 mg/dL.

The target patient population for this new, cardiovascular-event protection role will reflect some or all of the types of patients enrolled in REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial), which tested icosapent ethyl in 8,179 patients with either established cardiovascular disease or diabetes and at least one additional cardiovascular disease risk factor. This study provided the bulk of the data considered by the FDA panel.

REDUCE-IT showed that, during a median of 4.9 years, patients who received icosapent ethyl had a statistically significant 25% relative risk reduction in the trial’s primary, composite endpoint (New Engl J Med. 2019 Jan 3;380[1]:11-22).

Icosapent ethyl “appeared effective and safe,” and would be a “useful, new, added agent for treating patients” like those enrolled in the trial, said Kenneth D. Burman, MD, professor and chief of endocrinology at Medstar Washington (D.C.) Hospital Center and chair of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.

The advisory panel members appeared uniformly comfortable with recommending that the FDA add a cardiovascular disease indication based on the REDUCE-IT findings.

But while they agreed that icosapent ethyl should receive some type of indication for cardiovascular event reduction, the committee split over which patients the indication should include. Specifically, they diverged on the issue of primary prevention.

Some said that the patient enrollment that produced a positive result in REDUCE-IT should not be retrospectively subdivided, while others said that combining secondary- and primary-prevention patients in a single large trial inappropriately lumped together patients who would be better considered separately.

Committee members also expressed uncertainty over the appropriate triglyceride level to warrant treatment. The REDUCE-IT trial was designed to enroll patients with triglycerides of 135 mg/dL or greater, but several panel members suggested that, for labeling, the threshold should be at least 150 mg/dL, or even 200 mg/dL.

Safety was another aspect that generated a lot of panel discussion throughout their day-long discussion, with particular focus on a signal of a small but concerning increased rate of incident atrial fibrillation among patients who received icosapent ethyl, as well as a small but nearly significant increase in the rate of serious bleeds.

Further analyses presented during the meeting showed that an increased bleeding rate linked with icosapent ethyl was focused in patients who concurrently received one or more antiplatelet drugs or an anticoagulant.

However, panel members rejected the notion that these safety concerns warranted a boxed warning, agreeing that it could be managed with appropriate labeling information.

Clinician reaction

Clinicians who manage these types of patients viewed the prospect of an expanded indication for icosapent ethyl as an important advance.

The REDUCE-IT results by themselves “were convincing” for patients with established cardiovascular disease without need for a confirmatory trial, Robert H. Eckel, MD, an endocrinologist and professor of medicine at the University of Colorado at Denver, Aurora, said in an interview. But he remained unconvinced about efficacy for primary-prevention patients, or even for secondary-prevention patients with a triglyceride level below 150 mg/dL.

“Icosapent ethyl will clearly be a mainstay for managing high-risk patients. It gives us another treatment option,” Yehuda Handelsman, MD, an endocrinologist and medical director and principal investigator of the Metabolic Institute of America in Tarzana, Calif., said in an interview. “I do not see the atrial fibrillation or bleeding effects as reasons not to approve this drug. It should be a precaution. Overall, icosapent ethyl is one of the easier drugs for patients to take.”

Dr. Handelsman said it would be unethical to run a confirmatory trial and randomize patients to placebo. “Another trial makes no sense,” he said.

But the data from REDUCE-IT were “not as convincing” for primary-prevention patients, suggesting a need for caution about using icosapent ethyl for patients without established cardiovascular disease, Paul S. Jellinger, MD, an endocrinologist in Fort Lauderdale, Fla., said in an interview.

Cost-effectiveness

An analysis of the cost-effectiveness of icosapent ethyl as used in REDUCE-IT showed that the drug fell into the rare category of being a “dominant” treatment, meaning that it both improved patient outcomes and reduced medical costs. William S. Weintraub, MD, will report findings from this analysis on Nov. 16, 2019, at the annual scientific sessions of the American Heart Association.

The analysis used a wholesale acquisition cost for a 1-day dosage of icosapent ethyl of $4.16, derived from a commercial source for prescription-drug pricing and actual hospitalization costs for the patients in the trial.

Based on the REDUCE-IT outcomes, treatment with icosapent ethyl was linked with a boost in quality-adjusted life-years that extrapolated to an average 0.26 increase during the full lifetime of REDUCE-IT participants, at a cost that averaged $1,284 less per treated patient over their lifetime, according to Dr. Weintraub, director of Outcomes Research at Medstar Washington Hospital Center, Washington.

