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HHS floats Stark/anti-kickback revisions to support value-based care
The long-awaited reforms would create permanent exemptions and safe harbors to protect doctors participating in legitimate value-based arrangements. If finalized, the proposals also would offer flexibility for innovation and improved care coordination, while easing the compliance burden for health care professionals and maintaining safeguards against actual fraud and abuse, according to the U.S. Department of Health & Human Services.
The proposals acknowledge that the Stark Law has been an unintentional roadblock to value-based programs in part because it circumscribed parties’ exchanges of rewards for good behavior, said Donna K. Thiel, a Washington-based health law attorney.
“This should be helpful to doctors in that it removes some of the risk in such arrangements under the existing law,” she said in an interview. “If finalized, the new regulations will alleviate some roadblocks created by the Stark Law with respect to hospital-physician and other arrangements designed to enhance care coordination, improve quality, and reduce waste. Likewise, the changes to the [Anti-Kickback Statute] and Beneficiary Inducement laws loosen the reins on compensation arrangements that might be technical violations of those laws where the arrangement fosters [value-based payments] or efficiency, transparency, or innovation in the provision of health care.”
“These proposed rules would be a historic reform of how healthcare is regulated in America,” HHS Deputy Secretary Eric Hargan said in a statement. “They are part of a much broader effort to update, reform, and cut back our regulations to allow innovation toward a more affordable, higher quality, value-based health care system, while maintaining the important protections patients need.”
The two proposed measures – one rule by the Centers for Medicare and Medicaid Services and the other rule by the Office of Inspector General – include safe harbors for certain remuneration exchanged among participants in a value-based arrangement that fosters better coordinated and managed patient care. This includes care arrangements that improve quality, health outcomes, and efficiency, value-based arrangements with substantial downside financial risk, and value-based arrangements with full financial risk.
In addition, the proposals would protect certain tools and supports shared or delivered under patient engagement and support arrangements to improve quality, health outcomes, and efficiency. For example, a specialty physician practice could share data analytics services with a primary care physician practice in an effort to coordinate care and better manage shared patients, according to the HHS.
If finalized, the changes would modify existing safe harbor for personal services and management contracts to add flexibility with respect to outcomes-based payments and part-time arrangements, according to a fact sheet by the OIG. The rule would also modify existing safe harbors for local transportation to expand and modify mileage limits for rural areas and for transportation for discharged patients.
The proposals include guidance on several requirements that must be met for physicians and health care providers to comply with the Stark Law. For example, compensation provided to a doctor by another health care provider generally must be at fair-market value. As part of the proposals, the HHS offers guidance on how to determine if compensation meets this requirement and provides clarity on a range of other technical compliance requirements.
If the rules are approved, more physicians may be encouraged to become part of value-based arrangements, according to Anjali N.C. Downs, a health law attorney based in Washington.
“As stakeholders have long known, physicians are key components to achieving value-based health care delivery and payment systems,” Ms. Downs said in an interview. “The proposed rules remove regulatory barriers that chill physician’s willingness and ability to participate in or even consider participating in integrated care delivery models, alternative payment models, and incentive based arrangements based on outcomes and reductions in cost.”
However, Ms. Thiel noted the proposed rules do not scale back the affected laws as comprehensively as some stakeholders hoped.
“Some would like to see the Stark law repealed completely, opining that the Stark Law has become too complex, creating obstacles in the transition from the fee-for-service model,” Ms. Thiel said. “Because Stark is a strict liability law, meaning no proof of specific intent to violate is required, providers and doctors can violate Stark even when there is no corrupt intent involved. This new regulation purports to fix some of those issues, but others will remain. Some in the industry believe full repeal is necessary to allow the health industry to move forward with pay-for-performance initiatives.”
The agency is also proposing a safe harbor for donations of cybersecurity technology and services between aligned providers in both the fee-for-service and the value-based settings. For example, a local hospital looking to improve its cybersecurity and that of nearby providers could donate cybersecurity software to each physician that refers patients to its hospital, according to the HHS. In addition, the proposals would add protections for certain cybersecurity technology included as part of an electronic health records (EHR) arrangement.
Physician organizations expressed cautious optimism about the proposed changes.
“While the [American Medical Association] is assessing the full scope of today’s proposals, we are pleased to see that the administration has acknowledged a need for policy revisions in response to potential barriers that impede the delivery of patient-centric care,” AMA President Patrice A. Harris, MD, said in a statement. “Currently, the Stark Law and Anti-Kickback Statute can have a negative impact on the ability of physicians to assist with coordination because they inhibit collaborative partnerships, care continuity, and the engagement of patients in their care. These obstacles can hinder the health care system’s movement to value-based care.”
The proposed rules have been submitted to the Federal Registry and are not yet published. The HHS will accept mail and electronic comments about the proposals up to 75 days after publication in the registry.
The long-awaited reforms would create permanent exemptions and safe harbors to protect doctors participating in legitimate value-based arrangements. If finalized, the proposals also would offer flexibility for innovation and improved care coordination, while easing the compliance burden for health care professionals and maintaining safeguards against actual fraud and abuse, according to the U.S. Department of Health & Human Services.
The proposals acknowledge that the Stark Law has been an unintentional roadblock to value-based programs in part because it circumscribed parties’ exchanges of rewards for good behavior, said Donna K. Thiel, a Washington-based health law attorney.
“This should be helpful to doctors in that it removes some of the risk in such arrangements under the existing law,” she said in an interview. “If finalized, the new regulations will alleviate some roadblocks created by the Stark Law with respect to hospital-physician and other arrangements designed to enhance care coordination, improve quality, and reduce waste. Likewise, the changes to the [Anti-Kickback Statute] and Beneficiary Inducement laws loosen the reins on compensation arrangements that might be technical violations of those laws where the arrangement fosters [value-based payments] or efficiency, transparency, or innovation in the provision of health care.”
“These proposed rules would be a historic reform of how healthcare is regulated in America,” HHS Deputy Secretary Eric Hargan said in a statement. “They are part of a much broader effort to update, reform, and cut back our regulations to allow innovation toward a more affordable, higher quality, value-based health care system, while maintaining the important protections patients need.”
The two proposed measures – one rule by the Centers for Medicare and Medicaid Services and the other rule by the Office of Inspector General – include safe harbors for certain remuneration exchanged among participants in a value-based arrangement that fosters better coordinated and managed patient care. This includes care arrangements that improve quality, health outcomes, and efficiency, value-based arrangements with substantial downside financial risk, and value-based arrangements with full financial risk.
In addition, the proposals would protect certain tools and supports shared or delivered under patient engagement and support arrangements to improve quality, health outcomes, and efficiency. For example, a specialty physician practice could share data analytics services with a primary care physician practice in an effort to coordinate care and better manage shared patients, according to the HHS.
If finalized, the changes would modify existing safe harbor for personal services and management contracts to add flexibility with respect to outcomes-based payments and part-time arrangements, according to a fact sheet by the OIG. The rule would also modify existing safe harbors for local transportation to expand and modify mileage limits for rural areas and for transportation for discharged patients.
The proposals include guidance on several requirements that must be met for physicians and health care providers to comply with the Stark Law. For example, compensation provided to a doctor by another health care provider generally must be at fair-market value. As part of the proposals, the HHS offers guidance on how to determine if compensation meets this requirement and provides clarity on a range of other technical compliance requirements.
If the rules are approved, more physicians may be encouraged to become part of value-based arrangements, according to Anjali N.C. Downs, a health law attorney based in Washington.
“As stakeholders have long known, physicians are key components to achieving value-based health care delivery and payment systems,” Ms. Downs said in an interview. “The proposed rules remove regulatory barriers that chill physician’s willingness and ability to participate in or even consider participating in integrated care delivery models, alternative payment models, and incentive based arrangements based on outcomes and reductions in cost.”
However, Ms. Thiel noted the proposed rules do not scale back the affected laws as comprehensively as some stakeholders hoped.
“Some would like to see the Stark law repealed completely, opining that the Stark Law has become too complex, creating obstacles in the transition from the fee-for-service model,” Ms. Thiel said. “Because Stark is a strict liability law, meaning no proof of specific intent to violate is required, providers and doctors can violate Stark even when there is no corrupt intent involved. This new regulation purports to fix some of those issues, but others will remain. Some in the industry believe full repeal is necessary to allow the health industry to move forward with pay-for-performance initiatives.”
The agency is also proposing a safe harbor for donations of cybersecurity technology and services between aligned providers in both the fee-for-service and the value-based settings. For example, a local hospital looking to improve its cybersecurity and that of nearby providers could donate cybersecurity software to each physician that refers patients to its hospital, according to the HHS. In addition, the proposals would add protections for certain cybersecurity technology included as part of an electronic health records (EHR) arrangement.
Physician organizations expressed cautious optimism about the proposed changes.
“While the [American Medical Association] is assessing the full scope of today’s proposals, we are pleased to see that the administration has acknowledged a need for policy revisions in response to potential barriers that impede the delivery of patient-centric care,” AMA President Patrice A. Harris, MD, said in a statement. “Currently, the Stark Law and Anti-Kickback Statute can have a negative impact on the ability of physicians to assist with coordination because they inhibit collaborative partnerships, care continuity, and the engagement of patients in their care. These obstacles can hinder the health care system’s movement to value-based care.”
The proposed rules have been submitted to the Federal Registry and are not yet published. The HHS will accept mail and electronic comments about the proposals up to 75 days after publication in the registry.
The long-awaited reforms would create permanent exemptions and safe harbors to protect doctors participating in legitimate value-based arrangements. If finalized, the proposals also would offer flexibility for innovation and improved care coordination, while easing the compliance burden for health care professionals and maintaining safeguards against actual fraud and abuse, according to the U.S. Department of Health & Human Services.
The proposals acknowledge that the Stark Law has been an unintentional roadblock to value-based programs in part because it circumscribed parties’ exchanges of rewards for good behavior, said Donna K. Thiel, a Washington-based health law attorney.
