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Society of Thoracic Surgeons (STS): Annual Meeting
System overhaul eliminated CABG surgical site infections
ORLANDO – A system-wide quality improvement process that utilized define, measure, analyze, improve, and control and rapid adoption methodology eliminated surgical site infections among patients undergoing isolated coronary artery bypass with donor site surgery at a regional medical center.
Between March 2012 and March 2013 the overall decline in the rate of surgical site infections among 250 patients surpassed the center’s goal of a 40% decrease in the infection rate to a rate of 1.61; instead, the center achieved a rate of 0.7 during that time period. Since May, 2012, no surgical site infections have occurred among coronary artery bypass graft patients, Candis Kles, a critical care nurse at Athens (Ga.) Regional Medical Center, reported at the annual meeting of the Society of Thoracic Surgeons.
"We are now into our 23rd month without a deep/organ space infection with over 454 patients," Ms. Kles said in a May interview.
The quality improvement process was initiated after the infection rates at the center were found to be high (ranging up to 6.1), compared with National Healthcare Safety Network data. Using the define, measure, analyze, improve, and control methodology, a multidisciplinary team was convened, including cardiothoracic surgeons, nurses, and support personnel, and a 6-month process was undertaken to identify areas for improvement, said Ms. Kles who chaired the team.
"We also at this time partnered with the VHA National Hospital Engagement Network for some extra training and to help us along the process," she noted.
The team flow-charted processes – from scheduled surgery to discharge – and posted the flow charts in the operating room and cardiac intensive care unit to identify inconsistencies and potential problem areas. Frontline staff members were engaged and encouraged to participate in the improvement process by posting notes, suggestions, and questions on the flow charts.
A literature review was conducted to ensure that current practices mirrored best practices.
Despite an extensive evaluation of possible patient-, procedure-, and hospital-related factors that might be associated with the infection rate, no single cause of the high rate was identified, although a number of areas for improvement were recognized. Among the changes that were implemented were use of chlorhexidine oral rinse, which was administered until discharge; use of disposable EKG leads (after high bacterial counts were found on the leads in use prior to program initiation); use of silver-impregnated midsternal dressings; a change in surgical and suture techniques; development of patient educational materials, and standardization of all processes, Ms. Kles said, noting that the changes were implemented rapidly.
The success of the program is largely attributable to input from all levels and disciplines within the organization – including physicians who championed the process, and to staff engagement and buy in, she said.
The improvement in the infection rate resulted in cost avoidance of $212,355 (compared with a total excess cost of surgical site infections of $250,965 in 2011), and in a reduction from 156 to 24 excess hospital days.
Ms. Kles reported that as of February 2014 she is a member of the speakers bureau for Mölnlycke Health Care, a maker of surgical and wound care products.
ORLANDO – A system-wide quality improvement process that utilized define, measure, analyze, improve, and control and rapid adoption methodology eliminated surgical site infections among patients undergoing isolated coronary artery bypass with donor site surgery at a regional medical center.
Between March 2012 and March 2013 the overall decline in the rate of surgical site infections among 250 patients surpassed the center’s goal of a 40% decrease in the infection rate to a rate of 1.61; instead, the center achieved a rate of 0.7 during that time period. Since May, 2012, no surgical site infections have occurred among coronary artery bypass graft patients, Candis Kles, a critical care nurse at Athens (Ga.) Regional Medical Center, reported at the annual meeting of the Society of Thoracic Surgeons.
"We are now into our 23rd month without a deep/organ space infection with over 454 patients," Ms. Kles said in a May interview.
The quality improvement process was initiated after the infection rates at the center were found to be high (ranging up to 6.1), compared with National Healthcare Safety Network data. Using the define, measure, analyze, improve, and control methodology, a multidisciplinary team was convened, including cardiothoracic surgeons, nurses, and support personnel, and a 6-month process was undertaken to identify areas for improvement, said Ms. Kles who chaired the team.
"We also at this time partnered with the VHA National Hospital Engagement Network for some extra training and to help us along the process," she noted.
The team flow-charted processes – from scheduled surgery to discharge – and posted the flow charts in the operating room and cardiac intensive care unit to identify inconsistencies and potential problem areas. Frontline staff members were engaged and encouraged to participate in the improvement process by posting notes, suggestions, and questions on the flow charts.