Although the 0.26 lifetime increase in quality-adjusted life-years may sound modest, “in the cost-effectiveness world, 0.26 is actually significant,” Dr. Weintraub said. He also highlighted how unusual it is to find a patented drug that improves quality of life and longevity while also saving money.

“I know of no other on-patent, branded pharmaceutical that is dominant,” he said.

Off-patent pharmaceuticals, like statins, can be quite inexpensive and may also be dominant, he noted. Being dominant for cost-effectiveness means that icosapent ethyl “provides good value and is worth what we pay for it, well within social thresholds of willingness to pay,” Dr. Weintraub said.

REDUCE-IT was sponsored by Amarin, the company that markets icosapent ethyl (Vascepa). Dr. Burman has received research funding from AstraZeneca, Eisai, and IBSA. Dr. Eckel has received personal fees from Kowa Pharmaceuticals, Merck, Novartis, and Sanofi/Regeneron, as well as research funding from Endece, Ionis Pharmaceuticals, and UniQure. Dr. Handelsman has been a consultant to and received research funding from Amarin and several other companies. Dr. Jellinger has been a speaker on behalf of Amarin, Amgen, and Regeneron. Dr. Weintraub has received honoraria and research support from Amarin, and honoraria from AstraZeneca.

[email protected]

Icosapent ethyl, a highly purified form of the ethyl ester of eicosapentaenoic acid, received unanimous backing from a Food and Drug Administration advisory panel for a new indication for reducing cardiovascular event risk.

Icosapent ethyl (Vascepa) received initial agency approval in 2012 for the indication of cutting triglyceride levels once they reached at least 500 mg/dL.

The target patient population for this new, cardiovascular-event protection role will reflect some or all of the types of patients enrolled in REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial), which tested icosapent ethyl in 8,179 patients with either established cardiovascular disease or diabetes and at least one additional cardiovascular disease risk factor. This study provided the bulk of the data considered by the FDA panel.

REDUCE-IT showed that, during a median of 4.9 years, patients who received icosapent ethyl had a statistically significant 25% relative risk reduction in the trial’s primary, composite endpoint (New Engl J Med. 2019 Jan 3;380[1]:11-22).

Icosapent ethyl “appeared effective and safe,” and would be a “useful, new, added agent for treating patients” like those enrolled in the trial, said Kenneth D. Burman, MD, professor and chief of endocrinology at Medstar Washington (D.C.) Hospital Center and chair of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.

The advisory panel members appeared uniformly comfortable with recommending that the FDA add a cardiovascular disease indication based on the REDUCE-IT findings.

But while they agreed that icosapent ethyl should receive some type of indication for cardiovascular event reduction, the committee split over which patients the indication should include. Specifically, they diverged on the issue of primary prevention.

Some said that the patient enrollment that produced a positive result in REDUCE-IT should not be retrospectively subdivided, while others said that combining secondary- and primary-prevention patients in a single large trial inappropriately lumped together patients who would be better considered separately.

Committee members also expressed uncertainty over the appropriate triglyceride level to warrant treatment. The REDUCE-IT trial was designed to enroll patients with triglycerides of 135 mg/dL or greater, but several panel members suggested that, for labeling, the threshold should be at least 150 mg/dL, or even 200 mg/dL.

Safety was another aspect that generated a lot of panel discussion throughout their day-long discussion, with particular focus on a signal of a small but concerning increased rate of incident atrial fibrillation among patients who received icosapent ethyl, as well as a small but nearly significant increase in the rate of serious bleeds.

Further analyses presented during the meeting showed that an increased bleeding rate linked with icosapent ethyl was focused in patients who concurrently received one or more antiplatelet drugs or an anticoagulant.

However, panel members rejected the notion that these safety concerns warranted a boxed warning, agreeing that it could be managed with appropriate labeling information.

Clinician reaction

Clinicians who manage these types of patients viewed the prospect of an expanded indication for icosapent ethyl as an important advance.

The REDUCE-IT results by themselves “were convincing” for patients with established cardiovascular disease without need for a confirmatory trial, Robert H. Eckel, MD, an endocrinologist and professor of medicine at the University of Colorado at Denver, Aurora, said in an interview. But he remained unconvinced about efficacy for primary-prevention patients, or even for secondary-prevention patients with a triglyceride level below 150 mg/dL.

“Icosapent ethyl will clearly be a mainstay for managing high-risk patients. It gives us another treatment option,” Yehuda Handelsman, MD, an endocrinologist and medical director and principal investigator of the Metabolic Institute of America in Tarzana, Calif., said in an interview. “I do not see the atrial fibrillation or bleeding effects as reasons not to approve this drug. It should be a precaution. Overall, icosapent ethyl is one of the easier drugs for patients to take.”