“This should be helpful to doctors in that it removes some of the risk in such arrangements under the existing law,” she said in an interview. “If finalized, the new regulations will alleviate some roadblocks created by the Stark Law with respect to hospital-physician and other arrangements designed to enhance care coordination, improve quality, and reduce waste. Likewise, the changes to the [Anti-Kickback Statute] and Beneficiary Inducement laws loosen the reins on compensation arrangements that might be technical violations of those laws where the arrangement fosters [value-based payments] or efficiency, transparency, or innovation in the provision of health care.”
“These proposed rules would be a historic reform of how healthcare is regulated in America,” HHS Deputy Secretary Eric Hargan said in a statement. “They are part of a much broader effort to update, reform, and cut back our regulations to allow innovation toward a more affordable, higher quality, value-based health care system, while maintaining the important protections patients need.”
The two proposed measures – one rule by the Centers for Medicare and Medicaid Services and the other rule by the Office of Inspector General – include safe harbors for certain remuneration exchanged among participants in a value-based arrangement that fosters better coordinated and managed patient care. This includes care arrangements that improve quality, health outcomes, and efficiency, value-based arrangements with substantial downside financial risk, and value-based arrangements with full financial risk.
In addition, the proposals would protect certain tools and supports shared or delivered under patient engagement and support arrangements to improve quality, health outcomes, and efficiency. For example, a specialty physician practice could share data analytics services with a primary care physician practice in an effort to coordinate care and better manage shared patients, according to the HHS.
If finalized, the changes would modify existing safe harbor for personal services and management contracts to add flexibility with respect to outcomes-based payments and part-time arrangements, according to a fact sheet by the OIG. The rule would also modify existing safe harbors for local transportation to expand and modify mileage limits for rural areas and for transportation for discharged patients.
The proposals include guidance on several requirements that must be met for physicians and health care providers to comply with the Stark Law. For example, compensation provided to a doctor by another health care provider generally must be at fair-market value. As part of the proposals, the HHS offers guidance on how to determine if compensation meets this requirement and provides clarity on a range of other technical compliance requirements.
If the rules are approved, more physicians may be encouraged to become part of value-based arrangements, according to Anjali N.C. Downs, a health law attorney based in Washington.
“As stakeholders have long known, physicians are key components to achieving value-based health care delivery and payment systems,” Ms. Downs said in an interview. “The proposed rules remove regulatory barriers that chill physician’s willingness and ability to participate in or even consider participating in integrated care delivery models, alternative payment models, and incentive based arrangements based on outcomes and reductions in cost.”
However, Ms. Thiel noted the proposed rules do not scale back the affected laws as comprehensively as some stakeholders hoped.
“Some would like to see the Stark law repealed completely, opining that the Stark Law has become too complex, creating obstacles in the transition from the fee-for-service model,” Ms. Thiel said. “Because Stark is a strict liability law, meaning no proof of specific intent to violate is required, providers and doctors can violate Stark even when there is no corrupt intent involved. This new regulation purports to fix some of those issues, but others will remain. Some in the industry believe full repeal is necessary to allow the health industry to move forward with pay-for-performance initiatives.”
The agency is also proposing a safe harbor for donations of cybersecurity technology and services between aligned providers in both the fee-for-service and the value-based settings. For example, a local hospital looking to improve its cybersecurity and that of nearby providers could donate cybersecurity software to each physician that refers patients to its hospital, according to the HHS. In addition, the proposals would add protections for certain cybersecurity technology included as part of an electronic health records (EHR) arrangement.
Physician organizations expressed cautious optimism about the proposed changes.
“While the [American Medical Association] is assessing the full scope of today’s proposals, we are pleased to see that the administration has acknowledged a need for policy revisions in response to potential barriers that impede the delivery of patient-centric care,” AMA President Patrice A. Harris, MD, said in a statement. “Currently, the Stark Law and Anti-Kickback Statute can have a negative impact on the ability of physicians to assist with coordination because they inhibit collaborative partnerships, care continuity, and the engagement of patients in their care. These obstacles can hinder the health care system’s movement to value-based care.”
The proposed rules have been submitted to the Federal Registry and are not yet published. The HHS will accept mail and electronic comments about the proposals up to 75 days after publication in the registry.
Trump: No health insurance, no U.S. entry
Health insurance or the ability to pay for care soon will be a requirement for immigrants seeking U.S. visas, under a proclamation from President Trump.
Effective Nov. 3, 2019, visa applicants must demonstrate to immigration authorities that they can obtain coverage by an approved health insurer within 30 days of entering the United States or show evidence they possess the financial resources to pay for foreseeable medical costs. Approved coverage includes, but is not limited to, an employer-sponsored plan, an unsubsidized health plan offered in the individual market, a family member’s plan, or a visitor health insurance plan that provides coverage for at least 364 days, according to the proclamation.
President Trump said that the restriction protects Americans from bearing the burden of uncompensated health care costs generated by immigrants.
“While our health care system grapples with the challenges caused by uncompensated care, the United States government is making the problem worse by admitting thousands of aliens who have not demonstrated any ability to pay for their health care costs,” President Trump said in the proclamation. “Notably, data show that lawful immigrants are about three times more likely than United States citizens to lack health insurance. Immigrants who enter this country should not further saddle our health care system, and subsequently American taxpayers, with higher costs.”
The rule does not apply to refugees or asylum seekers, immigrants holding valid visas prior to Nov. 3, noncitizen children of U.S. citizens, unaccompanied minors, or permanent residents returning to the country after less than a year overseas.
The rule is the latest in a series of immigration restrictions by President Trump. Most recently in August 2019, the Trump administration amended the federal public charge rule, a longstanding policy that allows authorities to refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge. The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program, and several housing programs.
The proclamation is consistent with the President’s recent public charge rule, and it is sound immigration policy, said Dale Wilcox, executive director and general counsel for the Immigration Reform Law Institute.
“If U.S. citizens are responsible for the health care costs of the world, then the world will show up at our doorstep for free health care,” Mr. Wilcox said in an interview. “That is unfair to American citizens and would financially devastate health care providers. The impact of this proclamation would be a more manageable immigration policy that welcomes immigrants who will contribute to our country as well as benefit from it.”
J. Wesley Boyd, MD, of the Center for Bioethics at Harvard University, Boston, said he was saddened to learn about the proclamation, adding that the Trump administration is relying on inaccurate information and falsified facts to justify the new restriction. Dr. Boyd, cofounder of the Human Rights and Asylum Clinic at Cambridge Health Alliance in Cambridge, Mass., coauthored a 2018 study finding that immigrants pay more into the U.S. health care system than they use.
That analysis, which examined 188 peer-reviewed studies related to immigrants and U.S. health care expenditures, found that per capita expenditures from private and public insurance sources were about 40% lower for immigrants, compared with native-born Americans. Expenditures for undocumented immigrants were even lower. Immigrants also made a greater contribution to Medicare’s trust fund than they withdrew, the study found (Int J Health Serv. 2018 Aug. 8 doi: 10.1177/0020731418791963).
Immigrants use less health care resources because they are generally younger and healthier than native-born Americans, and they are less likely to access health care services – regardless of health status, Dr. Boyd said in an interview. In addition, many immigrants who contribute to Medicare through payroll and/or taxes are no longer in the U.S. when they reach Medicare age.
“The Trump administration, in this case, is making yet another set of excuses for why they are trying to keep immigrants out of the country,” Dr. Boyd said. “The potential impact of this restriction is devastating. Obviously, the Trump administration is doing anything that it possibly can to try to limit immigrants from coming into our country and seeking a better life for themselves.”
The proclamation also could have a chilling effect on immigrants currently in the United States who are in need of medical treatment, Dr. Boyd noted.
“The real effect is you’re going to have immigrants who are already here, not [accessing] health care when they need it, for fear they somehow become known to the government,” he said.
Health insurance or the ability to pay for care soon will be a requirement for immigrants seeking U.S. visas, under a proclamation from President Trump.
Effective Nov. 3, 2019, visa applicants must demonstrate to immigration authorities that they can obtain coverage by an approved health insurer within 30 days of entering the United States or show evidence they possess the financial resources to pay for foreseeable medical costs. Approved coverage includes, but is not limited to, an employer-sponsored plan, an unsubsidized health plan offered in the individual market, a family member’s plan, or a visitor health insurance plan that provides coverage for at least 364 days, according to the proclamation.
President Trump said that the restriction protects Americans from bearing the burden of uncompensated health care costs generated by immigrants.
“While our health care system grapples with the challenges caused by uncompensated care, the United States government is making the problem worse by admitting thousands of aliens who have not demonstrated any ability to pay for their health care costs,” President Trump said in the proclamation. “Notably, data show that lawful immigrants are about three times more likely than United States citizens to lack health insurance. Immigrants who enter this country should not further saddle our health care system, and subsequently American taxpayers, with higher costs.”
The rule does not apply to refugees or asylum seekers, immigrants holding valid visas prior to Nov. 3, noncitizen children of U.S. citizens, unaccompanied minors, or permanent residents returning to the country after less than a year overseas.
The rule is the latest in a series of immigration restrictions by President Trump. Most recently in August 2019, the Trump administration amended the federal public charge rule, a longstanding policy that allows authorities to refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge. The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program, and several housing programs.
The proclamation is consistent with the President’s recent public charge rule, and it is sound immigration policy, said Dale Wilcox, executive director and general counsel for the Immigration Reform Law Institute.
“If U.S. citizens are responsible for the health care costs of the world, then the world will show up at our doorstep for free health care,” Mr. Wilcox said in an interview. “That is unfair to American citizens and would financially devastate health care providers. The impact of this proclamation would be a more manageable immigration policy that welcomes immigrants who will contribute to our country as well as benefit from it.”
J. Wesley Boyd, MD, of the Center for Bioethics at Harvard University, Boston, said he was saddened to learn about the proclamation, adding that the Trump administration is relying on inaccurate information and falsified facts to justify the new restriction. Dr. Boyd, cofounder of the Human Rights and Asylum Clinic at Cambridge Health Alliance in Cambridge, Mass., coauthored a 2018 study finding that immigrants pay more into the U.S. health care system than they use.
