Thoracic Surgery News (Archived)

As of July 1, Medicaid will no longer pay heath care providers for preventable, health care–acquired injuries or illnesses. The final rule, which implements a part of the Affordable Care Act, takes another step forward in reducing unnecessary health care costs, Dr. Donald M. Berwick, administrator for the Center for Medicare and Medicaid Services, said during a press briefing.

Provider-preventable conditions that will no longer be reimbursed include catheter-associated vascular infections, pressure ulcers, blood incompatibilities, air embolisms, surgical site infections, wrong surgery, wrong-patient surgery, and wrong surgical site, Dr. Berwick said.

The rule is based on similar measures already implemented under Medicare and independently by many states, Dr. Berwick said. Currently, 27 states prohibit payment for health care–acquired conditions and 17 do not pay for preventable conditions, according to Cindy Mann, director of CMS’s Center for Medicaid, CHIP, and Survey and Certification.

The Washington State Medicaid program is considering ways to increase accountability-based payment systems, according to its chief medical officer, Dr. Jeffery Thompson, who spoke during the briefing. Dr. Thompson said the state has determined it could save as much as $100 million, one-sixth of its budget, by eliminating 30-day hospital readmissions.

Under the provision, states will have the flexibility to expand the list of conditions to not be reimbursed, pending CMS approval. States also will have the option to implement the provisions between July 1, 2011, and July 1, 2012.

As of July 1, Medicaid will no longer pay heath care providers for preventable, health care–acquired injuries or illnesses. The final rule, which implements a part of the Affordable Care Act, takes another step forward in reducing unnecessary health care costs, Dr. Donald M. Berwick, administrator for the Center for Medicare and Medicaid Services, said during a press briefing.

Provider-preventable conditions that will no longer be reimbursed include catheter-associated vascular infections, pressure ulcers, blood incompatibilities, air embolisms, surgical site infections, wrong surgery, wrong-patient surgery, and wrong surgical site, Dr. Berwick said.

The rule is based on similar measures already implemented under Medicare and independently by many states, Dr. Berwick said. Currently, 27 states prohibit payment for health care–acquired conditions and 17 do not pay for preventable conditions, according to Cindy Mann, director of CMS’s Center for Medicaid, CHIP, and Survey and Certification.

The Washington State Medicaid program is considering ways to increase accountability-based payment systems, according to its chief medical officer, Dr. Jeffery Thompson, who spoke during the briefing. Dr. Thompson said the state has determined it could save as much as $100 million, one-sixth of its budget, by eliminating 30-day hospital readmissions.

Under the provision, states will have the flexibility to expand the list of conditions to not be reimbursed, pending CMS approval. States also will have the option to implement the provisions between July 1, 2011, and July 1, 2012.

As of July 1, Medicaid will no longer pay heath care providers for preventable, health care–acquired injuries or illnesses. The final rule, which implements a part of the Affordable Care Act, takes another step forward in reducing unnecessary health care costs, Dr. Donald M. Berwick, administrator for the Center for Medicare and Medicaid Services, said during a press briefing.

Provider-preventable conditions that will no longer be reimbursed include catheter-associated vascular infections, pressure ulcers, blood incompatibilities, air embolisms, surgical site infections, wrong surgery, wrong-patient surgery, and wrong surgical site, Dr. Berwick said.

The rule is based on similar measures already implemented under Medicare and independently by many states, Dr. Berwick said. Currently, 27 states prohibit payment for health care–acquired conditions and 17 do not pay for preventable conditions, according to Cindy Mann, director of CMS’s Center for Medicaid, CHIP, and Survey and Certification.

The Washington State Medicaid program is considering ways to increase accountability-based payment systems, according to its chief medical officer, Dr. Jeffery Thompson, who spoke during the briefing. Dr. Thompson said the state has determined it could save as much as $100 million, one-sixth of its budget, by eliminating 30-day hospital readmissions.

Under the provision, states will have the flexibility to expand the list of conditions to not be reimbursed, pending CMS approval. States also will have the option to implement the provisions between July 1, 2011, and July 1, 2012.

NEW YORK – Outcomes for the MitraClip procedure were similar for cardiologists and cardiac surgeons in an ongoing study of "real-world" use of the percutaneous mitral valve repair system.

The EVEREST II Continued Access Study, known as REALISM, is a prospective, multicenter data analysis of outcomes with the investigational MitraClip System (Abbott), said Dr. Gorav Allawadi, a CT surgeon at the University of Virginia, Charlottesville.

A total of 433 patients were included in the 30-day follow-up analysis; 47 were treated by 6 cardiothoracic surgeons and 386 by interventional cardiologists. Both patient groups had a mean age over 70 years, two-thirds had NYHA Class III or IV, and over half had functional mitral regurgitation. More than half had coronary artery disease, and nearly two-thirds had atrial fibrillation.

MitraClip procedural results were similar for cardiothoracic surgeons and interventional cardiologists, although there was a trend for the surgeons to use more clips. A single clip was implanted in 49% of the surgeon-treated cohort and in 58% of those treated by interventional cardiologists. Two clips were used in 51% of patients treated by surgeons and in 36% of patients treated by interventional cardiologists. (Clips could not be deployed in 6% of the patients treated by interventional cardiologists.) Mean procedural times were similar, 135 minutes for the surgeons versus 145 minutes for the interventional cardiologists. Post-procedure hospital stays averaged 2.5 days in both groups; 90% of patients were discharged home without the need for home health care, Dr. Allawadi reported.

In-hospital complication rates were low and did not differ significantly between the groups. Deaths occurred in 2.1% of the surgeon-treated patients and in 3.4% of the interventional cardiologist-treated patients. Major stroke occurred in 1.3% in patients treated by interventional cardiologists and in none of the surgeon-treated patients.

Outcomes at 30 days were similar, with more than half of both groups achieving 1-plus mitral regurgitation status or better and 90% at 2-plus or below. Similarly, 85% of both groups had improved to NYHA class I or II by 30 days post-procedure.

Dr. Allawadi said that the similarity in outcomes should not discourage a multidisciplinary approach to the treatment of these patients. When the CT surgeon performs the MitraClip procedure at his institution, the cardiologist scrubs as well. And if the interventional cardiologist is doing the procedure, the surgeon is still closely involved.

In response to a question about why the surgeons tended to use more clips, he speculated that it might be because surgeons don’t have as much experience with the device as yet. "We’re still very much on the learning curve."

In May, Abbott undertook a voluntary global recall of MitraClip after receiving three reports of incidents where the radiopaque ring at the tip of the steerable guide catheter detached in the heart following implant. Abbott emphasized that the concern only involves delivery of the device and that patients with previously implanted MitraClip devices are not affected.

Abbott officials expect it will take several months to resume shipments of the system, which is marketed in Europe but is investigational in the U.S. The firm says the recall is not likely to impact anticipated U.S. approval of the device later this year, according to a report in "The Gray Sheet."

Dr. Allawadi disclosed consulting fees and honoraria from Abbott. ☐

Rebecca Kern of "The Gray Sheet" added to this article. "The Gray Sheet" and this publication are both owned by Elsevier.

NEW YORK – Outcomes for the MitraClip procedure were similar for cardiologists and cardiac surgeons in an ongoing study of "real-world" use of the percutaneous mitral valve repair system.

The EVEREST II Continued Access Study, known as REALISM, is a prospective, multicenter data analysis of outcomes with the investigational MitraClip System (Abbott), said Dr. Gorav Allawadi, a CT surgeon at the University of Virginia, Charlottesville.

A total of 433 patients were included in the 30-day follow-up analysis; 47 were treated by 6 cardiothoracic surgeons and 386 by interventional cardiologists. Both patient groups had a mean age over 70 years, two-thirds had NYHA Class III or IV, and over half had functional mitral regurgitation. More than half had coronary artery disease, and nearly two-thirds had atrial fibrillation.

MitraClip procedural results were similar for cardiothoracic surgeons and interventional cardiologists, although there was a trend for the surgeons to use more clips. A single clip was implanted in 49% of the surgeon-treated cohort and in 58% of those treated by interventional cardiologists. Two clips were used in 51% of patients treated by surgeons and in 36% of patients treated by interventional cardiologists. (Clips could not be deployed in 6% of the patients treated by interventional cardiologists.) Mean procedural times were similar, 135 minutes for the surgeons versus 145 minutes for the interventional cardiologists. Post-procedure hospital stays averaged 2.5 days in both groups; 90% of patients were discharged home without the need for home health care, Dr. Allawadi reported.

In-hospital complication rates were low and did not differ significantly between the groups. Deaths occurred in 2.1% of the surgeon-treated patients and in 3.4% of the interventional cardiologist-treated patients. Major stroke occurred in 1.3% in patients treated by interventional cardiologists and in none of the surgeon-treated patients.

Outcomes at 30 days were similar, with more than half of both groups achieving 1-plus mitral regurgitation status or better and 90% at 2-plus or below. Similarly, 85% of both groups had improved to NYHA class I or II by 30 days post-procedure.

Dr. Allawadi said that the similarity in outcomes should not discourage a multidisciplinary approach to the treatment of these patients. When the CT surgeon performs the MitraClip procedure at his institution, the cardiologist scrubs as well. And if the interventional cardiologist is doing the procedure, the surgeon is still closely involved.

In response to a question about why the surgeons tended to use more clips, he speculated that it might be because surgeons don’t have as much experience with the device as yet. "We’re still very much on the learning curve."

In May, Abbott undertook a voluntary global recall of MitraClip after receiving three reports of incidents where the radiopaque ring at the tip of the steerable guide catheter detached in the heart following implant. Abbott emphasized that the concern only involves delivery of the device and that patients with previously implanted MitraClip devices are not affected.

Abbott officials expect it will take several months to resume shipments of the system, which is marketed in Europe but is investigational in the U.S. The firm says the recall is not likely to impact anticipated U.S. approval of the device later this year, according to a report in "The Gray Sheet."

Dr. Allawadi disclosed consulting fees and honoraria from Abbott. ☐

Rebecca Kern of "The Gray Sheet" added to this article. "The Gray Sheet" and this publication are both owned by Elsevier.