Dr. Handelsman said it would be unethical to run a confirmatory trial and randomize patients to placebo. “Another trial makes no sense,” he said.

But the data from REDUCE-IT were “not as convincing” for primary-prevention patients, suggesting a need for caution about using icosapent ethyl for patients without established cardiovascular disease, Paul S. Jellinger, MD, an endocrinologist in Fort Lauderdale, Fla., said in an interview.

Cost-effectiveness

An analysis of the cost-effectiveness of icosapent ethyl as used in REDUCE-IT showed that the drug fell into the rare category of being a “dominant” treatment, meaning that it both improved patient outcomes and reduced medical costs. William S. Weintraub, MD, will report findings from this analysis on Nov. 16, 2019, at the annual scientific sessions of the American Heart Association.

The analysis used a wholesale acquisition cost for a 1-day dosage of icosapent ethyl of $4.16, derived from a commercial source for prescription-drug pricing and actual hospitalization costs for the patients in the trial.

Based on the REDUCE-IT outcomes, treatment with icosapent ethyl was linked with a boost in quality-adjusted life-years that extrapolated to an average 0.26 increase during the full lifetime of REDUCE-IT participants, at a cost that averaged $1,284 less per treated patient over their lifetime, according to Dr. Weintraub, director of Outcomes Research at Medstar Washington Hospital Center, Washington.

Although the 0.26 lifetime increase in quality-adjusted life-years may sound modest, “in the cost-effectiveness world, 0.26 is actually significant,” Dr. Weintraub said. He also highlighted how unusual it is to find a patented drug that improves quality of life and longevity while also saving money.

“I know of no other on-patent, branded pharmaceutical that is dominant,” he said.

Off-patent pharmaceuticals, like statins, can be quite inexpensive and may also be dominant, he noted. Being dominant for cost-effectiveness means that icosapent ethyl “provides good value and is worth what we pay for it, well within social thresholds of willingness to pay,” Dr. Weintraub said.

REDUCE-IT was sponsored by Amarin, the company that markets icosapent ethyl (Vascepa). Dr. Burman has received research funding from AstraZeneca, Eisai, and IBSA. Dr. Eckel has received personal fees from Kowa Pharmaceuticals, Merck, Novartis, and Sanofi/Regeneron, as well as research funding from Endece, Ionis Pharmaceuticals, and UniQure. Dr. Handelsman has been a consultant to and received research funding from Amarin and several other companies. Dr. Jellinger has been a speaker on behalf of Amarin, Amgen, and Regeneron. Dr. Weintraub has received honoraria and research support from Amarin, and honoraria from AstraZeneca.

[email protected]

Icosapent ethyl, a highly purified form of the ethyl ester of eicosapentaenoic acid, received unanimous backing from a Food and Drug Administration advisory panel for a new indication for reducing cardiovascular event risk.

Icosapent ethyl (Vascepa) received initial agency approval in 2012 for the indication of cutting triglyceride levels once they reached at least 500 mg/dL.

The target patient population for this new, cardiovascular-event protection role will reflect some or all of the types of patients enrolled in REDUCE-IT (Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial), which tested icosapent ethyl in 8,179 patients with either established cardiovascular disease or diabetes and at least one additional cardiovascular disease risk factor. This study provided the bulk of the data considered by the FDA panel.

REDUCE-IT showed that, during a median of 4.9 years, patients who received icosapent ethyl had a statistically significant 25% relative risk reduction in the trial’s primary, composite endpoint (New Engl J Med. 2019 Jan 3;380[1]:11-22).

Icosapent ethyl “appeared effective and safe,” and would be a “useful, new, added agent for treating patients” like those enrolled in the trial, said Kenneth D. Burman, MD, professor and chief of endocrinology at Medstar Washington (D.C.) Hospital Center and chair of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.

The advisory panel members appeared uniformly comfortable with recommending that the FDA add a cardiovascular disease indication based on the REDUCE-IT findings.

But while they agreed that icosapent ethyl should receive some type of indication for cardiovascular event reduction, the committee split over which patients the indication should include. Specifically, they diverged on the issue of primary prevention.

Some said that the patient enrollment that produced a positive result in REDUCE-IT should not be retrospectively subdivided, while others said that combining secondary- and primary-prevention patients in a single large trial inappropriately lumped together patients who would be better considered separately.