A literature review was conducted to ensure that current practices mirrored best practices.
Despite an extensive evaluation of possible patient-, procedure-, and hospital-related factors that might be associated with the infection rate, no single cause of the high rate was identified, although a number of areas for improvement were recognized. Among the changes that were implemented were use of chlorhexidine oral rinse, which was administered until discharge; use of disposable EKG leads (after high bacterial counts were found on the leads in use prior to program initiation); use of silver-impregnated midsternal dressings; a change in surgical and suture techniques; development of patient educational materials, and standardization of all processes, Ms. Kles said, noting that the changes were implemented rapidly.
The success of the program is largely attributable to input from all levels and disciplines within the organization – including physicians who championed the process, and to staff engagement and buy in, she said.
The improvement in the infection rate resulted in cost avoidance of $212,355 (compared with a total excess cost of surgical site infections of $250,965 in 2011), and in a reduction from 156 to 24 excess hospital days.
Ms. Kles reported that as of February 2014 she is a member of the speakers bureau for Mölnlycke Health Care, a maker of surgical and wound care products.
ORLANDO – A system-wide quality improvement process that utilized define, measure, analyze, improve, and control and rapid adoption methodology eliminated surgical site infections among patients undergoing isolated coronary artery bypass with donor site surgery at a regional medical center.
Between March 2012 and March 2013 the overall decline in the rate of surgical site infections among 250 patients surpassed the center’s goal of a 40% decrease in the infection rate to a rate of 1.61; instead, the center achieved a rate of 0.7 during that time period. Since May, 2012, no surgical site infections have occurred among coronary artery bypass graft patients, Candis Kles, a critical care nurse at Athens (Ga.) Regional Medical Center, reported at the annual meeting of the Society of Thoracic Surgeons.
"We are now into our 23rd month without a deep/organ space infection with over 454 patients," Ms. Kles said in a May interview.
The quality improvement process was initiated after the infection rates at the center were found to be high (ranging up to 6.1), compared with National Healthcare Safety Network data. Using the define, measure, analyze, improve, and control methodology, a multidisciplinary team was convened, including cardiothoracic surgeons, nurses, and support personnel, and a 6-month process was undertaken to identify areas for improvement, said Ms. Kles who chaired the team.
"We also at this time partnered with the VHA National Hospital Engagement Network for some extra training and to help us along the process," she noted.
The team flow-charted processes – from scheduled surgery to discharge – and posted the flow charts in the operating room and cardiac intensive care unit to identify inconsistencies and potential problem areas. Frontline staff members were engaged and encouraged to participate in the improvement process by posting notes, suggestions, and questions on the flow charts.
A literature review was conducted to ensure that current practices mirrored best practices.
Despite an extensive evaluation of possible patient-, procedure-, and hospital-related factors that might be associated with the infection rate, no single cause of the high rate was identified, although a number of areas for improvement were recognized. Among the changes that were implemented were use of chlorhexidine oral rinse, which was administered until discharge; use of disposable EKG leads (after high bacterial counts were found on the leads in use prior to program initiation); use of silver-impregnated midsternal dressings; a change in surgical and suture techniques; development of patient educational materials, and standardization of all processes, Ms. Kles said, noting that the changes were implemented rapidly.
The success of the program is largely attributable to input from all levels and disciplines within the organization – including physicians who championed the process, and to staff engagement and buy in, she said.
The improvement in the infection rate resulted in cost avoidance of $212,355 (compared with a total excess cost of surgical site infections of $250,965 in 2011), and in a reduction from 156 to 24 excess hospital days.
Ms. Kles reported that as of February 2014 she is a member of the speakers bureau for Mölnlycke Health Care, a maker of surgical and wound care products.
AT THE STS ANNUAL MEETING
Key clinical point: Cross-discipline buy in obliterated CABG surgical site infections.
Major finding: Since May, 2012, no surgical site infections have occurred among CABG patients.
Data source: An overview of a quality improvement process at a regional medical center.
Disclosures: Ms. Kles reported that as of February, 2014 she is a member of the speakers bureau for Mölnlycke Health Care.