NEW YORK – Outcomes for the MitraClip procedure were similar for cardiologists and cardiac surgeons in an ongoing study of "real-world" use of the percutaneous mitral valve repair system.

The EVEREST II Continued Access Study, known as REALISM, is a prospective, multicenter data analysis of outcomes with the investigational MitraClip System (Abbott), said Dr. Gorav Allawadi, a CT surgeon at the University of Virginia, Charlottesville.

A total of 433 patients were included in the 30-day follow-up analysis; 47 were treated by 6 cardiothoracic surgeons and 386 by interventional cardiologists. Both patient groups had a mean age over 70 years, two-thirds had NYHA Class III or IV, and over half had functional mitral regurgitation. More than half had coronary artery disease, and nearly two-thirds had atrial fibrillation.

MitraClip procedural results were similar for cardiothoracic surgeons and interventional cardiologists, although there was a trend for the surgeons to use more clips. A single clip was implanted in 49% of the surgeon-treated cohort and in 58% of those treated by interventional cardiologists. Two clips were used in 51% of patients treated by surgeons and in 36% of patients treated by interventional cardiologists. (Clips could not be deployed in 6% of the patients treated by interventional cardiologists.) Mean procedural times were similar, 135 minutes for the surgeons versus 145 minutes for the interventional cardiologists. Post-procedure hospital stays averaged 2.5 days in both groups; 90% of patients were discharged home without the need for home health care, Dr. Allawadi reported.

In-hospital complication rates were low and did not differ significantly between the groups. Deaths occurred in 2.1% of the surgeon-treated patients and in 3.4% of the interventional cardiologist-treated patients. Major stroke occurred in 1.3% in patients treated by interventional cardiologists and in none of the surgeon-treated patients.

Outcomes at 30 days were similar, with more than half of both groups achieving 1-plus mitral regurgitation status or better and 90% at 2-plus or below. Similarly, 85% of both groups had improved to NYHA class I or II by 30 days post-procedure.

Dr. Allawadi said that the similarity in outcomes should not discourage a multidisciplinary approach to the treatment of these patients. When the CT surgeon performs the MitraClip procedure at his institution, the cardiologist scrubs as well. And if the interventional cardiologist is doing the procedure, the surgeon is still closely involved.

In response to a question about why the surgeons tended to use more clips, he speculated that it might be because surgeons don’t have as much experience with the device as yet. "We’re still very much on the learning curve."

In May, Abbott undertook a voluntary global recall of MitraClip after receiving three reports of incidents where the radiopaque ring at the tip of the steerable guide catheter detached in the heart following implant. Abbott emphasized that the concern only involves delivery of the device and that patients with previously implanted MitraClip devices are not affected.

Abbott officials expect it will take several months to resume shipments of the system, which is marketed in Europe but is investigational in the U.S. The firm says the recall is not likely to impact anticipated U.S. approval of the device later this year, according to a report in "The Gray Sheet."

Dr. Allawadi disclosed consulting fees and honoraria from Abbott. ☐

Rebecca Kern of "The Gray Sheet" added to this article. "The Gray Sheet" and this publication are both owned by Elsevier.

A comprehensive course in ultrasound for residents that can be conducted at their institution is now available from the American College of Surgeons Division of Education in a CD-ROM format. Beginning with the "Ultrasound for Residents: A Basic Course," surgical residents are introduced to basic concepts in the physics of ultrasound, instrumentation and scanning techniques, and clinical applications. This introduction is followed by "Ultrasound for Residents: A Skills Companion," which provides residents with an overview of ultrasound related to breast, vascular, thyroid, and parathyroid, and abdominal applications.

Purchase of "Ultrasound for Residents: The Complete Course" gives purchasers an annual subscription that allows 1 year of unlimited access to course content for an unlimited number of surgical residents. Registration of participants is required for each offering of the course.

This course bundle does not provide AMA PRA Category 1 CME Credit ^TM.

A certificate of completion will be provided upon conclusion of the course including pre-/post-test requirements.

For more information, you can visit www.facs.org/education/ultrasound/residents.html or contact the Program for Verification of Surgical Knowledge and Skills at 866-918-479 or via e-mail at exportedcourses@facs.org. ☐

A comprehensive course in ultrasound for residents that can be conducted at their institution is now available from the American College of Surgeons Division of Education in a CD-ROM format. Beginning with the "Ultrasound for Residents: A Basic Course," surgical residents are introduced to basic concepts in the physics of ultrasound, instrumentation and scanning techniques, and clinical applications. This introduction is followed by "Ultrasound for Residents: A Skills Companion," which provides residents with an overview of ultrasound related to breast, vascular, thyroid, and parathyroid, and abdominal applications.

Purchase of "Ultrasound for Residents: The Complete Course" gives purchasers an annual subscription that allows 1 year of unlimited access to course content for an unlimited number of surgical residents. Registration of participants is required for each offering of the course.

This course bundle does not provide AMA PRA Category 1 CME Credit ^TM.

A certificate of completion will be provided upon conclusion of the course including pre-/post-test requirements.

For more information, you can visit www.facs.org/education/ultrasound/residents.html or contact the Program for Verification of Surgical Knowledge and Skills at 866-918-479 or via e-mail at exportedcourses@facs.org. ☐

A comprehensive course in ultrasound for residents that can be conducted at their institution is now available from the American College of Surgeons Division of Education in a CD-ROM format. Beginning with the "Ultrasound for Residents: A Basic Course," surgical residents are introduced to basic concepts in the physics of ultrasound, instrumentation and scanning techniques, and clinical applications. This introduction is followed by "Ultrasound for Residents: A Skills Companion," which provides residents with an overview of ultrasound related to breast, vascular, thyroid, and parathyroid, and abdominal applications.

Purchase of "Ultrasound for Residents: The Complete Course" gives purchasers an annual subscription that allows 1 year of unlimited access to course content for an unlimited number of surgical residents. Registration of participants is required for each offering of the course.

This course bundle does not provide AMA PRA Category 1 CME Credit ^TM.

A certificate of completion will be provided upon conclusion of the course including pre-/post-test requirements.

For more information, you can visit www.facs.org/education/ultrasound/residents.html or contact the Program for Verification of Surgical Knowledge and Skills at 866-918-479 or via e-mail at exportedcourses@facs.org. ☐

PHILADELPHIA – Outcomes following isolated coronary artery bypass surgery did not differ significantly based on the volume of such procedures that were performed by individual surgeons or at particular institutions in a study of more than 2,000 patients.

In the setting of a university-based, community-hospital, quality-improvement program, excellent surgical results can consistently be obtained even in relatively low-volume programs. Surgical outcomes are not associated with program or surgeon volume, but are directly correlated with focus on quality as manifested by compliance with evidence-based quality standards, according to the study’s lead investigator, Dr. Paul Kurlansky.

He and his colleagues from the Florida Heart Research Institute, Miami, studied 2,218 consecutive patients having isolated CABG from 2007 to 2009 in a university-based quality-improvement program that emphasized involvement of all surgeons in the academic quality endeavor. End points included operative mortality, major morbidity, and National Quality Forum (NQF)-endorsed process measures as defined by the Society of Thoracic Surgeons (STS).

Procedural volume was analyzed as a categorical and a continuous variable using general estimating equations that accounted for clustering effects and were adjusted for STS risk scores, as well as for propensity for operation in a low- vs. high-volume program, Dr. Kurlansky reported at the annual meeting of the American Association for Thoracic Surgery.

The annual program volume ranged from 67 to 292 procedures (median 136), and surgeon volume ranged from 1 to 124 procedures (median 58). Mortality among all hospitals was 0.8% (ranging from 0% to 2.23%); annual observed/expected mortality was 0.41% overall, ranging from 0% to 1.20%.

A comparison of low-volume (less than 200 cases/year) with high-volume centers (at least 200 cases/year) showed no significant difference in mortality (odds ratio 1.08), morbidity (OR 1.34), or any of the medication process measures.

In addition, there was no difference in mortality (OR 1.59), morbidity (OR 1.20), or medication failure (OR 0.57) between high- (at least 87 cases/year) and low-volume surgeons (less than 87 cases).

After adjusting for both STS risk score and for propensity score, the researchers found no association between either hospital or surgeon volume with regard to mortality or morbidity.

Lack of compliance with NQF measures, however, was significantly and highly predictive of morbidity (OR 1.51), regardless of volume, even after adjustment for predicted risk.

The findings indicate that outcome rather than volume is the metric by which cardiac surgical programs should be evaluated, according to Dr. Kurlansky. In addition, meaningful and active academic involvement may represent a new paradigm for the delivery of quality care at the community hospital level, he said.

"The quality process measures, I believe, are only a surrogate of the entire environment created by the academic affiliation, ones that shift the entire focus of the program toward accountability, education, and excellence: open disclosure, discussion of problems, awareness of advances, and striving toward excellence," he said in an interview.

The policy implications of this study are considerable. "The simple administrative approach of a volume threshold (such as that adopted by the Leapfrog group) may be completely inappropriate. Merely adding volume to a mediocre or poor program will only compound the problem, while potentially removing the excellent service provided to the patients of a high-performing, smaller program," he said.

Dr. Kurlansky pointed out that CABG surgery is unique in that it is a very mature, highly practiced, complex surgical procedure.

Dr. Kurlansky reported he had no disclosures relevant to this presentation. ☐

PHILADELPHIA – Outcomes following isolated coronary artery bypass surgery did not differ significantly based on the volume of such procedures that were performed by individual surgeons or at particular institutions in a study of more than 2,000 patients.

In the setting of a university-based, community-hospital, quality-improvement program, excellent surgical results can consistently be obtained even in relatively low-volume programs. Surgical outcomes are not associated with program or surgeon volume, but are directly correlated with focus on quality as manifested by compliance with evidence-based quality standards, according to the study’s lead investigator, Dr. Paul Kurlansky.

He and his colleagues from the Florida Heart Research Institute, Miami, studied 2,218 consecutive patients having isolated CABG from 2007 to 2009 in a university-based quality-improvement program that emphasized involvement of all surgeons in the academic quality endeavor. End points included operative mortality, major morbidity, and National Quality Forum (NQF)-endorsed process measures as defined by the Society of Thoracic Surgeons (STS).