That analysis, which examined 188 peer-reviewed studies related to immigrants and U.S. health care expenditures, found that per capita expenditures from private and public insurance sources were about 40% lower for immigrants, compared with native-born Americans. Expenditures for undocumented immigrants were even lower. Immigrants also made a greater contribution to Medicare’s trust fund than they withdrew, the study found (Int J Health Serv. 2018 Aug. 8 doi: 10.1177/0020731418791963).
Immigrants use less health care resources because they are generally younger and healthier than native-born Americans, and they are less likely to access health care services – regardless of health status, Dr. Boyd said in an interview. In addition, many immigrants who contribute to Medicare through payroll and/or taxes are no longer in the U.S. when they reach Medicare age.
“The Trump administration, in this case, is making yet another set of excuses for why they are trying to keep immigrants out of the country,” Dr. Boyd said. “The potential impact of this restriction is devastating. Obviously, the Trump administration is doing anything that it possibly can to try to limit immigrants from coming into our country and seeking a better life for themselves.”
The proclamation also could have a chilling effect on immigrants currently in the United States who are in need of medical treatment, Dr. Boyd noted.
“The real effect is you’re going to have immigrants who are already here, not [accessing] health care when they need it, for fear they somehow become known to the government,” he said.
Health insurance or the ability to pay for care soon will be a requirement for immigrants seeking U.S. visas, under a proclamation from President Trump.
Effective Nov. 3, 2019, visa applicants must demonstrate to immigration authorities that they can obtain coverage by an approved health insurer within 30 days of entering the United States or show evidence they possess the financial resources to pay for foreseeable medical costs. Approved coverage includes, but is not limited to, an employer-sponsored plan, an unsubsidized health plan offered in the individual market, a family member’s plan, or a visitor health insurance plan that provides coverage for at least 364 days, according to the proclamation.
President Trump said that the restriction protects Americans from bearing the burden of uncompensated health care costs generated by immigrants.
“While our health care system grapples with the challenges caused by uncompensated care, the United States government is making the problem worse by admitting thousands of aliens who have not demonstrated any ability to pay for their health care costs,” President Trump said in the proclamation. “Notably, data show that lawful immigrants are about three times more likely than United States citizens to lack health insurance. Immigrants who enter this country should not further saddle our health care system, and subsequently American taxpayers, with higher costs.”
The rule does not apply to refugees or asylum seekers, immigrants holding valid visas prior to Nov. 3, noncitizen children of U.S. citizens, unaccompanied minors, or permanent residents returning to the country after less than a year overseas.
The rule is the latest in a series of immigration restrictions by President Trump. Most recently in August 2019, the Trump administration amended the federal public charge rule, a longstanding policy that allows authorities to refuse to admit immigrants into the United States – or to adjust their legal status – if they are deemed likely to become a public charge. The revised regulation allows officials to consider previously excluded programs in their determination, including nonemergency Medicaid for nonpregnant adults, the Supplemental Nutrition Assistance Program, and several housing programs.
The proclamation is consistent with the President’s recent public charge rule, and it is sound immigration policy, said Dale Wilcox, executive director and general counsel for the Immigration Reform Law Institute.
“If U.S. citizens are responsible for the health care costs of the world, then the world will show up at our doorstep for free health care,” Mr. Wilcox said in an interview. “That is unfair to American citizens and would financially devastate health care providers. The impact of this proclamation would be a more manageable immigration policy that welcomes immigrants who will contribute to our country as well as benefit from it.”
J. Wesley Boyd, MD, of the Center for Bioethics at Harvard University, Boston, said he was saddened to learn about the proclamation, adding that the Trump administration is relying on inaccurate information and falsified facts to justify the new restriction. Dr. Boyd, cofounder of the Human Rights and Asylum Clinic at Cambridge Health Alliance in Cambridge, Mass., coauthored a 2018 study finding that immigrants pay more into the U.S. health care system than they use.
That analysis, which examined 188 peer-reviewed studies related to immigrants and U.S. health care expenditures, found that per capita expenditures from private and public insurance sources were about 40% lower for immigrants, compared with native-born Americans. Expenditures for undocumented immigrants were even lower. Immigrants also made a greater contribution to Medicare’s trust fund than they withdrew, the study found (Int J Health Serv. 2018 Aug. 8 doi: 10.1177/0020731418791963).
Immigrants use less health care resources because they are generally younger and healthier than native-born Americans, and they are less likely to access health care services – regardless of health status, Dr. Boyd said in an interview. In addition, many immigrants who contribute to Medicare through payroll and/or taxes are no longer in the U.S. when they reach Medicare age.
“The Trump administration, in this case, is making yet another set of excuses for why they are trying to keep immigrants out of the country,” Dr. Boyd said. “The potential impact of this restriction is devastating. Obviously, the Trump administration is doing anything that it possibly can to try to limit immigrants from coming into our country and seeking a better life for themselves.”
The proclamation also could have a chilling effect on immigrants currently in the United States who are in need of medical treatment, Dr. Boyd noted.
“The real effect is you’re going to have immigrants who are already here, not [accessing] health care when they need it, for fear they somehow become known to the government,” he said.
Appeals court to hear prescription drug privacy rights case
An appeals court may soon decide whether federal authorities can access a patient’s medical records through a statewide prescription drug monitoring database without a warrant or if such searches infringe upon privacy rights.
On Oct. 10, the 1st U.S. Circuit Court of Appeals will hear arguments in U.S. Department of Justice v. Jonas, which centers on an investigatory subpoena issued by the U.S. Drug Enforcement Agency in 2018 that sought records about a certain patient from New Hampshire’s Prescription Drug Monitoring Program (PDMP). The subpoena’s recipient, PDMP program manager Michelle Ricco-Jonas, refused to comply, citing state law that prohibits law enforcement from accessing the database without a court order based on probable cause. Releasing PDMP records to authorities without cause violate patients’ privacy protections under the Fourth Amendment, Ms. Jonas and the New Hampshire Attorney General’s Office argued.
The U.S. Department of Justice sued to enforce the subpoena, contending that the DEA’s authority to investigate suspected criminal drug activity preempts New Hampshire’s law under the Supremacy Clause. In November 2018, U.S. Magistrate Judge Andrea K. Johnstone agreed with the DOJ and recommended the district judge grant the government’s motion to enforce the subpoena, a decision affirmed by the U.S. District Court for the District of New Hampshire in January 2019. The court ruled the government met its burden to satisfy the modest requirements for enforcement of the subpoena. Attorneys for New Hampshire appealed to the 1st Circuit.
The case is being closely watched by states, physician groups, pharmacies, and patient advocacy groups. In a joint court brief by the New Hampshire Medical Society and the American Civil Liberties Union, the organizations urged the appeals court to protect patient privacy by finding in favor of New Hampshire.
“The DEA has sought to enforce a subpoena that both injures Jonas and threatens to invade the Fourth Amendment privacy rights of individuals whose private medical information resides in the database, and whose privacy and confidentiality Jonas is statutorily charged with protecting. ... but who have no ability to challenge that impending harm,” the groups wrote in the brief. “The prescription records at issue in this case reveal intimate, private, and potentially stigmatizing details about patients’ health, including details of those patients’ underlying medical conditions. For that reason, as with other medical records, people have a reasonable expectation of privacy in them.”
Oregon’s PDMP faced a similar legal challenge in 2012. In that case, the DEA attempted to access the records of one patient and two prescribing physicians from Oregon’s prescription database. The state sued to prevent release of the records, and the ACLU intervened as a plaintiff on behalf of several unnamed patients and a doctor. A district court ruled in favor of the plaintiffs, finding that the DEA’s actions constituted a Fourth Amendment violation. However, the 9th U.S. Circuit Court in 2017 overturned the decision, ruling that federal law regarding administrative subpoenas trumps Oregon law. In addition, the appeals court ruled that the ACLU lacked standing to intervene and seek relief different from that sought by Oregon. By invalidating ACLU from the suit, the Fourth Amendment argument was never resolved by the 9th Circuit.
New Hampshire is one of 49 states that have Prescription Drug Monitoring Programs in addition to the District of Columbia. The programs collect, monitor, and analyze electronically transmitted prescribing and dispensing data submitted by physicians and pharmacies with the aim of reducing prescription drug abuse and diversion.
An appeals court may soon decide whether federal authorities can access a patient’s medical records through a statewide prescription drug monitoring database without a warrant or if such searches infringe upon privacy rights.
On Oct. 10, the 1st U.S. Circuit Court of Appeals will hear arguments in U.S. Department of Justice v. Jonas, which centers on an investigatory subpoena issued by the U.S. Drug Enforcement Agency in 2018 that sought records about a certain patient from New Hampshire’s Prescription Drug Monitoring Program (PDMP). The subpoena’s recipient, PDMP program manager Michelle Ricco-Jonas, refused to comply, citing state law that prohibits law enforcement from accessing the database without a court order based on probable cause. Releasing PDMP records to authorities without cause violate patients’ privacy protections under the Fourth Amendment, Ms. Jonas and the New Hampshire Attorney General’s Office argued.
The U.S. Department of Justice sued to enforce the subpoena, contending that the DEA’s authority to investigate suspected criminal drug activity preempts New Hampshire’s law under the Supremacy Clause. In November 2018, U.S. Magistrate Judge Andrea K. Johnstone agreed with the DOJ and recommended the district judge grant the government’s motion to enforce the subpoena, a decision affirmed by the U.S. District Court for the District of New Hampshire in January 2019. The court ruled the government met its burden to satisfy the modest requirements for enforcement of the subpoena. Attorneys for New Hampshire appealed to the 1st Circuit.
The case is being closely watched by states, physician groups, pharmacies, and patient advocacy groups. In a joint court brief by the New Hampshire Medical Society and the American Civil Liberties Union, the organizations urged the appeals court to protect patient privacy by finding in favor of New Hampshire.