Committee members also expressed uncertainty over the appropriate triglyceride level to warrant treatment. The REDUCE-IT trial was designed to enroll patients with triglycerides of 135 mg/dL or greater, but several panel members suggested that, for labeling, the threshold should be at least 150 mg/dL, or even 200 mg/dL.

Safety was another aspect that generated a lot of panel discussion throughout their day-long discussion, with particular focus on a signal of a small but concerning increased rate of incident atrial fibrillation among patients who received icosapent ethyl, as well as a small but nearly significant increase in the rate of serious bleeds.

Further analyses presented during the meeting showed that an increased bleeding rate linked with icosapent ethyl was focused in patients who concurrently received one or more antiplatelet drugs or an anticoagulant.

However, panel members rejected the notion that these safety concerns warranted a boxed warning, agreeing that it could be managed with appropriate labeling information.

Clinician reaction

Clinicians who manage these types of patients viewed the prospect of an expanded indication for icosapent ethyl as an important advance.

The REDUCE-IT results by themselves “were convincing” for patients with established cardiovascular disease without need for a confirmatory trial, Robert H. Eckel, MD, an endocrinologist and professor of medicine at the University of Colorado at Denver, Aurora, said in an interview. But he remained unconvinced about efficacy for primary-prevention patients, or even for secondary-prevention patients with a triglyceride level below 150 mg/dL.

“Icosapent ethyl will clearly be a mainstay for managing high-risk patients. It gives us another treatment option,” Yehuda Handelsman, MD, an endocrinologist and medical director and principal investigator of the Metabolic Institute of America in Tarzana, Calif., said in an interview. “I do not see the atrial fibrillation or bleeding effects as reasons not to approve this drug. It should be a precaution. Overall, icosapent ethyl is one of the easier drugs for patients to take.”

Dr. Handelsman said it would be unethical to run a confirmatory trial and randomize patients to placebo. “Another trial makes no sense,” he said.

But the data from REDUCE-IT were “not as convincing” for primary-prevention patients, suggesting a need for caution about using icosapent ethyl for patients without established cardiovascular disease, Paul S. Jellinger, MD, an endocrinologist in Fort Lauderdale, Fla., said in an interview.

Cost-effectiveness

An analysis of the cost-effectiveness of icosapent ethyl as used in REDUCE-IT showed that the drug fell into the rare category of being a “dominant” treatment, meaning that it both improved patient outcomes and reduced medical costs. William S. Weintraub, MD, will report findings from this analysis on Nov. 16, 2019, at the annual scientific sessions of the American Heart Association.

The analysis used a wholesale acquisition cost for a 1-day dosage of icosapent ethyl of $4.16, derived from a commercial source for prescription-drug pricing and actual hospitalization costs for the patients in the trial.

Based on the REDUCE-IT outcomes, treatment with icosapent ethyl was linked with a boost in quality-adjusted life-years that extrapolated to an average 0.26 increase during the full lifetime of REDUCE-IT participants, at a cost that averaged $1,284 less per treated patient over their lifetime, according to Dr. Weintraub, director of Outcomes Research at Medstar Washington Hospital Center, Washington.

Although the 0.26 lifetime increase in quality-adjusted life-years may sound modest, “in the cost-effectiveness world, 0.26 is actually significant,” Dr. Weintraub said. He also highlighted how unusual it is to find a patented drug that improves quality of life and longevity while also saving money.

“I know of no other on-patent, branded pharmaceutical that is dominant,” he said.

Off-patent pharmaceuticals, like statins, can be quite inexpensive and may also be dominant, he noted. Being dominant for cost-effectiveness means that icosapent ethyl “provides good value and is worth what we pay for it, well within social thresholds of willingness to pay,” Dr. Weintraub said.

REDUCE-IT was sponsored by Amarin, the company that markets icosapent ethyl (Vascepa). Dr. Burman has received research funding from AstraZeneca, Eisai, and IBSA. Dr. Eckel has received personal fees from Kowa Pharmaceuticals, Merck, Novartis, and Sanofi/Regeneron, as well as research funding from Endece, Ionis Pharmaceuticals, and UniQure. Dr. Handelsman has been a consultant to and received research funding from Amarin and several other companies. Dr. Jellinger has been a speaker on behalf of Amarin, Amgen, and Regeneron. Dr. Weintraub has received honoraria and research support from Amarin, and honoraria from AstraZeneca.

