General Surgery

The American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP^®) is now in all 50 states and Washington, D.C. The ACS TQIP program reached this milestone on Aug. 2 with the addition of Meritus Medical Center in Hagerstown, Md., a Level III TQIP Site.

The TQIP pilot program began in 2009 with 23 centers, and the full TQIP program launched in 2010 with 65 centers. In 2014, Pediatric TQIP was added, and on July 1 of this year, Level III TQIP was launched. TQIP now has 561 enrolled sites (420 Level I and II Adult Sites, 40 Level III Sites, and 101 Pediatric Sites) and anticipates continued growth this year.

TQIP standardizes the collection and measurement of trauma data to generate quality improvement strategies and reduce disparities in trauma care nationwide. TQIP collects data from trauma centers, provides feedback about center performance, and identifies institutional improvements for better patient outcomes. TQIP provides hospitals with risk-adjusted benchmarking for accurate national comparisons. In addition, TQIP provides education and training to help trauma center staff improve the quality of their data and accurately interpret their benchmark reports. The program fosters clinical improvements with the support of Best Practice Guidelines (https://www.facs.org/quality-programs/trauma/tqip/best-practice), which allow enrolled centers to network and share best practice information at the TQIP annual meeting (https://www.facs.org/quality-programs/trauma/tqip/meeting) through the TQIP Google group (https://groups.google.com/forum/#!forum/trauma-quality-improvement-program---tqip), and in Web conferences.

For more information, visit the TQIP website (www.facs.org/quality-programs/trauma/tqip).

The American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP^®) is now in all 50 states and Washington, D.C. The ACS TQIP program reached this milestone on Aug. 2 with the addition of Meritus Medical Center in Hagerstown, Md., a Level III TQIP Site.

The TQIP pilot program began in 2009 with 23 centers, and the full TQIP program launched in 2010 with 65 centers. In 2014, Pediatric TQIP was added, and on July 1 of this year, Level III TQIP was launched. TQIP now has 561 enrolled sites (420 Level I and II Adult Sites, 40 Level III Sites, and 101 Pediatric Sites) and anticipates continued growth this year.

TQIP standardizes the collection and measurement of trauma data to generate quality improvement strategies and reduce disparities in trauma care nationwide. TQIP collects data from trauma centers, provides feedback about center performance, and identifies institutional improvements for better patient outcomes. TQIP provides hospitals with risk-adjusted benchmarking for accurate national comparisons. In addition, TQIP provides education and training to help trauma center staff improve the quality of their data and accurately interpret their benchmark reports. The program fosters clinical improvements with the support of Best Practice Guidelines (https://www.facs.org/quality-programs/trauma/tqip/best-practice), which allow enrolled centers to network and share best practice information at the TQIP annual meeting (https://www.facs.org/quality-programs/trauma/tqip/meeting) through the TQIP Google group (https://groups.google.com/forum/#!forum/trauma-quality-improvement-program---tqip), and in Web conferences.

For more information, visit the TQIP website (www.facs.org/quality-programs/trauma/tqip).

The American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP^®) is now in all 50 states and Washington, D.C. The ACS TQIP program reached this milestone on Aug. 2 with the addition of Meritus Medical Center in Hagerstown, Md., a Level III TQIP Site.

The TQIP pilot program began in 2009 with 23 centers, and the full TQIP program launched in 2010 with 65 centers. In 2014, Pediatric TQIP was added, and on July 1 of this year, Level III TQIP was launched. TQIP now has 561 enrolled sites (420 Level I and II Adult Sites, 40 Level III Sites, and 101 Pediatric Sites) and anticipates continued growth this year.

TQIP standardizes the collection and measurement of trauma data to generate quality improvement strategies and reduce disparities in trauma care nationwide. TQIP collects data from trauma centers, provides feedback about center performance, and identifies institutional improvements for better patient outcomes. TQIP provides hospitals with risk-adjusted benchmarking for accurate national comparisons. In addition, TQIP provides education and training to help trauma center staff improve the quality of their data and accurately interpret their benchmark reports. The program fosters clinical improvements with the support of Best Practice Guidelines (https://www.facs.org/quality-programs/trauma/tqip/best-practice), which allow enrolled centers to network and share best practice information at the TQIP annual meeting (https://www.facs.org/quality-programs/trauma/tqip/meeting) through the TQIP Google group (https://groups.google.com/forum/#!forum/trauma-quality-improvement-program---tqip), and in Web conferences.

For more information, visit the TQIP website (www.facs.org/quality-programs/trauma/tqip).

J. David Richardson, MD, FACS, 2015-2016 President of the American College of Surgeons (ACS) and Chair of the ACS Committee on Transition to Practice (TTP) Program in General Surgery, will host an informal Meet and Greet during the ACS Clinical Congress 2016, 12:00 noon – 1:00 pm, Tuesday, October 18, at the Walter E. Washington Convention Center. Dr. Richardson will be available to speak with Clinical Congress attendees at the Division of Education Booth in the ACS Resource Center in Hall B. Residents who are considering careers in general surgery as well as faculty and practicing surgeons may be interested in learning more about the TTP Program at https://www.facs.org/education/program/ttp. Dennis W. Ashley, MD, FACS, FCCM, TTP chief of the Mercer University School of Medicine Program, Cordele, GA, which has successfully incorporated the TTP Program, will join Dr. Richardson at the Meet and Greet. Contact [email protected] for more information or stop by the Division of Education booth at the Clinical Congress and learn more about this growing program.

J. David Richardson, MD, FACS, 2015-2016 President of the American College of Surgeons (ACS) and Chair of the ACS Committee on Transition to Practice (TTP) Program in General Surgery, will host an informal Meet and Greet during the ACS Clinical Congress 2016, 12:00 noon – 1:00 pm, Tuesday, October 18, at the Walter E. Washington Convention Center. Dr. Richardson will be available to speak with Clinical Congress attendees at the Division of Education Booth in the ACS Resource Center in Hall B. Residents who are considering careers in general surgery as well as faculty and practicing surgeons may be interested in learning more about the TTP Program at https://www.facs.org/education/program/ttp. Dennis W. Ashley, MD, FACS, FCCM, TTP chief of the Mercer University School of Medicine Program, Cordele, GA, which has successfully incorporated the TTP Program, will join Dr. Richardson at the Meet and Greet. Contact [email protected] for more information or stop by the Division of Education booth at the Clinical Congress and learn more about this growing program.

J. David Richardson, MD, FACS, 2015-2016 President of the American College of Surgeons (ACS) and Chair of the ACS Committee on Transition to Practice (TTP) Program in General Surgery, will host an informal Meet and Greet during the ACS Clinical Congress 2016, 12:00 noon – 1:00 pm, Tuesday, October 18, at the Walter E. Washington Convention Center. Dr. Richardson will be available to speak with Clinical Congress attendees at the Division of Education Booth in the ACS Resource Center in Hall B. Residents who are considering careers in general surgery as well as faculty and practicing surgeons may be interested in learning more about the TTP Program at https://www.facs.org/education/program/ttp. Dennis W. Ashley, MD, FACS, FCCM, TTP chief of the Mercer University School of Medicine Program, Cordele, GA, which has successfully incorporated the TTP Program, will join Dr. Richardson at the Meet and Greet. Contact [email protected] for more information or stop by the Division of Education booth at the Clinical Congress and learn more about this growing program.

The American College of Surgeons (ACS) has finalized a statement on professional attire for surgeons in and out of the operating room (OR). The new ACS guideline for appropriate attire is based on principles of professionalism, common sense, decorum, and the available evidence. It includes the following provisions:

• Soiled scrubs and/or hats should be changed as soon as feasible and certainly before speaking with family members after an operation.

• Scrubs and hats worn during dirty or contaminated cases should be changed prior to subsequent cases even if not visibly soiled.

• Dangling masks should not be worn at any time.

• Operating room scrubs should not be worn in the hospital facility outside of the OR area without a clean lab coat or appropriate cover.

• OR scrubs should not be worn at any time outside of the hospital perimeter.

• OR scrubs should be changed at least daily.

• During invasive procedures, the mouth, nose, and hair (skull and face) should be covered to avoid potential wound contamination. Large sideburns and ponytails should be covered or contained. There is no evidence that leaving ears, a limited amount of hair on the nape of the neck or a modest sideburn uncovered contributes to wound infections.