“The DEA has sought to enforce a subpoena that both injures Jonas and threatens to invade the Fourth Amendment privacy rights of individuals whose private medical information resides in the database, and whose privacy and confidentiality Jonas is statutorily charged with protecting. ... but who have no ability to challenge that impending harm,” the groups wrote in the brief. “The prescription records at issue in this case reveal intimate, private, and potentially stigmatizing details about patients’ health, including details of those patients’ underlying medical conditions. For that reason, as with other medical records, people have a reasonable expectation of privacy in them.”
Oregon’s PDMP faced a similar legal challenge in 2012. In that case, the DEA attempted to access the records of one patient and two prescribing physicians from Oregon’s prescription database. The state sued to prevent release of the records, and the ACLU intervened as a plaintiff on behalf of several unnamed patients and a doctor. A district court ruled in favor of the plaintiffs, finding that the DEA’s actions constituted a Fourth Amendment violation. However, the 9th U.S. Circuit Court in 2017 overturned the decision, ruling that federal law regarding administrative subpoenas trumps Oregon law. In addition, the appeals court ruled that the ACLU lacked standing to intervene and seek relief different from that sought by Oregon. By invalidating ACLU from the suit, the Fourth Amendment argument was never resolved by the 9th Circuit.
New Hampshire is one of 49 states that have Prescription Drug Monitoring Programs in addition to the District of Columbia. The programs collect, monitor, and analyze electronically transmitted prescribing and dispensing data submitted by physicians and pharmacies with the aim of reducing prescription drug abuse and diversion.
An appeals court may soon decide whether federal authorities can access a patient’s medical records through a statewide prescription drug monitoring database without a warrant or if such searches infringe upon privacy rights.
On Oct. 10, the 1st U.S. Circuit Court of Appeals will hear arguments in U.S. Department of Justice v. Jonas, which centers on an investigatory subpoena issued by the U.S. Drug Enforcement Agency in 2018 that sought records about a certain patient from New Hampshire’s Prescription Drug Monitoring Program (PDMP). The subpoena’s recipient, PDMP program manager Michelle Ricco-Jonas, refused to comply, citing state law that prohibits law enforcement from accessing the database without a court order based on probable cause. Releasing PDMP records to authorities without cause violate patients’ privacy protections under the Fourth Amendment, Ms. Jonas and the New Hampshire Attorney General’s Office argued.
The U.S. Department of Justice sued to enforce the subpoena, contending that the DEA’s authority to investigate suspected criminal drug activity preempts New Hampshire’s law under the Supremacy Clause. In November 2018, U.S. Magistrate Judge Andrea K. Johnstone agreed with the DOJ and recommended the district judge grant the government’s motion to enforce the subpoena, a decision affirmed by the U.S. District Court for the District of New Hampshire in January 2019. The court ruled the government met its burden to satisfy the modest requirements for enforcement of the subpoena. Attorneys for New Hampshire appealed to the 1st Circuit.
The case is being closely watched by states, physician groups, pharmacies, and patient advocacy groups. In a joint court brief by the New Hampshire Medical Society and the American Civil Liberties Union, the organizations urged the appeals court to protect patient privacy by finding in favor of New Hampshire.
“The DEA has sought to enforce a subpoena that both injures Jonas and threatens to invade the Fourth Amendment privacy rights of individuals whose private medical information resides in the database, and whose privacy and confidentiality Jonas is statutorily charged with protecting. ... but who have no ability to challenge that impending harm,” the groups wrote in the brief. “The prescription records at issue in this case reveal intimate, private, and potentially stigmatizing details about patients’ health, including details of those patients’ underlying medical conditions. For that reason, as with other medical records, people have a reasonable expectation of privacy in them.”
Oregon’s PDMP faced a similar legal challenge in 2012. In that case, the DEA attempted to access the records of one patient and two prescribing physicians from Oregon’s prescription database. The state sued to prevent release of the records, and the ACLU intervened as a plaintiff on behalf of several unnamed patients and a doctor. A district court ruled in favor of the plaintiffs, finding that the DEA’s actions constituted a Fourth Amendment violation. However, the 9th U.S. Circuit Court in 2017 overturned the decision, ruling that federal law regarding administrative subpoenas trumps Oregon law. In addition, the appeals court ruled that the ACLU lacked standing to intervene and seek relief different from that sought by Oregon. By invalidating ACLU from the suit, the Fourth Amendment argument was never resolved by the 9th Circuit.
New Hampshire is one of 49 states that have Prescription Drug Monitoring Programs in addition to the District of Columbia. The programs collect, monitor, and analyze electronically transmitted prescribing and dispensing data submitted by physicians and pharmacies with the aim of reducing prescription drug abuse and diversion.
White AAV patients post highest mortality rates
Age-adjusted mortality from antineutrophil cytoplasmic autoantibody–associated vasculitides (AAV) in the United States declined by nearly 2% each year between 1999 and 2017, based on data from the Centers for Disease Control and Prevention.
Significant morbidity and mortality are associated with untreated AAV, wrote Alexander W. Steinberg, MD, of Saint Joseph Hospital, Denver, Colo., and colleagues.
“Although population data from the United Kingdom have shown decreased AAV-related mortality during the past 20 years, it is unknown whether this pattern has occurred in the United States,” they wrote.
In a study published in Annals of Internal Medicine, the researchers identified 11,316 AAV-related deaths from 1999 to 2017 in the CDC data.
Overall, age-adjusted mortality was 1.86 per 1,000,000 persons, with highest rates among non-Hispanic whites, men, and residents of the Midwest. Mortality from AAV declined by an average of 1.6% in each year of the study period, and changes in subgroups stratified by gender, race, and geographic region were similar.
Mortality increased with age and was highest among individuals aged 75-84 years, but a significant decline in mortality occurred among individuals aged 65-74 years. “The decrease in overall mortality and mortality among persons aged 65 to 74 years may reflect increased longevity due to improved treatment of AAV and common comorbid conditions,” the researchers said.
“Surprisingly, the authors found much lower age-adjusted mortality rates for non-Hispanic black persons (0.77) and moderately lower mortality rates for Hispanic persons (1.57) than for non-Hispanic white persons (2.03),” wrote John R. Stone, MD, PhD, of Creighton University, Omaha, Neb., in an accompanying editorial.
“Suppose the mortality rate differences reported by Steinberg and colleagues are statistically significant, accurately represent death certificate diagnoses, and match people’s racial/ethnic self-identification. The data then show neither that the vasculitides actually have lower mortality rates in blacks or Hispanics compared with whites, nor that the diseases are indeed less frequent in blacks and Hispanics,” he said. “Rather, these differences probably signify how social inequities, social structural violence, and inferior health care access adversely influence diagnosis of rare diseases and promote health inequity,” Dr. Stone added. The findings suggest that clinicians should remain alert to AAV in some ethnic groups to improve diagnostic accuracy, he said.
“Moreover, improved AAV diagnosis in such groups is key to recruiting participants for research investigating whether therapies should differ among populations,” he emphasized.
The study findings were limited by possible under- or overreporting of AAV on death certificates, but they were strengthened by the large sample size, the researchers noted. “We hope that the mortality patterns presented here can be used to direct future research on the driving forces behind these trends,” they said.
Dr. Steinberg had no financial conflicts to disclose. Dr. Stone had no financial conflicts to disclose.
SOURCES: Steinberg AW et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1564; and Stone JR. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-2755.
Age-adjusted mortality from antineutrophil cytoplasmic autoantibody–associated vasculitides (AAV) in the United States declined by nearly 2% each year between 1999 and 2017, based on data from the Centers for Disease Control and Prevention.
Significant morbidity and mortality are associated with untreated AAV, wrote Alexander W. Steinberg, MD, of Saint Joseph Hospital, Denver, Colo., and colleagues.
“Although population data from the United Kingdom have shown decreased AAV-related mortality during the past 20 years, it is unknown whether this pattern has occurred in the United States,” they wrote.
In a study published in Annals of Internal Medicine, the researchers identified 11,316 AAV-related deaths from 1999 to 2017 in the CDC data.
Overall, age-adjusted mortality was 1.86 per 1,000,000 persons, with highest rates among non-Hispanic whites, men, and residents of the Midwest. Mortality from AAV declined by an average of 1.6% in each year of the study period, and changes in subgroups stratified by gender, race, and geographic region were similar.
Mortality increased with age and was highest among individuals aged 75-84 years, but a significant decline in mortality occurred among individuals aged 65-74 years. “The decrease in overall mortality and mortality among persons aged 65 to 74 years may reflect increased longevity due to improved treatment of AAV and common comorbid conditions,” the researchers said.
“Surprisingly, the authors found much lower age-adjusted mortality rates for non-Hispanic black persons (0.77) and moderately lower mortality rates for Hispanic persons (1.57) than for non-Hispanic white persons (2.03),” wrote John R. Stone, MD, PhD, of Creighton University, Omaha, Neb., in an accompanying editorial.
“Suppose the mortality rate differences reported by Steinberg and colleagues are statistically significant, accurately represent death certificate diagnoses, and match people’s racial/ethnic self-identification. The data then show neither that the vasculitides actually have lower mortality rates in blacks or Hispanics compared with whites, nor that the diseases are indeed less frequent in blacks and Hispanics,” he said. “Rather, these differences probably signify how social inequities, social structural violence, and inferior health care access adversely influence diagnosis of rare diseases and promote health inequity,” Dr. Stone added. The findings suggest that clinicians should remain alert to AAV in some ethnic groups to improve diagnostic accuracy, he said.
“Moreover, improved AAV diagnosis in such groups is key to recruiting participants for research investigating whether therapies should differ among populations,” he emphasized.
The study findings were limited by possible under- or overreporting of AAV on death certificates, but they were strengthened by the large sample size, the researchers noted. “We hope that the mortality patterns presented here can be used to direct future research on the driving forces behind these trends,” they said.
Dr. Steinberg had no financial conflicts to disclose. Dr. Stone had no financial conflicts to disclose.
SOURCES: Steinberg AW et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1564; and Stone JR. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-2755.
