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Clinical Practice Improvement Activities: The New Reporting Requirement
As was summarized last month, Centers for Medicare and Medicaid Services (CMS) released the final rule pertaining to the Medicare Access and CHIP Reauthorization Act (MACRA) on October 14, 2016. In the ensuing weeks, Division of Advocacy and Health Policy staff had the opportunity to read and further analyze the rule. In general, the initial favorable impression held up under more careful scrutiny. Based on the provisions in the final rule, we continue to make adjustments and modifications to the resources available to Fellows to assist them to prepare for 2017 on the website found at www.facs.org/qpp. By the time this column is printed/released, I anticipate that the video series found on the website will have been updated and expanded upon.
Because change is unsettling, one of the most frequent topics of conversation and question concerning MACRA is the new reporting requirement known as Improvement Activities. Previously, in the proposed rule, this component was known as the Clinical Practice Improvement Activities. In the final rule, the nomenclature was shortened to Improvement Activities.
The reporting mechanism specified by CMS for 2017 is simple attestation. That attestation may be accomplished via any traditional reporting mechanism other than by claims. Accordingly, the use of CMS approved “traditional” registries (registry reporting option) or qualified clinical data registries, such as the ACS’ Surgeon Specific Registry (SSR), will be valid modes by which one may report. Discussions are underway to determine how best to incorporate the Improvement Activities into the SSR. Alternatively, CMS plans to make available a portal on its website where providers will be able to attest to their having satisfied the Improvement Activity requirement.
In reviewing the list of 93 activities, examples of such that likely would or could be applicable to surgeons include:
• Use of a QCDR (qualified clinical data registry) to generate regular performance feedback (20 points)
• Participation in a QCDR, clinical data registries, or other registries run by other government agencies or private entities such as a hospital or medical or surgical society (10 points)
• Provision of episodic care management, including management across transitions and referrals that could include routine and timely follow-up to hospitalizations and ED visits and/or managing care intensively through new diagnoses, injuries and exacerbations of illness (10 points)
• Provision of specialist reports back to referring providers to close the referral loop (10 points)
• Timely communication of test results defined as timely identification of abnormal test results with timely follow-up (10 points)
• Participation in a QCDR, demonstrating performance of activities that promote use of standard practices, tools and processes for quality improvement (10 points)
• Bilateral exchange of necessary patient information to guide patient care that could include participation in a health information exchange or use of structured referral notes (10 points)
• Participation in a QCDR, demonstrating performance of activities that promote implementation of shared clinical decision making capabilities (10 points)
• Use of evidence-based decision aids to support shared decision-making (10 points)
• Participation in Maintenance of Certification Part IV (10 points)
• Annual registration by eligible clinician or group in the prescription drug monitoring program of the state where they practice (10 points)
• Consultation of prescription drug monitoring program prior to the issuance of a Controlled Substance Schedule II opioid prescription that lasts for longer than 3 days (20 points)
• Use of tools that assist specialty practices in tracking specific measures that are meaningful to their practice, such as use of the Surgical Risk Calculator (10 points)
• Seeing new and follow-up Medicaid patients in a timely manner, including individuals dually eligible for Medicaid and Medicare (20 points)
Based upon the list above (and others not included), and because the requirement specified for reporting the Improvement Activities is simple attestation, I am confident that all surgeons will be able to meet the requirement with minimal effort and achieve full credit for this component of the MIPS Composite Performance score. In these last weeks of 2016, I would encourage all Fellows to visit the ACS QPP website at www.facs.org/qpp to map out their overall strategy for success with the new Medicare physician payment system that will become effective beginning in January of 2017.
Until next month ….
Dr. Bailey is a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.
As was summarized last month, Centers for Medicare and Medicaid Services (CMS) released the final rule pertaining to the Medicare Access and CHIP Reauthorization Act (MACRA) on October 14, 2016. In the ensuing weeks, Division of Advocacy and Health Policy staff had the opportunity to read and further analyze the rule. In general, the initial favorable impression held up under more careful scrutiny. Based on the provisions in the final rule, we continue to make adjustments and modifications to the resources available to Fellows to assist them to prepare for 2017 on the website found at www.facs.org/qpp. By the time this column is printed/released, I anticipate that the video series found on the website will have been updated and expanded upon.
Because change is unsettling, one of the most frequent topics of conversation and question concerning MACRA is the new reporting requirement known as Improvement Activities. Previously, in the proposed rule, this component was known as the Clinical Practice Improvement Activities. In the final rule, the nomenclature was shortened to Improvement Activities.
The reporting mechanism specified by CMS for 2017 is simple attestation. That attestation may be accomplished via any traditional reporting mechanism other than by claims. Accordingly, the use of CMS approved “traditional” registries (registry reporting option) or qualified clinical data registries, such as the ACS’ Surgeon Specific Registry (SSR), will be valid modes by which one may report. Discussions are underway to determine how best to incorporate the Improvement Activities into the SSR. Alternatively, CMS plans to make available a portal on its website where providers will be able to attest to their having satisfied the Improvement Activity requirement.
In reviewing the list of 93 activities, examples of such that likely would or could be applicable to surgeons include:
• Use of a QCDR (qualified clinical data registry) to generate regular performance feedback (20 points)
• Participation in a QCDR, clinical data registries, or other registries run by other government agencies or private entities such as a hospital or medical or surgical society (10 points)
• Provision of episodic care management, including management across transitions and referrals that could include routine and timely follow-up to hospitalizations and ED visits and/or managing care intensively through new diagnoses, injuries and exacerbations of illness (10 points)
• Provision of specialist reports back to referring providers to close the referral loop (10 points)
• Timely communication of test results defined as timely identification of abnormal test results with timely follow-up (10 points)
• Participation in a QCDR, demonstrating performance of activities that promote use of standard practices, tools and processes for quality improvement (10 points)
• Bilateral exchange of necessary patient information to guide patient care that could include participation in a health information exchange or use of structured referral notes (10 points)
• Participation in a QCDR, demonstrating performance of activities that promote implementation of shared clinical decision making capabilities (10 points)
• Use of evidence-based decision aids to support shared decision-making (10 points)
• Participation in Maintenance of Certification Part IV (10 points)
• Annual registration by eligible clinician or group in the prescription drug monitoring program of the state where they practice (10 points)
• Consultation of prescription drug monitoring program prior to the issuance of a Controlled Substance Schedule II opioid prescription that lasts for longer than 3 days (20 points)
• Use of tools that assist specialty practices in tracking specific measures that are meaningful to their practice, such as use of the Surgical Risk Calculator (10 points)
• Seeing new and follow-up Medicaid patients in a timely manner, including individuals dually eligible for Medicaid and Medicare (20 points)
Based upon the list above (and others not included), and because the requirement specified for reporting the Improvement Activities is simple attestation, I am confident that all surgeons will be able to meet the requirement with minimal effort and achieve full credit for this component of the MIPS Composite Performance score. In these last weeks of 2016, I would encourage all Fellows to visit the ACS QPP website at www.facs.org/qpp to map out their overall strategy for success with the new Medicare physician payment system that will become effective beginning in January of 2017.
Until next month ….
Dr. Bailey is a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.
As was summarized last month, Centers for Medicare and Medicaid Services (CMS) released the final rule pertaining to the Medicare Access and CHIP Reauthorization Act (MACRA) on October 14, 2016. In the ensuing weeks, Division of Advocacy and Health Policy staff had the opportunity to read and further analyze the rule. In general, the initial favorable impression held up under more careful scrutiny. Based on the provisions in the final rule, we continue to make adjustments and modifications to the resources available to Fellows to assist them to prepare for 2017 on the website found at www.facs.org/qpp. By the time this column is printed/released, I anticipate that the video series found on the website will have been updated and expanded upon.
Because change is unsettling, one of the most frequent topics of conversation and question concerning MACRA is the new reporting requirement known as Improvement Activities. Previously, in the proposed rule, this component was known as the Clinical Practice Improvement Activities. In the final rule, the nomenclature was shortened to Improvement Activities.
The reporting mechanism specified by CMS for 2017 is simple attestation. That attestation may be accomplished via any traditional reporting mechanism other than by claims. Accordingly, the use of CMS approved “traditional” registries (registry reporting option) or qualified clinical data registries, such as the ACS’ Surgeon Specific Registry (SSR), will be valid modes by which one may report. Discussions are underway to determine how best to incorporate the Improvement Activities into the SSR. Alternatively, CMS plans to make available a portal on its website where providers will be able to attest to their having satisfied the Improvement Activity requirement.
In reviewing the list of 93 activities, examples of such that likely would or could be applicable to surgeons include:
• Use of a QCDR (qualified clinical data registry) to generate regular performance feedback (20 points)
• Participation in a QCDR, clinical data registries, or other registries run by other government agencies or private entities such as a hospital or medical or surgical society (10 points)
• Provision of episodic care management, including management across transitions and referrals that could include routine and timely follow-up to hospitalizations and ED visits and/or managing care intensively through new diagnoses, injuries and exacerbations of illness (10 points)
• Provision of specialist reports back to referring providers to close the referral loop (10 points)
• Timely communication of test results defined as timely identification of abnormal test results with timely follow-up (10 points)
• Participation in a QCDR, demonstrating performance of activities that promote use of standard practices, tools and processes for quality improvement (10 points)
• Bilateral exchange of necessary patient information to guide patient care that could include participation in a health information exchange or use of structured referral notes (10 points)
• Participation in a QCDR, demonstrating performance of activities that promote implementation of shared clinical decision making capabilities (10 points)
• Use of evidence-based decision aids to support shared decision-making (10 points)
• Participation in Maintenance of Certification Part IV (10 points)
• Annual registration by eligible clinician or group in the prescription drug monitoring program of the state where they practice (10 points)
• Consultation of prescription drug monitoring program prior to the issuance of a Controlled Substance Schedule II opioid prescription that lasts for longer than 3 days (20 points)
• Use of tools that assist specialty practices in tracking specific measures that are meaningful to their practice, such as use of the Surgical Risk Calculator (10 points)
• Seeing new and follow-up Medicaid patients in a timely manner, including individuals dually eligible for Medicaid and Medicare (20 points)
Based upon the list above (and others not included), and because the requirement specified for reporting the Improvement Activities is simple attestation, I am confident that all surgeons will be able to meet the requirement with minimal effort and achieve full credit for this component of the MIPS Composite Performance score. In these last weeks of 2016, I would encourage all Fellows to visit the ACS QPP website at www.facs.org/qpp to map out their overall strategy for success with the new Medicare physician payment system that will become effective beginning in January of 2017.
Until next month ….
Dr. Bailey is a pediatric surgeon, and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, D.C.