Procedural volume was analyzed as a categorical and a continuous variable using general estimating equations that accounted for clustering effects and were adjusted for STS risk scores, as well as for propensity for operation in a low- vs. high-volume program, Dr. Kurlansky reported at the annual meeting of the American Association for Thoracic Surgery.

The annual program volume ranged from 67 to 292 procedures (median 136), and surgeon volume ranged from 1 to 124 procedures (median 58). Mortality among all hospitals was 0.8% (ranging from 0% to 2.23%); annual observed/expected mortality was 0.41% overall, ranging from 0% to 1.20%.

A comparison of low-volume (less than 200 cases/year) with high-volume centers (at least 200 cases/year) showed no significant difference in mortality (odds ratio 1.08), morbidity (OR 1.34), or any of the medication process measures.

In addition, there was no difference in mortality (OR 1.59), morbidity (OR 1.20), or medication failure (OR 0.57) between high- (at least 87 cases/year) and low-volume surgeons (less than 87 cases).

After adjusting for both STS risk score and for propensity score, the researchers found no association between either hospital or surgeon volume with regard to mortality or morbidity.

Lack of compliance with NQF measures, however, was significantly and highly predictive of morbidity (OR 1.51), regardless of volume, even after adjustment for predicted risk.

The findings indicate that outcome rather than volume is the metric by which cardiac surgical programs should be evaluated, according to Dr. Kurlansky. In addition, meaningful and active academic involvement may represent a new paradigm for the delivery of quality care at the community hospital level, he said.

"The quality process measures, I believe, are only a surrogate of the entire environment created by the academic affiliation, ones that shift the entire focus of the program toward accountability, education, and excellence: open disclosure, discussion of problems, awareness of advances, and striving toward excellence," he said in an interview.

The policy implications of this study are considerable. "The simple administrative approach of a volume threshold (such as that adopted by the Leapfrog group) may be completely inappropriate. Merely adding volume to a mediocre or poor program will only compound the problem, while potentially removing the excellent service provided to the patients of a high-performing, smaller program," he said.

Dr. Kurlansky pointed out that CABG surgery is unique in that it is a very mature, highly practiced, complex surgical procedure.

Dr. Kurlansky reported he had no disclosures relevant to this presentation. ☐

PHILADELPHIA – Outcomes following isolated coronary artery bypass surgery did not differ significantly based on the volume of such procedures that were performed by individual surgeons or at particular institutions in a study of more than 2,000 patients.

In the setting of a university-based, community-hospital, quality-improvement program, excellent surgical results can consistently be obtained even in relatively low-volume programs. Surgical outcomes are not associated with program or surgeon volume, but are directly correlated with focus on quality as manifested by compliance with evidence-based quality standards, according to the study’s lead investigator, Dr. Paul Kurlansky.

He and his colleagues from the Florida Heart Research Institute, Miami, studied 2,218 consecutive patients having isolated CABG from 2007 to 2009 in a university-based quality-improvement program that emphasized involvement of all surgeons in the academic quality endeavor. End points included operative mortality, major morbidity, and National Quality Forum (NQF)-endorsed process measures as defined by the Society of Thoracic Surgeons (STS).

Procedural volume was analyzed as a categorical and a continuous variable using general estimating equations that accounted for clustering effects and were adjusted for STS risk scores, as well as for propensity for operation in a low- vs. high-volume program, Dr. Kurlansky reported at the annual meeting of the American Association for Thoracic Surgery.

The annual program volume ranged from 67 to 292 procedures (median 136), and surgeon volume ranged from 1 to 124 procedures (median 58). Mortality among all hospitals was 0.8% (ranging from 0% to 2.23%); annual observed/expected mortality was 0.41% overall, ranging from 0% to 1.20%.

A comparison of low-volume (less than 200 cases/year) with high-volume centers (at least 200 cases/year) showed no significant difference in mortality (odds ratio 1.08), morbidity (OR 1.34), or any of the medication process measures.

In addition, there was no difference in mortality (OR 1.59), morbidity (OR 1.20), or medication failure (OR 0.57) between high- (at least 87 cases/year) and low-volume surgeons (less than 87 cases).

After adjusting for both STS risk score and for propensity score, the researchers found no association between either hospital or surgeon volume with regard to mortality or morbidity.

Lack of compliance with NQF measures, however, was significantly and highly predictive of morbidity (OR 1.51), regardless of volume, even after adjustment for predicted risk.

The findings indicate that outcome rather than volume is the metric by which cardiac surgical programs should be evaluated, according to Dr. Kurlansky. In addition, meaningful and active academic involvement may represent a new paradigm for the delivery of quality care at the community hospital level, he said.

"The quality process measures, I believe, are only a surrogate of the entire environment created by the academic affiliation, ones that shift the entire focus of the program toward accountability, education, and excellence: open disclosure, discussion of problems, awareness of advances, and striving toward excellence," he said in an interview.

The policy implications of this study are considerable. "The simple administrative approach of a volume threshold (such as that adopted by the Leapfrog group) may be completely inappropriate. Merely adding volume to a mediocre or poor program will only compound the problem, while potentially removing the excellent service provided to the patients of a high-performing, smaller program," he said.

Dr. Kurlansky pointed out that CABG surgery is unique in that it is a very mature, highly practiced, complex surgical procedure.

Dr. Kurlansky reported he had no disclosures relevant to this presentation. ☐

WASHINGTON – At a recent hearing on public reporting of hospital performance data, panelists agreed on the importance of measuring for quality, but not on which measurement standards to use.

Current data used to evaluate performance are limited to too small a number of determining factors, asserted Nancy Foster, vice president for quality and patient safety at the American Hospital Association. Ms. Foster served on the five-person panel at a forum titled "Public Reporting of Quality Outcomes: What’s the Best Path Forward?"

It was sponsored by the Alliance for Health Reform and The Commonwealth Fund.

On March 31, the Centers for Medicare and Medicaid Services published data on hospitals’ incidence of eight conditions: foreign object remaining after surgery, air embolisms, blood incompatibility, late-stage pressure ulcers, falls and trauma, vascular catheter–associated infections, catheter-associated urinary tract infections, and manifestations of poor glycemic control.

The data presents each condition per 1,000 discharges and includes national rates of hospital-association conditions. The data were based on claims information submitted by Medicare patients from October 2008 through June 2010.

Ms. Foster maintains that the CMS data are not clinically sound. One example she gave was of hospitals with high reimbursement rates, so-called safety net hospitals that provide care to all individuals regardless of their ability to pay. These facilities, she emphasized, are generally located in communities that lack sufficient health care resources for the populations they serve.

"It shouldn’t be a surprise to us that if they can’t get their medications following discharge from the hospital, that if they can’t get into the right physician office or rehab treatment or whatever else they need, those patients are going to come back to us in larger numbers than in communities where they have adequate access to all those kinds of resources," Ms. Foster said.

Physicians will sometimes avoid treating patients who are sicker or on Medicaid because they are high risk and could make the hospital’s public reports look bad, said Dr. David Share, vice president of Value Partnerships at Blue Cross Blue Shield of Michigan.

"Sometimes the way we measure [quality] actually forces providers to focus on cohorts of patients who aren’t going to get the most benefit, but they’ll focus there because they’re concerned that they won’t look good if they don’t," Dr. Share said. He added that lower-quality outcomes could also be based on a poor hospital system, not necessarily individual physician performance, which he said should be measured separately.

Gerald Shea, assistant to the president of governmental affairs for the AFL-CIO, Washington, argued that improvement is also a question of cost, which he said amounts to nearly $250,000 to test and institute a quality measure.

"We’ve been severely hampered in this enterprise by basically only being able to develop those measures when somebody came forward and said ‘we’ll pay to develop them.’ "

While he admitted that there may be flaws in the current data from public reporting, Mr. Shea said reports have increased awareness for quality care and encouraged significant changes within hospitals. Since 2000, hospitals have increased their attention on factors including readmission rates, the importance of collegial cooperation, and hospital-association conditions, he said.

The Affordable Care Act will require health exchange plans to publicly report on quality of care based on 65 measures.

"There’s a lot of pressure now and a lot of opportunity to use public reporting and transparency as a true level to foster high performance in the country," said Dr. Anne-Marie Audet, vice president for health systems quality and efficiency at The Commonwealth Fund. Dr. Audet said systems continue to focus on ways to create better care and better health at a lower cost.

Thomas Scully, senior counsel at the law office of Alston & Bird in Washington, also served on the panel.

WASHINGTON – At a recent hearing on public reporting of hospital performance data, panelists agreed on the importance of measuring for quality, but not on which measurement standards to use.

Current data used to evaluate performance are limited to too small a number of determining factors, asserted Nancy Foster, vice president for quality and patient safety at the American Hospital Association. Ms. Foster served on the five-person panel at a forum titled "Public Reporting of Quality Outcomes: What’s the Best Path Forward?"

It was sponsored by the Alliance for Health Reform and The Commonwealth Fund.

On March 31, the Centers for Medicare and Medicaid Services published data on hospitals’ incidence of eight conditions: foreign object remaining after surgery, air embolisms, blood incompatibility, late-stage pressure ulcers, falls and trauma, vascular catheter–associated infections, catheter-associated urinary tract infections, and manifestations of poor glycemic control.

The data presents each condition per 1,000 discharges and includes national rates of hospital-association conditions. The data were based on claims information submitted by Medicare patients from October 2008 through June 2010.

Ms. Foster maintains that the CMS data are not clinically sound. One example she gave was of hospitals with high reimbursement rates, so-called safety net hospitals that provide care to all individuals regardless of their ability to pay. These facilities, she emphasized, are generally located in communities that lack sufficient health care resources for the populations they serve.

"It shouldn’t be a surprise to us that if they can’t get their medications following discharge from the hospital, that if they can’t get into the right physician office or rehab treatment or whatever else they need, those patients are going to come back to us in larger numbers than in communities where they have adequate access to all those kinds of resources," Ms. Foster said.

Physicians will sometimes avoid treating patients who are sicker or on Medicaid because they are high risk and could make the hospital’s public reports look bad, said Dr. David Share, vice president of Value Partnerships at Blue Cross Blue Shield of Michigan.