[email protected]

The Venous Venous Venous @VEITHsymposium program has become a popular staple of the the VEITHsymposium. Now in its 13th year, the Venous Venous Venous program, which will be held on Wednesday, Thursday, and Friday, features a mixture of didactic sessions and workshops to cover the full gamut of venous disorders and their treatments, surgical, endovascular, and medical. It is “considered to be the best and most complete program,” on venous diseases according to conference organizers.

The didactic Program I (Sessions 63-70) on Superficial Venous Disease will be held all day Thursday and will detail the latest developments in venous clinical examinations and imaging, superficial vein strategies and techniques, thermal and non-thermal ablation, and there will be a special session on venous societal issues and governance.

Moderated by Kathleen J. Ozsvath, MD, and Harold J. Welch, MD, this special program will feature discussions on the future of venous reimbursement In a non-fee for service environment, upcoming venous trials, appropriate use criteria to limit inappropriate venous care, and more.

The didactic Program L (Sessions 87-94) on Deep Venous Disease will be all day Friday and the sessions will include discussions on illiocaval stenting, wound care, and surgical and interventional management strategies for thromboembolic events in the venous system. A special medical management session will address topics including statin use, reversal agents for the DOAC, and the potential utility of e-selectin inhibition, and more.

In addition, two special non-CME workshops – “Ask the Experts” sessions – are being offered on Wednesday afternoon this year:

Module 1: Current Superficial Venous Treatment, Wounds, and Edema will focus on endothermal therapy, cyanoacrylate, MOCA, VTE and recanalization, perforators, sclerotherapy, CVI and lymphadema, lipedema, and wound care and compression.

Module 2: Thrombus Management will address thrombolysis and thrombectomy, stents, IVUS, valves, and Nutcracker syndrome.

The workshops will include video case presentations, lectures and demonstrations on vein management by experts, plus hands-on opportunities where participants can rotate through multiple training stations staffed by professionals to assist them.

The Venous Venous Venous @VEITHsymposium program has become a popular staple of the the VEITHsymposium. Now in its 13th year, the Venous Venous Venous program, which will be held on Wednesday, Thursday, and Friday, features a mixture of didactic sessions and workshops to cover the full gamut of venous disorders and their treatments, surgical, endovascular, and medical. It is “considered to be the best and most complete program,” on venous diseases according to conference organizers.

The didactic Program I (Sessions 63-70) on Superficial Venous Disease will be held all day Thursday and will detail the latest developments in venous clinical examinations and imaging, superficial vein strategies and techniques, thermal and non-thermal ablation, and there will be a special session on venous societal issues and governance.

Moderated by Kathleen J. Ozsvath, MD, and Harold J. Welch, MD, this special program will feature discussions on the future of venous reimbursement In a non-fee for service environment, upcoming venous trials, appropriate use criteria to limit inappropriate venous care, and more.

The didactic Program L (Sessions 87-94) on Deep Venous Disease will be all day Friday and the sessions will include discussions on illiocaval stenting, wound care, and surgical and interventional management strategies for thromboembolic events in the venous system. A special medical management session will address topics including statin use, reversal agents for the DOAC, and the potential utility of e-selectin inhibition, and more.

In addition, two special non-CME workshops – “Ask the Experts” sessions – are being offered on Wednesday afternoon this year:

Module 1: Current Superficial Venous Treatment, Wounds, and Edema will focus on endothermal therapy, cyanoacrylate, MOCA, VTE and recanalization, perforators, sclerotherapy, CVI and lymphadema, lipedema, and wound care and compression.

Module 2: Thrombus Management will address thrombolysis and thrombectomy, stents, IVUS, valves, and Nutcracker syndrome.

The workshops will include video case presentations, lectures and demonstrations on vein management by experts, plus hands-on opportunities where participants can rotate through multiple training stations staffed by professionals to assist them.

The Venous Venous Venous @VEITHsymposium program has become a popular staple of the the VEITHsymposium. Now in its 13th year, the Venous Venous Venous program, which will be held on Wednesday, Thursday, and Friday, features a mixture of didactic sessions and workshops to cover the full gamut of venous disorders and their treatments, surgical, endovascular, and medical. It is “considered to be the best and most complete program,” on venous diseases according to conference organizers.

The didactic Program I (Sessions 63-70) on Superficial Venous Disease will be held all day Thursday and will detail the latest developments in venous clinical examinations and imaging, superficial vein strategies and techniques, thermal and non-thermal ablation, and there will be a special session on venous societal issues and governance.