New Officers–Elect Elected at Annual Business Meeting
Barbara Lee Bass, MD, FACS, the John F. and Carolyn Bookout Distinguished Endowed Chair and chair, department of surgery, Houston Methodist Hospital, TX, was elected President-Elect of the American College of Surgeons (ACS) at the October 19 Annual Business Meeting of the Members. Dr. Bass is executive director, Houston Methodist Institute for Technology, Innovation and Education (MITIE), a state-of-the-art education and research facility developed to safely train practicing health care professionals in new technologies and procedures. She is professor of surgery at Weill Cornell Medical College, New York, NY, and senior member of the Houston Methodist Hospital Research Institute. A Fellow of the College since 1988, former ACS Regent, and former ACS Governor, Dr. Bass is the recipient of the 2013 ACS Distinguished Service Award—the College’s highest honor.
The First Vice-President-Elect is Charles D. Mabry, MD, FACS, a general surgeon from Pine Bluff, AR, and associate professor of surgery and practice management advisor to the chair, department of surgery, University of Arkansas for Medical Sciences, Little Rock. He is medical director of quality, Jefferson Regional Medical Center, Pine Bluff, and serves on the Arkansas Governor’s Trauma Advisory Committee, chairing the Committee’s Quality Improvement Subcommittee. He is Chairman of the Board for the Arkansas Preferred Provider Organization. Dr. Mabry has served on the ACS Young Surgeons Committee, as an ACS representative on the American Medical Association Relative Value Update Committee, as a member of the General Surgery Coding and Reimbursement Committee, and as an ACS Regent.
The Second Vice-President-Elect is Basil A. Pruitt, Jr., MD, FACS, FCCM, MCCM, the Dr. Ferdinand P. Herff Chair in Surgery, clinical professor of surgery, department of surgery, trauma division, University of Texas Health Science Center, San Antonio, and professor of surgery at USUHS. Dr. Pruitt is an esteemed leader in four broad areas: burn, trauma, injury, and critical care surgery; biomedical research and scholarship; organizational leadership and development; and mentorship. He is a former ACS Governor, Scudder Orator, and Excelsior Surgical Society/Edward D. Churchill Lecturer.
Barbara Lee Bass, MD, FACS, the John F. and Carolyn Bookout Distinguished Endowed Chair and chair, department of surgery, Houston Methodist Hospital, TX, was elected President-Elect of the American College of Surgeons (ACS) at the October 19 Annual Business Meeting of the Members. Dr. Bass is executive director, Houston Methodist Institute for Technology, Innovation and Education (MITIE), a state-of-the-art education and research facility developed to safely train practicing health care professionals in new technologies and procedures. She is professor of surgery at Weill Cornell Medical College, New York, NY, and senior member of the Houston Methodist Hospital Research Institute. A Fellow of the College since 1988, former ACS Regent, and former ACS Governor, Dr. Bass is the recipient of the 2013 ACS Distinguished Service Award—the College’s highest honor.
The First Vice-President-Elect is Charles D. Mabry, MD, FACS, a general surgeon from Pine Bluff, AR, and associate professor of surgery and practice management advisor to the chair, department of surgery, University of Arkansas for Medical Sciences, Little Rock. He is medical director of quality, Jefferson Regional Medical Center, Pine Bluff, and serves on the Arkansas Governor’s Trauma Advisory Committee, chairing the Committee’s Quality Improvement Subcommittee. He is Chairman of the Board for the Arkansas Preferred Provider Organization. Dr. Mabry has served on the ACS Young Surgeons Committee, as an ACS representative on the American Medical Association Relative Value Update Committee, as a member of the General Surgery Coding and Reimbursement Committee, and as an ACS Regent.
The Second Vice-President-Elect is Basil A. Pruitt, Jr., MD, FACS, FCCM, MCCM, the Dr. Ferdinand P. Herff Chair in Surgery, clinical professor of surgery, department of surgery, trauma division, University of Texas Health Science Center, San Antonio, and professor of surgery at USUHS. Dr. Pruitt is an esteemed leader in four broad areas: burn, trauma, injury, and critical care surgery; biomedical research and scholarship; organizational leadership and development; and mentorship. He is a former ACS Governor, Scudder Orator, and Excelsior Surgical Society/Edward D. Churchill Lecturer.
Barbara Lee Bass, MD, FACS, the John F. and Carolyn Bookout Distinguished Endowed Chair and chair, department of surgery, Houston Methodist Hospital, TX, was elected President-Elect of the American College of Surgeons (ACS) at the October 19 Annual Business Meeting of the Members. Dr. Bass is executive director, Houston Methodist Institute for Technology, Innovation and Education (MITIE), a state-of-the-art education and research facility developed to safely train practicing health care professionals in new technologies and procedures. She is professor of surgery at Weill Cornell Medical College, New York, NY, and senior member of the Houston Methodist Hospital Research Institute. A Fellow of the College since 1988, former ACS Regent, and former ACS Governor, Dr. Bass is the recipient of the 2013 ACS Distinguished Service Award—the College’s highest honor.
The First Vice-President-Elect is Charles D. Mabry, MD, FACS, a general surgeon from Pine Bluff, AR, and associate professor of surgery and practice management advisor to the chair, department of surgery, University of Arkansas for Medical Sciences, Little Rock. He is medical director of quality, Jefferson Regional Medical Center, Pine Bluff, and serves on the Arkansas Governor’s Trauma Advisory Committee, chairing the Committee’s Quality Improvement Subcommittee. He is Chairman of the Board for the Arkansas Preferred Provider Organization. Dr. Mabry has served on the ACS Young Surgeons Committee, as an ACS representative on the American Medical Association Relative Value Update Committee, as a member of the General Surgery Coding and Reimbursement Committee, and as an ACS Regent.
The Second Vice-President-Elect is Basil A. Pruitt, Jr., MD, FACS, FCCM, MCCM, the Dr. Ferdinand P. Herff Chair in Surgery, clinical professor of surgery, department of surgery, trauma division, University of Texas Health Science Center, San Antonio, and professor of surgery at USUHS. Dr. Pruitt is an esteemed leader in four broad areas: burn, trauma, injury, and critical care surgery; biomedical research and scholarship; organizational leadership and development; and mentorship. He is a former ACS Governor, Scudder Orator, and Excelsior Surgical Society/Edward D. Churchill Lecturer.
New Regents, B/G Executive Committee Members Elected
Two new members of the American College of Surgeons (ACS) Board of Regents (B/R) were elected at the October 19 Annual Business Meeting of Members: Anthony Atala, MD, FACS, and Fabrizio Michelassi, MD, FACS. Dr. Atala is director, Wake Forest Institute for Regenerative Medicine, and W. Boyce Professor and Chair, department of urology, Wake Forest University, Winston Salem, NC. Dr. Michelassi is the Lewis Atterbury Stimson Professor and Chair, Weill Cornell Medical Center, and surgeon-in-chief, New York-Presbyterian/Weill Cornell Medical Center, NY, and Immediate Past-Chair of the Board of Governors (B/G).
The 2016-2017 Chair of the B/R is Michael J. Zinner, MD, FACS, an ACS Regent since 2010 and founding chief executive officer and executive medical director, Miami Cancer Institute, Baptist Health South Florida, Coral Gables. The Vice-Chair is Leigh A. Neumayer, MD, MS, FACS, a Regent since 2009 and professor and chair, department of surgery, University of Arizona, and Margaret and Fenton Maynard Endowed Chair in Breast Cancer Research, University of Arizona College of Medicine, Tucson.
Replacing Dr. Michelassi as Chair of the B/G Executive Committee is Diana L. Farmer, MD, FACS, a pediatric surgeon, Pearl Stamps Stewart Professor of Surgery, and chair, department of surgery, University of California Davis Health System, Sacramento. Steven C. Stain, MD, FACS, a general surgeon and Henry and Sally Schaffer Chair and Professor, department of surgery, Albany Medical Center, NY, has been elected Vice-Chair; and Susan K. Mosier, MD, MBA, FACS, an ophthalmologist, Secretary, Kansas Department of Health and Environment, and State Health Officer for Kansas, Topeka, has been elected Secretary.
In addition, S. Rob Todd, MD, FACS, FCCM, was elected to serve an initial one-year term on the Executive Committee of the B/G. Dr. Todd is professor and chief, section of acute care surgery, department of surgery, and program director, surgical critical care residency, Baylor College of Medicine; and chief, general surgery, and director, Ginni and Richard Mithoff Trauma Center, Ben Taub Hospital, Houston, TX. Elected to an initial two-year term on the B/G Executive Committee was Nicole S. Gibran, MD, FACS, David and Nancy Auth-Washington Research Foundation Endowed Chair for Restorative Burn Surgery, professor, department of surgery, director, UW Medicine Regional Burn Center at Harborview Medical Center, and adjunct professor, department of medicine, division of dermatology, University of Washington, Seattle.
Two new members of the American College of Surgeons (ACS) Board of Regents (B/R) were elected at the October 19 Annual Business Meeting of Members: Anthony Atala, MD, FACS, and Fabrizio Michelassi, MD, FACS. Dr. Atala is director, Wake Forest Institute for Regenerative Medicine, and W. Boyce Professor and Chair, department of urology, Wake Forest University, Winston Salem, NC. Dr. Michelassi is the Lewis Atterbury Stimson Professor and Chair, Weill Cornell Medical Center, and surgeon-in-chief, New York-Presbyterian/Weill Cornell Medical Center, NY, and Immediate Past-Chair of the Board of Governors (B/G).
The 2016-2017 Chair of the B/R is Michael J. Zinner, MD, FACS, an ACS Regent since 2010 and founding chief executive officer and executive medical director, Miami Cancer Institute, Baptist Health South Florida, Coral Gables. The Vice-Chair is Leigh A. Neumayer, MD, MS, FACS, a Regent since 2009 and professor and chair, department of surgery, University of Arizona, and Margaret and Fenton Maynard Endowed Chair in Breast Cancer Research, University of Arizona College of Medicine, Tucson.
Replacing Dr. Michelassi as Chair of the B/G Executive Committee is Diana L. Farmer, MD, FACS, a pediatric surgeon, Pearl Stamps Stewart Professor of Surgery, and chair, department of surgery, University of California Davis Health System, Sacramento. Steven C. Stain, MD, FACS, a general surgeon and Henry and Sally Schaffer Chair and Professor, department of surgery, Albany Medical Center, NY, has been elected Vice-Chair; and Susan K. Mosier, MD, MBA, FACS, an ophthalmologist, Secretary, Kansas Department of Health and Environment, and State Health Officer for Kansas, Topeka, has been elected Secretary.