• Jewelry worn on the head or neck, where the items might fall into or contaminate the sterile field, should be removed or appropriately covered during procedures.

• The ACS encourages surgeons to wear clean, appropriate professional attire (not scrubs) during all patient encounters outside of the OR.

The ACS Statement on Operating Room Attire provides detailed guidelines on wearing the skullcap in a way that ensures patient safety and facilitates enforcement of the standard on wearing scrubs only within the perimeter of the hospital by suggesting the adoption of distinctively colored scrub suits for OR personnel.

In addition, the ACS is collaborating with the Centers for Medicare & Medicaid Services and The Joint Commission to ensure that their policies and regulatory oversight activities are aligned with the College’s recommendations.

The statement will be published in the October Bulletin.

The American College of Surgeons (ACS) has finalized a statement on professional attire for surgeons in and out of the operating room (OR). The new ACS guideline for appropriate attire is based on principles of professionalism, common sense, decorum, and the available evidence. It includes the following provisions:

• Soiled scrubs and/or hats should be changed as soon as feasible and certainly before speaking with family members after an operation.

• Scrubs and hats worn during dirty or contaminated cases should be changed prior to subsequent cases even if not visibly soiled.

• Dangling masks should not be worn at any time.

• Operating room scrubs should not be worn in the hospital facility outside of the OR area without a clean lab coat or appropriate cover.

• OR scrubs should not be worn at any time outside of the hospital perimeter.

• OR scrubs should be changed at least daily.

• During invasive procedures, the mouth, nose, and hair (skull and face) should be covered to avoid potential wound contamination. Large sideburns and ponytails should be covered or contained. There is no evidence that leaving ears, a limited amount of hair on the nape of the neck or a modest sideburn uncovered contributes to wound infections.

• Jewelry worn on the head or neck, where the items might fall into or contaminate the sterile field, should be removed or appropriately covered during procedures.

• The ACS encourages surgeons to wear clean, appropriate professional attire (not scrubs) during all patient encounters outside of the OR.

The ACS Statement on Operating Room Attire provides detailed guidelines on wearing the skullcap in a way that ensures patient safety and facilitates enforcement of the standard on wearing scrubs only within the perimeter of the hospital by suggesting the adoption of distinctively colored scrub suits for OR personnel.

In addition, the ACS is collaborating with the Centers for Medicare & Medicaid Services and The Joint Commission to ensure that their policies and regulatory oversight activities are aligned with the College’s recommendations.

The statement will be published in the October Bulletin.

The American College of Surgeons (ACS) has finalized a statement on professional attire for surgeons in and out of the operating room (OR). The new ACS guideline for appropriate attire is based on principles of professionalism, common sense, decorum, and the available evidence. It includes the following provisions:

• Soiled scrubs and/or hats should be changed as soon as feasible and certainly before speaking with family members after an operation.

• Scrubs and hats worn during dirty or contaminated cases should be changed prior to subsequent cases even if not visibly soiled.

• Dangling masks should not be worn at any time.

• Operating room scrubs should not be worn in the hospital facility outside of the OR area without a clean lab coat or appropriate cover.

• OR scrubs should not be worn at any time outside of the hospital perimeter.

• OR scrubs should be changed at least daily.

• During invasive procedures, the mouth, nose, and hair (skull and face) should be covered to avoid potential wound contamination. Large sideburns and ponytails should be covered or contained. There is no evidence that leaving ears, a limited amount of hair on the nape of the neck or a modest sideburn uncovered contributes to wound infections.

• Jewelry worn on the head or neck, where the items might fall into or contaminate the sterile field, should be removed or appropriately covered during procedures.

• The ACS encourages surgeons to wear clean, appropriate professional attire (not scrubs) during all patient encounters outside of the OR.

The ACS Statement on Operating Room Attire provides detailed guidelines on wearing the skullcap in a way that ensures patient safety and facilitates enforcement of the standard on wearing scrubs only within the perimeter of the hospital by suggesting the adoption of distinctively colored scrub suits for OR personnel.

In addition, the ACS is collaborating with the Centers for Medicare & Medicaid Services and The Joint Commission to ensure that their policies and regulatory oversight activities are aligned with the College’s recommendations.

The statement will be published in the October Bulletin.

Register online for the seventh annual American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP®) Scientific Meeting and Training, November 5-7 at the Omni Orlando Resort at ChampionsGate, FL. Register for the conference at https://www.compusystems.com/servlet/ar?evt_uid=785.

The meeting will convene trauma medical directors, program managers, coordinators, and registrars from participating and prospective TQIP hospitals. J. Wayne Meredith, MD, FACS, MCCM, Winston-Salem, NC, the 2014 recipient of the ACS Distinguished Service Award and Past-Medical Director, ACS Trauma Programs, will deliver the keynote address. The program will include sessions for new TQIP centers, new staff at existing centers, and participants in need of a TQIP refresher. Breakout sessions focused on registrar and abstractor concerns, matters that relate to the trauma medical director and trauma program manager-focused issues will enhance the learning experience and instruct participants in their role on the TQIP team.

Visit the TQIP annual meeting website at https://www.facs.org/tqipmeeting to view the conference schedule and obtain information about lodging, transportation, and a social outing to Cirque du Soleil. For more information, contact ACS TQIP staff at [email protected].

Register online for the seventh annual American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP®) Scientific Meeting and Training, November 5-7 at the Omni Orlando Resort at ChampionsGate, FL. Register for the conference at https://www.compusystems.com/servlet/ar?evt_uid=785.

The meeting will convene trauma medical directors, program managers, coordinators, and registrars from participating and prospective TQIP hospitals. J. Wayne Meredith, MD, FACS, MCCM, Winston-Salem, NC, the 2014 recipient of the ACS Distinguished Service Award and Past-Medical Director, ACS Trauma Programs, will deliver the keynote address. The program will include sessions for new TQIP centers, new staff at existing centers, and participants in need of a TQIP refresher. Breakout sessions focused on registrar and abstractor concerns, matters that relate to the trauma medical director and trauma program manager-focused issues will enhance the learning experience and instruct participants in their role on the TQIP team.

Visit the TQIP annual meeting website at https://www.facs.org/tqipmeeting to view the conference schedule and obtain information about lodging, transportation, and a social outing to Cirque du Soleil. For more information, contact ACS TQIP staff at [email protected].

Register online for the seventh annual American College of Surgeons (ACS) Trauma Quality Improvement Program (TQIP®) Scientific Meeting and Training, November 5-7 at the Omni Orlando Resort at ChampionsGate, FL. Register for the conference at https://www.compusystems.com/servlet/ar?evt_uid=785.

The meeting will convene trauma medical directors, program managers, coordinators, and registrars from participating and prospective TQIP hospitals. J. Wayne Meredith, MD, FACS, MCCM, Winston-Salem, NC, the 2014 recipient of the ACS Distinguished Service Award and Past-Medical Director, ACS Trauma Programs, will deliver the keynote address. The program will include sessions for new TQIP centers, new staff at existing centers, and participants in need of a TQIP refresher. Breakout sessions focused on registrar and abstractor concerns, matters that relate to the trauma medical director and trauma program manager-focused issues will enhance the learning experience and instruct participants in their role on the TQIP team.

Visit the TQIP annual meeting website at https://www.facs.org/tqipmeeting to view the conference schedule and obtain information about lodging, transportation, and a social outing to Cirque du Soleil. For more information, contact ACS TQIP staff at [email protected].

Patricia L. Turner, MD, FACS, Director of the American College of Surgeons Division of Member Services, received the 2016 National Medical Association (NMA) Council on Concerns of Women Physicians (CCWP) Service Award. Dr. Turner received the award July 31 at the CCWP Annual Muriel Petioni, MD, Awards Luncheon, which took place during the NMA’s 114th Annual Convention and Scientific Assembly in Los Angeles.

This award honors women physicians who, through research, community service, and activism, strive to eliminate health care disparities, provide people of color with quality health care, and address women’s health and professional issues. The awards program, the most highly attended event of the convention, continues to grow in popularity. This year’s program featured award-winning actress and television director Regina King. Read more about the NMA and the award at http://www.afassanoco.com/nma/ccwpprogram.html.