Moderated by Kathleen J. Ozsvath, MD, and Harold J. Welch, MD, this special program will feature discussions on the future of venous reimbursement In a non-fee for service environment, upcoming venous trials, appropriate use criteria to limit inappropriate venous care, and more.

The didactic Program L (Sessions 87-94) on Deep Venous Disease will be all day Friday and the sessions will include discussions on illiocaval stenting, wound care, and surgical and interventional management strategies for thromboembolic events in the venous system. A special medical management session will address topics including statin use, reversal agents for the DOAC, and the potential utility of e-selectin inhibition, and more.

In addition, two special non-CME workshops – “Ask the Experts” sessions – are being offered on Wednesday afternoon this year:

Module 1: Current Superficial Venous Treatment, Wounds, and Edema will focus on endothermal therapy, cyanoacrylate, MOCA, VTE and recanalization, perforators, sclerotherapy, CVI and lymphadema, lipedema, and wound care and compression.

Module 2: Thrombus Management will address thrombolysis and thrombectomy, stents, IVUS, valves, and Nutcracker syndrome.

The workshops will include video case presentations, lectures and demonstrations on vein management by experts, plus hands-on opportunities where participants can rotate through multiple training stations staffed by professionals to assist them.

Developments in carotid artery disease diagnosis and treatment have always been an important component of the VEITHsymposium programs and there will be sessions focusing on this critical area of patient management throughout the entire meeting.

This year, sessions will include a Tuesday focus on unresolved controversies in the management of carotid artery disease. The session will be moderated by Bruce A. Perler, MD, and L. Nelson Hopkins, MD, and include presentations on the value of using biomarkers of brain injury associated with carotid interventions, and how to assess and treat such adverse events as cerebral hyperfusion syndrome and intracranial artery dissection, as well as best medical treatments for carotid patients.

Of particular interest, there will be a debate Tuesday on the need for completion imaging with duplex or angiography with Hans-Henning Eckstein, MD, PhD, and R. Clement Darling III, MD.

Presentations will also address some of the latest treatment techniques for carotid artery disease. For example, on Wednesday morning, Norman H. Kumins, MD, of the Cleveland Medical Center, will present a study on the duration of blood flow reversal during transcarotid artery revascularization (TCAR), an “increasingly popular alternative to carotid endarterctomy and transfemoral artery carotid stenting,” which is designed to provide increased neuroprotection during the placement and angioplasty of the carotid stent. They analyzed the relationship between the length of TCAR flow reversal time (FRT) and major adverse events in 307 patients who underwent TCAR at four high-volume institutions. They separated patients into short (3-7minutes); medium(8-12 minutes); and long group (greater than 12 minutes) FRT. They designated a subset of the long group patients of those with greater than or equal to 20 or more minutes FRT, which they defined as the very long group. The stroke, myocardial infarction, and death rates at 30 days were assessed for all patients and were compared them between groups.

Dr. Kumins will detail how the overall stroke rate was 1.3%, with all strokes considered minor, and all patients showing full recovery. The four strokes occurred in patients with FRT of 6, 7, 11, and 12 minutes, showing no difference in the composite stroke/death or stroke/death/MI rates among the groups, the researchers indicated.

Dr. Kumins will discuss how flow reversal time does not affect stroke rates in patients undergoing TCAR, and suggest that operators should focus on the technical aspects of the procedure during flow reversal rather than being concerned about the amount of FRT.

Developments in carotid artery disease diagnosis and treatment have always been an important component of the VEITHsymposium programs and there will be sessions focusing on this critical area of patient management throughout the entire meeting.

This year, sessions will include a Tuesday focus on unresolved controversies in the management of carotid artery disease. The session will be moderated by Bruce A. Perler, MD, and L. Nelson Hopkins, MD, and include presentations on the value of using biomarkers of brain injury associated with carotid interventions, and how to assess and treat such adverse events as cerebral hyperfusion syndrome and intracranial artery dissection, as well as best medical treatments for carotid patients.

Of particular interest, there will be a debate Tuesday on the need for completion imaging with duplex or angiography with Hans-Henning Eckstein, MD, PhD, and R. Clement Darling III, MD.

Presentations will also address some of the latest treatment techniques for carotid artery disease. For example, on Wednesday morning, Norman H. Kumins, MD, of the Cleveland Medical Center, will present a study on the duration of blood flow reversal during transcarotid artery revascularization (TCAR), an “increasingly popular alternative to carotid endarterctomy and transfemoral artery carotid stenting,” which is designed to provide increased neuroprotection during the placement and angioplasty of the carotid stent. They analyzed the relationship between the length of TCAR flow reversal time (FRT) and major adverse events in 307 patients who underwent TCAR at four high-volume institutions. They separated patients into short (3-7minutes); medium(8-12 minutes); and long group (greater than 12 minutes) FRT. They designated a subset of the long group patients of those with greater than or equal to 20 or more minutes FRT, which they defined as the very long group. The stroke, myocardial infarction, and death rates at 30 days were assessed for all patients and were compared them between groups.