In addition, S. Rob Todd, MD, FACS, FCCM, was elected to serve an initial one-year term on the Executive Committee of the B/G. Dr. Todd is professor and chief, section of acute care surgery, department of surgery, and program director, surgical critical care residency, Baylor College of Medicine; and chief, general surgery, and director, Ginni and Richard Mithoff Trauma Center, Ben Taub Hospital, Houston, TX. Elected to an initial two-year term on the B/G Executive Committee was Nicole S. Gibran, MD, FACS, David and Nancy Auth-Washington Research Foundation Endowed Chair for Restorative Burn Surgery, professor, department of surgery, director, UW Medicine Regional Burn Center at Harborview Medical Center, and adjunct professor, department of medicine, division of dermatology, University of Washington, Seattle.
Two new members of the American College of Surgeons (ACS) Board of Regents (B/R) were elected at the October 19 Annual Business Meeting of Members: Anthony Atala, MD, FACS, and Fabrizio Michelassi, MD, FACS. Dr. Atala is director, Wake Forest Institute for Regenerative Medicine, and W. Boyce Professor and Chair, department of urology, Wake Forest University, Winston Salem, NC. Dr. Michelassi is the Lewis Atterbury Stimson Professor and Chair, Weill Cornell Medical Center, and surgeon-in-chief, New York-Presbyterian/Weill Cornell Medical Center, NY, and Immediate Past-Chair of the Board of Governors (B/G).
The 2016-2017 Chair of the B/R is Michael J. Zinner, MD, FACS, an ACS Regent since 2010 and founding chief executive officer and executive medical director, Miami Cancer Institute, Baptist Health South Florida, Coral Gables. The Vice-Chair is Leigh A. Neumayer, MD, MS, FACS, a Regent since 2009 and professor and chair, department of surgery, University of Arizona, and Margaret and Fenton Maynard Endowed Chair in Breast Cancer Research, University of Arizona College of Medicine, Tucson.
Replacing Dr. Michelassi as Chair of the B/G Executive Committee is Diana L. Farmer, MD, FACS, a pediatric surgeon, Pearl Stamps Stewart Professor of Surgery, and chair, department of surgery, University of California Davis Health System, Sacramento. Steven C. Stain, MD, FACS, a general surgeon and Henry and Sally Schaffer Chair and Professor, department of surgery, Albany Medical Center, NY, has been elected Vice-Chair; and Susan K. Mosier, MD, MBA, FACS, an ophthalmologist, Secretary, Kansas Department of Health and Environment, and State Health Officer for Kansas, Topeka, has been elected Secretary.
In addition, S. Rob Todd, MD, FACS, FCCM, was elected to serve an initial one-year term on the Executive Committee of the B/G. Dr. Todd is professor and chief, section of acute care surgery, department of surgery, and program director, surgical critical care residency, Baylor College of Medicine; and chief, general surgery, and director, Ginni and Richard Mithoff Trauma Center, Ben Taub Hospital, Houston, TX. Elected to an initial two-year term on the B/G Executive Committee was Nicole S. Gibran, MD, FACS, David and Nancy Auth-Washington Research Foundation Endowed Chair for Restorative Burn Surgery, professor, department of surgery, director, UW Medicine Regional Burn Center at Harborview Medical Center, and adjunct professor, department of medicine, division of dermatology, University of Washington, Seattle.
FDA bans powdered gloves
The Food and Drug Administration has banned powdered gloves for use in health care settings, citing “numerous risks to patients and health care workers.” The ban extends to gloves currently in commercial distribution and in the hands of the ultimate user, meaning powdered gloves will have to be pulled from examination rooms and operating theaters.
“A thorough review of all currently available information supports FDA’s conclusion that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove should be banned,” according to a FDA final rule available now online and scheduled for publication in the Federal Register on Dec. 19, 2016. The ban will become effective 30 days after the document’s publication in the Federal Register.
Notes the final document, “The benefits of powdered gloves appear to only include greater ease of donning and doffing, decreased tackiness, and a degree of added comfort, which FDA believes are nominal when compared to the risks posed by these devices.”
Since viable nonpowdered alternatives exist, the FDA believes that the ban would not have significant economic impact and that shortages should not affect care delivery.
Many nonpowdered gloves, said the FDA, now “have the same level of protection, dexterity, and performance” as powdered gloves.
Powder may still be used in the glove manufacturing process, but the FDA continues to recommend that no more than 2 mg of residual powder per glove remains after the manufacturing process.
Though the final document banning powdered gloves notes that the FDA received many comments asking for a ban of all natural rubber latex (NRL) gloves, the ban applied only to powdered gloves. The FDA noted that NRL gloves already must carry a statement alerting users to the risks of allergic reaction, and also noted that eliminating powder from NRL gloves reduces the risk of latex sensitization.
In explaining its analysis of the costs and benefits of the powdered glove ban, the FDA estimated that the annual net benefits would range between $26.8 million and $31.8 million.
When this ban comes into force, it will be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit.
[email protected]
On Twitter @karioakes
The Food and Drug Administration has banned powdered gloves for use in health care settings, citing “numerous risks to patients and health care workers.” The ban extends to gloves currently in commercial distribution and in the hands of the ultimate user, meaning powdered gloves will have to be pulled from examination rooms and operating theaters.
“A thorough review of all currently available information supports FDA’s conclusion that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove should be banned,” according to a FDA final rule available now online and scheduled for publication in the Federal Register on Dec. 19, 2016. The ban will become effective 30 days after the document’s publication in the Federal Register.
Notes the final document, “The benefits of powdered gloves appear to only include greater ease of donning and doffing, decreased tackiness, and a degree of added comfort, which FDA believes are nominal when compared to the risks posed by these devices.”
Since viable nonpowdered alternatives exist, the FDA believes that the ban would not have significant economic impact and that shortages should not affect care delivery.
Many nonpowdered gloves, said the FDA, now “have the same level of protection, dexterity, and performance” as powdered gloves.
Powder may still be used in the glove manufacturing process, but the FDA continues to recommend that no more than 2 mg of residual powder per glove remains after the manufacturing process.
Though the final document banning powdered gloves notes that the FDA received many comments asking for a ban of all natural rubber latex (NRL) gloves, the ban applied only to powdered gloves. The FDA noted that NRL gloves already must carry a statement alerting users to the risks of allergic reaction, and also noted that eliminating powder from NRL gloves reduces the risk of latex sensitization.
In explaining its analysis of the costs and benefits of the powdered glove ban, the FDA estimated that the annual net benefits would range between $26.8 million and $31.8 million.
When this ban comes into force, it will be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit.
[email protected]
On Twitter @karioakes
The Food and Drug Administration has banned powdered gloves for use in health care settings, citing “numerous risks to patients and health care workers.” The ban extends to gloves currently in commercial distribution and in the hands of the ultimate user, meaning powdered gloves will have to be pulled from examination rooms and operating theaters.
“A thorough review of all currently available information supports FDA’s conclusion that powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove should be banned,” according to a FDA final rule available now online and scheduled for publication in the Federal Register on Dec. 19, 2016. The ban will become effective 30 days after the document’s publication in the Federal Register.
Notes the final document, “The benefits of powdered gloves appear to only include greater ease of donning and doffing, decreased tackiness, and a degree of added comfort, which FDA believes are nominal when compared to the risks posed by these devices.”
Since viable nonpowdered alternatives exist, the FDA believes that the ban would not have significant economic impact and that shortages should not affect care delivery.
Many nonpowdered gloves, said the FDA, now “have the same level of protection, dexterity, and performance” as powdered gloves.
Powder may still be used in the glove manufacturing process, but the FDA continues to recommend that no more than 2 mg of residual powder per glove remains after the manufacturing process.
Though the final document banning powdered gloves notes that the FDA received many comments asking for a ban of all natural rubber latex (NRL) gloves, the ban applied only to powdered gloves. The FDA noted that NRL gloves already must carry a statement alerting users to the risks of allergic reaction, and also noted that eliminating powder from NRL gloves reduces the risk of latex sensitization.
In explaining its analysis of the costs and benefits of the powdered glove ban, the FDA estimated that the annual net benefits would range between $26.8 million and $31.8 million.
When this ban comes into force, it will be only the second such ban; the first was the 1983 ban of prosthetic hair fibers, which were found to provide no public health benefit.
[email protected]
On Twitter @karioakes
What referring physicians need to know about bariatric surgery success rates
NEW ORLEANS – About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m2 at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m2 or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.
Indeed, patients with a baseline BMI of 40 kg/m2 or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m2 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.
“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m2. And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
“These patients are being referred to us. We don’t seek them out. The biggest impetus for this study was to be able to show referring physicians that outcomes are better when treatment is sought earlier. Every patient who shows up at our clinics with a BMI of 65 must have had a BMI of 35 at some point in time. I think we miss the boat on a lot of those patients,” the surgeon said. “Society at large should recognize that bariatric surgery is the most effective treatment for obesity, but it’s also the most underutilized one.”
The Michigan Bariatric Surgery Collaborative is a unique statewide, payer-funded consortium focused on quality improvement. Dr. Varban presented an analysis of 19,764 patients who underwent a primary bariatric procedure in Michigan during 2006-2015 for whom complete 1-year follow-up data were available. The mean preoperative BMI for the overall group was 48 kg/m2, and the mean postoperative BMI at 1 year was 33 kg/m2.
Thirty-eight percent of patients achieved a BMI below 30 kg/m2 at 1 year; their mean BMI at that time was 26.7 kg/m2. The mean BMI 1 year post surgery in the 62% of patients who didn’t reach the goal was 36.7 kg/m2.
Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m2 1 year post surgery had a preoperative BMI of 40 kg/m2 or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m2 or below.
Among patients with a preoperative BMI of 50-59 kg/m2, only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m2, only 0.4% had a BMI of less than 30 kg/m2 at 1 year.
“Patients with a BMI of 50 kg/m2 or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.
Why is a postsurgical BMI below 30 kg/m2 such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m2 or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.
In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.
The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.
Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.
Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m2 at 1 year and those who did not.
Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.
Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m2 in 2006 and 46.9 kg/m2 in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m2, respectively, in those years.
Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m2 before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.
Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.
“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.
Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
NEW ORLEANS – About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m2 at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m2 or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.
Indeed, patients with a baseline BMI of 40 kg/m2 or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m2 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.
“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m2. And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
“These patients are being referred to us. We don’t seek them out. The biggest impetus for this study was to be able to show referring physicians that outcomes are better when treatment is sought earlier. Every patient who shows up at our clinics with a BMI of 65 must have had a BMI of 35 at some point in time. I think we miss the boat on a lot of those patients,” the surgeon said. “Society at large should recognize that bariatric surgery is the most effective treatment for obesity, but it’s also the most underutilized one.”
The Michigan Bariatric Surgery Collaborative is a unique statewide, payer-funded consortium focused on quality improvement. Dr. Varban presented an analysis of 19,764 patients who underwent a primary bariatric procedure in Michigan during 2006-2015 for whom complete 1-year follow-up data were available. The mean preoperative BMI for the overall group was 48 kg/m2, and the mean postoperative BMI at 1 year was 33 kg/m2.