"Sometimes the way we measure [quality] actually forces providers to focus on cohorts of patients who aren’t going to get the most benefit, but they’ll focus there because they’re concerned that they won’t look good if they don’t," Dr. Share said. He added that lower-quality outcomes could also be based on a poor hospital system, not necessarily individual physician performance, which he said should be measured separately.

Gerald Shea, assistant to the president of governmental affairs for the AFL-CIO, Washington, argued that improvement is also a question of cost, which he said amounts to nearly $250,000 to test and institute a quality measure.

"We’ve been severely hampered in this enterprise by basically only being able to develop those measures when somebody came forward and said ‘we’ll pay to develop them.’ "

While he admitted that there may be flaws in the current data from public reporting, Mr. Shea said reports have increased awareness for quality care and encouraged significant changes within hospitals. Since 2000, hospitals have increased their attention on factors including readmission rates, the importance of collegial cooperation, and hospital-association conditions, he said.

The Affordable Care Act will require health exchange plans to publicly report on quality of care based on 65 measures.

"There’s a lot of pressure now and a lot of opportunity to use public reporting and transparency as a true level to foster high performance in the country," said Dr. Anne-Marie Audet, vice president for health systems quality and efficiency at The Commonwealth Fund. Dr. Audet said systems continue to focus on ways to create better care and better health at a lower cost.

Thomas Scully, senior counsel at the law office of Alston & Bird in Washington, also served on the panel.

WASHINGTON – At a recent hearing on public reporting of hospital performance data, panelists agreed on the importance of measuring for quality, but not on which measurement standards to use.

Current data used to evaluate performance are limited to too small a number of determining factors, asserted Nancy Foster, vice president for quality and patient safety at the American Hospital Association. Ms. Foster served on the five-person panel at a forum titled "Public Reporting of Quality Outcomes: What’s the Best Path Forward?"

It was sponsored by the Alliance for Health Reform and The Commonwealth Fund.

On March 31, the Centers for Medicare and Medicaid Services published data on hospitals’ incidence of eight conditions: foreign object remaining after surgery, air embolisms, blood incompatibility, late-stage pressure ulcers, falls and trauma, vascular catheter–associated infections, catheter-associated urinary tract infections, and manifestations of poor glycemic control.

The data presents each condition per 1,000 discharges and includes national rates of hospital-association conditions. The data were based on claims information submitted by Medicare patients from October 2008 through June 2010.

Ms. Foster maintains that the CMS data are not clinically sound. One example she gave was of hospitals with high reimbursement rates, so-called safety net hospitals that provide care to all individuals regardless of their ability to pay. These facilities, she emphasized, are generally located in communities that lack sufficient health care resources for the populations they serve.

"It shouldn’t be a surprise to us that if they can’t get their medications following discharge from the hospital, that if they can’t get into the right physician office or rehab treatment or whatever else they need, those patients are going to come back to us in larger numbers than in communities where they have adequate access to all those kinds of resources," Ms. Foster said.

Physicians will sometimes avoid treating patients who are sicker or on Medicaid because they are high risk and could make the hospital’s public reports look bad, said Dr. David Share, vice president of Value Partnerships at Blue Cross Blue Shield of Michigan.

"Sometimes the way we measure [quality] actually forces providers to focus on cohorts of patients who aren’t going to get the most benefit, but they’ll focus there because they’re concerned that they won’t look good if they don’t," Dr. Share said. He added that lower-quality outcomes could also be based on a poor hospital system, not necessarily individual physician performance, which he said should be measured separately.

Gerald Shea, assistant to the president of governmental affairs for the AFL-CIO, Washington, argued that improvement is also a question of cost, which he said amounts to nearly $250,000 to test and institute a quality measure.

"We’ve been severely hampered in this enterprise by basically only being able to develop those measures when somebody came forward and said ‘we’ll pay to develop them.’ "

While he admitted that there may be flaws in the current data from public reporting, Mr. Shea said reports have increased awareness for quality care and encouraged significant changes within hospitals. Since 2000, hospitals have increased their attention on factors including readmission rates, the importance of collegial cooperation, and hospital-association conditions, he said.

The Affordable Care Act will require health exchange plans to publicly report on quality of care based on 65 measures.

"There’s a lot of pressure now and a lot of opportunity to use public reporting and transparency as a true level to foster high performance in the country," said Dr. Anne-Marie Audet, vice president for health systems quality and efficiency at The Commonwealth Fund. Dr. Audet said systems continue to focus on ways to create better care and better health at a lower cost.

Thomas Scully, senior counsel at the law office of Alston & Bird in Washington, also served on the panel.

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. The 2-year follow-up results show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman of the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and left ventricular (LV) volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction. Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness endpoint between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

Freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years. The "need for surgery in patients in the clip group was almost entirely in the first several months; after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years." When early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting and research monies from Abbott Vascular. ☐

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. The 2-year follow-up results show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman of the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and left ventricular (LV) volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction. Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness endpoint between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

Freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years. The "need for surgery in patients in the clip group was almost entirely in the first several months; after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years." When early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting and research monies from Abbott Vascular. ☐

NEW ORLEANS – The durability and safety of treating mitral regurgitation with a percutaneous device as compared with that of surgical repair or replacement persisted at 2 years, based on an updated analysis of the EVEREST II trial results presented at the annual meeting of the American College of Cardiology.

"Our fundamental finding is that outcomes are very stable between 1 and 2 years of follow-up," Dr. Ted Feldman, principal investigator, announced at a press briefing. The 2-year follow-up results show both approaches reduced MR, and meaningful clinical benefits persisted, said Dr. Feldman of the NorthShore University HealthSystem in Evanston, Ill.

Clinical outcome measures at 2 years showed MR grade and left ventricular (LV) volumes remained stable between 1 and 2 years in both groups. The inter-group comparison showed a more favorable reduction in MR and a greater reduction in LV diastolic volume with surgery at 1 and 2 years, and no difference in systolic volume reduction. Also, NYHA functional class was stable between years 1 and 2. "Interestingly, the inter-group comparison showed a more favorable NYHA class outcome at both years with the clip," he reported.

EVEREST II (Endovascular Valve Edge-to-Edge Repair Study) is a prospective, multicenter, randomized controlled phase II trial comparing the safety and efficacy of the MitraClip System with mitral valve surgery in the treatment of MR. The study enrolled 279 patients with 3+ or 4+ MR who were either symptomatic or were asymptomatic with a baseline left ejection fraction of 60%. Approximately half of the patients had New York Heart Association (NYHA) functional class III or IV heart failure.

At the meeting, Dr. Feldman presented two analyses of the 2-year data. The composite primary efficacy endpoint was freedom from death, MV surgery for valve dysfunction (for device patients) or re-operation (for surgery patients), and MR greater than 2+ at 12 months.

In the intention-to-treat analysis, the primary composite endpoint was met at 2 years by 52% of the percutaneous group and by 66% of the surgery group; in the 1-year analysis, these figures were 55% and 73%, respectively.

More patients receiving the clip later underwent MV surgery (22%) compared to the few patients in the surgery arm who required re-operation (3.6%). There was no significant difference in mortality or recurrent MR.

In the second analysis, there was no statistical difference in the effectiveness endpoint between the two arms of the study. "When subsequent surgery within 90 days on device patients is considered a success, we see similarly stable results at 1 and 2 years," he noted.

In this analysis, the primary endpoint was met at 2 years by 63% of the percutaneous group and by 66% of the surgery group. By removing the subsequent need for MV surgery as an end point event, 6.2% of the percutaneous group and 3.6% of the surgery group had MV surgery or re-operation.

There was no difference in the Kaplan-Meier mortality plot for the intention-to-treat analysis at any time point, he stressed. At 1 year, 95% of the patients in each arm were alive; at 2 years, 91% of the surgery arm and 90% of the percutaneous arm were still alive.

Freedom from MV surgery/re-operation, however, favored the surgical arm: 96% versus 78% at 2 years. The "need for surgery in patients in the clip group was almost entirely in the first several months; after 6 months the curves overlapped at 1 and 2 years," he observed. "Importantly, 78% of device patients are free from MV surgery at 2 years." When early failures were excluded, there were no differences in need for MV surgery or reoperation.

At a press conference, Dr. Feldman explained that the two analyses "answer different questions." "The intention-to-treat analysis gives the patient the odds of success with the clip at the end of the year," he said. "It tells them that 78% will be free of the need for surgery at 2 years, and 97% will have NYHA functional class I or II."

The second analysis answers the question, ‘What if I am in the 20% needing surgery?’ It counts the combined strategy of the clip, with surgery as needed.

Dr. Feldman reported consulting and research monies from Abbott Vascular. ☐

A 56-year-old male is undergoing an aortic valve replacement through a full sternotomy with standard aortic and right atrial cannulation at a temperature of 34 degrees. You are preparing to place your last annulus suture when you notice a large bolus of air travel through your arterial line, into the arterial perfuser and into the patient’s aorta.

Directed questions:

1. What organ is at greatest risk for damage due to massive air embolism?

2. What is the first instruction you should give to your perfusionist when you first note an air embolism?

3. What is the first instruction you should give to your anesthesiologist?

4. What strategy can be used to "de-air" the cerebral circulation?

5. What neuroprotective strategies can be employed intraoperatively?

6. What therapeutic adjuncts can be employed postoperatively to minimize neurologic sequelae?

7. What is most common source of air emboli?

8. What routine strategies can be employed to minimize the risk of massive air embolism?

Key Points and Answers to Questions:

1. The greatest concern from massive air embolism is a stroke. Massive air embolism is rare with an estimated frequency of less than 0.01% but carries a significant morbidity and mortality.

2. Upon detection of air embolism, the cardiopulmonary bypass machine should be stopped to avoid further injection of air into the arterial circulation. An expeditious search for the source of the air should take place and steps taken to de-air the circuit to be able to resume cardiopulmonary bypass.

3. The patient should be placed in steep trendelenberg position to minimize further travel of air into the cerebral circulation. Hopefully, air will return into the proximal aorta and can be aspirated or drained via the aortotomy.

4. Retrograde cerebral perfusion can be performed to flush the air from the cerebral circulation. A cannula can be inserted into the superior vena cava and perfused with cold blood (< 20 degrees) in a retrograde fashion. The aorta may need to be opened to allow egress of air from the cerebral circulation.