Patricia L. Turner, MD, FACS, Director of the American College of Surgeons Division of Member Services, received the 2016 National Medical Association (NMA) Council on Concerns of Women Physicians (CCWP) Service Award. Dr. Turner received the award July 31 at the CCWP Annual Muriel Petioni, MD, Awards Luncheon, which took place during the NMA’s 114th Annual Convention and Scientific Assembly in Los Angeles.

This award honors women physicians who, through research, community service, and activism, strive to eliminate health care disparities, provide people of color with quality health care, and address women’s health and professional issues. The awards program, the most highly attended event of the convention, continues to grow in popularity. This year’s program featured award-winning actress and television director Regina King. Read more about the NMA and the award at http://www.afassanoco.com/nma/ccwpprogram.html.

Patricia L. Turner, MD, FACS, Director of the American College of Surgeons Division of Member Services, received the 2016 National Medical Association (NMA) Council on Concerns of Women Physicians (CCWP) Service Award. Dr. Turner received the award July 31 at the CCWP Annual Muriel Petioni, MD, Awards Luncheon, which took place during the NMA’s 114th Annual Convention and Scientific Assembly in Los Angeles.

This award honors women physicians who, through research, community service, and activism, strive to eliminate health care disparities, provide people of color with quality health care, and address women’s health and professional issues. The awards program, the most highly attended event of the convention, continues to grow in popularity. This year’s program featured award-winning actress and television director Regina King. Read more about the NMA and the award at http://www.afassanoco.com/nma/ccwpprogram.html.

The porcine acellular dermal mesh product Strattice was associated with significantly lower odds of hernia recurrence, compared with several other biologic mesh products, in a study of 223 patients who underwent open ventral hernia repair.

Prospective operative outcomes data from a tertiary referral hernia center showed that at a mean follow-up of 18.2 months, the rate of hernia recurrence was 35% in 40 patients who were treated with Alloderm (LifeCell Corporation), 34.5% in 23 patients treated with AlloMax (Bard/Davol), 37.1% in 70 patients treated with FlexHD (Ethicon), and 59.1% in 22 patients treated with Xenmatrix (Bard/Davol), compared with 14.7% in 68 patients treated with Strattice (LifeCell Corporation). Alloderm, AlloMax, and FlexHD are all human acellular dermal mesh products, and Strattice and Xenmatrix are both porcine acellular dermal mesh products, Ciara R. Huntington, MD, and her colleagues at the Carolinas Medical Center in Charlotte, N.C., reported.

Photo courtesy Acelity. STRATTICETM Reconstructive Tissue Matrix

After multivariate analysis to adjust for factors such as comorbidities, hernia size, and intraoperative techniques, the odds ratios for recurrence with each product as compared with Strattice were 2.4 with Alloderm, 2.9 with FlexHD, 3.4 with AlloMax, and 7.8 with Xenmatrix. The odds for recurrence were significantly greater with all except Alloderm, the investigators said (Surgery. 2016. doi: 10.1016/j.surg.2016.07.008).

The significant differences between the two porcine acellular dermal meshes (Xenmatrix and Strattice) may reflect variation in tissue processing and design in biomesh engineering, they noted.

Study subjects were adults with a mean age of 57.7 years and mean body mass index of 34.8 kg/m². Overall, 9.8% had an American Society of Anesthesiology classification of 4, 54.6% had a classification of 3, and 35.6% had a classification of 1 or 2. Average operative time was 241 minutes with estimated blood loss of 202 mL.

Average hernia defect size was 257 cm², with average mesh size of 384 cm².

“Component separation was performed in 47.5% of cases, and abdomen was left open prior to definitive closure in 10.7%. Biologic mesh was used to bridge fascial defects in 19.6% of cases. The mesh was placed in the preperitoneal space in 38.2% of cases,” the investigators wrote, noting that a concomitant procedure was performed in 82% of cases.

Sepsis developed in 6.7% of patients, 36.3% had a wound infection, and 24.3% required a negative pressure dressing for healing. The inpatient mortality rate was 1.4%.

However, mesh infections requiring explantation occurred in less than 1% of cases.

On adjusted analysis, Xenmatrix was the most expensive mesh and AlloMax was the least expensive (mean of $59,122 and $22,304, respectively). Strattice costs averaged $40,490.

Ventral hernia repair (VHR) is a common operation, with about 350,000 performed each year. Rates of postoperative wound infection and hernia recurrence vary widely, but may be improved with appropriate mesh selection. However, prospective data to guide selection are lacking, the investigators said.

“The great number of meshes available for use complicates the debate surrounding the best timing and use of biologic mesh in VHR, and the search for the better mesh for use in the abdominal wall reconstruction continues. Biologic mesh usually is reserved for the patients at the highest risk for developing a postoperative wound complication, and although there is a current dearth of high-level evidence supporting its use, this report confirms that complications are low despite obvious surgical complexity presented herein,” they wrote.

The findings of this study – the largest report of outcomes with biologic mesh in ventral hernia repair to date, according to the authors – support the safety of using biologic mesh in high-risk patients, they said.

They noted, however, that the study may still be underpowered to make final clinical decisions.

“Although our study provides useful information to the practicing surgeon, there is much work to be done regarding the selection of biologic mesh,” they wrote, adding that while “a well-performing biologic mesh should be in the toolkit of every general surgeon who may face complex abdominal walls requiring reconstruction in patients that are at high risk for a postoperative wound complication,” additional research is necessary to further clarify the role of biologic mesh in these operations.

Dr. Huntington reported having no disclosures. Other authors reported having been awarded honoraria, speaking fees, surgical research funding, and education grants from W.L. Gore and Associates, Ethicon, Novadaq, Bard/Davol, and LifeCell Corporation.

[email protected]

The porcine acellular dermal mesh product Strattice was associated with significantly lower odds of hernia recurrence, compared with several other biologic mesh products, in a study of 223 patients who underwent open ventral hernia repair.

Prospective operative outcomes data from a tertiary referral hernia center showed that at a mean follow-up of 18.2 months, the rate of hernia recurrence was 35% in 40 patients who were treated with Alloderm (LifeCell Corporation), 34.5% in 23 patients treated with AlloMax (Bard/Davol), 37.1% in 70 patients treated with FlexHD (Ethicon), and 59.1% in 22 patients treated with Xenmatrix (Bard/Davol), compared with 14.7% in 68 patients treated with Strattice (LifeCell Corporation). Alloderm, AlloMax, and FlexHD are all human acellular dermal mesh products, and Strattice and Xenmatrix are both porcine acellular dermal mesh products, Ciara R. Huntington, MD, and her colleagues at the Carolinas Medical Center in Charlotte, N.C., reported.

Photo courtesy Acelity. STRATTICETM Reconstructive Tissue Matrix

After multivariate analysis to adjust for factors such as comorbidities, hernia size, and intraoperative techniques, the odds ratios for recurrence with each product as compared with Strattice were 2.4 with Alloderm, 2.9 with FlexHD, 3.4 with AlloMax, and 7.8 with Xenmatrix. The odds for recurrence were significantly greater with all except Alloderm, the investigators said (Surgery. 2016. doi: 10.1016/j.surg.2016.07.008).

The significant differences between the two porcine acellular dermal meshes (Xenmatrix and Strattice) may reflect variation in tissue processing and design in biomesh engineering, they noted.

Study subjects were adults with a mean age of 57.7 years and mean body mass index of 34.8 kg/m². Overall, 9.8% had an American Society of Anesthesiology classification of 4, 54.6% had a classification of 3, and 35.6% had a classification of 1 or 2. Average operative time was 241 minutes with estimated blood loss of 202 mL.

Average hernia defect size was 257 cm², with average mesh size of 384 cm².

“Component separation was performed in 47.5% of cases, and abdomen was left open prior to definitive closure in 10.7%. Biologic mesh was used to bridge fascial defects in 19.6% of cases. The mesh was placed in the preperitoneal space in 38.2% of cases,” the investigators wrote, noting that a concomitant procedure was performed in 82% of cases.

Sepsis developed in 6.7% of patients, 36.3% had a wound infection, and 24.3% required a negative pressure dressing for healing. The inpatient mortality rate was 1.4%.

However, mesh infections requiring explantation occurred in less than 1% of cases.