Thirty-eight percent of patients achieved a BMI below 30 kg/m2 at 1 year; their mean BMI at that time was 26.7 kg/m2. The mean BMI 1 year post surgery in the 62% of patients who didn’t reach the goal was 36.7 kg/m2.
Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m2 1 year post surgery had a preoperative BMI of 40 kg/m2 or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m2 or below.
Among patients with a preoperative BMI of 50-59 kg/m2, only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m2, only 0.4% had a BMI of less than 30 kg/m2 at 1 year.
“Patients with a BMI of 50 kg/m2 or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.
Why is a postsurgical BMI below 30 kg/m2 such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m2 or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.
In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.
The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.
Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.
Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m2 at 1 year and those who did not.
Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.
Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m2 in 2006 and 46.9 kg/m2 in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m2, respectively, in those years.
Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m2 before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.
Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.
“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.
Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
NEW ORLEANS – About one-third of bariatric surgery patients achieve a body mass index below 30 kg/m2 at 1 year of follow-up, and the strongest predictor of success is having a BMI of 40 kg/m2 or less at the time of surgery, Oliver A. Varban, MD, reported at Obesity Week 2016.
Indeed, patients with a baseline BMI of 40 kg/m2 or less were fully 13.3-fold more likely to have a BMI of less than 30 kg/m2 1 year post surgery in a study of 19,764 patients in the Michigan Bariatric Surgery Collaborative database, according to Dr. Varban, surgical director of the adult bariatric surgery program at the University of Michigan, Ann Arbor.
“In order to optimize outcomes of bariatric surgery, patients should be encouraged to consider it when their BMI is less than 40 kg/m2. And policies that obstruct or delay surgery can actually result in inferior outcomes,” he said at the meeting, which was presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.
“These patients are being referred to us. We don’t seek them out. The biggest impetus for this study was to be able to show referring physicians that outcomes are better when treatment is sought earlier. Every patient who shows up at our clinics with a BMI of 65 must have had a BMI of 35 at some point in time. I think we miss the boat on a lot of those patients,” the surgeon said. “Society at large should recognize that bariatric surgery is the most effective treatment for obesity, but it’s also the most underutilized one.”
The Michigan Bariatric Surgery Collaborative is a unique statewide, payer-funded consortium focused on quality improvement. Dr. Varban presented an analysis of 19,764 patients who underwent a primary bariatric procedure in Michigan during 2006-2015 for whom complete 1-year follow-up data were available. The mean preoperative BMI for the overall group was 48 kg/m2, and the mean postoperative BMI at 1 year was 33 kg/m2.
Thirty-eight percent of patients achieved a BMI below 30 kg/m2 at 1 year; their mean BMI at that time was 26.7 kg/m2. The mean BMI 1 year post surgery in the 62% of patients who didn’t reach the goal was 36.7 kg/m2.
Only 6.2% of patients who didn’t get to a BMI of less than 30 kg/m2 1 year post surgery had a preoperative BMI of 40 kg/m2 or below, whereas 31.7% of patients who achieved the goal did have a baseline BMI of 40 kg/m2 or below.
Among patients with a preoperative BMI of 50-59 kg/m2, only 7.6% reached the target. And among those with a preoperative BMI of 60 kg/m2, only 0.4% had a BMI of less than 30 kg/m2 at 1 year.
“Patients with a BMI of 50 kg/m2 or more should be given realistic expectations about the type of weight loss they’ll have after bariatric surgery,” Dr. Varban said.
Why is a postsurgical BMI below 30 kg/m2 such an important benchmark? Abundant evidence indicates that having a BMI of 30 kg/m2 or higher is associated with a 50%-100% increase in the risk of premature death compared to that of normal-weight individuals. Successful bariatric surgery reduces that risk by 30%-40%.
In the Michigan study, patients who reached the BMI target had a significantly higher rate of resolution of common comorbid conditions associated with morbid obesity, including type 2 diabetes, hypertension, dyslipidemia, and sleep apnea. They also scored higher on a patient satisfaction survey.
The mean percent preoperative weight loss was 2.3% in patients who didn’t achieve the target BMI and similar at 2.5% in those who did. Thus, preoperative weight loss is not a major contributor to postoperative success, Dr. Varban continued.
Failure to reach the postoperative BMI goal was significantly more common among patients who were black or Hispanic, had an annual income below $25,000, or didn’t have private insurance.
Thirty-day perioperative complication rates didn’t differ between patients who attained a BMI below 30 kg/m2 at 1 year and those who did not.
Dr. Varban said it will come to no surprise to bariatric surgeons that the likelihood of attaining the target 1-year BMI varied according to the type of bariatric surgery: Compared to patients who underwent adjustable laparoscopic banding, the success rate was 19-fold higher with Roux-en-Y gastric bypass, 7.2-fold higher with sleeve gastrectomy, and a whopping 72-fold higher in patients who had a duodenal switch procedure.
Neither the mean preoperative nor 1-year postoperative BMI figures changed much over the study period, even though sleeve gastrectomy became much more common after 2010. For example, the mean preoperative BMI was 48.3 kg/m2 in 2006 and 46.9 kg/m2 in 2015, while the mean postoperative BMIs were 32.7 and 32.6 kg/m2, respectively, in those years.
Dr. Varban said that as he ran the numbers, he was surprised to see that the baseline BMI was so high – far higher than he would have guessed. But since then as he has discussed the study findings with referring physicians throughout Michigan, he’s come to understand the explanation: Many of them are content to wait until their morbidly obese patients grow to a BMI above 50 kg/m2 before making the referral because they consider the alternate criterion for bariatric surgery referral – that is, failure to achieve significant weight loss after 1 year of medically supervised attempts – to be too much for them to take on.
Amir A. Ghaferi, MD, a University of Michigan bariatric surgeon and coinvestigator in the study, rose from the audience to urge his colleagues to focus on the health policy implications of the findings.
“Maybe our bariatric surgery criteria aren’t right. We’ve been talking a lot amongst ourselves about pushing the BMI threshold lower and reducing some of the insurance barriers. I think what this study demonstrates from a policy perspective is we need to get these patients sooner, without so many barriers ahead of us and in front of the patients, in order to achieve the best possible outcomes,” Dr. Ghaferi said.
Dr. Varban reported receiving research funding from Blue Cross Blue Shield of Michigan.
OBESITY WEEK 2016
Key clinical point:
Major finding: Patients who underwent bariatric surgery when their BMI was 40 kg/m2 or below were 13.3-fold more likely to have a BMI below 30 kg/m2 1 year later.
Data source: A study of 1-year outcomes in nearly 20,000 patients in the Michigan Bariatric Surgery Collaborative database.
Disclosures: The study presenter reported receiving research funding from Blue Cross Blue Shield of Michigan.
FDA warning: General anesthetics may damage young brains
The Food and Drug Administration has issued a warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.
“Recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.” The studies suggesting a problem with longer or repeat exposures “had limitations, and it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure.” Further research is needed, the agency said.
FDA is adding its warning to the labels of 11 general anesthetics and sedatives, including desflurane, halothane, ketamine, lorazepam injection, methohexital, pentobarbital, and propofol. The drugs block N-methyl-D-aspartate (NMDA) receptors and/or potentiate gamma-aminobutyric acid (GABA) activity. No specific medications have been shown to be safer than any other, the agency said.
FDA will continue to monitor the situation, and update its warning as additional information comes in. “We urge health care professionals, patients, parents, and caregivers to report side effects involving anesthetic and sedation drugs or other medicines to the FDA MedWatch program,” the FDA said.
The Food and Drug Administration has issued a warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.
“Recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.” The studies suggesting a problem with longer or repeat exposures “had limitations, and it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure.” Further research is needed, the agency said.
FDA is adding its warning to the labels of 11 general anesthetics and sedatives, including desflurane, halothane, ketamine, lorazepam injection, methohexital, pentobarbital, and propofol. The drugs block N-methyl-D-aspartate (NMDA) receptors and/or potentiate gamma-aminobutyric acid (GABA) activity. No specific medications have been shown to be safer than any other, the agency said.
FDA will continue to monitor the situation, and update its warning as additional information comes in. “We urge health care professionals, patients, parents, and caregivers to report side effects involving anesthetic and sedation drugs or other medicines to the FDA MedWatch program,” the FDA said.
The Food and Drug Administration has issued a warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains.
“Recent human studies suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning.” The studies suggesting a problem with longer or repeat exposures “had limitations, and it is unclear whether any negative effects seen in children’s learning or behavior were due to the drugs or to other factors, such as the underlying medical condition that led to the need for the surgery or procedure.” Further research is needed, the agency said.
FDA is adding its warning to the labels of 11 general anesthetics and sedatives, including desflurane, halothane, ketamine, lorazepam injection, methohexital, pentobarbital, and propofol. The drugs block N-methyl-D-aspartate (NMDA) receptors and/or potentiate gamma-aminobutyric acid (GABA) activity. No specific medications have been shown to be safer than any other, the agency said.
FDA will continue to monitor the situation, and update its warning as additional information comes in. “We urge health care professionals, patients, parents, and caregivers to report side effects involving anesthetic and sedation drugs or other medicines to the FDA MedWatch program,” the FDA said.
More tricuspid valve regurgitation should be fixed
CHICAGO – Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.
Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.
A 2015 study followed 645 consecutive patients who underwent primary repair of degenerative mitral regurgitation. The patients who had concomitant TVR, he said, “had far less TR, better right ventricle function, and it’s safe. There was lower mortality and morbidity” (J Am Coll Cardiol. 2015 May 12;65[18]:1931-8).
Citing a study of 5,589 patients undergoing surgery for mitral valve regurgitation only, 16% of these had severe – grade 3-4+ – TR preoperatively. However, at discharge, 62% of those had severe residual TR. Despite a “good” mitral result, said Dr. Bolling, multiple studies dating back to the 1980s have demonstrated that surgical repair of just the mitral valve still results in functional tricuspid regurgitation (FTR) rates of up to 67%. “There’s no guarantee of FTR ‘getting better,’” said Dr. Bolling.
The problem lies fundamentally in the annular dilation and change of shape of the tricuspid annulus, and so these issues must be addressed for a good functional result, he said. This dilation and distortion has been shown to occur in up to 75% of all cases of MR (Circulation. 2006;114:1-492).
“Placing an ‘undersized’ tricuspid ring is actually restoring normal sizing to the annulus,” said Dr. Bolling. The normal tricuspid annular dimension is 2.8 cm, plus or minus 0.5 cm, he said. Patients fare better both in the immediate postoperative period and at follow-up with an “undersized” TV repair for FTR, he said.
And surgeons shouldn’t worry about stenosis with an “undersized” TV repair, he said. High school geometry shows that a 26-mm valve diameter yields an area of about 4 square cm, for a 2- to 3-mm gradient, said Dr. Bolling.