Dr. Kumins will detail how the overall stroke rate was 1.3%, with all strokes considered minor, and all patients showing full recovery. The four strokes occurred in patients with FRT of 6, 7, 11, and 12 minutes, showing no difference in the composite stroke/death or stroke/death/MI rates among the groups, the researchers indicated.

Dr. Kumins will discuss how flow reversal time does not affect stroke rates in patients undergoing TCAR, and suggest that operators should focus on the technical aspects of the procedure during flow reversal rather than being concerned about the amount of FRT.

Developments in carotid artery disease diagnosis and treatment have always been an important component of the VEITHsymposium programs and there will be sessions focusing on this critical area of patient management throughout the entire meeting.

This year, sessions will include a Tuesday focus on unresolved controversies in the management of carotid artery disease. The session will be moderated by Bruce A. Perler, MD, and L. Nelson Hopkins, MD, and include presentations on the value of using biomarkers of brain injury associated with carotid interventions, and how to assess and treat such adverse events as cerebral hyperfusion syndrome and intracranial artery dissection, as well as best medical treatments for carotid patients.

Of particular interest, there will be a debate Tuesday on the need for completion imaging with duplex or angiography with Hans-Henning Eckstein, MD, PhD, and R. Clement Darling III, MD.

Presentations will also address some of the latest treatment techniques for carotid artery disease. For example, on Wednesday morning, Norman H. Kumins, MD, of the Cleveland Medical Center, will present a study on the duration of blood flow reversal during transcarotid artery revascularization (TCAR), an “increasingly popular alternative to carotid endarterctomy and transfemoral artery carotid stenting,” which is designed to provide increased neuroprotection during the placement and angioplasty of the carotid stent. They analyzed the relationship between the length of TCAR flow reversal time (FRT) and major adverse events in 307 patients who underwent TCAR at four high-volume institutions. They separated patients into short (3-7minutes); medium(8-12 minutes); and long group (greater than 12 minutes) FRT. They designated a subset of the long group patients of those with greater than or equal to 20 or more minutes FRT, which they defined as the very long group. The stroke, myocardial infarction, and death rates at 30 days were assessed for all patients and were compared them between groups.

Dr. Kumins will detail how the overall stroke rate was 1.3%, with all strokes considered minor, and all patients showing full recovery. The four strokes occurred in patients with FRT of 6, 7, 11, and 12 minutes, showing no difference in the composite stroke/death or stroke/death/MI rates among the groups, the researchers indicated.

Dr. Kumins will discuss how flow reversal time does not affect stroke rates in patients undergoing TCAR, and suggest that operators should focus on the technical aspects of the procedure during flow reversal rather than being concerned about the amount of FRT.

This year at the VEITHsymposium, lower extremity arterial disease diagnosis and treatment takes pride of place in multiple sessions on each day.

For example, Tuesday will feature a special afternoon program on Hot New Topics In Lower Extremity Occlusive Disease Treatment, and on Wednesday morning, an associate faculty session will be held on Progress In Lower Extremity Occlusive Disease And Its Treatments.

In one particular presentation on Wednesday morning, Arsalan Wafi, MBBS, a clinical researcher at St. George’s Vascular Institute, London, will present a 10-year prospective study demonstrating that the poor mobility, lack of statin use, and socioeconomic deprivation are all associated with worse survival after a major lower limb amputation. Dr. Wafi will discuss how he and his colleagues assessed consecutive 805 major lower limb amputation patients seen in the Roehampton Rehabilitation Center between January 2007 and January 2018, using prospective records, which included demographics, etiologies of limb loss, operative details, medications, and mortality data over a 10-year follow-up period.

A total of 611 (76%) occurred in men, and 194 (24%) in women. Etiologies included diabetes mellitus, peripheral vascular disease, and other causes such as trauma, malignancy, sepsis, and complex regional pain syndrome.