On adjusted analysis, Xenmatrix was the most expensive mesh and AlloMax was the least expensive (mean of $59,122 and $22,304, respectively). Strattice costs averaged $40,490.

Ventral hernia repair (VHR) is a common operation, with about 350,000 performed each year. Rates of postoperative wound infection and hernia recurrence vary widely, but may be improved with appropriate mesh selection. However, prospective data to guide selection are lacking, the investigators said.

“The great number of meshes available for use complicates the debate surrounding the best timing and use of biologic mesh in VHR, and the search for the better mesh for use in the abdominal wall reconstruction continues. Biologic mesh usually is reserved for the patients at the highest risk for developing a postoperative wound complication, and although there is a current dearth of high-level evidence supporting its use, this report confirms that complications are low despite obvious surgical complexity presented herein,” they wrote.

The findings of this study – the largest report of outcomes with biologic mesh in ventral hernia repair to date, according to the authors – support the safety of using biologic mesh in high-risk patients, they said.

They noted, however, that the study may still be underpowered to make final clinical decisions.

“Although our study provides useful information to the practicing surgeon, there is much work to be done regarding the selection of biologic mesh,” they wrote, adding that while “a well-performing biologic mesh should be in the toolkit of every general surgeon who may face complex abdominal walls requiring reconstruction in patients that are at high risk for a postoperative wound complication,” additional research is necessary to further clarify the role of biologic mesh in these operations.

Dr. Huntington reported having no disclosures. Other authors reported having been awarded honoraria, speaking fees, surgical research funding, and education grants from W.L. Gore and Associates, Ethicon, Novadaq, Bard/Davol, and LifeCell Corporation.

[email protected]

The porcine acellular dermal mesh product Strattice was associated with significantly lower odds of hernia recurrence, compared with several other biologic mesh products, in a study of 223 patients who underwent open ventral hernia repair.

Prospective operative outcomes data from a tertiary referral hernia center showed that at a mean follow-up of 18.2 months, the rate of hernia recurrence was 35% in 40 patients who were treated with Alloderm (LifeCell Corporation), 34.5% in 23 patients treated with AlloMax (Bard/Davol), 37.1% in 70 patients treated with FlexHD (Ethicon), and 59.1% in 22 patients treated with Xenmatrix (Bard/Davol), compared with 14.7% in 68 patients treated with Strattice (LifeCell Corporation). Alloderm, AlloMax, and FlexHD are all human acellular dermal mesh products, and Strattice and Xenmatrix are both porcine acellular dermal mesh products, Ciara R. Huntington, MD, and her colleagues at the Carolinas Medical Center in Charlotte, N.C., reported.

Photo courtesy Acelity. STRATTICETM Reconstructive Tissue Matrix

After multivariate analysis to adjust for factors such as comorbidities, hernia size, and intraoperative techniques, the odds ratios for recurrence with each product as compared with Strattice were 2.4 with Alloderm, 2.9 with FlexHD, 3.4 with AlloMax, and 7.8 with Xenmatrix. The odds for recurrence were significantly greater with all except Alloderm, the investigators said (Surgery. 2016. doi: 10.1016/j.surg.2016.07.008).

The significant differences between the two porcine acellular dermal meshes (Xenmatrix and Strattice) may reflect variation in tissue processing and design in biomesh engineering, they noted.

Study subjects were adults with a mean age of 57.7 years and mean body mass index of 34.8 kg/m². Overall, 9.8% had an American Society of Anesthesiology classification of 4, 54.6% had a classification of 3, and 35.6% had a classification of 1 or 2. Average operative time was 241 minutes with estimated blood loss of 202 mL.

Average hernia defect size was 257 cm², with average mesh size of 384 cm².

“Component separation was performed in 47.5% of cases, and abdomen was left open prior to definitive closure in 10.7%. Biologic mesh was used to bridge fascial defects in 19.6% of cases. The mesh was placed in the preperitoneal space in 38.2% of cases,” the investigators wrote, noting that a concomitant procedure was performed in 82% of cases.

Sepsis developed in 6.7% of patients, 36.3% had a wound infection, and 24.3% required a negative pressure dressing for healing. The inpatient mortality rate was 1.4%.

However, mesh infections requiring explantation occurred in less than 1% of cases.

On adjusted analysis, Xenmatrix was the most expensive mesh and AlloMax was the least expensive (mean of $59,122 and $22,304, respectively). Strattice costs averaged $40,490.

Ventral hernia repair (VHR) is a common operation, with about 350,000 performed each year. Rates of postoperative wound infection and hernia recurrence vary widely, but may be improved with appropriate mesh selection. However, prospective data to guide selection are lacking, the investigators said.

“The great number of meshes available for use complicates the debate surrounding the best timing and use of biologic mesh in VHR, and the search for the better mesh for use in the abdominal wall reconstruction continues. Biologic mesh usually is reserved for the patients at the highest risk for developing a postoperative wound complication, and although there is a current dearth of high-level evidence supporting its use, this report confirms that complications are low despite obvious surgical complexity presented herein,” they wrote.

The findings of this study – the largest report of outcomes with biologic mesh in ventral hernia repair to date, according to the authors – support the safety of using biologic mesh in high-risk patients, they said.

They noted, however, that the study may still be underpowered to make final clinical decisions.

“Although our study provides useful information to the practicing surgeon, there is much work to be done regarding the selection of biologic mesh,” they wrote, adding that while “a well-performing biologic mesh should be in the toolkit of every general surgeon who may face complex abdominal walls requiring reconstruction in patients that are at high risk for a postoperative wound complication,” additional research is necessary to further clarify the role of biologic mesh in these operations.

Dr. Huntington reported having no disclosures. Other authors reported having been awarded honoraria, speaking fees, surgical research funding, and education grants from W.L. Gore and Associates, Ethicon, Novadaq, Bard/Davol, and LifeCell Corporation.

[email protected]

In light of increasing antibiotic resistance among pathogens, the World Health Organization has revised its global rankings of critically important antimicrobials used in human medicine, designating quinolones, third- and fourth-generation cephalosporins, macrolides and ketolides, and glycopeptides as among the highest-priority drugs in the world.

Peter C. Collignon, MBBS, of Canberra (Australia) Hospital and his colleagues on the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance, created the rankings for use in developing risk management strategies related to antimicrobial use in food production animals. According to Dr. Collignon and his coauthors, the rankings are intended to help regulators and other stakeholders know which types of antimicrobials used in animals present potentially higher risks to human populations and help inform how this use might be better managed (e.g. restriction to single-animal therapy or prohibition of mass treatment and extra-label use) to minimize the risk of transmission of resistance to the human population.

©thegoodphoto/Thinkstock

WHO studies previously suggested that antimicrobials which currently have no veterinary equivalent (for example, carbapenems) “as well as any new class of antimicrobial developed for human therapy should not be used in animals.” Dr. Collignon’s WHO Advisory Group followed two essential criteria to designate antimicrobials of utmost importance to human health in the new study: 1. antimicrobials that are the sole, or one of limited available therapies, to treat serious bacterial infections in people and 2. antimicrobials used to treat infections in people caused by either (a) bacteria that may be transmitted to humans from nonhuman sources or (b) bacteria that may acquire resistance genes from nonhuman sources.

The highest-priority and most critically important antimicrobials are those which meet the criteria listed above and that are used in greatest volume or highest frequency by humans. Another criteria for prioritization involves antimicrobial classes where evidence suggests that the “transmission of resistant bacteria or resistance genes from nonhuman sources is already occurring, or has occurred previously.” Quinolones, third- and fourth-generation cephalosporins, macrolides and ketolides, and glycopeptides were the only antimicrobials that met all criteria for prioritization.

“Antimicrobial resistance remains a threat to human health and drivers of resistance act in all sectors; human, animal, and the environment,” the WHO Advisory Group concluded. “Prioritizing the antimicrobials that are critically important for humans is a valuable and strategic risk-management tool and will be improved with the evidence-based approach which is currently underway.”

Read the full study in Clinical Infectious Diseases (doi: 10.1093/cid/ciw475).

[email protected]

In light of increasing antibiotic resistance among pathogens, the World Health Organization has revised its global rankings of critically important antimicrobials used in human medicine, designating quinolones, third- and fourth-generation cephalosporins, macrolides and ketolides, and glycopeptides as among the highest-priority drugs in the world.