Detection of tricuspid regurgitation can itself be a tricky prospect, because tricuspid regurgitation is dynamic. “You should look for functional tricuspid regurgitation preoperatively,” said Dr. Bolling. “Under anesthesia, four-plus TR can become mild.” Accordingly, any significant intraoperative TR or a dilated annulus should be considered indications for tricuspid valve repair, he said.
Though adding TV repair to mitral surgery may add some complexity, it does not necessarily add risk, said Dr. Bolling, citing a study of 110 matched patients with FTR that found a trend toward lower 30-day mortality for combined repair, when compared to mitral repair only (2% versus 8.5%, P = .2).
However, the single-intervention group had a 40% rate of tricuspid progression compared to 5% when both valves were repaired, and the 5-year survival rate was higher for those who had the combined surgery (74% versus 45%; Ann Thorac Surg. 2009 Mar;87[3]:698-703).
According to American College of Cardiology/American Heart Association (ACC/AHA) guidelines for managing valvular heart disease, which were last updated in 2014, patients with severe TR who are undergoing left-sided valve surgery should have concomitant TV repair, a class I recommendation.
The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2012 guidelines are in accord with the ACC/AHA for this population, also issuing a class I recommendation.
For patients with greater than mild TR who have tricuspid annular dilation or right-sided heart failure, TV repair is a class IIa recommendation, according to the ACC/AHA guidelines. For patients with FTR who also have either pulmonary hypertension or right ventricular dilation or dysfunction, TV repair is an ACC/AHA class IIb recommendation.
In the European guidelines, patients with moderate secondary TR with a tricuspid annulus over 40 mm in diameter who are undergoing left-sided valve surgery, or who have right ventricular dilation or dysfunction, should undergo TV repair. This is a class IIa recommendation in the ESC/EACTS schema.
Dr. Bolling reported financial relationships with the Sorin Group, Medtronic, and Edwards Lifesciences.
[email protected]
On Twitter @karioakes
CHICAGO – Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.
Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.
A 2015 study followed 645 consecutive patients who underwent primary repair of degenerative mitral regurgitation. The patients who had concomitant TVR, he said, “had far less TR, better right ventricle function, and it’s safe. There was lower mortality and morbidity” (J Am Coll Cardiol. 2015 May 12;65[18]:1931-8).
Citing a study of 5,589 patients undergoing surgery for mitral valve regurgitation only, 16% of these had severe – grade 3-4+ – TR preoperatively. However, at discharge, 62% of those had severe residual TR. Despite a “good” mitral result, said Dr. Bolling, multiple studies dating back to the 1980s have demonstrated that surgical repair of just the mitral valve still results in functional tricuspid regurgitation (FTR) rates of up to 67%. “There’s no guarantee of FTR ‘getting better,’” said Dr. Bolling.
The problem lies fundamentally in the annular dilation and change of shape of the tricuspid annulus, and so these issues must be addressed for a good functional result, he said. This dilation and distortion has been shown to occur in up to 75% of all cases of MR (Circulation. 2006;114:1-492).
“Placing an ‘undersized’ tricuspid ring is actually restoring normal sizing to the annulus,” said Dr. Bolling. The normal tricuspid annular dimension is 2.8 cm, plus or minus 0.5 cm, he said. Patients fare better both in the immediate postoperative period and at follow-up with an “undersized” TV repair for FTR, he said.
And surgeons shouldn’t worry about stenosis with an “undersized” TV repair, he said. High school geometry shows that a 26-mm valve diameter yields an area of about 4 square cm, for a 2- to 3-mm gradient, said Dr. Bolling.
Detection of tricuspid regurgitation can itself be a tricky prospect, because tricuspid regurgitation is dynamic. “You should look for functional tricuspid regurgitation preoperatively,” said Dr. Bolling. “Under anesthesia, four-plus TR can become mild.” Accordingly, any significant intraoperative TR or a dilated annulus should be considered indications for tricuspid valve repair, he said.
Though adding TV repair to mitral surgery may add some complexity, it does not necessarily add risk, said Dr. Bolling, citing a study of 110 matched patients with FTR that found a trend toward lower 30-day mortality for combined repair, when compared to mitral repair only (2% versus 8.5%, P = .2).
However, the single-intervention group had a 40% rate of tricuspid progression compared to 5% when both valves were repaired, and the 5-year survival rate was higher for those who had the combined surgery (74% versus 45%; Ann Thorac Surg. 2009 Mar;87[3]:698-703).
According to American College of Cardiology/American Heart Association (ACC/AHA) guidelines for managing valvular heart disease, which were last updated in 2014, patients with severe TR who are undergoing left-sided valve surgery should have concomitant TV repair, a class I recommendation.
The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2012 guidelines are in accord with the ACC/AHA for this population, also issuing a class I recommendation.
For patients with greater than mild TR who have tricuspid annular dilation or right-sided heart failure, TV repair is a class IIa recommendation, according to the ACC/AHA guidelines. For patients with FTR who also have either pulmonary hypertension or right ventricular dilation or dysfunction, TV repair is an ACC/AHA class IIb recommendation.
In the European guidelines, patients with moderate secondary TR with a tricuspid annulus over 40 mm in diameter who are undergoing left-sided valve surgery, or who have right ventricular dilation or dysfunction, should undergo TV repair. This is a class IIa recommendation in the ESC/EACTS schema.
Dr. Bolling reported financial relationships with the Sorin Group, Medtronic, and Edwards Lifesciences.
[email protected]
On Twitter @karioakes
CHICAGO – Fixing the tricuspid valve should be part of left-sided heart operations in many cases of functional tricuspid regurgitation, but study data and international guidelines supporting the practice are too frequently ignored, said Steven Bolling, MD.
Speaking during Heart Valve Summit 2016, Dr. Bolling said that of the approximately four million U.S. individuals with mitral regurgitation, about 1.6 million, or 40%, have concomitant tricuspid regurgitation (TR). Yet, he said, only about 7,000 concomitant tricuspid valve (TV) repairs are performed in the 60,000 patients receiving mitral valve (MV) repair surgery annually, for a TV repair rate of less than 12%. “Tricuspid regurgitation is ignored,” said Dr. Bolling, a conference organizer and professor of surgery at the University of Michigan, Ann Arbor.
A 2015 study followed 645 consecutive patients who underwent primary repair of degenerative mitral regurgitation. The patients who had concomitant TVR, he said, “had far less TR, better right ventricle function, and it’s safe. There was lower mortality and morbidity” (J Am Coll Cardiol. 2015 May 12;65[18]:1931-8).
Citing a study of 5,589 patients undergoing surgery for mitral valve regurgitation only, 16% of these had severe – grade 3-4+ – TR preoperatively. However, at discharge, 62% of those had severe residual TR. Despite a “good” mitral result, said Dr. Bolling, multiple studies dating back to the 1980s have demonstrated that surgical repair of just the mitral valve still results in functional tricuspid regurgitation (FTR) rates of up to 67%. “There’s no guarantee of FTR ‘getting better,’” said Dr. Bolling.
The problem lies fundamentally in the annular dilation and change of shape of the tricuspid annulus, and so these issues must be addressed for a good functional result, he said. This dilation and distortion has been shown to occur in up to 75% of all cases of MR (Circulation. 2006;114:1-492).
“Placing an ‘undersized’ tricuspid ring is actually restoring normal sizing to the annulus,” said Dr. Bolling. The normal tricuspid annular dimension is 2.8 cm, plus or minus 0.5 cm, he said. Patients fare better both in the immediate postoperative period and at follow-up with an “undersized” TV repair for FTR, he said.
And surgeons shouldn’t worry about stenosis with an “undersized” TV repair, he said. High school geometry shows that a 26-mm valve diameter yields an area of about 4 square cm, for a 2- to 3-mm gradient, said Dr. Bolling.
Detection of tricuspid regurgitation can itself be a tricky prospect, because tricuspid regurgitation is dynamic. “You should look for functional tricuspid regurgitation preoperatively,” said Dr. Bolling. “Under anesthesia, four-plus TR can become mild.” Accordingly, any significant intraoperative TR or a dilated annulus should be considered indications for tricuspid valve repair, he said.
Though adding TV repair to mitral surgery may add some complexity, it does not necessarily add risk, said Dr. Bolling, citing a study of 110 matched patients with FTR that found a trend toward lower 30-day mortality for combined repair, when compared to mitral repair only (2% versus 8.5%, P = .2).
However, the single-intervention group had a 40% rate of tricuspid progression compared to 5% when both valves were repaired, and the 5-year survival rate was higher for those who had the combined surgery (74% versus 45%; Ann Thorac Surg. 2009 Mar;87[3]:698-703).
According to American College of Cardiology/American Heart Association (ACC/AHA) guidelines for managing valvular heart disease, which were last updated in 2014, patients with severe TR who are undergoing left-sided valve surgery should have concomitant TV repair, a class I recommendation.
The European Society of Cardiology and the European Association for Cardio-Thoracic Surgery (ESC/EACTS) 2012 guidelines are in accord with the ACC/AHA for this population, also issuing a class I recommendation.
For patients with greater than mild TR who have tricuspid annular dilation or right-sided heart failure, TV repair is a class IIa recommendation, according to the ACC/AHA guidelines. For patients with FTR who also have either pulmonary hypertension or right ventricular dilation or dysfunction, TV repair is an ACC/AHA class IIb recommendation.
In the European guidelines, patients with moderate secondary TR with a tricuspid annulus over 40 mm in diameter who are undergoing left-sided valve surgery, or who have right ventricular dilation or dysfunction, should undergo TV repair. This is a class IIa recommendation in the ESC/EACTS schema.
Dr. Bolling reported financial relationships with the Sorin Group, Medtronic, and Edwards Lifesciences.
[email protected]
On Twitter @karioakes
EXPERT ANALYSIS FROM HEART VALVE SUMMIT 2016
Noncancerous disease has a significant impact on lung cancer surgery survival
After older patients undergo lung resection for stage I non–small-cell lung cancer, they are actually at greater risk of death from something other than lung cancer for up to 2.5 years, according to researchers at Memorial Sloan Kettering Cancer Center, New York. The findings were published online in the Journal of Clinical Oncology (2016;34: doi: 10.1200/JCO.2016.69.0834).
“As age increases, the risk of competing events increases, such as death from noncancer diseases,” wrote Takashi Eguchi, MD, and coauthors. “In this era of personalized cancer therapy, important to the stratification of individualized treatments is the determination of how both cancer and noncancer risk factors – specifically, comorbidities associated with increasing age – contribute to the risk of death.”
The researchers examined outcomes in three different age groups: younger than 65, 65-74, and 75 and older. The study focused on 2,186 patients with pathologic stage I non–small-cell lung cancer (NSCLC) among a population of 5,371 consecutive patients who had resection for primary lung cancer from 2000 to 2011. Seventy percent of patients in the study group were 65 and older, and 29.2% were 75 and older.