Breath test could improve lung cancer screening
ORLANDO – The presence of certain carbonyl volatile organic compounds in exhaled breath can aid in the detection of early lung cancer, according to Dr. Michael Bousamra.
An analysis of volatile organic compounds (VOCs) in the exhaled breath of 10 lung cancer patients and 88 controls, including 45 who were smokers and 43 who were nonsmokers, identified four carbonyl VOCs that occurred significantly more often in the lung cancer patients’ breath samples than in the control samples: 2-butanone, 3-hydroxy-2-butanone, hydroxylacetaldehyde, and 4-hydroxyhexenal.
Further study of 151 patients with suspicious lung nodules found no single VOC marker that was independently predictive of lung cancer, but when the levels of three or more were elevated in a single patient, the sensitivity and specificity for lung cancer were 60% and 95.2%, respectively. When the levels of at least two of the VOCs were elevated, the sensitivity and specificity were 84.7% and 81%, respectively, and when at least one was elevated, the sensitivity and specificity were 93.8% and 45.2%, respectively.
The absence of VOC elevation was predictive of benign disease in 80% of cases, Dr. Bousamra of the University of Louisville, Ky., reported at the annual meeting of the Society of Thoracic Surgeons.
Notably, the concentrations of three of four VOCs in samples from lung cancer patients decreased to the level found in healthy controls after resection, he explained.
This finding "lends credence to the notion that these carbonyl markers really aren’t indicators of something other than cancer," Dr. Bousamra said.
Of the 151 patients in the study, 109 were diagnosed with lung cancer and 42 with benign nodules. Of those who had lung cancer, 1 had stage 0 disease, 47 had stage I, 18 had stage II, 26 had stage III, and 17 had stage IV.
The exhaled breath samples were collected using a 1-L Tedlar bag and were analyzed by investigators who were blinded to the preoperative diagnosis and pathology, he said.
The findings suggest that these specific VOCs in exhaled breath could be used as an adjunct to computed tomography (CT) for the diagnosis of early lung cancer. In this study, the VOCs were also useful for distinguishing benign from malignant nodules, Dr. Bousamra noted at the meeting.
"When three or four carbonyl markers were elevated, the probability of cancer was very high; when no carbonyl markers – or even one – was elevated, associated pulmonary disease was likely benign. I think that clinical decision making could be assisted in these instances," he said.
Carbonyl VOC testing, however, is not quite ready for prime time, he noted.
Exhaled breath has long been considered a promising noninvasive tool for the diagnosis of early lung cancer, but the studies conducted to date have failed to achieve clinical significance because of a lack of specificity and challenges associated with complex volatile mixtures.
Although the findings of the current study advance the possibility of using exhaled breath in lung cancer diagnosis and clinical decision making, the study was limited by an inadequate control group. In addition, further study is needed in patients who have pulmonary nodules and benign pulmonary disease, as well as in patients following resection, Dr. Bousamra said.
The study also lacked a specific look at patients with chronic obstructive pulmonary disease and other interstitial lung disease common in patients with lung cancer, he noted.
He estimated, however, that VOC testing could be in place to help with the diagnosis of lung cancer within 2 years.
The possibilities for this type of testing are exciting, and the work of Dr. Bousamra and his colleagues represents a window into the future of lung cancer screening and diagnosis, according to the invited discussant, Dr. Tom Varghese Jr., who is with the University of Washington in Seattle.
Lung cancer is the leading cause of cancer deaths worldwide, with higher mortality than the next three leading causes of cancer death combined, Dr. Varghese said.
A large screening trial showed that using low-dose CT for screening could reduce mortality by 20% – a finding that led to the recent endorsement by the U.S. Preventive Services Task Force of low-dose screening CTs for patients who are at high risk.
Such a screening program, if it were applied using strict criteria, "would avert 12,000 lung cancer deaths today," he asserted.
Adding measurement of VOCs in exhaled breath to the screening protocol could result in fewer invasive procedures for abnormal screening results, and VOC measurement could thus prove to be a simple, straight-forward cost-saving measure, Dr. Varghese added.