Dr. Wafi will present data showing that living in a deprived area and being further away from the rehabilitation center were both significantly associated with poorer survival. Diabetes mellitus or peripheral vascular disease were associated with significantly shorter survival, compared with other etiologies, and not being on a statin was associated with significantly worse survival among the vascular patients. In addition, poorer overall mobility at discharge from rehabilitation was associated with poorer survival, according to the researchers. However there was no significant difference in survival between below-knee and above-knee amputees, or between unilateral and bilateral amputees.

Thursday will be highlighted by a session on New Devices For Treating Lower Extremity Lesions By Endovascular Or Open Techniques, and Friday will see a session New Developments In The Treatment Of Popliteal Diseases And Aneurysms.

This is only one of many such studies focused on lower extremity arterial disease at this year’s VEITHsymposium.

This year at the VEITHsymposium, lower extremity arterial disease diagnosis and treatment takes pride of place in multiple sessions on each day.

For example, Tuesday will feature a special afternoon program on Hot New Topics In Lower Extremity Occlusive Disease Treatment, and on Wednesday morning, an associate faculty session will be held on Progress In Lower Extremity Occlusive Disease And Its Treatments.

In one particular presentation on Wednesday morning, Arsalan Wafi, MBBS, a clinical researcher at St. George’s Vascular Institute, London, will present a 10-year prospective study demonstrating that the poor mobility, lack of statin use, and socioeconomic deprivation are all associated with worse survival after a major lower limb amputation. Dr. Wafi will discuss how he and his colleagues assessed consecutive 805 major lower limb amputation patients seen in the Roehampton Rehabilitation Center between January 2007 and January 2018, using prospective records, which included demographics, etiologies of limb loss, operative details, medications, and mortality data over a 10-year follow-up period.

A total of 611 (76%) occurred in men, and 194 (24%) in women. Etiologies included diabetes mellitus, peripheral vascular disease, and other causes such as trauma, malignancy, sepsis, and complex regional pain syndrome.

Dr. Wafi will present data showing that living in a deprived area and being further away from the rehabilitation center were both significantly associated with poorer survival. Diabetes mellitus or peripheral vascular disease were associated with significantly shorter survival, compared with other etiologies, and not being on a statin was associated with significantly worse survival among the vascular patients. In addition, poorer overall mobility at discharge from rehabilitation was associated with poorer survival, according to the researchers. However there was no significant difference in survival between below-knee and above-knee amputees, or between unilateral and bilateral amputees.

Thursday will be highlighted by a session on New Devices For Treating Lower Extremity Lesions By Endovascular Or Open Techniques, and Friday will see a session New Developments In The Treatment Of Popliteal Diseases And Aneurysms.

This is only one of many such studies focused on lower extremity arterial disease at this year’s VEITHsymposium.

This year at the VEITHsymposium, lower extremity arterial disease diagnosis and treatment takes pride of place in multiple sessions on each day.

For example, Tuesday will feature a special afternoon program on Hot New Topics In Lower Extremity Occlusive Disease Treatment, and on Wednesday morning, an associate faculty session will be held on Progress In Lower Extremity Occlusive Disease And Its Treatments.

In one particular presentation on Wednesday morning, Arsalan Wafi, MBBS, a clinical researcher at St. George’s Vascular Institute, London, will present a 10-year prospective study demonstrating that the poor mobility, lack of statin use, and socioeconomic deprivation are all associated with worse survival after a major lower limb amputation. Dr. Wafi will discuss how he and his colleagues assessed consecutive 805 major lower limb amputation patients seen in the Roehampton Rehabilitation Center between January 2007 and January 2018, using prospective records, which included demographics, etiologies of limb loss, operative details, medications, and mortality data over a 10-year follow-up period.

A total of 611 (76%) occurred in men, and 194 (24%) in women. Etiologies included diabetes mellitus, peripheral vascular disease, and other causes such as trauma, malignancy, sepsis, and complex regional pain syndrome.

Dr. Wafi will present data showing that living in a deprived area and being further away from the rehabilitation center were both significantly associated with poorer survival. Diabetes mellitus or peripheral vascular disease were associated with significantly shorter survival, compared with other etiologies, and not being on a statin was associated with significantly worse survival among the vascular patients. In addition, poorer overall mobility at discharge from rehabilitation was associated with poorer survival, according to the researchers. However there was no significant difference in survival between below-knee and above-knee amputees, or between unilateral and bilateral amputees.

Thursday will be highlighted by a session on New Devices For Treating Lower Extremity Lesions By Endovascular Or Open Techniques, and Friday will see a session New Developments In The Treatment Of Popliteal Diseases And Aneurysms.

This is only one of many such studies focused on lower extremity arterial disease at this year’s VEITHsymposium.