In all age groups, the calculated 5-year cumulative incidence of death (CID) for lung cancer–specific causes exceeded that for noncancer causes, but at significant intervals the 65-and-over groups were more likely to die from the latter. For the overall study group, noncancer-specific causes accounted for a higher CID through 18 months after surgery, when the CID for both cancer and noncancer causes crossed at around 2.9. At 5 years, the overall lung cancer–specific CID was 10.4 vs. 5.3 for noncancer specific causes.
However, in the older age groups, those trends were more pronounced. In those aged 65-74, CID for both causes met at around 3.15 at 18 months (10.7 for lung cancer–specific and 4.9 for noncancer specific at 5 years), whereas for those 75 and older, CID for noncancer causes exceeded that for lung cancer–related causes for 2.5 years, when both were around 6; reaching 13.2 for lung cancer–specific and 9 for noncancer-specific at 5 years.
In the 65-and-younger group, lung cancer– and noncancer-specific CIDs were equal for about 3 months after surgery, when the lung cancer deaths tracked upward and the trends diverged (at 5 years, CID was 7.5 for lung cancer–specific and 1 for noncancer specific).
“We have shown that in patients with stage I NSCLC, the majority of postoperative severe morbidity, 1-year mortality, and 5-year noncancer-specific mortality were attributable to cardiorespiratory diseases,” Dr. Eguchi and colleagues said.
“We have also shown that short-term mortality is primarily attributable to noncancer-specific diseases.” The findings underscore the importance of screening older patients for noncancer-specific diseases that could alter outcomes, the researchers said.
Of the 2,186 stage I NSCLC patients in the study, 167 developed severe morbidities after surgery; 68.3% developed respiratory problems and 18.6% went on to develop cardiovascular problems. Patients who had lobectomy were more likely to develop respiratory problems than were those who had sublobar resection, Dr. Eguchi and coauthors said.
Respiratory and cardiovascular diseases were the most frequent causes of death early after surgery. At 30 days, respiratory disease accounted for 5 deaths and cardiovascular disease 7 of 15 total deaths at 30 days; and at 90 days, 11 and 7, respectively, of 27 overall deaths. Even at 1 year, noncancer issues were the leading cause of death (50%), followed by lung cancer–specific causes (27.8%) and other cancer specific disease (13.3%).
“Noncancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Dr. Eguchi and coauthors said. “These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status and help determine patients’ optimal treatment options.”
The study received financial support from coauthor Prasad S. Adusumilli, MD. Dr. Eguchi and Dr. Adusumilli and the other coauthors had no relevant financial disclosures.
Every surgeon performing lung resection comes across elderly patients who are at a higher risk than usual for a formal lung resection. In this era of screening and the abundant use of CT scans, this is increasingly common. Selection of the optimal treatment approach is often done intuitively, balancing the increased risk of surgery vs. the improved cancer-specific survival and the baseline life expectancy of the patient. This manuscript provides more quantitative estimates of this balance and draws attention, through a competing risks analysis, to the importance of non–cancer-related mortality in elderly patients.
The authors point out that non–cancer-related mortality is more common than cancer-related mortality for up to 2.5 years after surgery in patients greater than 75 years of age. This way of examining a situation is different from the usual emphasis on 30-day (and more recently the 90-day) perioperative mortality. The manuscript significantly adds to the decision-making framework of this increasingly important population and is a useful read for all lung cancer surgeons.
Sai Yendamuri, MD, is an attending surgeon in the department of thoracic surgery, the director, Thoracic Surgery Research Laboratory, and associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y. He is associate medical editor for Thoracic Surgery News.
Every surgeon performing lung resection comes across elderly patients who are at a higher risk than usual for a formal lung resection. In this era of screening and the abundant use of CT scans, this is increasingly common. Selection of the optimal treatment approach is often done intuitively, balancing the increased risk of surgery vs. the improved cancer-specific survival and the baseline life expectancy of the patient. This manuscript provides more quantitative estimates of this balance and draws attention, through a competing risks analysis, to the importance of non–cancer-related mortality in elderly patients.
The authors point out that non–cancer-related mortality is more common than cancer-related mortality for up to 2.5 years after surgery in patients greater than 75 years of age. This way of examining a situation is different from the usual emphasis on 30-day (and more recently the 90-day) perioperative mortality. The manuscript significantly adds to the decision-making framework of this increasingly important population and is a useful read for all lung cancer surgeons.
Sai Yendamuri, MD, is an attending surgeon in the department of thoracic surgery, the director, Thoracic Surgery Research Laboratory, and associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y. He is associate medical editor for Thoracic Surgery News.
Every surgeon performing lung resection comes across elderly patients who are at a higher risk than usual for a formal lung resection. In this era of screening and the abundant use of CT scans, this is increasingly common. Selection of the optimal treatment approach is often done intuitively, balancing the increased risk of surgery vs. the improved cancer-specific survival and the baseline life expectancy of the patient. This manuscript provides more quantitative estimates of this balance and draws attention, through a competing risks analysis, to the importance of non–cancer-related mortality in elderly patients.
The authors point out that non–cancer-related mortality is more common than cancer-related mortality for up to 2.5 years after surgery in patients greater than 75 years of age. This way of examining a situation is different from the usual emphasis on 30-day (and more recently the 90-day) perioperative mortality. The manuscript significantly adds to the decision-making framework of this increasingly important population and is a useful read for all lung cancer surgeons.
Sai Yendamuri, MD, is an attending surgeon in the department of thoracic surgery, the director, Thoracic Surgery Research Laboratory, and associate professor of oncology at Roswell Park Cancer Institute, Buffalo, N.Y. He is associate medical editor for Thoracic Surgery News.
After older patients undergo lung resection for stage I non–small-cell lung cancer, they are actually at greater risk of death from something other than lung cancer for up to 2.5 years, according to researchers at Memorial Sloan Kettering Cancer Center, New York. The findings were published online in the Journal of Clinical Oncology (2016;34: doi: 10.1200/JCO.2016.69.0834).
“As age increases, the risk of competing events increases, such as death from noncancer diseases,” wrote Takashi Eguchi, MD, and coauthors. “In this era of personalized cancer therapy, important to the stratification of individualized treatments is the determination of how both cancer and noncancer risk factors – specifically, comorbidities associated with increasing age – contribute to the risk of death.”
The researchers examined outcomes in three different age groups: younger than 65, 65-74, and 75 and older. The study focused on 2,186 patients with pathologic stage I non–small-cell lung cancer (NSCLC) among a population of 5,371 consecutive patients who had resection for primary lung cancer from 2000 to 2011. Seventy percent of patients in the study group were 65 and older, and 29.2% were 75 and older.
In all age groups, the calculated 5-year cumulative incidence of death (CID) for lung cancer–specific causes exceeded that for noncancer causes, but at significant intervals the 65-and-over groups were more likely to die from the latter. For the overall study group, noncancer-specific causes accounted for a higher CID through 18 months after surgery, when the CID for both cancer and noncancer causes crossed at around 2.9. At 5 years, the overall lung cancer–specific CID was 10.4 vs. 5.3 for noncancer specific causes.
However, in the older age groups, those trends were more pronounced. In those aged 65-74, CID for both causes met at around 3.15 at 18 months (10.7 for lung cancer–specific and 4.9 for noncancer specific at 5 years), whereas for those 75 and older, CID for noncancer causes exceeded that for lung cancer–related causes for 2.5 years, when both were around 6; reaching 13.2 for lung cancer–specific and 9 for noncancer-specific at 5 years.
In the 65-and-younger group, lung cancer– and noncancer-specific CIDs were equal for about 3 months after surgery, when the lung cancer deaths tracked upward and the trends diverged (at 5 years, CID was 7.5 for lung cancer–specific and 1 for noncancer specific).
“We have shown that in patients with stage I NSCLC, the majority of postoperative severe morbidity, 1-year mortality, and 5-year noncancer-specific mortality were attributable to cardiorespiratory diseases,” Dr. Eguchi and colleagues said.
“We have also shown that short-term mortality is primarily attributable to noncancer-specific diseases.” The findings underscore the importance of screening older patients for noncancer-specific diseases that could alter outcomes, the researchers said.
Of the 2,186 stage I NSCLC patients in the study, 167 developed severe morbidities after surgery; 68.3% developed respiratory problems and 18.6% went on to develop cardiovascular problems. Patients who had lobectomy were more likely to develop respiratory problems than were those who had sublobar resection, Dr. Eguchi and coauthors said.
Respiratory and cardiovascular diseases were the most frequent causes of death early after surgery. At 30 days, respiratory disease accounted for 5 deaths and cardiovascular disease 7 of 15 total deaths at 30 days; and at 90 days, 11 and 7, respectively, of 27 overall deaths. Even at 1 year, noncancer issues were the leading cause of death (50%), followed by lung cancer–specific causes (27.8%) and other cancer specific disease (13.3%).
“Noncancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Dr. Eguchi and coauthors said. “These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status and help determine patients’ optimal treatment options.”
The study received financial support from coauthor Prasad S. Adusumilli, MD. Dr. Eguchi and Dr. Adusumilli and the other coauthors had no relevant financial disclosures.
After older patients undergo lung resection for stage I non–small-cell lung cancer, they are actually at greater risk of death from something other than lung cancer for up to 2.5 years, according to researchers at Memorial Sloan Kettering Cancer Center, New York. The findings were published online in the Journal of Clinical Oncology (2016;34: doi: 10.1200/JCO.2016.69.0834).
“As age increases, the risk of competing events increases, such as death from noncancer diseases,” wrote Takashi Eguchi, MD, and coauthors. “In this era of personalized cancer therapy, important to the stratification of individualized treatments is the determination of how both cancer and noncancer risk factors – specifically, comorbidities associated with increasing age – contribute to the risk of death.”
The researchers examined outcomes in three different age groups: younger than 65, 65-74, and 75 and older. The study focused on 2,186 patients with pathologic stage I non–small-cell lung cancer (NSCLC) among a population of 5,371 consecutive patients who had resection for primary lung cancer from 2000 to 2011. Seventy percent of patients in the study group were 65 and older, and 29.2% were 75 and older.
In all age groups, the calculated 5-year cumulative incidence of death (CID) for lung cancer–specific causes exceeded that for noncancer causes, but at significant intervals the 65-and-over groups were more likely to die from the latter. For the overall study group, noncancer-specific causes accounted for a higher CID through 18 months after surgery, when the CID for both cancer and noncancer causes crossed at around 2.9. At 5 years, the overall lung cancer–specific CID was 10.4 vs. 5.3 for noncancer specific causes.