Dr. Eric Gartman, FCCP, comments: Current lung cancer screening recommendations remain quite controversial, and no matter one’s stance on the data, it would have to be agreed upon that further guidance on the appropriate screening population and further reduction in CT false positives are needed. In the near future, biomarker and exhaled breath phenotypes will dramatically change our screening for lung cancer and lead to earlier diagnoses.
ORLANDO – The presence of certain carbonyl volatile organic compounds in exhaled breath can aid in the detection of early lung cancer, according to Dr. Michael Bousamra.
An analysis of volatile organic compounds (VOCs) in the exhaled breath of 10 lung cancer patients and 88 controls, including 45 who were smokers and 43 who were nonsmokers, identified four carbonyl VOCs that occurred significantly more often in the lung cancer patients’ breath samples than in the control samples: 2-butanone, 3-hydroxy-2-butanone, hydroxylacetaldehyde, and 4-hydroxyhexenal.
Further study of 151 patients with suspicious lung nodules found no single VOC marker that was independently predictive of lung cancer, but when the levels of three or more were elevated in a single patient, the sensitivity and specificity for lung cancer were 60% and 95.2%, respectively. When the levels of at least two of the VOCs were elevated, the sensitivity and specificity were 84.7% and 81%, respectively, and when at least one was elevated, the sensitivity and specificity were 93.8% and 45.2%, respectively.
The absence of VOC elevation was predictive of benign disease in 80% of cases, Dr. Bousamra of the University of Louisville, Ky., reported at the annual meeting of the Society of Thoracic Surgeons.
Notably, the concentrations of three of four VOCs in samples from lung cancer patients decreased to the level found in healthy controls after resection, he explained.
This finding "lends credence to the notion that these carbonyl markers really aren’t indicators of something other than cancer," Dr. Bousamra said.
Of the 151 patients in the study, 109 were diagnosed with lung cancer and 42 with benign nodules. Of those who had lung cancer, 1 had stage 0 disease, 47 had stage I, 18 had stage II, 26 had stage III, and 17 had stage IV.
The exhaled breath samples were collected using a 1-L Tedlar bag and were analyzed by investigators who were blinded to the preoperative diagnosis and pathology, he said.
The findings suggest that these specific VOCs in exhaled breath could be used as an adjunct to computed tomography (CT) for the diagnosis of early lung cancer. In this study, the VOCs were also useful for distinguishing benign from malignant nodules, Dr. Bousamra noted at the meeting.
"When three or four carbonyl markers were elevated, the probability of cancer was very high; when no carbonyl markers – or even one – was elevated, associated pulmonary disease was likely benign. I think that clinical decision making could be assisted in these instances," he said.
Carbonyl VOC testing, however, is not quite ready for prime time, he noted.
Exhaled breath has long been considered a promising noninvasive tool for the diagnosis of early lung cancer, but the studies conducted to date have failed to achieve clinical significance because of a lack of specificity and challenges associated with complex volatile mixtures.
Although the findings of the current study advance the possibility of using exhaled breath in lung cancer diagnosis and clinical decision making, the study was limited by an inadequate control group. In addition, further study is needed in patients who have pulmonary nodules and benign pulmonary disease, as well as in patients following resection, Dr. Bousamra said.
The study also lacked a specific look at patients with chronic obstructive pulmonary disease and other interstitial lung disease common in patients with lung cancer, he noted.
He estimated, however, that VOC testing could be in place to help with the diagnosis of lung cancer within 2 years.
The possibilities for this type of testing are exciting, and the work of Dr. Bousamra and his colleagues represents a window into the future of lung cancer screening and diagnosis, according to the invited discussant, Dr. Tom Varghese Jr., who is with the University of Washington in Seattle.
Lung cancer is the leading cause of cancer deaths worldwide, with higher mortality than the next three leading causes of cancer death combined, Dr. Varghese said.
A large screening trial showed that using low-dose CT for screening could reduce mortality by 20% – a finding that led to the recent endorsement by the U.S. Preventive Services Task Force of low-dose screening CTs for patients who are at high risk.
Such a screening program, if it were applied using strict criteria, "would avert 12,000 lung cancer deaths today," he asserted.