Peter C. Collignon, MBBS, of Canberra (Australia) Hospital and his colleagues on the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance, created the rankings for use in developing risk management strategies related to antimicrobial use in food production animals. According to Dr. Collignon and his coauthors, the rankings are intended to help regulators and other stakeholders know which types of antimicrobials used in animals present potentially higher risks to human populations and help inform how this use might be better managed (e.g. restriction to single-animal therapy or prohibition of mass treatment and extra-label use) to minimize the risk of transmission of resistance to the human population.

©thegoodphoto/Thinkstock

WHO studies previously suggested that antimicrobials which currently have no veterinary equivalent (for example, carbapenems) “as well as any new class of antimicrobial developed for human therapy should not be used in animals.” Dr. Collignon’s WHO Advisory Group followed two essential criteria to designate antimicrobials of utmost importance to human health in the new study: 1. antimicrobials that are the sole, or one of limited available therapies, to treat serious bacterial infections in people and 2. antimicrobials used to treat infections in people caused by either (a) bacteria that may be transmitted to humans from nonhuman sources or (b) bacteria that may acquire resistance genes from nonhuman sources.

The highest-priority and most critically important antimicrobials are those which meet the criteria listed above and that are used in greatest volume or highest frequency by humans. Another criteria for prioritization involves antimicrobial classes where evidence suggests that the “transmission of resistant bacteria or resistance genes from nonhuman sources is already occurring, or has occurred previously.” Quinolones, third- and fourth-generation cephalosporins, macrolides and ketolides, and glycopeptides were the only antimicrobials that met all criteria for prioritization.

“Antimicrobial resistance remains a threat to human health and drivers of resistance act in all sectors; human, animal, and the environment,” the WHO Advisory Group concluded. “Prioritizing the antimicrobials that are critically important for humans is a valuable and strategic risk-management tool and will be improved with the evidence-based approach which is currently underway.”

Read the full study in Clinical Infectious Diseases (doi: 10.1093/cid/ciw475).

[email protected]

In light of increasing antibiotic resistance among pathogens, the World Health Organization has revised its global rankings of critically important antimicrobials used in human medicine, designating quinolones, third- and fourth-generation cephalosporins, macrolides and ketolides, and glycopeptides as among the highest-priority drugs in the world.

Peter C. Collignon, MBBS, of Canberra (Australia) Hospital and his colleagues on the WHO Advisory Group on Integrated Surveillance of Antimicrobial Resistance, created the rankings for use in developing risk management strategies related to antimicrobial use in food production animals. According to Dr. Collignon and his coauthors, the rankings are intended to help regulators and other stakeholders know which types of antimicrobials used in animals present potentially higher risks to human populations and help inform how this use might be better managed (e.g. restriction to single-animal therapy or prohibition of mass treatment and extra-label use) to minimize the risk of transmission of resistance to the human population.

©thegoodphoto/Thinkstock

WHO studies previously suggested that antimicrobials which currently have no veterinary equivalent (for example, carbapenems) “as well as any new class of antimicrobial developed for human therapy should not be used in animals.” Dr. Collignon’s WHO Advisory Group followed two essential criteria to designate antimicrobials of utmost importance to human health in the new study: 1. antimicrobials that are the sole, or one of limited available therapies, to treat serious bacterial infections in people and 2. antimicrobials used to treat infections in people caused by either (a) bacteria that may be transmitted to humans from nonhuman sources or (b) bacteria that may acquire resistance genes from nonhuman sources.

The highest-priority and most critically important antimicrobials are those which meet the criteria listed above and that are used in greatest volume or highest frequency by humans. Another criteria for prioritization involves antimicrobial classes where evidence suggests that the “transmission of resistant bacteria or resistance genes from nonhuman sources is already occurring, or has occurred previously.” Quinolones, third- and fourth-generation cephalosporins, macrolides and ketolides, and glycopeptides were the only antimicrobials that met all criteria for prioritization.

“Antimicrobial resistance remains a threat to human health and drivers of resistance act in all sectors; human, animal, and the environment,” the WHO Advisory Group concluded. “Prioritizing the antimicrobials that are critically important for humans is a valuable and strategic risk-management tool and will be improved with the evidence-based approach which is currently underway.”

Read the full study in Clinical Infectious Diseases (doi: 10.1093/cid/ciw475).

[email protected]

Progress in the development of new oral anticoagulants (NOACs), as well as agents for their reversal, has lowered the threshold to use these therapeutics as first line agents for the management of nonvalvular atrial fibrillation and venous thromboembolism.^1,2 Despite this increase in adoption, however, debate persists as to whether patients chronically maintained on vitamin K antagonists (VKAs), such as warfarin, should be switched to NOACs. The recently published research letter by Pokorney et al. assessed the stability of international normalized ratios (INRs) in patients on long-term warfarin therapy in order to address this question.³

Specifically, prospective registry data from 3,749 patients with at least three INR values in the first 6 months of therapy as well as six or more in the following year were included. Patients were deemed stable if 80% or more of their INRs were in a therapeutic range defined as an INR between 2 and 3.3 During the initiation period, only one in four patients taking warfarin had a stable INR.³ Furthermore, stability in the first 6 months was found to have limited ability to predict stability in the subsequent year (concordance index of 0.61). With regard to time in therapeutic range (TTR), only 32% of patients had a TTR of greater than 80% during the first 6 months with less than half (42%) of these patients able to maintain this in the following year.

Findings from Pokorney et al. add to the growing body of literature demonstrating the difficulty of achieving and maintaining a therapeutic INR while on warfarin therapy.^4-7 Clinically, these findings are important, as deviations from TTR have been shown to be associated with increased risk of bleeding and thrombosis as well as increased health care costs.^8-10 Mechanistically, patient factors such as differences in vitamin K consumption, comorbid conditions, drug-drug interactions, and medication compliance, as well as genetic differences that impact drug metabolism undoubtedly contribute to the variation of INR noted in patients on warfarin therapy.

Attempts to improve stability have included the administration of low-dose oral vitamin K. However, recent data from a multicenter randomized control trial suggests that while such therapy may help to decrease extreme variations in INR, it does not lead to an increased TTR.¹¹ Furthermore, while significant work has been conducted in identifying specific gene variants, such as CYP2C9 and VKORC, which encode cytochrome P450 and vitamin K epoxide reductase enzymes, respectively, economic analyses suggest that testing for these gene variants would not be cost-effective.¹² Additionally, clinical prediction tools, which incorporate important patient factors to help guide anticoagulation explain less than 10% of TTR variability.⁴

Nonetheless, some caution is warranted in the interpretation of the results reported by Pokorney and his colleagues. The proportion of registry patients treated with warfarin who had a low TTR was much lower than that previously reported by the pivotal U.S. trials of NOACs (55%-68%) and significantly lower than the results of a recent nationwide Swedish registry involving 40,449 patients.¹³

In the Swedish registry, the mean individual TTR was 70% with more than half the patients having a TTR of 70% or more, emphasizing the importance of health care system effects. Moreover, regardless of whether a patient is on warfarin or a NOAC, patients with a lower TTR have higher rates of diabetes, chronic obstructive pulmonary disease, heart failure, and renal failure, which may contribute to the need for additional therapies that may influence TTR.

For example, INR may be increased by ciprofloxacin or omeprazole when taken with warfarin, and CYP3A4 and P-glycoprotein (P-gp) inducers and inhibitors can result in an increased or decreased anticoagulation effect when used with NOACs. Recent reports have also highlighted variability in the safety of NOACs, particularly among patients with renal or liver insufficiency, African Americans, or patients with a prior history of GI bleeding.^14-16 For these subgroups, determining NOAC activity to improve clinical safety of these agents is difficult.

PT or INR testing is largely insensitive or otherwise highly variable and the blood draw time relative to the most recent dose significantly influences the measured level of anti-Xa activity. Importantly, socioeconomic factors and family support systems also influence TTR, as important determinants of access to needed drugs or the ability to sustain related costs over time.