5. In addition to retrograde cerebral perfusion, deep hypothermia and corticosteroids might be beneficial. Hypothermia decreases brain oxygen consumption and allows for more time for retrograde perfusion under circulatory arrest.

6. Postoperatively, continued use of steroids and moderate hypothermia might be beneficial and some have recommended barbiturate coma to minimize brain metabolism. Reports suggest a benefit of hyperbaric oxygen therapy in the immediate postoperative period. The benefit of hyperbaric oxygen therapy appears greatest when instituted within about 5 hours of surgery and seems less efficacious if there is a delay in the initiation of therapy.

7. The most common source of air emboli is unremoved air from the cardiac chambers.

8. Important strategies include careful inspection of the arterial circuit for air prior to initiation of bypass, stringent use of cardiopulmonary bypass safety alarms which monitor the reservoir level and bubble monitors to detect air in the cardiopulmonary bypass circuit, compulsive de-airing maneuvers at conclusion of surgery, and careful examination for residual intracardiac air with transesophageal echo.

Select References and Additional Resources

PIHammon JW. (2008). Extracorporeal Circulation: Perfusion System. In Cohn LH (Ed), Cardiac Surgery in the Adult. (3^rd edition, 350-370). New York: McGraw-Hill.

PIKern JA, Arnold S. Massive Cerebral Embolization: Successful Treatment with Retrograde Perfusion. Annals of Thoracic Surgery. 69: 1266, 2000.

PIMills NL, Ochsner JL. Massive air embolism during cardiopulmonary bypass: causes, prevention and management. Journal of Thoracic and Cardiovascular Surgery. 80:708–717, 1980.

PIUtley JR. Techniques for avoiding neurologic injury during adult cardiac surgery. Journal of Cardiothoracic and Vascular Anesthesia. 10(1): 38-44, 1996.

PIZiser A, Adir Y, et al. Hyperbaric oxygen therapy for massive arterial air embolism during cardiac operations. Journal of Thoracic and Cardiovascular Surgery. 117(4): 818, 1999.

This Challenge was provided by Resident Medical Editor, Dr. Christian Peyre.

A 56-year-old male is undergoing an aortic valve replacement through a full sternotomy with standard aortic and right atrial cannulation at a temperature of 34 degrees. You are preparing to place your last annulus suture when you notice a large bolus of air travel through your arterial line, into the arterial perfuser and into the patient’s aorta.

Directed questions:

1. What organ is at greatest risk for damage due to massive air embolism?

2. What is the first instruction you should give to your perfusionist when you first note an air embolism?

3. What is the first instruction you should give to your anesthesiologist?

4. What strategy can be used to "de-air" the cerebral circulation?

5. What neuroprotective strategies can be employed intraoperatively?

6. What therapeutic adjuncts can be employed postoperatively to minimize neurologic sequelae?

7. What is most common source of air emboli?

8. What routine strategies can be employed to minimize the risk of massive air embolism?

Key Points and Answers to Questions:

1. The greatest concern from massive air embolism is a stroke. Massive air embolism is rare with an estimated frequency of less than 0.01% but carries a significant morbidity and mortality.

2. Upon detection of air embolism, the cardiopulmonary bypass machine should be stopped to avoid further injection of air into the arterial circulation. An expeditious search for the source of the air should take place and steps taken to de-air the circuit to be able to resume cardiopulmonary bypass.

3. The patient should be placed in steep trendelenberg position to minimize further travel of air into the cerebral circulation. Hopefully, air will return into the proximal aorta and can be aspirated or drained via the aortotomy.

4. Retrograde cerebral perfusion can be performed to flush the air from the cerebral circulation. A cannula can be inserted into the superior vena cava and perfused with cold blood (< 20 degrees) in a retrograde fashion. The aorta may need to be opened to allow egress of air from the cerebral circulation.

5. In addition to retrograde cerebral perfusion, deep hypothermia and corticosteroids might be beneficial. Hypothermia decreases brain oxygen consumption and allows for more time for retrograde perfusion under circulatory arrest.

6. Postoperatively, continued use of steroids and moderate hypothermia might be beneficial and some have recommended barbiturate coma to minimize brain metabolism. Reports suggest a benefit of hyperbaric oxygen therapy in the immediate postoperative period. The benefit of hyperbaric oxygen therapy appears greatest when instituted within about 5 hours of surgery and seems less efficacious if there is a delay in the initiation of therapy.

7. The most common source of air emboli is unremoved air from the cardiac chambers.

8. Important strategies include careful inspection of the arterial circuit for air prior to initiation of bypass, stringent use of cardiopulmonary bypass safety alarms which monitor the reservoir level and bubble monitors to detect air in the cardiopulmonary bypass circuit, compulsive de-airing maneuvers at conclusion of surgery, and careful examination for residual intracardiac air with transesophageal echo.

Select References and Additional Resources

PIHammon JW. (2008). Extracorporeal Circulation: Perfusion System. In Cohn LH (Ed), Cardiac Surgery in the Adult. (3^rd edition, 350-370). New York: McGraw-Hill.

PIKern JA, Arnold S. Massive Cerebral Embolization: Successful Treatment with Retrograde Perfusion. Annals of Thoracic Surgery. 69: 1266, 2000.

PIMills NL, Ochsner JL. Massive air embolism during cardiopulmonary bypass: causes, prevention and management. Journal of Thoracic and Cardiovascular Surgery. 80:708–717, 1980.

PIUtley JR. Techniques for avoiding neurologic injury during adult cardiac surgery. Journal of Cardiothoracic and Vascular Anesthesia. 10(1): 38-44, 1996.

PIZiser A, Adir Y, et al. Hyperbaric oxygen therapy for massive arterial air embolism during cardiac operations. Journal of Thoracic and Cardiovascular Surgery. 117(4): 818, 1999.

This Challenge was provided by Resident Medical Editor, Dr. Christian Peyre.

A 56-year-old male is undergoing an aortic valve replacement through a full sternotomy with standard aortic and right atrial cannulation at a temperature of 34 degrees. You are preparing to place your last annulus suture when you notice a large bolus of air travel through your arterial line, into the arterial perfuser and into the patient’s aorta.

Directed questions:

1. What organ is at greatest risk for damage due to massive air embolism?

2. What is the first instruction you should give to your perfusionist when you first note an air embolism?

3. What is the first instruction you should give to your anesthesiologist?

4. What strategy can be used to "de-air" the cerebral circulation?

5. What neuroprotective strategies can be employed intraoperatively?

6. What therapeutic adjuncts can be employed postoperatively to minimize neurologic sequelae?

7. What is most common source of air emboli?

8. What routine strategies can be employed to minimize the risk of massive air embolism?

Key Points and Answers to Questions:

1. The greatest concern from massive air embolism is a stroke. Massive air embolism is rare with an estimated frequency of less than 0.01% but carries a significant morbidity and mortality.

2. Upon detection of air embolism, the cardiopulmonary bypass machine should be stopped to avoid further injection of air into the arterial circulation. An expeditious search for the source of the air should take place and steps taken to de-air the circuit to be able to resume cardiopulmonary bypass.

3. The patient should be placed in steep trendelenberg position to minimize further travel of air into the cerebral circulation. Hopefully, air will return into the proximal aorta and can be aspirated or drained via the aortotomy.

4. Retrograde cerebral perfusion can be performed to flush the air from the cerebral circulation. A cannula can be inserted into the superior vena cava and perfused with cold blood (< 20 degrees) in a retrograde fashion. The aorta may need to be opened to allow egress of air from the cerebral circulation.

5. In addition to retrograde cerebral perfusion, deep hypothermia and corticosteroids might be beneficial. Hypothermia decreases brain oxygen consumption and allows for more time for retrograde perfusion under circulatory arrest.

6. Postoperatively, continued use of steroids and moderate hypothermia might be beneficial and some have recommended barbiturate coma to minimize brain metabolism. Reports suggest a benefit of hyperbaric oxygen therapy in the immediate postoperative period. The benefit of hyperbaric oxygen therapy appears greatest when instituted within about 5 hours of surgery and seems less efficacious if there is a delay in the initiation of therapy.

7. The most common source of air emboli is unremoved air from the cardiac chambers.

8. Important strategies include careful inspection of the arterial circuit for air prior to initiation of bypass, stringent use of cardiopulmonary bypass safety alarms which monitor the reservoir level and bubble monitors to detect air in the cardiopulmonary bypass circuit, compulsive de-airing maneuvers at conclusion of surgery, and careful examination for residual intracardiac air with transesophageal echo.

Select References and Additional Resources

PIHammon JW. (2008). Extracorporeal Circulation: Perfusion System. In Cohn LH (Ed), Cardiac Surgery in the Adult. (3^rd edition, 350-370). New York: McGraw-Hill.

PIKern JA, Arnold S. Massive Cerebral Embolization: Successful Treatment with Retrograde Perfusion. Annals of Thoracic Surgery. 69: 1266, 2000.

PIMills NL, Ochsner JL. Massive air embolism during cardiopulmonary bypass: causes, prevention and management. Journal of Thoracic and Cardiovascular Surgery. 80:708–717, 1980.

PIUtley JR. Techniques for avoiding neurologic injury during adult cardiac surgery. Journal of Cardiothoracic and Vascular Anesthesia. 10(1): 38-44, 1996.

PIZiser A, Adir Y, et al. Hyperbaric oxygen therapy for massive arterial air embolism during cardiac operations. Journal of Thoracic and Cardiovascular Surgery. 117(4): 818, 1999.

This Challenge was provided by Resident Medical Editor, Dr. Christian Peyre.

PHILADELPHIA – Current clinical practice is to repair symptomatic diaphragmatic hernias to avoid complications such as obstruction or gangrene. However, practice patterns are based largely on limited data from institutional case series, according to Dr. Subroto Paul and his colleagues at Cornell University in New York.

Mortality was significantly higher in those patients with uncomplicated hernia who went on to readmission with obstruction or gangrene, Dr. Paul said at the annual meeting of the American Association for Thoracic Surgery, where he presented an analysis of the National Inpatient Sample (NIS) database.