Age-adjusted mortality from antineutrophil cytoplasmic autoantibody–associated vasculitides (AAV) in the United States declined by nearly 2% each year between 1999 and 2017, based on data from the Centers for Disease Control and Prevention.
Significant morbidity and mortality are associated with untreated AAV, wrote Alexander W. Steinberg, MD, of Saint Joseph Hospital, Denver, Colo., and colleagues.
“Although population data from the United Kingdom have shown decreased AAV-related mortality during the past 20 years, it is unknown whether this pattern has occurred in the United States,” they wrote.
In a study published in Annals of Internal Medicine, the researchers identified 11,316 AAV-related deaths from 1999 to 2017 in the CDC data.
Overall, age-adjusted mortality was 1.86 per 1,000,000 persons, with highest rates among non-Hispanic whites, men, and residents of the Midwest. Mortality from AAV declined by an average of 1.6% in each year of the study period, and changes in subgroups stratified by gender, race, and geographic region were similar.
Mortality increased with age and was highest among individuals aged 75-84 years, but a significant decline in mortality occurred among individuals aged 65-74 years. “The decrease in overall mortality and mortality among persons aged 65 to 74 years may reflect increased longevity due to improved treatment of AAV and common comorbid conditions,” the researchers said.
“Surprisingly, the authors found much lower age-adjusted mortality rates for non-Hispanic black persons (0.77) and moderately lower mortality rates for Hispanic persons (1.57) than for non-Hispanic white persons (2.03),” wrote John R. Stone, MD, PhD, of Creighton University, Omaha, Neb., in an accompanying editorial.
“Suppose the mortality rate differences reported by Steinberg and colleagues are statistically significant, accurately represent death certificate diagnoses, and match people’s racial/ethnic self-identification. The data then show neither that the vasculitides actually have lower mortality rates in blacks or Hispanics compared with whites, nor that the diseases are indeed less frequent in blacks and Hispanics,” he said. “Rather, these differences probably signify how social inequities, social structural violence, and inferior health care access adversely influence diagnosis of rare diseases and promote health inequity,” Dr. Stone added. The findings suggest that clinicians should remain alert to AAV in some ethnic groups to improve diagnostic accuracy, he said.
“Moreover, improved AAV diagnosis in such groups is key to recruiting participants for research investigating whether therapies should differ among populations,” he emphasized.
The study findings were limited by possible under- or overreporting of AAV on death certificates, but they were strengthened by the large sample size, the researchers noted. “We hope that the mortality patterns presented here can be used to direct future research on the driving forces behind these trends,” they said.
Dr. Steinberg had no financial conflicts to disclose. Dr. Stone had no financial conflicts to disclose.
SOURCES: Steinberg AW et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1564; and Stone JR. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-2755.
FROM ANNALS OF INTERNAL MEDICINE
Key clinical point: The mortality rate from antineutrophil cytoplasmic autoantibody–associated vasculitides (AAV) in the United States was 1.86 per 1,000,000 individuals from 1999 to 2017.
Major finding: Age-adjusted mortality from AAV decreased by approximately 2% each year between 1999 and 2017.
Study details: The data come from a review of 11,316 AAV-related deaths.
Disclosures: Dr. Steinberg had no financial conflicts to disclose.
Source: Steinberg AW et al. Ann Intern Med. 2019 Oct 8. doi: 10.7326/M19-1564.
F-BEVAR safe in patients with one kidney
CHICAGO – Patients who have one kidney do as well after fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal or thoracoabdominal aortic aneurysm as patients with both kidneys, according to a study of almost 300 patients presented at the annual meeting of the Midwestern Vascular Surgery Society.
“Despite the worse baseline renal function associated with single functioning kidney patients, F-BEVAR is safe and effective with nearly identical outcomes in patients with a SFK [single functioning kidney] as compared to patients with two functioning kidneys,” said Keouna Pather of Mayo Clinic, Rochester, Minn.
The study evaluated 287 F-BEVAR patients enrolled in a physician-sponsored investigation device exemption study from November 2013 to October 2018. Thirty of those patients had one kidney, the remaining 257 were the control group. Ms. Pather noted that characteristics were similar between both patient groups with the exception that SFK patients were younger (age 70 vs. 74 years; P = .009) and had larger renal artery diameter (6 vs. 5.7 mm; P = .05). “Patients with a SFK had enlargement of their renal artery in a compensatory fashion,” she said.
Survival at 2 years was 92% for SFK patients and 84% for controls.
“The SFK patients did start at a worse baseline of CKD [chronic kidney disease] stages as compared to controls,” she noted. In the SFK group, 63% (n = 19) had Stage III CKD versus 40% (n = 104) of controls (P = .02). Likewise, rates of Stage IV CKD were 10% (n = 3) and 2% (n = 4), respectively (P = .03).
In terms of outcomes, two patients in the control group died within 30 days but none in the SFK group did, Ms. Pather said. Also, a higher percentage of SFK patients had estimated blood loss greater than 1 L, compared with controls (20% vs. 7%; P = .02). All other outcomes, including rates of acute kidney injury (20% vs. 12%; P = .26), were not statistically different, she said.
“Between the groups, there was no significant difference in CKD progression that needed stenting,” she added, with 27% (n = 8) and 26% (n = 67) of the SFK and controls progressing to CKD Stages III to V.
The study also identified predictors of acute kidney injury in SFK patients: total fluoroscopy time (hours), which raised the risk by 78.5%, and estimated blood loss greater than 1 L, which increased risk by 109%.
Predictors of renal function deterioration in SFK patients were renal artery occlusion or reintervention for branch stenosis or kink, which raised the risk threefold; a Crawford extent II, which more than doubled the risk; and acute kidney injury, which raised chances almost fivefold. “Development of postoperative AKI [acute kidney injury] is the most important predictor for renal function deterioration,” Pather said.
When freedom from renal function deterioration at 2 years was compared between the two groups, again the results were similar because of the small sample size of the SFK group: 100% for the SFK group and 84% for controls.
Ms. Pather had no financial relationships to disclose.
CHICAGO – Patients who have one kidney do as well after fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal or thoracoabdominal aortic aneurysm as patients with both kidneys, according to a study of almost 300 patients presented at the annual meeting of the Midwestern Vascular Surgery Society.
“Despite the worse baseline renal function associated with single functioning kidney patients, F-BEVAR is safe and effective with nearly identical outcomes in patients with a SFK [single functioning kidney] as compared to patients with two functioning kidneys,” said Keouna Pather of Mayo Clinic, Rochester, Minn.
The study evaluated 287 F-BEVAR patients enrolled in a physician-sponsored investigation device exemption study from November 2013 to October 2018. Thirty of those patients had one kidney, the remaining 257 were the control group. Ms. Pather noted that characteristics were similar between both patient groups with the exception that SFK patients were younger (age 70 vs. 74 years; P = .009) and had larger renal artery diameter (6 vs. 5.7 mm; P = .05). “Patients with a SFK had enlargement of their renal artery in a compensatory fashion,” she said.
Survival at 2 years was 92% for SFK patients and 84% for controls.
“The SFK patients did start at a worse baseline of CKD [chronic kidney disease] stages as compared to controls,” she noted. In the SFK group, 63% (n = 19) had Stage III CKD versus 40% (n = 104) of controls (P = .02). Likewise, rates of Stage IV CKD were 10% (n = 3) and 2% (n = 4), respectively (P = .03).
In terms of outcomes, two patients in the control group died within 30 days but none in the SFK group did, Ms. Pather said. Also, a higher percentage of SFK patients had estimated blood loss greater than 1 L, compared with controls (20% vs. 7%; P = .02). All other outcomes, including rates of acute kidney injury (20% vs. 12%; P = .26), were not statistically different, she said.
“Between the groups, there was no significant difference in CKD progression that needed stenting,” she added, with 27% (n = 8) and 26% (n = 67) of the SFK and controls progressing to CKD Stages III to V.
The study also identified predictors of acute kidney injury in SFK patients: total fluoroscopy time (hours), which raised the risk by 78.5%, and estimated blood loss greater than 1 L, which increased risk by 109%.
Predictors of renal function deterioration in SFK patients were renal artery occlusion or reintervention for branch stenosis or kink, which raised the risk threefold; a Crawford extent II, which more than doubled the risk; and acute kidney injury, which raised chances almost fivefold. “Development of postoperative AKI [acute kidney injury] is the most important predictor for renal function deterioration,” Pather said.
When freedom from renal function deterioration at 2 years was compared between the two groups, again the results were similar because of the small sample size of the SFK group: 100% for the SFK group and 84% for controls.
Ms. Pather had no financial relationships to disclose.
CHICAGO – Patients who have one kidney do as well after fenestrated-branched endovascular aneurysm repair (F-BEVAR) of pararenal or thoracoabdominal aortic aneurysm as patients with both kidneys, according to a study of almost 300 patients presented at the annual meeting of the Midwestern Vascular Surgery Society.
“Despite the worse baseline renal function associated with single functioning kidney patients, F-BEVAR is safe and effective with nearly identical outcomes in patients with a SFK [single functioning kidney] as compared to patients with two functioning kidneys,” said Keouna Pather of Mayo Clinic, Rochester, Minn.
The study evaluated 287 F-BEVAR patients enrolled in a physician-sponsored investigation device exemption study from November 2013 to October 2018. Thirty of those patients had one kidney, the remaining 257 were the control group. Ms. Pather noted that characteristics were similar between both patient groups with the exception that SFK patients were younger (age 70 vs. 74 years; P = .009) and had larger renal artery diameter (6 vs. 5.7 mm; P = .05). “Patients with a SFK had enlargement of their renal artery in a compensatory fashion,” she said.
Survival at 2 years was 92% for SFK patients and 84% for controls.
“The SFK patients did start at a worse baseline of CKD [chronic kidney disease] stages as compared to controls,” she noted. In the SFK group, 63% (n = 19) had Stage III CKD versus 40% (n = 104) of controls (P = .02). Likewise, rates of Stage IV CKD were 10% (n = 3) and 2% (n = 4), respectively (P = .03).