Taken together, prior INR stability on warfarin therapy does not ensure continued stability and, as a consequence, long-term warfarin therapy requires close monitoring in order to remain effective. To this end, further development of point-of-care coagulometers for self-testing and self-management, which have been found to be acceptable and preferred by patients, should be pursued.¹⁷ Similarly, attempts to decrease INR variability through research on optimizing computer assisted dosing programs remains warranted.¹⁸ NOACs offer an advantage over warfarin therapy in that they have a more predictable pharmacokinetic profile, which precludes the need for routine monitoring of anticoagulation parameters. However, many of the same factors, which influence TTR for warfarin do so for NOACs; NOACs have increased bleeding risk in comparison to warfarin for a number of demographic groups; and the high cost of NOACs may influence patient compliance.

Accordingly, until further data is available, consideration of the conversion of a patient on warfarin with a low TTR to a NOAC should be individualized.

Madhukar S. Patel, MD, is a general surgeon at the Department of Surgery, Massachusetts General Hospital, Boston, and Elliot L. Chaikof, MD, is Surgeon-in-Chief, Beth Israel Deaconess Medical Center, and Chairman, Roberta and Stephen R. Weiner Department of Surgery, Johnson and Johnson Professor of Surgery, Harvard Medical School. Dr. Chaikof is also an associate editor for Vascular Specialist. They have no relevant conflicts.

References

1. Lancet. 2014;383:955-62.

2. Nat Rev Cardiol. 2014;11:693-703.

3. JAMA. 2016;316:661-3.

4. Thromb J. 2016;14:14.

5. J Thromb Haemost. 2010;8:2182-91.

6. Thromb Haemost. 2009;101:552-6.

7. Am J Cardiovasc Drugs. 2015;15:205-11.

8. Circ Cardiovasc Qual Outcomes. 2008;1:84-91.

9. CMAJ. 2007;176:1589-94.

10. J Med Econ. 2015;18:333-40.

11. Thromb Haemost. 2016;116:480-5.

12. Ann Intern Med. 2009;150:73-83.

13. JAMA Cardiol. 2016;1:172-80.

14. N Engl J Med. 2013;369:2093-104.

15. JAMA Intern Med. 2015;175:18-24.

16. J Am Coll Cardiol. 2014;63:891-900.

17. Can Fam Physician. 2011;57:e292-8.

18. J Thromb Haemost. 2008;6:935-43.

Progress in the development of new oral anticoagulants (NOACs), as well as agents for their reversal, has lowered the threshold to use these therapeutics as first line agents for the management of nonvalvular atrial fibrillation and venous thromboembolism.^1,2 Despite this increase in adoption, however, debate persists as to whether patients chronically maintained on vitamin K antagonists (VKAs), such as warfarin, should be switched to NOACs. The recently published research letter by Pokorney et al. assessed the stability of international normalized ratios (INRs) in patients on long-term warfarin therapy in order to address this question.³

Specifically, prospective registry data from 3,749 patients with at least three INR values in the first 6 months of therapy as well as six or more in the following year were included. Patients were deemed stable if 80% or more of their INRs were in a therapeutic range defined as an INR between 2 and 3.3 During the initiation period, only one in four patients taking warfarin had a stable INR.³ Furthermore, stability in the first 6 months was found to have limited ability to predict stability in the subsequent year (concordance index of 0.61). With regard to time in therapeutic range (TTR), only 32% of patients had a TTR of greater than 80% during the first 6 months with less than half (42%) of these patients able to maintain this in the following year.

Findings from Pokorney et al. add to the growing body of literature demonstrating the difficulty of achieving and maintaining a therapeutic INR while on warfarin therapy.^4-7 Clinically, these findings are important, as deviations from TTR have been shown to be associated with increased risk of bleeding and thrombosis as well as increased health care costs.^8-10 Mechanistically, patient factors such as differences in vitamin K consumption, comorbid conditions, drug-drug interactions, and medication compliance, as well as genetic differences that impact drug metabolism undoubtedly contribute to the variation of INR noted in patients on warfarin therapy.

Attempts to improve stability have included the administration of low-dose oral vitamin K. However, recent data from a multicenter randomized control trial suggests that while such therapy may help to decrease extreme variations in INR, it does not lead to an increased TTR.¹¹ Furthermore, while significant work has been conducted in identifying specific gene variants, such as CYP2C9 and VKORC, which encode cytochrome P450 and vitamin K epoxide reductase enzymes, respectively, economic analyses suggest that testing for these gene variants would not be cost-effective.¹² Additionally, clinical prediction tools, which incorporate important patient factors to help guide anticoagulation explain less than 10% of TTR variability.⁴

Nonetheless, some caution is warranted in the interpretation of the results reported by Pokorney and his colleagues. The proportion of registry patients treated with warfarin who had a low TTR was much lower than that previously reported by the pivotal U.S. trials of NOACs (55%-68%) and significantly lower than the results of a recent nationwide Swedish registry involving 40,449 patients.¹³

In the Swedish registry, the mean individual TTR was 70% with more than half the patients having a TTR of 70% or more, emphasizing the importance of health care system effects. Moreover, regardless of whether a patient is on warfarin or a NOAC, patients with a lower TTR have higher rates of diabetes, chronic obstructive pulmonary disease, heart failure, and renal failure, which may contribute to the need for additional therapies that may influence TTR.

For example, INR may be increased by ciprofloxacin or omeprazole when taken with warfarin, and CYP3A4 and P-glycoprotein (P-gp) inducers and inhibitors can result in an increased or decreased anticoagulation effect when used with NOACs. Recent reports have also highlighted variability in the safety of NOACs, particularly among patients with renal or liver insufficiency, African Americans, or patients with a prior history of GI bleeding.^14-16 For these subgroups, determining NOAC activity to improve clinical safety of these agents is difficult.

PT or INR testing is largely insensitive or otherwise highly variable and the blood draw time relative to the most recent dose significantly influences the measured level of anti-Xa activity. Importantly, socioeconomic factors and family support systems also influence TTR, as important determinants of access to needed drugs or the ability to sustain related costs over time.

Taken together, prior INR stability on warfarin therapy does not ensure continued stability and, as a consequence, long-term warfarin therapy requires close monitoring in order to remain effective. To this end, further development of point-of-care coagulometers for self-testing and self-management, which have been found to be acceptable and preferred by patients, should be pursued.¹⁷ Similarly, attempts to decrease INR variability through research on optimizing computer assisted dosing programs remains warranted.¹⁸ NOACs offer an advantage over warfarin therapy in that they have a more predictable pharmacokinetic profile, which precludes the need for routine monitoring of anticoagulation parameters. However, many of the same factors, which influence TTR for warfarin do so for NOACs; NOACs have increased bleeding risk in comparison to warfarin for a number of demographic groups; and the high cost of NOACs may influence patient compliance.

Accordingly, until further data is available, consideration of the conversion of a patient on warfarin with a low TTR to a NOAC should be individualized.

Madhukar S. Patel, MD, is a general surgeon at the Department of Surgery, Massachusetts General Hospital, Boston, and Elliot L. Chaikof, MD, is Surgeon-in-Chief, Beth Israel Deaconess Medical Center, and Chairman, Roberta and Stephen R. Weiner Department of Surgery, Johnson and Johnson Professor of Surgery, Harvard Medical School. Dr. Chaikof is also an associate editor for Vascular Specialist. They have no relevant conflicts.

References

1. Lancet. 2014;383:955-62.

2. Nat Rev Cardiol. 2014;11:693-703.

3. JAMA. 2016;316:661-3.

4. Thromb J. 2016;14:14.

5. J Thromb Haemost. 2010;8:2182-91.

6. Thromb Haemost. 2009;101:552-6.

7. Am J Cardiovasc Drugs. 2015;15:205-11.

8. Circ Cardiovasc Qual Outcomes. 2008;1:84-91.

9. CMAJ. 2007;176:1589-94.

10. J Med Econ. 2015;18:333-40.

11. Thromb Haemost. 2016;116:480-5.

12. Ann Intern Med. 2009;150:73-83.

13. JAMA Cardiol. 2016;1:172-80.

14. N Engl J Med. 2013;369:2093-104.

15. JAMA Intern Med. 2015;175:18-24.

16. J Am Coll Cardiol. 2014;63:891-900.

17. Can Fam Physician. 2011;57:e292-8.

18. J Thromb Haemost. 2008;6:935-43.

Progress in the development of new oral anticoagulants (NOACs), as well as agents for their reversal, has lowered the threshold to use these therapeutics as first line agents for the management of nonvalvular atrial fibrillation and venous thromboembolism.^1,2 Despite this increase in adoption, however, debate persists as to whether patients chronically maintained on vitamin K antagonists (VKAs), such as warfarin, should be switched to NOACs. The recently published research letter by Pokorney et al. assessed the stability of international normalized ratios (INRs) in patients on long-term warfarin therapy in order to address this question.³

Specifically, prospective registry data from 3,749 patients with at least three INR values in the first 6 months of therapy as well as six or more in the following year were included. Patients were deemed stable if 80% or more of their INRs were in a therapeutic range defined as an INR between 2 and 3.3 During the initiation period, only one in four patients taking warfarin had a stable INR.³ Furthermore, stability in the first 6 months was found to have limited ability to predict stability in the subsequent year (concordance index of 0.61). With regard to time in therapeutic range (TTR), only 32% of patients had a TTR of greater than 80% during the first 6 months with less than half (42%) of these patients able to maintain this in the following year.