However, in the older age groups, those trends were more pronounced. In those aged 65-74, CID for both causes met at around 3.15 at 18 months (10.7 for lung cancer–specific and 4.9 for noncancer specific at 5 years), whereas for those 75 and older, CID for noncancer causes exceeded that for lung cancer–related causes for 2.5 years, when both were around 6; reaching 13.2 for lung cancer–specific and 9 for noncancer-specific at 5 years.
In the 65-and-younger group, lung cancer– and noncancer-specific CIDs were equal for about 3 months after surgery, when the lung cancer deaths tracked upward and the trends diverged (at 5 years, CID was 7.5 for lung cancer–specific and 1 for noncancer specific).
“We have shown that in patients with stage I NSCLC, the majority of postoperative severe morbidity, 1-year mortality, and 5-year noncancer-specific mortality were attributable to cardiorespiratory diseases,” Dr. Eguchi and colleagues said.
“We have also shown that short-term mortality is primarily attributable to noncancer-specific diseases.” The findings underscore the importance of screening older patients for noncancer-specific diseases that could alter outcomes, the researchers said.
Of the 2,186 stage I NSCLC patients in the study, 167 developed severe morbidities after surgery; 68.3% developed respiratory problems and 18.6% went on to develop cardiovascular problems. Patients who had lobectomy were more likely to develop respiratory problems than were those who had sublobar resection, Dr. Eguchi and coauthors said.
Respiratory and cardiovascular diseases were the most frequent causes of death early after surgery. At 30 days, respiratory disease accounted for 5 deaths and cardiovascular disease 7 of 15 total deaths at 30 days; and at 90 days, 11 and 7, respectively, of 27 overall deaths. Even at 1 year, noncancer issues were the leading cause of death (50%), followed by lung cancer–specific causes (27.8%) and other cancer specific disease (13.3%).
“Noncancer-specific mortality represents a significant competing event for lung cancer–specific mortality, with an increasing impact as age increases,” Dr. Eguchi and coauthors said. “These findings can provide patients with more accurate information on survivorship on the basis of their individual preoperative status and help determine patients’ optimal treatment options.”
The study received financial support from coauthor Prasad S. Adusumilli, MD. Dr. Eguchi and Dr. Adusumilli and the other coauthors had no relevant financial disclosures.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Risk of non-cancer death after curative resection of stage 1 non–small-call lung cancer (NSCLC) exceeded that of lung-cancer deaths 1.5 to 2.5 years after surgery in older patients.
Major finding: In patients aged 75 and older the risk of non–lung-cancer–related death exceeded the risk of death from lung cancer for 2.5 years after surgery, whereas in patients 65 and younger the risk of non–lung cancer death exceeded that of lung-cancer death for 3 months after surgery.
Data Source: Single-center analysis of 5,371 consecutive patients who had curative lung cancer resection from 2000 to 2011, 2,186 of whom had stage 1 NSCLC.
Disclosures: The study received financial support from coauthor Prasad S. Adusumilli, MD. Dr. Eguchi and Dr. Adusumilli and the other coauthors had no relevant financial relationships to disclose.
Expandable cardiac valve in children found feasible
Young children and infants who require cardiac valve replacement are limited to fixed-diameter prostheses that cannot accommodate their growth, but researchers at Boston Children’s Hospital have reinforced an expandable bovine jugular vein graft using an external stent and implanted it in 42 patients with acceptable short-term results, according to a report in the Journal of Thoracic and Cardiovascular Surgery.
In 4 years, the modified Melody valve (Medtronic) has proved amenable to enlargement via catheterization as the child grows, Sitaram M. Emani, MD, and coauthors said. “The valve was competent with low gradient acutely postoperatively in all patients,” Dr. Emani and his coauthors said (J Thorac Cardiovasc Surg. 2016 Dec;152[6]:1514-23).
The Melody valve is approved for transcatheter implantation into the RVOT and can be modified for the semilunar or AV positions, Dr. Emani and his coauthors said. The valve has achieved competence within a size range of 10-22 mm.
The researchers implanted the valve in four positions: RVOT (14), mitral (24), aortic (one), or tricuspid (three). The median age at implantation was 10 months, with a range of 3 weeks to 5.8 years. The patients had an average of one previous valve replacement or repair procedure.
Six deaths occurred in the study population; three before discharge. Those three patients had replacement to salvage a moribund circulation in the setting of mechanical circulatory support and severely depressed ventricular function. The other three patients who died were able to demonstrate adequate valve function, and autopsy did not show any signs of valvular thrombosis or deterioration, the researchers said.
Using Kaplan-Meier analysis, Dr. Emani and his coauthors estimated the freedom from death or transplantation was 83% at 12 months and 77% at 24 months.
The average time between catheter-based dilations was around 10 months, they wrote, “but this might be increased by more aggressive dilation.” Early in the study, the researchers were not aggressive with dilations because of concerns about valve injury, but then they found that patients tolerated increases in valve diameter by as much as 4 mm.
“Further investigation is needed to determine whether the device retains expandability over the long term after multiple dilations,” Dr. Emani and his coauthors said.
Further refinements in valve design and implantation techniques may lead to prevention of reoperation and perivalvular complications, they suggested.
The researchers did note a couple limitations of their study: the heterogeneous cohort prohibits any generalization of the outcomes, particularly mortality, and concomitant procedures performed during the valve replacement would affect mortality.
Dr. Emani and his colleagues had no financial relationships to disclose.
In his invited commentary, Carl L. Backer, MD, of Northwestern University, Chicago, noted three advantages of the use of the stent-expandable bovine valve for infants and children: It can be used when no prosthetic is small enough to fit in the annulus, it does not require anticoagulation with warfarin after placement, and it can be dilated as the child grows (J Thorac Cardiovasc Surg. 2016 Dec:152[6];1524-5).
But, Dr. Backer added, “one note of caution that I would raise relates to the late complications noted in previous trials with tissue valves on the left side of the heart in children.” He noted such experience had been reported with the Mitroflow bovine pericardial bioprosthesis (LivaNova) (Circulation. 2014;130[1];51-60) and the Perimount Magna (Edwards Lifesciences) (Ann Thorac Surg. 2016;102[1];308-11). “The follow-up of Emani and colleagues at two years is good; however, there is always the possibility that premature calcification and stenosis of these valves, particularly those placed on the left side of the heart, could lead to the need for early explantation,” Dr. Backer said.
Nonetheless, the findings of Dr. Emani and his colleagues showed that the concept of implanting a stented jugular vein graft valve in infants and young children “is proving to be safe and efficacious,” Dr. Backer said. “In these children for whom there are limited options, this appears to be an important addition to our surgical strategies,” he concluded.
Dr. Backer had no financial relationships to disclose.
In his invited commentary, Carl L. Backer, MD, of Northwestern University, Chicago, noted three advantages of the use of the stent-expandable bovine valve for infants and children: It can be used when no prosthetic is small enough to fit in the annulus, it does not require anticoagulation with warfarin after placement, and it can be dilated as the child grows (J Thorac Cardiovasc Surg. 2016 Dec:152[6];1524-5).
But, Dr. Backer added, “one note of caution that I would raise relates to the late complications noted in previous trials with tissue valves on the left side of the heart in children.” He noted such experience had been reported with the Mitroflow bovine pericardial bioprosthesis (LivaNova) (Circulation. 2014;130[1];51-60) and the Perimount Magna (Edwards Lifesciences) (Ann Thorac Surg. 2016;102[1];308-11). “The follow-up of Emani and colleagues at two years is good; however, there is always the possibility that premature calcification and stenosis of these valves, particularly those placed on the left side of the heart, could lead to the need for early explantation,” Dr. Backer said.
Nonetheless, the findings of Dr. Emani and his colleagues showed that the concept of implanting a stented jugular vein graft valve in infants and young children “is proving to be safe and efficacious,” Dr. Backer said. “In these children for whom there are limited options, this appears to be an important addition to our surgical strategies,” he concluded.
Dr. Backer had no financial relationships to disclose.
In his invited commentary, Carl L. Backer, MD, of Northwestern University, Chicago, noted three advantages of the use of the stent-expandable bovine valve for infants and children: It can be used when no prosthetic is small enough to fit in the annulus, it does not require anticoagulation with warfarin after placement, and it can be dilated as the child grows (J Thorac Cardiovasc Surg. 2016 Dec:152[6];1524-5).
But, Dr. Backer added, “one note of caution that I would raise relates to the late complications noted in previous trials with tissue valves on the left side of the heart in children.” He noted such experience had been reported with the Mitroflow bovine pericardial bioprosthesis (LivaNova) (Circulation. 2014;130[1];51-60) and the Perimount Magna (Edwards Lifesciences) (Ann Thorac Surg. 2016;102[1];308-11). “The follow-up of Emani and colleagues at two years is good; however, there is always the possibility that premature calcification and stenosis of these valves, particularly those placed on the left side of the heart, could lead to the need for early explantation,” Dr. Backer said.
Nonetheless, the findings of Dr. Emani and his colleagues showed that the concept of implanting a stented jugular vein graft valve in infants and young children “is proving to be safe and efficacious,” Dr. Backer said. “In these children for whom there are limited options, this appears to be an important addition to our surgical strategies,” he concluded.
Dr. Backer had no financial relationships to disclose.
Young children and infants who require cardiac valve replacement are limited to fixed-diameter prostheses that cannot accommodate their growth, but researchers at Boston Children’s Hospital have reinforced an expandable bovine jugular vein graft using an external stent and implanted it in 42 patients with acceptable short-term results, according to a report in the Journal of Thoracic and Cardiovascular Surgery.
In 4 years, the modified Melody valve (Medtronic) has proved amenable to enlargement via catheterization as the child grows, Sitaram M. Emani, MD, and coauthors said. “The valve was competent with low gradient acutely postoperatively in all patients,” Dr. Emani and his coauthors said (J Thorac Cardiovasc Surg. 2016 Dec;152[6]:1514-23).
The Melody valve is approved for transcatheter implantation into the RVOT and can be modified for the semilunar or AV positions, Dr. Emani and his coauthors said. The valve has achieved competence within a size range of 10-22 mm.
The researchers implanted the valve in four positions: RVOT (14), mitral (24), aortic (one), or tricuspid (three). The median age at implantation was 10 months, with a range of 3 weeks to 5.8 years. The patients had an average of one previous valve replacement or repair procedure.
Six deaths occurred in the study population; three before discharge. Those three patients had replacement to salvage a moribund circulation in the setting of mechanical circulatory support and severely depressed ventricular function. The other three patients who died were able to demonstrate adequate valve function, and autopsy did not show any signs of valvular thrombosis or deterioration, the researchers said.
Using Kaplan-Meier analysis, Dr. Emani and his coauthors estimated the freedom from death or transplantation was 83% at 12 months and 77% at 24 months.
The average time between catheter-based dilations was around 10 months, they wrote, “but this might be increased by more aggressive dilation.” Early in the study, the researchers were not aggressive with dilations because of concerns about valve injury, but then they found that patients tolerated increases in valve diameter by as much as 4 mm.