In terms of outcomes, two patients in the control group died within 30 days but none in the SFK group did, Ms. Pather said. Also, a higher percentage of SFK patients had estimated blood loss greater than 1 L, compared with controls (20% vs. 7%; P = .02). All other outcomes, including rates of acute kidney injury (20% vs. 12%; P = .26), were not statistically different, she said.
“Between the groups, there was no significant difference in CKD progression that needed stenting,” she added, with 27% (n = 8) and 26% (n = 67) of the SFK and controls progressing to CKD Stages III to V.
The study also identified predictors of acute kidney injury in SFK patients: total fluoroscopy time (hours), which raised the risk by 78.5%, and estimated blood loss greater than 1 L, which increased risk by 109%.
Predictors of renal function deterioration in SFK patients were renal artery occlusion or reintervention for branch stenosis or kink, which raised the risk threefold; a Crawford extent II, which more than doubled the risk; and acute kidney injury, which raised chances almost fivefold. “Development of postoperative AKI [acute kidney injury] is the most important predictor for renal function deterioration,” Pather said.
When freedom from renal function deterioration at 2 years was compared between the two groups, again the results were similar because of the small sample size of the SFK group: 100% for the SFK group and 84% for controls.
Ms. Pather had no financial relationships to disclose.
REPORTING FROM MIDWESTERN VASCULAR 2019
Key clinical point: Fenestrated-branched endovascular repair of abdominal aortic aneurysm is safe and effective.
Major finding: Two-year survival rates were 92% for one-kidney patients and 84% for those with two kidneys.
Study details: Retrospective review of a prospectively collected database of 287 patients who had F-BEVAR from 2013 to 2018.
Disclosures: Ms. Pather has no financial relationships to disclose.
Source: Pather K et al. Midwestern Vascular 2019, Abstract 2.
Hypoxia-related discoveries net Nobel Prize
Three researchers have won the 2019 Nobel Prize in Physiology or Medicine “for their discoveries of how cells sense and adapt to oxygen availability.”
William G. Kaelin Jr., MD; Sir Peter J. Ratcliffe, MB ChB, MD; and Gregg L. Semenza, MD, PhD, described the molecular machinery that regulates gene activity in response to oxygen levels.
Their work “established the basis for our understanding of how oxygen levels affect cellular metabolism and physiological function” and “paved the way for promising new strategies to fight anemia, cancer, and many other diseases,” according to a statement by The Nobel Assembly at Karolinska Institutet.
Dr. Semenza, of Johns Hopkins Medicine in Baltimore, studied how the erythropoietin (EPO) gene is regulated by oxygen levels. Via experiments in mice, he identified DNA segments next to the EPO gene that mediate the response to hypoxia.
Dr. Ratcliffe, of the University of Oxford (England) and the Francis Crick Institute in London, also studied oxygen-dependent regulation of the EPO gene. Both his and Dr. Semenza’s groups found the oxygen-sensing mechanism was present in nearly all tissues.
Dr. Semenza also discovered a protein complex, hypoxia-inducible factor (HIF), that binds to the identified DNA segments in an oxygen-dependent manner. Additional investigation revealed that HIF consists of two transcription factors, HIF-1a and ARNT.
Several research groups found that HIF-1a is protected from degradation in hypoxia. In low-oxygen conditions, the amount of HIF-1a increases so it can bind to and regulate EPO and other genes with HIF-binding DNA segments. However, at normal oxygen levels, ubiquitin is added to HIF-1a, tagging it for degradation in the proteasome. It wasn’t clear how ubiquitin binds to HIF-1a in an oxygen-dependent manner, but Dr. Kaelin’s work provided some insight.
Dr. Kaelin, of the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, was researching von Hippel-Lindau’s (VHL) syndrome, an inherited disorder in which mutations can lead to tumors in multiple organs. He found the VHL gene encodes a protein that prevents cancer onset, and cancer cells without a functional VHL gene express high levels of hypoxia-regulated genes.
Research by other groups showed that VHL is part of a complex that labels proteins with ubiquitin, tagging them for degradation. Dr. Ratcliffe and his group found that VHL is required for the degradation of HIF-1a at normal oxygen levels.
Dr. Kaelin’s and Dr. Ratcliffe’s groups also showed that, under normal oxygen conditions, hydroxyl groups are added at two locations in HIF-1a. This modification – prolyl hydroxylation – allows VHL to bind to HIF-1a. So the researchers found that normal oxygen levels control HIF-1a degradation with the help of prolyl hydroxylases.
Additional research by Dr. Ratcliffe’s group and others revealed the specific prolyl hydroxylases involved in HIF-1a degradation. The researchers also found that HIF-1a’s gene-activating function was regulated by oxygen-dependent hydroxylation.
This work has improved the understanding of how different oxygen levels regulate physiological processes. In particular, oxygen sensing is essential for erythropoiesis, so these findings have implications for the treatment of anemia.
“There are several drugs that are now in clinical trials that serve to increase HIF activity and, as a result, will increase the production of erythropoietin and stimulate red blood cell production,” Dr. Semenza said in an interview after the announcement of his Nobel win. “These are all small molecules that can be given by mouth, and that may be a great convenience for patients who, at the present time, may require injections of recombinant human erythropoietin.”
Three researchers have won the 2019 Nobel Prize in Physiology or Medicine “for their discoveries of how cells sense and adapt to oxygen availability.”
William G. Kaelin Jr., MD; Sir Peter J. Ratcliffe, MB ChB, MD; and Gregg L. Semenza, MD, PhD, described the molecular machinery that regulates gene activity in response to oxygen levels.
Their work “established the basis for our understanding of how oxygen levels affect cellular metabolism and physiological function” and “paved the way for promising new strategies to fight anemia, cancer, and many other diseases,” according to a statement by The Nobel Assembly at Karolinska Institutet.
Dr. Semenza, of Johns Hopkins Medicine in Baltimore, studied how the erythropoietin (EPO) gene is regulated by oxygen levels. Via experiments in mice, he identified DNA segments next to the EPO gene that mediate the response to hypoxia.
Dr. Ratcliffe, of the University of Oxford (England) and the Francis Crick Institute in London, also studied oxygen-dependent regulation of the EPO gene. Both his and Dr. Semenza’s groups found the oxygen-sensing mechanism was present in nearly all tissues.
Dr. Semenza also discovered a protein complex, hypoxia-inducible factor (HIF), that binds to the identified DNA segments in an oxygen-dependent manner. Additional investigation revealed that HIF consists of two transcription factors, HIF-1a and ARNT.
Several research groups found that HIF-1a is protected from degradation in hypoxia. In low-oxygen conditions, the amount of HIF-1a increases so it can bind to and regulate EPO and other genes with HIF-binding DNA segments. However, at normal oxygen levels, ubiquitin is added to HIF-1a, tagging it for degradation in the proteasome. It wasn’t clear how ubiquitin binds to HIF-1a in an oxygen-dependent manner, but Dr. Kaelin’s work provided some insight.
Dr. Kaelin, of the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, was researching von Hippel-Lindau’s (VHL) syndrome, an inherited disorder in which mutations can lead to tumors in multiple organs. He found the VHL gene encodes a protein that prevents cancer onset, and cancer cells without a functional VHL gene express high levels of hypoxia-regulated genes.
Research by other groups showed that VHL is part of a complex that labels proteins with ubiquitin, tagging them for degradation. Dr. Ratcliffe and his group found that VHL is required for the degradation of HIF-1a at normal oxygen levels.
Dr. Kaelin’s and Dr. Ratcliffe’s groups also showed that, under normal oxygen conditions, hydroxyl groups are added at two locations in HIF-1a. This modification – prolyl hydroxylation – allows VHL to bind to HIF-1a. So the researchers found that normal oxygen levels control HIF-1a degradation with the help of prolyl hydroxylases.
Additional research by Dr. Ratcliffe’s group and others revealed the specific prolyl hydroxylases involved in HIF-1a degradation. The researchers also found that HIF-1a’s gene-activating function was regulated by oxygen-dependent hydroxylation.
This work has improved the understanding of how different oxygen levels regulate physiological processes. In particular, oxygen sensing is essential for erythropoiesis, so these findings have implications for the treatment of anemia.
“There are several drugs that are now in clinical trials that serve to increase HIF activity and, as a result, will increase the production of erythropoietin and stimulate red blood cell production,” Dr. Semenza said in an interview after the announcement of his Nobel win. “These are all small molecules that can be given by mouth, and that may be a great convenience for patients who, at the present time, may require injections of recombinant human erythropoietin.”
Three researchers have won the 2019 Nobel Prize in Physiology or Medicine “for their discoveries of how cells sense and adapt to oxygen availability.”
William G. Kaelin Jr., MD; Sir Peter J. Ratcliffe, MB ChB, MD; and Gregg L. Semenza, MD, PhD, described the molecular machinery that regulates gene activity in response to oxygen levels.
Their work “established the basis for our understanding of how oxygen levels affect cellular metabolism and physiological function” and “paved the way for promising new strategies to fight anemia, cancer, and many other diseases,” according to a statement by The Nobel Assembly at Karolinska Institutet.
Dr. Semenza, of Johns Hopkins Medicine in Baltimore, studied how the erythropoietin (EPO) gene is regulated by oxygen levels. Via experiments in mice, he identified DNA segments next to the EPO gene that mediate the response to hypoxia.
Dr. Ratcliffe, of the University of Oxford (England) and the Francis Crick Institute in London, also studied oxygen-dependent regulation of the EPO gene. Both his and Dr. Semenza’s groups found the oxygen-sensing mechanism was present in nearly all tissues.
Dr. Semenza also discovered a protein complex, hypoxia-inducible factor (HIF), that binds to the identified DNA segments in an oxygen-dependent manner. Additional investigation revealed that HIF consists of two transcription factors, HIF-1a and ARNT.
Several research groups found that HIF-1a is protected from degradation in hypoxia. In low-oxygen conditions, the amount of HIF-1a increases so it can bind to and regulate EPO and other genes with HIF-binding DNA segments. However, at normal oxygen levels, ubiquitin is added to HIF-1a, tagging it for degradation in the proteasome. It wasn’t clear how ubiquitin binds to HIF-1a in an oxygen-dependent manner, but Dr. Kaelin’s work provided some insight.