Over a 10-year period, 193,554 patient admissions were identified for the primary diagnosis of diaphragmatic hernia of any type. An uncomplicated diaphragmatic hernia was the diagnosis in 161,777 (83.6%) admissions. Of these, 38,764 (24.0%) patients underwent an elective repair of their hernia as the principal procedure for their admission.

A diagnosis of diaphragmatic hernia with obstruction or gangrene was the reason for admission in 31,127 (16.1%) and 651 (0.3%) patients, respectively. Mortality was significantly higher in patients who were admitted with obstruction or gangrene (4.5% vs. 27.5%, respectively), compared with patients who were admitted for an elective hernia repair (1%).

Morbidity from pneumonia and sepsis was also significantly higher in patients who were admitted for obstruction or gangrene.

Symptomatic admission was associated with more intensive hospitalization, as evidenced by significantly increasing length of stay – 6 days (uncomplicated) vs. 9 days (obstruction) vs. 17.5 days (gangrene) – and the need for mechanical ventilation (3.6% vs. 9.7 vs. 41.3%, respectively).

Based on their mortality data, the authors also performed a lifetime risk analysis that suggested that elective repair is associated with a favorable risk-benefit profile for patients in their 50s, 60s, and perhaps early 70s.

"In this large national database study, the prevalence of diaphragmatic hernia per hospital admission is 1:2,000. Admissions resulting from gangrene or obstruction are not uncommon and are associated with worse outcomes than [is repair] in uncomplicated hernias.

"This analysis suggests the practice of repair of uncomplicated diaphragmatic hernia may avoid the morbidity and mortality associated with either obstruction or gangrene," he concluded.

Dr. Paul reported that he had no relevant disclosures. ☐

PHILADELPHIA – Current clinical practice is to repair symptomatic diaphragmatic hernias to avoid complications such as obstruction or gangrene. However, practice patterns are based largely on limited data from institutional case series, according to Dr. Subroto Paul and his colleagues at Cornell University in New York.

Mortality was significantly higher in those patients with uncomplicated hernia who went on to readmission with obstruction or gangrene, Dr. Paul said at the annual meeting of the American Association for Thoracic Surgery, where he presented an analysis of the National Inpatient Sample (NIS) database.

Over a 10-year period, 193,554 patient admissions were identified for the primary diagnosis of diaphragmatic hernia of any type. An uncomplicated diaphragmatic hernia was the diagnosis in 161,777 (83.6%) admissions. Of these, 38,764 (24.0%) patients underwent an elective repair of their hernia as the principal procedure for their admission.

A diagnosis of diaphragmatic hernia with obstruction or gangrene was the reason for admission in 31,127 (16.1%) and 651 (0.3%) patients, respectively. Mortality was significantly higher in patients who were admitted with obstruction or gangrene (4.5% vs. 27.5%, respectively), compared with patients who were admitted for an elective hernia repair (1%).

Morbidity from pneumonia and sepsis was also significantly higher in patients who were admitted for obstruction or gangrene.

Symptomatic admission was associated with more intensive hospitalization, as evidenced by significantly increasing length of stay – 6 days (uncomplicated) vs. 9 days (obstruction) vs. 17.5 days (gangrene) – and the need for mechanical ventilation (3.6% vs. 9.7 vs. 41.3%, respectively).

Based on their mortality data, the authors also performed a lifetime risk analysis that suggested that elective repair is associated with a favorable risk-benefit profile for patients in their 50s, 60s, and perhaps early 70s.

"In this large national database study, the prevalence of diaphragmatic hernia per hospital admission is 1:2,000. Admissions resulting from gangrene or obstruction are not uncommon and are associated with worse outcomes than [is repair] in uncomplicated hernias.

"This analysis suggests the practice of repair of uncomplicated diaphragmatic hernia may avoid the morbidity and mortality associated with either obstruction or gangrene," he concluded.

Dr. Paul reported that he had no relevant disclosures. ☐

PHILADELPHIA – Current clinical practice is to repair symptomatic diaphragmatic hernias to avoid complications such as obstruction or gangrene. However, practice patterns are based largely on limited data from institutional case series, according to Dr. Subroto Paul and his colleagues at Cornell University in New York.

Mortality was significantly higher in those patients with uncomplicated hernia who went on to readmission with obstruction or gangrene, Dr. Paul said at the annual meeting of the American Association for Thoracic Surgery, where he presented an analysis of the National Inpatient Sample (NIS) database.

Over a 10-year period, 193,554 patient admissions were identified for the primary diagnosis of diaphragmatic hernia of any type. An uncomplicated diaphragmatic hernia was the diagnosis in 161,777 (83.6%) admissions. Of these, 38,764 (24.0%) patients underwent an elective repair of their hernia as the principal procedure for their admission.

A diagnosis of diaphragmatic hernia with obstruction or gangrene was the reason for admission in 31,127 (16.1%) and 651 (0.3%) patients, respectively. Mortality was significantly higher in patients who were admitted with obstruction or gangrene (4.5% vs. 27.5%, respectively), compared with patients who were admitted for an elective hernia repair (1%).

Morbidity from pneumonia and sepsis was also significantly higher in patients who were admitted for obstruction or gangrene.

Symptomatic admission was associated with more intensive hospitalization, as evidenced by significantly increasing length of stay – 6 days (uncomplicated) vs. 9 days (obstruction) vs. 17.5 days (gangrene) – and the need for mechanical ventilation (3.6% vs. 9.7 vs. 41.3%, respectively).

Based on their mortality data, the authors also performed a lifetime risk analysis that suggested that elective repair is associated with a favorable risk-benefit profile for patients in their 50s, 60s, and perhaps early 70s.

"In this large national database study, the prevalence of diaphragmatic hernia per hospital admission is 1:2,000. Admissions resulting from gangrene or obstruction are not uncommon and are associated with worse outcomes than [is repair] in uncomplicated hernias.

"This analysis suggests the practice of repair of uncomplicated diaphragmatic hernia may avoid the morbidity and mortality associated with either obstruction or gangrene," he concluded.

Dr. Paul reported that he had no relevant disclosures. ☐

BOCA RATON, FLA. – Adherence to Surgical Care Improvement Program measures that are aimed at preventing surgical site infections has not had the desired effect, according to a large national Veterans Affairs study.

There is widespread agreement that reducing surgical site infections is a worthy quality improvement goal. These infections are associated with a twofold increase in mortality, a 60% increase in ICU admission, and a fivefold greater likelihood of hospital readmission after discharge.

But the VA study results showing that the SCIP hasn’t reduced surgical site infection rates call into question whether the program is worth continuing.

"SCIP adherence is not informative to third-party payers, administrators, or patients. The policy of continued SCIP measurement for public reporting and payment should be reevaluated," Dr. Mary T. Hawn declared in presenting the VA study findings at the annual meeting of the American Surgical Association.

SCIP is a multiyear partnership that was initiated in 2003 with the goal of reducing surgical morbidity and mortality at U.S. hospitals. Among the 10 national organizations that are represented on the SCIP steering committee are the American College of Surgeons, the American Hospital Association, the U.S. Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Hawn presented a retrospective study of 60,853 procedures performed at 112 VA hospitals during 2005-2009. The outcome measure was the combined rate of superficial and deep surgical site infections (SSIs) occurring within 30 days of surgery.

The independent variables were adherence to each of five SCIP surgical site infection prevention measures that hospitals are required to collect and report. The five measures are timely administration of a prophylactic antibiotic, timely discontinuation of the antibiotic, appropriate antibiotic coverage, hair removal, and normothermia for colon procedures.

In addition, investigators tracked the impact of rates of adherence to all five measures in a given case, a combined metric they called composite SCIP.

This was the first study to use individual patient-level data for evaluating SCIP. Investigators were able to adjust for the presence of comorbid conditions that are known to affect the risk of SSIs, such as diabetes, dyspnea, and corticosteroid use, noted Dr. Hawn of the University of Alabama at Birmingham.

The overall SSI rate was 6.2%. It didn’t vary significantly over the 5-year study period, which began when the SCIP measures were first implemented in the VA system. Rates of adherence to the five SCIP measures quickly climbed to high levels during the first 6 months, probably because of the VA’s pay-for-performance incentives, she explained.

A first look at the data suggested that SCIP might be performing as intended. For example, there was an 81% adherence rate to the composite SCIP measure, and surgical cases meeting that standard had a 45% lower SSI rate than did those in which all five measures weren’t met. However, when patient-level SSI risk factors were introduced in a multivariate logistic regression analysis, there was no longer any association between SCIP adherence and SSI rates.

SCIP adherence rates ranged from a high of 86.4% for orthopedic surgery to a low of 60.4% for colorectal procedures. Adherence rates for gynecologic and vascular procedures were 85.9% and 81.6%, respectively.

In a separate analysis, Dr. Hawn and her colleagues looked at the relationship between a hospital’s adherence to SCIP measures and the institutional SSI rate. Once again, they found that there was none. The difference in hospital rates of SCIP adherence accounted for a mere 2% of the variation in hospital-wide SSI rates.

Dr. Hawn said that it is particularly troubling, in light of the VA data, to consider that public reporting of the SCIP adherence rates is being used to guide patients to what are supposed to be high-quality hospitals. "Are we really guiding patients to the right hospitals?" she asked.

Discussant Dr. David B. Hoyt noted that the collection of SCIP data constitutes a huge cost for American hospitals.

"It’s essential that quality measurement systems put in place actually correlate with improvement in quality. This study today is a critical example of how a well-intended process can in fact fail to reduce surgical infections. Overall, the SCIP program does not achieve its goal," said Dr. Hoyt, executive director of the American College of Surgeons.

"The data collection burden has increased in the last several years, and unless indicators that are ineffective are dropped, the expense of adding new indicators cannot be accommodated," he added.

Dr. Donald E. Fry commented that the SCIP measures are valid. The trouble is, they’re not inclusive.

"To paraphrase Paul Simon, ‘There must be 50 ways to get an SSI.’ And antibiotics are only a small portion of that," said Dr. Fry, executive vice president at Michael Pine and Associates, Chicago, an analytic health care consulting firm.

"I hope that this presentation will be a significant stimulus for us to go forward with not measuring silly process measures. This is not synchronized swimming. We need to be measuring outcomes. We need objective measures of what it is we’re trying to do, looking at how good hospitals do it well and bad ones don’t do it so well, and coming up with an entire strategy for SSIs," he said.