“Further investigation is needed to determine whether the device retains expandability over the long term after multiple dilations,” Dr. Emani and his coauthors said.
Further refinements in valve design and implantation techniques may lead to prevention of reoperation and perivalvular complications, they suggested.
The researchers did note a couple limitations of their study: the heterogeneous cohort prohibits any generalization of the outcomes, particularly mortality, and concomitant procedures performed during the valve replacement would affect mortality.
Dr. Emani and his colleagues had no financial relationships to disclose.
Young children and infants who require cardiac valve replacement are limited to fixed-diameter prostheses that cannot accommodate their growth, but researchers at Boston Children’s Hospital have reinforced an expandable bovine jugular vein graft using an external stent and implanted it in 42 patients with acceptable short-term results, according to a report in the Journal of Thoracic and Cardiovascular Surgery.
In 4 years, the modified Melody valve (Medtronic) has proved amenable to enlargement via catheterization as the child grows, Sitaram M. Emani, MD, and coauthors said. “The valve was competent with low gradient acutely postoperatively in all patients,” Dr. Emani and his coauthors said (J Thorac Cardiovasc Surg. 2016 Dec;152[6]:1514-23).
The Melody valve is approved for transcatheter implantation into the RVOT and can be modified for the semilunar or AV positions, Dr. Emani and his coauthors said. The valve has achieved competence within a size range of 10-22 mm.
The researchers implanted the valve in four positions: RVOT (14), mitral (24), aortic (one), or tricuspid (three). The median age at implantation was 10 months, with a range of 3 weeks to 5.8 years. The patients had an average of one previous valve replacement or repair procedure.
Six deaths occurred in the study population; three before discharge. Those three patients had replacement to salvage a moribund circulation in the setting of mechanical circulatory support and severely depressed ventricular function. The other three patients who died were able to demonstrate adequate valve function, and autopsy did not show any signs of valvular thrombosis or deterioration, the researchers said.
Using Kaplan-Meier analysis, Dr. Emani and his coauthors estimated the freedom from death or transplantation was 83% at 12 months and 77% at 24 months.
The average time between catheter-based dilations was around 10 months, they wrote, “but this might be increased by more aggressive dilation.” Early in the study, the researchers were not aggressive with dilations because of concerns about valve injury, but then they found that patients tolerated increases in valve diameter by as much as 4 mm.
“Further investigation is needed to determine whether the device retains expandability over the long term after multiple dilations,” Dr. Emani and his coauthors said.
Further refinements in valve design and implantation techniques may lead to prevention of reoperation and perivalvular complications, they suggested.
The researchers did note a couple limitations of their study: the heterogeneous cohort prohibits any generalization of the outcomes, particularly mortality, and concomitant procedures performed during the valve replacement would affect mortality.
Dr. Emani and his colleagues had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: An expandable cardiac valve adapted for infants and children demonstrates acceptable function and can accommodate the child’s growth.
Major finding: At 12 months after implantation of a bovine jugular vein graft reinforced with an external stent modified for surgical valve replacement in pediatric patients, Kaplan-Meier analysis indicated that 83% of those surviving would be free from reoperation at 12 months.
Data source: Single-center study of 42 patients who underwent implantation between 2010 and 2014.
Disclosures: Dr. Emani and his coauthors had no financial relationships to disclose.
Lower-risk approach for aortic arch repair
In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.
In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).
In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.
One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.
“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.
Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.
On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”
Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.
In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.
Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.
Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.
Dr. Tulzer and coauthors had no financial relationships to disclose.
While the outcomes that Dr. Tulzer and colleagues reported are “remarkable,” the findings raise a question if mortality and risk of interventions are the sole determinants in selecting a surgical strategy, Petros V. Anagnostopoulos, MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1475-6). “The mortality should be low irrespective of approach,” Dr. Anagnostopoulos said.
He said that even if the surgeon pursues repair for coarctation and hypoplastic aortic arch through a thoracotomy instead of the median sternotomy the Austrian authors advocate and coarctation should recur, most of these cases can be treated with catheterization at low risk. “Will such a suboptimal outcome prove to be superior to that of a patient who has perfect anatomic repair but potentially faces adverse neurodevelopmental consequences of a neonatal cardiopulmonary bypass run?” he asked.
But the long-term outcomes are “poorly defined” as clinical investigators continue to “push the limits” to avoid deep hypothermia by using perfusion modifications to perform arch reconstruction, said Dr. Anagnostopoulos of the division of pediatric cardiothoracic surgery, American Family Children’s Hospital, University of Wisconsin, Madison. “It may be time to start taking into account not only survival and accuracy of repair, but also long-term sequelae of our therapies,” he concluded.
Dr. Anagnostopoulos had no financial relationships to disclose.
While the outcomes that Dr. Tulzer and colleagues reported are “remarkable,” the findings raise a question if mortality and risk of interventions are the sole determinants in selecting a surgical strategy, Petros V. Anagnostopoulos, MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1475-6). “The mortality should be low irrespective of approach,” Dr. Anagnostopoulos said.
He said that even if the surgeon pursues repair for coarctation and hypoplastic aortic arch through a thoracotomy instead of the median sternotomy the Austrian authors advocate and coarctation should recur, most of these cases can be treated with catheterization at low risk. “Will such a suboptimal outcome prove to be superior to that of a patient who has perfect anatomic repair but potentially faces adverse neurodevelopmental consequences of a neonatal cardiopulmonary bypass run?” he asked.
But the long-term outcomes are “poorly defined” as clinical investigators continue to “push the limits” to avoid deep hypothermia by using perfusion modifications to perform arch reconstruction, said Dr. Anagnostopoulos of the division of pediatric cardiothoracic surgery, American Family Children’s Hospital, University of Wisconsin, Madison. “It may be time to start taking into account not only survival and accuracy of repair, but also long-term sequelae of our therapies,” he concluded.
Dr. Anagnostopoulos had no financial relationships to disclose.
While the outcomes that Dr. Tulzer and colleagues reported are “remarkable,” the findings raise a question if mortality and risk of interventions are the sole determinants in selecting a surgical strategy, Petros V. Anagnostopoulos, MD, said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:1475-6). “The mortality should be low irrespective of approach,” Dr. Anagnostopoulos said.
He said that even if the surgeon pursues repair for coarctation and hypoplastic aortic arch through a thoracotomy instead of the median sternotomy the Austrian authors advocate and coarctation should recur, most of these cases can be treated with catheterization at low risk. “Will such a suboptimal outcome prove to be superior to that of a patient who has perfect anatomic repair but potentially faces adverse neurodevelopmental consequences of a neonatal cardiopulmonary bypass run?” he asked.
But the long-term outcomes are “poorly defined” as clinical investigators continue to “push the limits” to avoid deep hypothermia by using perfusion modifications to perform arch reconstruction, said Dr. Anagnostopoulos of the division of pediatric cardiothoracic surgery, American Family Children’s Hospital, University of Wisconsin, Madison. “It may be time to start taking into account not only survival and accuracy of repair, but also long-term sequelae of our therapies,” he concluded.
Dr. Anagnostopoulos had no financial relationships to disclose.
In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.
In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).
In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.
One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.
“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.
Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.
On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”
Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.
In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.
Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.
Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.
Dr. Tulzer and coauthors had no financial relationships to disclose.
In newborns with a borderline hypoplastic aortic arch, the type of operation and surgical approach can be critical in determining the risk of recurrent obstruction, but aortic arch reconstruction through a median sternotomy on bypass may carry a lower risk of recurrence than use of a thoracotomy.
In a study of 183 newborns and infants (median age of 15 days) who had surgery for coarctation and hypoplastic aortic arch over a 17-year period, researchers led by Andreas Tulzer, MD, of Children’s Heart Center, Linz, Austria, found that resection and extended end-to-end anastomosis (REEEA) as well as end-to-side anastomosis (ESA) yielded low mortality. The findings were published in the December 2016 issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:1506-13).
In the study, 72 patients had a median sternotomy – 71 with cardiopulmonary bypass (CPB) – and the remaining 111 had a lateral thoracotomy. Fifty-two patients (28.4%) had an additional ventricular septal defect closure. In the 71 patients who had median sternotomy with CPB, 41 had REEEA and 30 had ESA.
One patient who had median sternotomy with CPB had complications whereas 10 who had undergone primary repair with REEEA through a lateral thoracotomy had complications, for complications rates of 1.4% and 9%, respectively.
“Access through a median sternotomy with the use of CPB was superior to a lateral thoracotomy in terms of necessary reinterventions,” noted Dr. Tulzer and coauthors.
Of the 131 patients who had isolated repair of coarctation of the aorta with associated hypoplastic aortic arch, 116 had REEEA and 15 had ESA. There were no in-hospital deaths in this group and one patient needed an early reintervention. One patient had a severe neurologic complication.
On long-term follow-up of 139 patients at a median duration of 6.3 years, no late deaths were reported. “The calculated freedom from mortality (early and late) at 10 years for the entire group was 99.27%,” the researchers said. “In none of the patients of the follow-up population did we notice any signs of permanent left laryngeal nerve injury, bronchial compression, or left pulmonary artery stenosis.”
Lateral thoracotomy as access was a significant risk factor for recurrent obstruction at P = .03.
In the study, an experienced pediatric cardiologist and a pediatric cardiac surgeon determined which of three procedures to use – ESA on bypass, REEEA with a median sternotomy on CPB, or REEEA with a lateral thoracotomy without CPB – based on the size and anatomy of the proximal transverse aortic arch. In the early study period, cut-off values were proximal transverse arch diameters of 4 mm or less in newborns and young infants, but in the later study period the cut-off was z scores of –4.5 or less.
Adverse outcomes were minimal. There was one death within 30 days of surgery in the overall population (0.54%). The one severe complication consisted of paraplegia and cerebral hypoxemia after REEEA. At 10 years, 99.27% of all patients survived and 90.12% were free from intervention.
Either approach with REEEA and ESA is safe and effective, Dr. Tulzer and colleagues said, but they did determine a suitable population for the median sternotomy using CPB. “In patients with proximal transverse aortic arch, z scores of less than –4.59, arch repair should be performed through a median sternotomy using CPB, rather than through a lateral thoracotomy to reduce the risk for recurrent arch obstructions,” the researchers concluded.
Dr. Tulzer and coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Aortic arch reconstruction through a median sternotomy on bypass in newborns and infants had lower rates for recurrent obstruction than did a thoracotomy approach.
Major finding: Of 11 patients who required reintervention, one had a median sternotomy and 10 had a lateral thoracotomy.
Data source: Retrospective review of 183 consecutive newborns and infants with coarctation and hypoplastic aortic arch from 1996 to 2013.
Disclosures: Dr. Tulzer and coauthors had no financial relationships to disclose.