Dr. Kaelin, of the Dana-Farber Cancer Institute and Harvard Medical School, both in Boston, was researching von Hippel-Lindau’s (VHL) syndrome, an inherited disorder in which mutations can lead to tumors in multiple organs. He found the VHL gene encodes a protein that prevents cancer onset, and cancer cells without a functional VHL gene express high levels of hypoxia-regulated genes.
Research by other groups showed that VHL is part of a complex that labels proteins with ubiquitin, tagging them for degradation. Dr. Ratcliffe and his group found that VHL is required for the degradation of HIF-1a at normal oxygen levels.
Dr. Kaelin’s and Dr. Ratcliffe’s groups also showed that, under normal oxygen conditions, hydroxyl groups are added at two locations in HIF-1a. This modification – prolyl hydroxylation – allows VHL to bind to HIF-1a. So the researchers found that normal oxygen levels control HIF-1a degradation with the help of prolyl hydroxylases.
Additional research by Dr. Ratcliffe’s group and others revealed the specific prolyl hydroxylases involved in HIF-1a degradation. The researchers also found that HIF-1a’s gene-activating function was regulated by oxygen-dependent hydroxylation.
This work has improved the understanding of how different oxygen levels regulate physiological processes. In particular, oxygen sensing is essential for erythropoiesis, so these findings have implications for the treatment of anemia.
“There are several drugs that are now in clinical trials that serve to increase HIF activity and, as a result, will increase the production of erythropoietin and stimulate red blood cell production,” Dr. Semenza said in an interview after the announcement of his Nobel win. “These are all small molecules that can be given by mouth, and that may be a great convenience for patients who, at the present time, may require injections of recombinant human erythropoietin.”
Isolated iliac disease a marker for better health status?
CHICAGO – Surgery and endovascular treatment for peripheral artery disease (PAD) among patients with claudication improves health status more in the setting of isolated iliac disease and multilevel disease than in other forms of PAD, which suggests that vascular specialists should give pause before pursuing interventions on superficial femoral and infrapopliteal artery lesions, a researcher of the PORTRAIT registry reported at the annual meeting of the Midwestern Vascular Surgery Society.
“Our analysis demonstrated that interventions for aortoiliac disease and multilevel disease appeared to improve overall health status more over time compared to femoral-popliteal disease and infrapopliteal disease,” said Todd R. Vogel, MD, of the University of Missouri Health System in Columbia.
The study evaluated improvement in Peripheral Artery Questionnaire (PAQ) scores from baseline to post intervention in 623 patients in the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry. The patients were selected and combined with anatomic data on the nature of their claudication. Aortoiliac-only (AI) disease represented 20.4% (n = 127) of the study group, femoral-popliteal-only (FP) 35.5% (n = 221), infrapopliteal/distal (IP) 6.3% (n = 39), and multilevel disease (ML) 37.9% (n = 236).
In terms of demographics, patients in the AI group tended to be younger (average age of 61.2 years vs. 66.6 years for the study overall; P less than .001) and had a higher rate of smokers (96.1% former and current smokers vs. 90.7% overall; P less than .001). Otherwise, Dr. Vogel noted, demographics, smoking status, and severity of claudication were similar across the disease groups.
Rates of medical intervention were similar in the AI and ML disease groups, which were primarily endovascular procedures: 26% and 27%, respectively. The AI group had the highest rates of endovascular interventions, at 24%, with the FP group at 15%, IP at 11% and ML at 21%. Those who did not have surgery or endovascular aneurysm repair were treated medically.
“The AI group did significantly better at 3 months than the other groups,” Dr. Vogel pointed out, noting that at 12 months those patients had an average PAQ score of around 78 versus scores of around 75 for FP, 74 for IP, and 70 for ML.
“In the AI group, there’s also an immediate increase in quality of life that is sustained over time,” he said. At 3 months, PAQ scores in AI patients who had endovascular aneurysm repair increased 41 points over baseline, leveling off to a 38.8-point gain at 12 months, the highest gains across all disease groups and all treatment categories.
“However,” Dr. Vogel added, “the group with ML disease probably was the most improved over time on the PAQ scores,” he said, explaining that across the board, this group had lower baseline PAQ scores than all the other groups.
“No significant benefits were found with intervention versus medical management for FP and IP,” he said. “This suggests that intervention should be considered after medical management has been exhausted.”
Dr. Vogel also said the findings support aggressive treatment of AI and ML for symptomatic claudication. “This anatomic region represents the greatest potential benefit for improving overall health status in patients with symptomatic PAD,” he said.
Dr. Vogel had no relevant financial relationships to disclose.
CHICAGO – Surgery and endovascular treatment for peripheral artery disease (PAD) among patients with claudication improves health status more in the setting of isolated iliac disease and multilevel disease than in other forms of PAD, which suggests that vascular specialists should give pause before pursuing interventions on superficial femoral and infrapopliteal artery lesions, a researcher of the PORTRAIT registry reported at the annual meeting of the Midwestern Vascular Surgery Society.
“Our analysis demonstrated that interventions for aortoiliac disease and multilevel disease appeared to improve overall health status more over time compared to femoral-popliteal disease and infrapopliteal disease,” said Todd R. Vogel, MD, of the University of Missouri Health System in Columbia.
The study evaluated improvement in Peripheral Artery Questionnaire (PAQ) scores from baseline to post intervention in 623 patients in the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry. The patients were selected and combined with anatomic data on the nature of their claudication. Aortoiliac-only (AI) disease represented 20.4% (n = 127) of the study group, femoral-popliteal-only (FP) 35.5% (n = 221), infrapopliteal/distal (IP) 6.3% (n = 39), and multilevel disease (ML) 37.9% (n = 236).
In terms of demographics, patients in the AI group tended to be younger (average age of 61.2 years vs. 66.6 years for the study overall; P less than .001) and had a higher rate of smokers (96.1% former and current smokers vs. 90.7% overall; P less than .001). Otherwise, Dr. Vogel noted, demographics, smoking status, and severity of claudication were similar across the disease groups.
Rates of medical intervention were similar in the AI and ML disease groups, which were primarily endovascular procedures: 26% and 27%, respectively. The AI group had the highest rates of endovascular interventions, at 24%, with the FP group at 15%, IP at 11% and ML at 21%. Those who did not have surgery or endovascular aneurysm repair were treated medically.
“The AI group did significantly better at 3 months than the other groups,” Dr. Vogel pointed out, noting that at 12 months those patients had an average PAQ score of around 78 versus scores of around 75 for FP, 74 for IP, and 70 for ML.
“In the AI group, there’s also an immediate increase in quality of life that is sustained over time,” he said. At 3 months, PAQ scores in AI patients who had endovascular aneurysm repair increased 41 points over baseline, leveling off to a 38.8-point gain at 12 months, the highest gains across all disease groups and all treatment categories.
“However,” Dr. Vogel added, “the group with ML disease probably was the most improved over time on the PAQ scores,” he said, explaining that across the board, this group had lower baseline PAQ scores than all the other groups.
“No significant benefits were found with intervention versus medical management for FP and IP,” he said. “This suggests that intervention should be considered after medical management has been exhausted.”
Dr. Vogel also said the findings support aggressive treatment of AI and ML for symptomatic claudication. “This anatomic region represents the greatest potential benefit for improving overall health status in patients with symptomatic PAD,” he said.
Dr. Vogel had no relevant financial relationships to disclose.
CHICAGO – Surgery and endovascular treatment for peripheral artery disease (PAD) among patients with claudication improves health status more in the setting of isolated iliac disease and multilevel disease than in other forms of PAD, which suggests that vascular specialists should give pause before pursuing interventions on superficial femoral and infrapopliteal artery lesions, a researcher of the PORTRAIT registry reported at the annual meeting of the Midwestern Vascular Surgery Society.
“Our analysis demonstrated that interventions for aortoiliac disease and multilevel disease appeared to improve overall health status more over time compared to femoral-popliteal disease and infrapopliteal disease,” said Todd R. Vogel, MD, of the University of Missouri Health System in Columbia.
The study evaluated improvement in Peripheral Artery Questionnaire (PAQ) scores from baseline to post intervention in 623 patients in the PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry. The patients were selected and combined with anatomic data on the nature of their claudication. Aortoiliac-only (AI) disease represented 20.4% (n = 127) of the study group, femoral-popliteal-only (FP) 35.5% (n = 221), infrapopliteal/distal (IP) 6.3% (n = 39), and multilevel disease (ML) 37.9% (n = 236).
In terms of demographics, patients in the AI group tended to be younger (average age of 61.2 years vs. 66.6 years for the study overall; P less than .001) and had a higher rate of smokers (96.1% former and current smokers vs. 90.7% overall; P less than .001). Otherwise, Dr. Vogel noted, demographics, smoking status, and severity of claudication were similar across the disease groups.
Rates of medical intervention were similar in the AI and ML disease groups, which were primarily endovascular procedures: 26% and 27%, respectively. The AI group had the highest rates of endovascular interventions, at 24%, with the FP group at 15%, IP at 11% and ML at 21%. Those who did not have surgery or endovascular aneurysm repair were treated medically.
“The AI group did significantly better at 3 months than the other groups,” Dr. Vogel pointed out, noting that at 12 months those patients had an average PAQ score of around 78 versus scores of around 75 for FP, 74 for IP, and 70 for ML.
“In the AI group, there’s also an immediate increase in quality of life that is sustained over time,” he said. At 3 months, PAQ scores in AI patients who had endovascular aneurysm repair increased 41 points over baseline, leveling off to a 38.8-point gain at 12 months, the highest gains across all disease groups and all treatment categories.
“However,” Dr. Vogel added, “the group with ML disease probably was the most improved over time on the PAQ scores,” he said, explaining that across the board, this group had lower baseline PAQ scores than all the other groups.