Findings from Pokorney et al. add to the growing body of literature demonstrating the difficulty of achieving and maintaining a therapeutic INR while on warfarin therapy.^4-7 Clinically, these findings are important, as deviations from TTR have been shown to be associated with increased risk of bleeding and thrombosis as well as increased health care costs.^8-10 Mechanistically, patient factors such as differences in vitamin K consumption, comorbid conditions, drug-drug interactions, and medication compliance, as well as genetic differences that impact drug metabolism undoubtedly contribute to the variation of INR noted in patients on warfarin therapy.

Attempts to improve stability have included the administration of low-dose oral vitamin K. However, recent data from a multicenter randomized control trial suggests that while such therapy may help to decrease extreme variations in INR, it does not lead to an increased TTR.¹¹ Furthermore, while significant work has been conducted in identifying specific gene variants, such as CYP2C9 and VKORC, which encode cytochrome P450 and vitamin K epoxide reductase enzymes, respectively, economic analyses suggest that testing for these gene variants would not be cost-effective.¹² Additionally, clinical prediction tools, which incorporate important patient factors to help guide anticoagulation explain less than 10% of TTR variability.⁴

Nonetheless, some caution is warranted in the interpretation of the results reported by Pokorney and his colleagues. The proportion of registry patients treated with warfarin who had a low TTR was much lower than that previously reported by the pivotal U.S. trials of NOACs (55%-68%) and significantly lower than the results of a recent nationwide Swedish registry involving 40,449 patients.¹³

In the Swedish registry, the mean individual TTR was 70% with more than half the patients having a TTR of 70% or more, emphasizing the importance of health care system effects. Moreover, regardless of whether a patient is on warfarin or a NOAC, patients with a lower TTR have higher rates of diabetes, chronic obstructive pulmonary disease, heart failure, and renal failure, which may contribute to the need for additional therapies that may influence TTR.

For example, INR may be increased by ciprofloxacin or omeprazole when taken with warfarin, and CYP3A4 and P-glycoprotein (P-gp) inducers and inhibitors can result in an increased or decreased anticoagulation effect when used with NOACs. Recent reports have also highlighted variability in the safety of NOACs, particularly among patients with renal or liver insufficiency, African Americans, or patients with a prior history of GI bleeding.^14-16 For these subgroups, determining NOAC activity to improve clinical safety of these agents is difficult.

PT or INR testing is largely insensitive or otherwise highly variable and the blood draw time relative to the most recent dose significantly influences the measured level of anti-Xa activity. Importantly, socioeconomic factors and family support systems also influence TTR, as important determinants of access to needed drugs or the ability to sustain related costs over time.

Taken together, prior INR stability on warfarin therapy does not ensure continued stability and, as a consequence, long-term warfarin therapy requires close monitoring in order to remain effective. To this end, further development of point-of-care coagulometers for self-testing and self-management, which have been found to be acceptable and preferred by patients, should be pursued.¹⁷ Similarly, attempts to decrease INR variability through research on optimizing computer assisted dosing programs remains warranted.¹⁸ NOACs offer an advantage over warfarin therapy in that they have a more predictable pharmacokinetic profile, which precludes the need for routine monitoring of anticoagulation parameters. However, many of the same factors, which influence TTR for warfarin do so for NOACs; NOACs have increased bleeding risk in comparison to warfarin for a number of demographic groups; and the high cost of NOACs may influence patient compliance.

Accordingly, until further data is available, consideration of the conversion of a patient on warfarin with a low TTR to a NOAC should be individualized.

Madhukar S. Patel, MD, is a general surgeon at the Department of Surgery, Massachusetts General Hospital, Boston, and Elliot L. Chaikof, MD, is Surgeon-in-Chief, Beth Israel Deaconess Medical Center, and Chairman, Roberta and Stephen R. Weiner Department of Surgery, Johnson and Johnson Professor of Surgery, Harvard Medical School. Dr. Chaikof is also an associate editor for Vascular Specialist. They have no relevant conflicts.

References

1. Lancet. 2014;383:955-62.

2. Nat Rev Cardiol. 2014;11:693-703.

3. JAMA. 2016;316:661-3.

4. Thromb J. 2016;14:14.

5. J Thromb Haemost. 2010;8:2182-91.

6. Thromb Haemost. 2009;101:552-6.

7. Am J Cardiovasc Drugs. 2015;15:205-11.

8. Circ Cardiovasc Qual Outcomes. 2008;1:84-91.

9. CMAJ. 2007;176:1589-94.

10. J Med Econ. 2015;18:333-40.

11. Thromb Haemost. 2016;116:480-5.

12. Ann Intern Med. 2009;150:73-83.

13. JAMA Cardiol. 2016;1:172-80.

14. N Engl J Med. 2013;369:2093-104.

15. JAMA Intern Med. 2015;175:18-24.

16. J Am Coll Cardiol. 2014;63:891-900.

17. Can Fam Physician. 2011;57:e292-8.

18. J Thromb Haemost. 2008;6:935-43.

BOSTON – Patients who receive robot-assisted laparoscopic surgery (RALS), an increasingly widespread facet of surgical medicine, tend to be higher income white males, according to an extensive new study presented at Minimally Invasive Surgery Week.

“We wanted to look at how the technology is rolling out ... and what some of those characteristics are that are occurring, not only with the types of patients that are picking up these surgeries but also who the surgeons are that are performing these surgeries,” the study’s lead investigator, Michael A. Palese, MD, of Mount Sinai Health System, New York, explained during a video interview.

A total of 63,725 RALS cases were included, all of which occurred during 2009-2015. In addition to affluent white males being the predominant recipients of this type of surgery, younger white male surgeons tended to be the ones more likely to perform RALS. Across specialties, RALS use has increased substantially over the study period, with the largest increases seen among cardiothoracic surgeons (from 197 cases, 3.1% of all cases per year, to 1,159, 8.7% of all cases). Among general surgeons, RALS use increased from 98 cases (3.2%) to 2,559 cases (19.1%), and for orthopedic surgeons, 55 (0.8%) to 985 (7.4%).

Dr. Palese discussed the genesis of the study, the importance of the study’s findings, and where he foresees RALS heading in the near future. He did not report any relevant financial disclosures.

[email protected]

BOSTON – Patients who receive robot-assisted laparoscopic surgery (RALS), an increasingly widespread facet of surgical medicine, tend to be higher income white males, according to an extensive new study presented at Minimally Invasive Surgery Week.

“We wanted to look at how the technology is rolling out ... and what some of those characteristics are that are occurring, not only with the types of patients that are picking up these surgeries but also who the surgeons are that are performing these surgeries,” the study’s lead investigator, Michael A. Palese, MD, of Mount Sinai Health System, New York, explained during a video interview.

A total of 63,725 RALS cases were included, all of which occurred during 2009-2015. In addition to affluent white males being the predominant recipients of this type of surgery, younger white male surgeons tended to be the ones more likely to perform RALS. Across specialties, RALS use has increased substantially over the study period, with the largest increases seen among cardiothoracic surgeons (from 197 cases, 3.1% of all cases per year, to 1,159, 8.7% of all cases). Among general surgeons, RALS use increased from 98 cases (3.2%) to 2,559 cases (19.1%), and for orthopedic surgeons, 55 (0.8%) to 985 (7.4%).

Dr. Palese discussed the genesis of the study, the importance of the study’s findings, and where he foresees RALS heading in the near future. He did not report any relevant financial disclosures.