The SCIP study was funded by the VA. Dr. Hawn declared having no relevant financial interests. ☐

BOCA RATON, FLA. – Adherence to Surgical Care Improvement Program measures that are aimed at preventing surgical site infections has not had the desired effect, according to a large national Veterans Affairs study.

There is widespread agreement that reducing surgical site infections is a worthy quality improvement goal. These infections are associated with a twofold increase in mortality, a 60% increase in ICU admission, and a fivefold greater likelihood of hospital readmission after discharge.

But the VA study results showing that the SCIP hasn’t reduced surgical site infection rates call into question whether the program is worth continuing.

"SCIP adherence is not informative to third-party payers, administrators, or patients. The policy of continued SCIP measurement for public reporting and payment should be reevaluated," Dr. Mary T. Hawn declared in presenting the VA study findings at the annual meeting of the American Surgical Association.

SCIP is a multiyear partnership that was initiated in 2003 with the goal of reducing surgical morbidity and mortality at U.S. hospitals. Among the 10 national organizations that are represented on the SCIP steering committee are the American College of Surgeons, the American Hospital Association, the U.S. Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Hawn presented a retrospective study of 60,853 procedures performed at 112 VA hospitals during 2005-2009. The outcome measure was the combined rate of superficial and deep surgical site infections (SSIs) occurring within 30 days of surgery.

The independent variables were adherence to each of five SCIP surgical site infection prevention measures that hospitals are required to collect and report. The five measures are timely administration of a prophylactic antibiotic, timely discontinuation of the antibiotic, appropriate antibiotic coverage, hair removal, and normothermia for colon procedures.

In addition, investigators tracked the impact of rates of adherence to all five measures in a given case, a combined metric they called composite SCIP.

This was the first study to use individual patient-level data for evaluating SCIP. Investigators were able to adjust for the presence of comorbid conditions that are known to affect the risk of SSIs, such as diabetes, dyspnea, and corticosteroid use, noted Dr. Hawn of the University of Alabama at Birmingham.

The overall SSI rate was 6.2%. It didn’t vary significantly over the 5-year study period, which began when the SCIP measures were first implemented in the VA system. Rates of adherence to the five SCIP measures quickly climbed to high levels during the first 6 months, probably because of the VA’s pay-for-performance incentives, she explained.

A first look at the data suggested that SCIP might be performing as intended. For example, there was an 81% adherence rate to the composite SCIP measure, and surgical cases meeting that standard had a 45% lower SSI rate than did those in which all five measures weren’t met. However, when patient-level SSI risk factors were introduced in a multivariate logistic regression analysis, there was no longer any association between SCIP adherence and SSI rates.

SCIP adherence rates ranged from a high of 86.4% for orthopedic surgery to a low of 60.4% for colorectal procedures. Adherence rates for gynecologic and vascular procedures were 85.9% and 81.6%, respectively.

In a separate analysis, Dr. Hawn and her colleagues looked at the relationship between a hospital’s adherence to SCIP measures and the institutional SSI rate. Once again, they found that there was none. The difference in hospital rates of SCIP adherence accounted for a mere 2% of the variation in hospital-wide SSI rates.

Dr. Hawn said that it is particularly troubling, in light of the VA data, to consider that public reporting of the SCIP adherence rates is being used to guide patients to what are supposed to be high-quality hospitals. "Are we really guiding patients to the right hospitals?" she asked.

Discussant Dr. David B. Hoyt noted that the collection of SCIP data constitutes a huge cost for American hospitals.

"It’s essential that quality measurement systems put in place actually correlate with improvement in quality. This study today is a critical example of how a well-intended process can in fact fail to reduce surgical infections. Overall, the SCIP program does not achieve its goal," said Dr. Hoyt, executive director of the American College of Surgeons.

"The data collection burden has increased in the last several years, and unless indicators that are ineffective are dropped, the expense of adding new indicators cannot be accommodated," he added.

Dr. Donald E. Fry commented that the SCIP measures are valid. The trouble is, they’re not inclusive.

"To paraphrase Paul Simon, ‘There must be 50 ways to get an SSI.’ And antibiotics are only a small portion of that," said Dr. Fry, executive vice president at Michael Pine and Associates, Chicago, an analytic health care consulting firm.

"I hope that this presentation will be a significant stimulus for us to go forward with not measuring silly process measures. This is not synchronized swimming. We need to be measuring outcomes. We need objective measures of what it is we’re trying to do, looking at how good hospitals do it well and bad ones don’t do it so well, and coming up with an entire strategy for SSIs," he said.

The SCIP study was funded by the VA. Dr. Hawn declared having no relevant financial interests. ☐

BOCA RATON, FLA. – Adherence to Surgical Care Improvement Program measures that are aimed at preventing surgical site infections has not had the desired effect, according to a large national Veterans Affairs study.

There is widespread agreement that reducing surgical site infections is a worthy quality improvement goal. These infections are associated with a twofold increase in mortality, a 60% increase in ICU admission, and a fivefold greater likelihood of hospital readmission after discharge.

But the VA study results showing that the SCIP hasn’t reduced surgical site infection rates call into question whether the program is worth continuing.

"SCIP adherence is not informative to third-party payers, administrators, or patients. The policy of continued SCIP measurement for public reporting and payment should be reevaluated," Dr. Mary T. Hawn declared in presenting the VA study findings at the annual meeting of the American Surgical Association.

SCIP is a multiyear partnership that was initiated in 2003 with the goal of reducing surgical morbidity and mortality at U.S. hospitals. Among the 10 national organizations that are represented on the SCIP steering committee are the American College of Surgeons, the American Hospital Association, the U.S. Department of Veterans Affairs, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, and the Joint Commission.

Dr. Hawn presented a retrospective study of 60,853 procedures performed at 112 VA hospitals during 2005-2009. The outcome measure was the combined rate of superficial and deep surgical site infections (SSIs) occurring within 30 days of surgery.

The independent variables were adherence to each of five SCIP surgical site infection prevention measures that hospitals are required to collect and report. The five measures are timely administration of a prophylactic antibiotic, timely discontinuation of the antibiotic, appropriate antibiotic coverage, hair removal, and normothermia for colon procedures.

In addition, investigators tracked the impact of rates of adherence to all five measures in a given case, a combined metric they called composite SCIP.

This was the first study to use individual patient-level data for evaluating SCIP. Investigators were able to adjust for the presence of comorbid conditions that are known to affect the risk of SSIs, such as diabetes, dyspnea, and corticosteroid use, noted Dr. Hawn of the University of Alabama at Birmingham.

The overall SSI rate was 6.2%. It didn’t vary significantly over the 5-year study period, which began when the SCIP measures were first implemented in the VA system. Rates of adherence to the five SCIP measures quickly climbed to high levels during the first 6 months, probably because of the VA’s pay-for-performance incentives, she explained.

A first look at the data suggested that SCIP might be performing as intended. For example, there was an 81% adherence rate to the composite SCIP measure, and surgical cases meeting that standard had a 45% lower SSI rate than did those in which all five measures weren’t met. However, when patient-level SSI risk factors were introduced in a multivariate logistic regression analysis, there was no longer any association between SCIP adherence and SSI rates.

SCIP adherence rates ranged from a high of 86.4% for orthopedic surgery to a low of 60.4% for colorectal procedures. Adherence rates for gynecologic and vascular procedures were 85.9% and 81.6%, respectively.

In a separate analysis, Dr. Hawn and her colleagues looked at the relationship between a hospital’s adherence to SCIP measures and the institutional SSI rate. Once again, they found that there was none. The difference in hospital rates of SCIP adherence accounted for a mere 2% of the variation in hospital-wide SSI rates.

Dr. Hawn said that it is particularly troubling, in light of the VA data, to consider that public reporting of the SCIP adherence rates is being used to guide patients to what are supposed to be high-quality hospitals. "Are we really guiding patients to the right hospitals?" she asked.

Discussant Dr. David B. Hoyt noted that the collection of SCIP data constitutes a huge cost for American hospitals.

"It’s essential that quality measurement systems put in place actually correlate with improvement in quality. This study today is a critical example of how a well-intended process can in fact fail to reduce surgical infections. Overall, the SCIP program does not achieve its goal," said Dr. Hoyt, executive director of the American College of Surgeons.

"The data collection burden has increased in the last several years, and unless indicators that are ineffective are dropped, the expense of adding new indicators cannot be accommodated," he added.

Dr. Donald E. Fry commented that the SCIP measures are valid. The trouble is, they’re not inclusive.

"To paraphrase Paul Simon, ‘There must be 50 ways to get an SSI.’ And antibiotics are only a small portion of that," said Dr. Fry, executive vice president at Michael Pine and Associates, Chicago, an analytic health care consulting firm.

"I hope that this presentation will be a significant stimulus for us to go forward with not measuring silly process measures. This is not synchronized swimming. We need to be measuring outcomes. We need objective measures of what it is we’re trying to do, looking at how good hospitals do it well and bad ones don’t do it so well, and coming up with an entire strategy for SSIs," he said.

The SCIP study was funded by the VA. Dr. Hawn declared having no relevant financial interests. ☐

BOCA RATON, FLA. — Minimally invasive esophagectomy has advanced to the point where it offers significant advantages over open esophagectomy in terms of operative morbidity and mortality, judging by results of a single-center review of 980 cases.

Published series indicate that the operative mortality of open esophagectomy is 8%-21%, although a few high-volume medical centers have reported rates as low as 3%.

"There is a perception among patients and physicians that open esophagectomy is to be avoided at all costs because of it substantial morbidity," Dr. James D. Luketich said at the annual meeting of the American Surgical Association.

In his review of 980 consecutive, elective, nonurgent, minimally invasive esophagectomies, the 30-day mortality was just 1.8%. Median operative time was 6.7 hours, which dropped to 4 hours in cases that were not done by residents. The median ICU stay was 2.0 days, with a median hospital length of stay of 8 days. A median 21 lymph nodes were dissected, and 98% of cases had negative surgical margins.