“No significant benefits were found with intervention versus medical management for FP and IP,” he said. “This suggests that intervention should be considered after medical management has been exhausted.”
Dr. Vogel also said the findings support aggressive treatment of AI and ML for symptomatic claudication. “This anatomic region represents the greatest potential benefit for improving overall health status in patients with symptomatic PAD,” he said.
Dr. Vogel had no relevant financial relationships to disclose.
REPORTING FROM MIDWESTERN VASCULAR 2019
Study questions preemptive TEVAR for extended type A dissections
CHICAGO – The need for additional intervention after repair of the ascending aorta in extended type A aortic dissection has been thought to follow the practice for type B dissection and favor preemptive thoracic endovascular aortic repair. However, preemptive TEVAR may, at least in the midterm, provide no benefit in patients with extended type A dissections, according to results reported at the annual meeting of the Midwestern Vascular Surgery Society.
“TEVAR does not appear to be indicated in patients with extended type A dissections after acute aortic repair,” said Amy B. Reed, MD, of the University of Minnesota.
The study’s hypothesis was that growth rates of dissection and the need for additional intervention in the descending thoracic aorta are similar between extended type A (ExTA) and type B aortic dissection after initial repair of the ascending aorta. Dr. Reed noted that investigators from the INSTEAD-XL trial reported that preemptive TEVAR improved outcomes in patients with type B dissections (Circ Cardiovasc Interv. 2013;6:407-16). “The thinking has been that patients with uncomplicated ExTA would also benefit from early TEVAR,” Dr. Reed said.
The study evaluated 87 consecutive patients from 2011 to 2018, 43 with ExTA and 44 with type B dissections. Characteristics of both groups were similar, except the type B group had a significantly higher rate of coronary artery disease, 16% vs. 0% (P = .01). The distal extent of the dissection was beyond the aortic bifurcation in 75% of the ExTA patients and 52% of the type B group, “so we felt that these groups were really well matched,” Dr. Reed said.
Of the 43 ExTA patients, five had repair and 38 had no intervention. At an average follow-up of 33 months, 23 of the no-intervention patients showed no growth of their dissection, Dr. Reed said. In the type B group, 15 had no repair, and of those nine showed no growth (one patient died early and five did show growth).
“When we look at intervention-free survival, there’s a significant difference between our ExTA patients vs. our type B patients over time, with significantly more type B patients requiring intervention,” she said. At 28 months, 88% of ExTA were intervention free, whereas at 9 months 35% of type B patients were.
“We feel that, following the repair of ascending acute aortic dissection, in those patients with ExTA dissections, there does appear to be a slow progression of distal aortic disease,” Dr. Reed said. “Rarely do these patients develop complications such as dissection needing intervention either in the acute hospital period or delayed.”
Because the findings are based on medium-term follow-up, she said, “We certainly need further follow-up to confirm these midterm findings.”
Dr. Reed had no relevant financial relationships to disclose.
CHICAGO – The need for additional intervention after repair of the ascending aorta in extended type A aortic dissection has been thought to follow the practice for type B dissection and favor preemptive thoracic endovascular aortic repair. However, preemptive TEVAR may, at least in the midterm, provide no benefit in patients with extended type A dissections, according to results reported at the annual meeting of the Midwestern Vascular Surgery Society.
“TEVAR does not appear to be indicated in patients with extended type A dissections after acute aortic repair,” said Amy B. Reed, MD, of the University of Minnesota.
The study’s hypothesis was that growth rates of dissection and the need for additional intervention in the descending thoracic aorta are similar between extended type A (ExTA) and type B aortic dissection after initial repair of the ascending aorta. Dr. Reed noted that investigators from the INSTEAD-XL trial reported that preemptive TEVAR improved outcomes in patients with type B dissections (Circ Cardiovasc Interv. 2013;6:407-16). “The thinking has been that patients with uncomplicated ExTA would also benefit from early TEVAR,” Dr. Reed said.
The study evaluated 87 consecutive patients from 2011 to 2018, 43 with ExTA and 44 with type B dissections. Characteristics of both groups were similar, except the type B group had a significantly higher rate of coronary artery disease, 16% vs. 0% (P = .01). The distal extent of the dissection was beyond the aortic bifurcation in 75% of the ExTA patients and 52% of the type B group, “so we felt that these groups were really well matched,” Dr. Reed said.
Of the 43 ExTA patients, five had repair and 38 had no intervention. At an average follow-up of 33 months, 23 of the no-intervention patients showed no growth of their dissection, Dr. Reed said. In the type B group, 15 had no repair, and of those nine showed no growth (one patient died early and five did show growth).
“When we look at intervention-free survival, there’s a significant difference between our ExTA patients vs. our type B patients over time, with significantly more type B patients requiring intervention,” she said. At 28 months, 88% of ExTA were intervention free, whereas at 9 months 35% of type B patients were.
“We feel that, following the repair of ascending acute aortic dissection, in those patients with ExTA dissections, there does appear to be a slow progression of distal aortic disease,” Dr. Reed said. “Rarely do these patients develop complications such as dissection needing intervention either in the acute hospital period or delayed.”
Because the findings are based on medium-term follow-up, she said, “We certainly need further follow-up to confirm these midterm findings.”
Dr. Reed had no relevant financial relationships to disclose.
CHICAGO – The need for additional intervention after repair of the ascending aorta in extended type A aortic dissection has been thought to follow the practice for type B dissection and favor preemptive thoracic endovascular aortic repair. However, preemptive TEVAR may, at least in the midterm, provide no benefit in patients with extended type A dissections, according to results reported at the annual meeting of the Midwestern Vascular Surgery Society.
“TEVAR does not appear to be indicated in patients with extended type A dissections after acute aortic repair,” said Amy B. Reed, MD, of the University of Minnesota.
The study’s hypothesis was that growth rates of dissection and the need for additional intervention in the descending thoracic aorta are similar between extended type A (ExTA) and type B aortic dissection after initial repair of the ascending aorta. Dr. Reed noted that investigators from the INSTEAD-XL trial reported that preemptive TEVAR improved outcomes in patients with type B dissections (Circ Cardiovasc Interv. 2013;6:407-16). “The thinking has been that patients with uncomplicated ExTA would also benefit from early TEVAR,” Dr. Reed said.
The study evaluated 87 consecutive patients from 2011 to 2018, 43 with ExTA and 44 with type B dissections. Characteristics of both groups were similar, except the type B group had a significantly higher rate of coronary artery disease, 16% vs. 0% (P = .01). The distal extent of the dissection was beyond the aortic bifurcation in 75% of the ExTA patients and 52% of the type B group, “so we felt that these groups were really well matched,” Dr. Reed said.
Of the 43 ExTA patients, five had repair and 38 had no intervention. At an average follow-up of 33 months, 23 of the no-intervention patients showed no growth of their dissection, Dr. Reed said. In the type B group, 15 had no repair, and of those nine showed no growth (one patient died early and five did show growth).
“When we look at intervention-free survival, there’s a significant difference between our ExTA patients vs. our type B patients over time, with significantly more type B patients requiring intervention,” she said. At 28 months, 88% of ExTA were intervention free, whereas at 9 months 35% of type B patients were.
“We feel that, following the repair of ascending acute aortic dissection, in those patients with ExTA dissections, there does appear to be a slow progression of distal aortic disease,” Dr. Reed said. “Rarely do these patients develop complications such as dissection needing intervention either in the acute hospital period or delayed.”
Because the findings are based on medium-term follow-up, she said, “We certainly need further follow-up to confirm these midterm findings.”
Dr. Reed had no relevant financial relationships to disclose.
REPORTING FROM MIDWESTERN VASCULAR 2019
Prepare for VAM 2020
Mark your calendars: the 2020 Vascular Annual Meeting will take place June 17-20 at the Toronto Convention Center in Toronto, Ontario, Canada. All U.S. residents entering Canada will be required to travel with a valid passport. Your passport expiration date may not be within six months of your travel dates. For additional information (including passport requirements for international travelers), please visit the Canada Border Services Agency’s website. Read all future VAM details here.
Mark your calendars: the 2020 Vascular Annual Meeting will take place June 17-20 at the Toronto Convention Center in Toronto, Ontario, Canada. All U.S. residents entering Canada will be required to travel with a valid passport. Your passport expiration date may not be within six months of your travel dates. For additional information (including passport requirements for international travelers), please visit the Canada Border Services Agency’s website. Read all future VAM details here.
Mark your calendars: the 2020 Vascular Annual Meeting will take place June 17-20 at the Toronto Convention Center in Toronto, Ontario, Canada. All U.S. residents entering Canada will be required to travel with a valid passport. Your passport expiration date may not be within six months of your travel dates. For additional information (including passport requirements for international travelers), please visit the Canada Border Services Agency’s website. Read all future VAM details here.
Utilize SVS Patient Resources
Our website contains many resources that SVS members can use for help with managing a practice, continuing education, patient education materials and much more. The patient resource pages on the site cover a variety of vascular conditions, tests and treatments. Most recently, we’ve added a page for Transcarotid Artery Revascularization (TCAR). This, and most of our pages, can give patients and/or their loved ones a better understanding of their vascular condition, as well as how it’s being tested and treated. Take a look at our pages and share with your patients today.
Our website contains many resources that SVS members can use for help with managing a practice, continuing education, patient education materials and much more. The patient resource pages on the site cover a variety of vascular conditions, tests and treatments. Most recently, we’ve added a page for Transcarotid Artery Revascularization (TCAR). This, and most of our pages, can give patients and/or their loved ones a better understanding of their vascular condition, as well as how it’s being tested and treated. Take a look at our pages and share with your patients today.
Our website contains many resources that SVS members can use for help with managing a practice, continuing education, patient education materials and much more. The patient resource pages on the site cover a variety of vascular conditions, tests and treatments. Most recently, we’ve added a page for Transcarotid Artery Revascularization (TCAR). This, and most of our pages, can give patients and/or their loved ones a better understanding of their vascular condition, as well as how it’s being tested and treated. Take a look at our pages and share with your patients today.