[email protected]

BOSTON – Patients who receive robot-assisted laparoscopic surgery (RALS), an increasingly widespread facet of surgical medicine, tend to be higher income white males, according to an extensive new study presented at Minimally Invasive Surgery Week.

“We wanted to look at how the technology is rolling out ... and what some of those characteristics are that are occurring, not only with the types of patients that are picking up these surgeries but also who the surgeons are that are performing these surgeries,” the study’s lead investigator, Michael A. Palese, MD, of Mount Sinai Health System, New York, explained during a video interview.

A total of 63,725 RALS cases were included, all of which occurred during 2009-2015. In addition to affluent white males being the predominant recipients of this type of surgery, younger white male surgeons tended to be the ones more likely to perform RALS. Across specialties, RALS use has increased substantially over the study period, with the largest increases seen among cardiothoracic surgeons (from 197 cases, 3.1% of all cases per year, to 1,159, 8.7% of all cases). Among general surgeons, RALS use increased from 98 cases (3.2%) to 2,559 cases (19.1%), and for orthopedic surgeons, 55 (0.8%) to 985 (7.4%).

Dr. Palese discussed the genesis of the study, the importance of the study’s findings, and where he foresees RALS heading in the near future. He did not report any relevant financial disclosures.

[email protected]

Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.

The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.

“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updated medication guides for these drugs reflecting those same warnings,” said Doug Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research, during a telebriefing.

Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.

In addition, the FDA has issued a safety communication to “warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed,” Dr. Throckmorton said.

The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.

A coalition of health officials from multiple cities, states, and U.S. territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health Commissioner Leana Wen, MD.

As an emergency physician, Dr. Wen said that she has seen firsthand the alarming trends; one in three unintentional overdose deaths from prescribed opioids also involve benzodiazepines, she noted.

“In my state of Maryland in 2014, benzodiazepines were associated with 19% of prescription opioid deaths, and 59% of benzodiazepine-associated deaths involved prescription opioids. We also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of a fatal overdose,” she said.

Dr. Throckmorton further noted that emergency department visits and deaths involving patients prescribed both opioids and benzodiazepines have increased significantly over time. From 2004 to 2011, the rate of nonmedical use–related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.

“Communities have been seeing this trend for some time, but ultimately we needed data in order to act today,” FDA Commissioner Robert Califf, MD, said during the telebriefing.

The current action is just “one part of a larger effort to address this epidemic.

“We remain focused and deeply committed to contributing to the comprehensive effort to address the opioid epidemic,” Dr. Califf said. The FDA “will continue to monitor these products carefully and take additional actions as needed, and will share updates with the public as necessary as we work to address this public health crisis.”

Dr. Califf noted that the current action is part of the FDA’s Opioids Action Plan, which is “importantly not meant just to cover illicit or abusive use of opioids.”

“So, you’ll be hearing a lot more from us, because this is a national crisis that is not going away. We’re making progress on the prescribing, and we’re seeing a reduction in the use of opioids now,” he noted. “But we’re still seeing many overdoses.

“This is a continuum, and we’ll continue to try to do everything we can to address the epidemic,” Dr. Califf concluded.

[email protected]

Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.

The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.

“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updated medication guides for these drugs reflecting those same warnings,” said Doug Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research, during a telebriefing.

Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.

In addition, the FDA has issued a safety communication to “warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed,” Dr. Throckmorton said.

The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.

A coalition of health officials from multiple cities, states, and U.S. territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health Commissioner Leana Wen, MD.

As an emergency physician, Dr. Wen said that she has seen firsthand the alarming trends; one in three unintentional overdose deaths from prescribed opioids also involve benzodiazepines, she noted.

“In my state of Maryland in 2014, benzodiazepines were associated with 19% of prescription opioid deaths, and 59% of benzodiazepine-associated deaths involved prescription opioids. We also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of a fatal overdose,” she said.

Dr. Throckmorton further noted that emergency department visits and deaths involving patients prescribed both opioids and benzodiazepines have increased significantly over time. From 2004 to 2011, the rate of nonmedical use–related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.

“Communities have been seeing this trend for some time, but ultimately we needed data in order to act today,” FDA Commissioner Robert Califf, MD, said during the telebriefing.

The current action is just “one part of a larger effort to address this epidemic.

“We remain focused and deeply committed to contributing to the comprehensive effort to address the opioid epidemic,” Dr. Califf said. The FDA “will continue to monitor these products carefully and take additional actions as needed, and will share updates with the public as necessary as we work to address this public health crisis.”

Dr. Califf noted that the current action is part of the FDA’s Opioids Action Plan, which is “importantly not meant just to cover illicit or abusive use of opioids.”

“So, you’ll be hearing a lot more from us, because this is a national crisis that is not going away. We’re making progress on the prescribing, and we’re seeing a reduction in the use of opioids now,” he noted. “But we’re still seeing many overdoses.

“This is a continuum, and we’ll continue to try to do everything we can to address the epidemic,” Dr. Califf concluded.

[email protected]

Labeling for prescription opioid pain or cough medicines and benzodiazepines will now carry the strongest available warning regarding serious side effects and death associated with their combined use, according to the Food and Drug Administration.

The new boxed warnings urge health care professionals to limit prescribing opioid pain medicines with benzodiazepines or other central nervous system depressants only to patients for whom alternative treatment options are inadequate, and to limit dosages and treatment duration to the minimum possible while achieving the desired clinical effect.

“First, the FDA is requiring companies to update their product labeling for ... benzodiazepines and opioids to include possible harms when they are used together. Second, we are requiring new or updated medication guides for these drugs reflecting those same warnings,” said Doug Throckmorton, MD, deputy director of the FDA’s Center for Drug Evaluation and Research, during a telebriefing.

Opioids will include a warning regarding prescribing with benzodiazepines and other central nervous system depressants, including alcohol. Benzodiazepines will include a warning regarding prescribing with opioids.

In addition, the FDA has issued a safety communication to “warn the public about the serious risk of taking these products together to help make doctors more cautious and patients better informed,” Dr. Throckmorton said.

The action comes amid ongoing efforts to address an epidemic of opioid addiction across the United States, and in response to a first-of-its-kind “citizen petition” calling for the boxed warnings.

A coalition of health officials from multiple cities, states, and U.S. territories initiated that petition in February, and thousands of concerned community members started an additional online petition. Those petitions were in response to both the increasing combined use of opioids and benzodiazepines and a concomitant increase in the risk of serious side effects and deaths associated with their combined use, according to Baltimore City Health Commissioner Leana Wen, MD.

As an emergency physician, Dr. Wen said that she has seen firsthand the alarming trends; one in three unintentional overdose deaths from prescribed opioids also involve benzodiazepines, she noted.

“In my state of Maryland in 2014, benzodiazepines were associated with 19% of prescription opioid deaths, and 59% of benzodiazepine-associated deaths involved prescription opioids. We also noted the growing biological evidence that combining these medications caused sleepiness and slowed breathing, increasing the likelihood of a fatal overdose,” she said.

Dr. Throckmorton further noted that emergency department visits and deaths involving patients prescribed both opioids and benzodiazepines have increased significantly over time. From 2004 to 2011, the rate of nonmedical use–related emergency department visits increased significantly each year, and overdose deaths involving both drug classes during that period nearly tripled on an annual basis.

“Communities have been seeing this trend for some time, but ultimately we needed data in order to act today,” FDA Commissioner Robert Califf, MD, said during the telebriefing.

The current action is just “one part of a larger effort to address this epidemic.

“We remain focused and deeply committed to contributing to the comprehensive effort to address the opioid epidemic,” Dr. Califf said. The FDA “will continue to monitor these products carefully and take additional actions as needed, and will share updates with the public as necessary as we work to address this public health crisis.”

Dr. Califf noted that the current action is part of the FDA’s Opioids Action Plan, which is “importantly not meant just to cover illicit or abusive use of opioids.”

“So, you’ll be hearing a lot more from us, because this is a national crisis that is not going away. We’re making progress on the prescribing, and we’re seeing a reduction in the use of opioids now,” he noted. “But we’re still seeing many overdoses.

“This is a continuum, and we’ll continue to try to do everything we can to address the epidemic,” Dr. Califf concluded.

[email protected]