"A less invasive surgical approach for esophageal cancer would improve the standard of care by reducing morbidity and shortening hospital stays and time to return to daily activities. If successful, surgeons might see more early-stage referrals from Barrett’s patients now in surveillance," added Dr. Luketich, professor of surgery and chief of the Heart, Lung and Esophageal Surgery Institute at the University of Pittsburgh Medical Center.

Using a modified Ivor-Lewis approach involving laparoscopic conduit preparation, videothoracoscopic esophageal mobilization, and an intrathoracic anastomosis is preferable to the McKeown approach when the minimally invasive route is chosen. It entails fewer conduit complications and lower mortality, Dr. Luketich said.

In this series, 49% of patients underwent a modified McKeown approach involving videothoracoscopic esophageal mobilization, laparoscopic conduit preparation, and neck anastomosis, whereas 51% were treated via the modified Ivor-Lewis approach.

This was a nonrandomized study, but patients in the two study arms were essentially the same in terms of baseline characteristics. In all, 95% were operated on for malignant disease, 80% were men, and 31% received preoperative chemotherapy and/or radiotherapy. Patients who were operated on in the most recent years of the series underwent the Ivor-Lewis approach because Dr. Luketich has come to prefer it. He noted that most trainees are more comfortable with it; they have far more experience with operating in the chest than the neck.

Furthermore, outcomes are better than results with the McKeown approach. Indeed, the 30-day mortality rate was just 1.2% with the Ivor-Lewis minimally invasive esophagectomy chest (MIE-chest) approach vs. 2.5% with the McKeown MIE-neck approach. The major morbidity rate was 31% in the MIE-chest group, significantly less than the 36% with the MIE-neck group. This difference was driven by the increased risk of laryngeal nerve injury with the McKeown approach. The incidence of vocal cord paresis or paralysis was 8% in the MIE-neck patients, compared with 1% in the MIE-chest group.

Rates of other complications were closely similar in the two groups: 6% for empyema, 5% for acute respiratory distress syndrome, 5% for pulmonary embolism, 2% for acute MI, 3% for heart failure, and 5% for anastomotic leak requiring surgery.

Quality of life assessments using the Short Form-36 indicate that by 90 days, post-MIE patients scored in the age-adjusted normal range. "I think by 90 days the patients have bounced back," Dr. Luketich added.

"Laparoscopy–VATS [video-assisted thoracic surgery]–chest anastomosis is now our preferred approach to most esophageal cancers," he concluded.

Discussant Dr. David J. Sugarbaker called Dr. Luketich’s study "a landmark paper."

"Dr. Luketich has ... developed a procedure that is rapidly becoming a standard of care worldwide. This is the largest experience reported to date," noted Dr. Sugarbaker, professor of surgical oncology and chief of the division of thoracic surgery at Brigham and Women’s Hospital and Harvard Medical School, Boston.

Dr. Luketich declared that he had no financial conflicts of interest. ☐

BOCA RATON, FLA. — Minimally invasive esophagectomy has advanced to the point where it offers significant advantages over open esophagectomy in terms of operative morbidity and mortality, judging by results of a single-center review of 980 cases.

Published series indicate that the operative mortality of open esophagectomy is 8%-21%, although a few high-volume medical centers have reported rates as low as 3%.

"There is a perception among patients and physicians that open esophagectomy is to be avoided at all costs because of it substantial morbidity," Dr. James D. Luketich said at the annual meeting of the American Surgical Association.

In his review of 980 consecutive, elective, nonurgent, minimally invasive esophagectomies, the 30-day mortality was just 1.8%. Median operative time was 6.7 hours, which dropped to 4 hours in cases that were not done by residents. The median ICU stay was 2.0 days, with a median hospital length of stay of 8 days. A median 21 lymph nodes were dissected, and 98% of cases had negative surgical margins.

"A less invasive surgical approach for esophageal cancer would improve the standard of care by reducing morbidity and shortening hospital stays and time to return to daily activities. If successful, surgeons might see more early-stage referrals from Barrett’s patients now in surveillance," added Dr. Luketich, professor of surgery and chief of the Heart, Lung and Esophageal Surgery Institute at the University of Pittsburgh Medical Center.

Using a modified Ivor-Lewis approach involving laparoscopic conduit preparation, videothoracoscopic esophageal mobilization, and an intrathoracic anastomosis is preferable to the McKeown approach when the minimally invasive route is chosen. It entails fewer conduit complications and lower mortality, Dr. Luketich said.

In this series, 49% of patients underwent a modified McKeown approach involving videothoracoscopic esophageal mobilization, laparoscopic conduit preparation, and neck anastomosis, whereas 51% were treated via the modified Ivor-Lewis approach.

This was a nonrandomized study, but patients in the two study arms were essentially the same in terms of baseline characteristics. In all, 95% were operated on for malignant disease, 80% were men, and 31% received preoperative chemotherapy and/or radiotherapy. Patients who were operated on in the most recent years of the series underwent the Ivor-Lewis approach because Dr. Luketich has come to prefer it. He noted that most trainees are more comfortable with it; they have far more experience with operating in the chest than the neck.

Furthermore, outcomes are better than results with the McKeown approach. Indeed, the 30-day mortality rate was just 1.2% with the Ivor-Lewis minimally invasive esophagectomy chest (MIE-chest) approach vs. 2.5% with the McKeown MIE-neck approach. The major morbidity rate was 31% in the MIE-chest group, significantly less than the 36% with the MIE-neck group. This difference was driven by the increased risk of laryngeal nerve injury with the McKeown approach. The incidence of vocal cord paresis or paralysis was 8% in the MIE-neck patients, compared with 1% in the MIE-chest group.

Rates of other complications were closely similar in the two groups: 6% for empyema, 5% for acute respiratory distress syndrome, 5% for pulmonary embolism, 2% for acute MI, 3% for heart failure, and 5% for anastomotic leak requiring surgery.

Quality of life assessments using the Short Form-36 indicate that by 90 days, post-MIE patients scored in the age-adjusted normal range. "I think by 90 days the patients have bounced back," Dr. Luketich added.

"Laparoscopy–VATS [video-assisted thoracic surgery]–chest anastomosis is now our preferred approach to most esophageal cancers," he concluded.

Discussant Dr. David J. Sugarbaker called Dr. Luketich’s study "a landmark paper."

"Dr. Luketich has ... developed a procedure that is rapidly becoming a standard of care worldwide. This is the largest experience reported to date," noted Dr. Sugarbaker, professor of surgical oncology and chief of the division of thoracic surgery at Brigham and Women’s Hospital and Harvard Medical School, Boston.

Dr. Luketich declared that he had no financial conflicts of interest. ☐

BOCA RATON, FLA. — Minimally invasive esophagectomy has advanced to the point where it offers significant advantages over open esophagectomy in terms of operative morbidity and mortality, judging by results of a single-center review of 980 cases.

Published series indicate that the operative mortality of open esophagectomy is 8%-21%, although a few high-volume medical centers have reported rates as low as 3%.

"There is a perception among patients and physicians that open esophagectomy is to be avoided at all costs because of it substantial morbidity," Dr. James D. Luketich said at the annual meeting of the American Surgical Association.

In his review of 980 consecutive, elective, nonurgent, minimally invasive esophagectomies, the 30-day mortality was just 1.8%. Median operative time was 6.7 hours, which dropped to 4 hours in cases that were not done by residents. The median ICU stay was 2.0 days, with a median hospital length of stay of 8 days. A median 21 lymph nodes were dissected, and 98% of cases had negative surgical margins.

"A less invasive surgical approach for esophageal cancer would improve the standard of care by reducing morbidity and shortening hospital stays and time to return to daily activities. If successful, surgeons might see more early-stage referrals from Barrett’s patients now in surveillance," added Dr. Luketich, professor of surgery and chief of the Heart, Lung and Esophageal Surgery Institute at the University of Pittsburgh Medical Center.

Using a modified Ivor-Lewis approach involving laparoscopic conduit preparation, videothoracoscopic esophageal mobilization, and an intrathoracic anastomosis is preferable to the McKeown approach when the minimally invasive route is chosen. It entails fewer conduit complications and lower mortality, Dr. Luketich said.

In this series, 49% of patients underwent a modified McKeown approach involving videothoracoscopic esophageal mobilization, laparoscopic conduit preparation, and neck anastomosis, whereas 51% were treated via the modified Ivor-Lewis approach.

This was a nonrandomized study, but patients in the two study arms were essentially the same in terms of baseline characteristics. In all, 95% were operated on for malignant disease, 80% were men, and 31% received preoperative chemotherapy and/or radiotherapy. Patients who were operated on in the most recent years of the series underwent the Ivor-Lewis approach because Dr. Luketich has come to prefer it. He noted that most trainees are more comfortable with it; they have far more experience with operating in the chest than the neck.

Furthermore, outcomes are better than results with the McKeown approach. Indeed, the 30-day mortality rate was just 1.2% with the Ivor-Lewis minimally invasive esophagectomy chest (MIE-chest) approach vs. 2.5% with the McKeown MIE-neck approach. The major morbidity rate was 31% in the MIE-chest group, significantly less than the 36% with the MIE-neck group. This difference was driven by the increased risk of laryngeal nerve injury with the McKeown approach. The incidence of vocal cord paresis or paralysis was 8% in the MIE-neck patients, compared with 1% in the MIE-chest group.

Rates of other complications were closely similar in the two groups: 6% for empyema, 5% for acute respiratory distress syndrome, 5% for pulmonary embolism, 2% for acute MI, 3% for heart failure, and 5% for anastomotic leak requiring surgery.

Quality of life assessments using the Short Form-36 indicate that by 90 days, post-MIE patients scored in the age-adjusted normal range. "I think by 90 days the patients have bounced back," Dr. Luketich added.

"Laparoscopy–VATS [video-assisted thoracic surgery]–chest anastomosis is now our preferred approach to most esophageal cancers," he concluded.

Discussant Dr. David J. Sugarbaker called Dr. Luketich’s study "a landmark paper."

"Dr. Luketich has ... developed a procedure that is rapidly becoming a standard of care worldwide. This is the largest experience reported to date," noted Dr. Sugarbaker, professor of surgical oncology and chief of the division of thoracic surgery at Brigham and Women’s Hospital and Harvard Medical School, Boston.

Dr. Luketich declared that he had no financial conflicts of interest. ☐