Adding measurement of VOCs in exhaled breath to the screening protocol could result in fewer invasive procedures for abnormal screening results, and VOC measurement could thus prove to be a simple, straight-forward cost-saving measure, Dr. Varghese added.
Dr. Eric Gartman, FCCP, comments: Current lung cancer screening recommendations remain quite controversial, and no matter one’s stance on the data, it would have to be agreed upon that further guidance on the appropriate screening population and further reduction in CT false positives are needed. In the near future, biomarker and exhaled breath phenotypes will dramatically change our screening for lung cancer and lead to earlier diagnoses.
ORLANDO – The presence of certain carbonyl volatile organic compounds in exhaled breath can aid in the detection of early lung cancer, according to Dr. Michael Bousamra.
An analysis of volatile organic compounds (VOCs) in the exhaled breath of 10 lung cancer patients and 88 controls, including 45 who were smokers and 43 who were nonsmokers, identified four carbonyl VOCs that occurred significantly more often in the lung cancer patients’ breath samples than in the control samples: 2-butanone, 3-hydroxy-2-butanone, hydroxylacetaldehyde, and 4-hydroxyhexenal.
Further study of 151 patients with suspicious lung nodules found no single VOC marker that was independently predictive of lung cancer, but when the levels of three or more were elevated in a single patient, the sensitivity and specificity for lung cancer were 60% and 95.2%, respectively. When the levels of at least two of the VOCs were elevated, the sensitivity and specificity were 84.7% and 81%, respectively, and when at least one was elevated, the sensitivity and specificity were 93.8% and 45.2%, respectively.
The absence of VOC elevation was predictive of benign disease in 80% of cases, Dr. Bousamra of the University of Louisville, Ky., reported at the annual meeting of the Society of Thoracic Surgeons.
Notably, the concentrations of three of four VOCs in samples from lung cancer patients decreased to the level found in healthy controls after resection, he explained.
This finding "lends credence to the notion that these carbonyl markers really aren’t indicators of something other than cancer," Dr. Bousamra said.
Of the 151 patients in the study, 109 were diagnosed with lung cancer and 42 with benign nodules. Of those who had lung cancer, 1 had stage 0 disease, 47 had stage I, 18 had stage II, 26 had stage III, and 17 had stage IV.
The exhaled breath samples were collected using a 1-L Tedlar bag and were analyzed by investigators who were blinded to the preoperative diagnosis and pathology, he said.
The findings suggest that these specific VOCs in exhaled breath could be used as an adjunct to computed tomography (CT) for the diagnosis of early lung cancer. In this study, the VOCs were also useful for distinguishing benign from malignant nodules, Dr. Bousamra noted at the meeting.
"When three or four carbonyl markers were elevated, the probability of cancer was very high; when no carbonyl markers – or even one – was elevated, associated pulmonary disease was likely benign. I think that clinical decision making could be assisted in these instances," he said.
Carbonyl VOC testing, however, is not quite ready for prime time, he noted.
Exhaled breath has long been considered a promising noninvasive tool for the diagnosis of early lung cancer, but the studies conducted to date have failed to achieve clinical significance because of a lack of specificity and challenges associated with complex volatile mixtures.
Although the findings of the current study advance the possibility of using exhaled breath in lung cancer diagnosis and clinical decision making, the study was limited by an inadequate control group. In addition, further study is needed in patients who have pulmonary nodules and benign pulmonary disease, as well as in patients following resection, Dr. Bousamra said.
The study also lacked a specific look at patients with chronic obstructive pulmonary disease and other interstitial lung disease common in patients with lung cancer, he noted.
He estimated, however, that VOC testing could be in place to help with the diagnosis of lung cancer within 2 years.
The possibilities for this type of testing are exciting, and the work of Dr. Bousamra and his colleagues represents a window into the future of lung cancer screening and diagnosis, according to the invited discussant, Dr. Tom Varghese Jr., who is with the University of Washington in Seattle.
Lung cancer is the leading cause of cancer deaths worldwide, with higher mortality than the next three leading causes of cancer death combined, Dr. Varghese said.
A large screening trial showed that using low-dose CT for screening could reduce mortality by 20% – a finding that led to the recent endorsement by the U.S. Preventive Services Task Force of low-dose screening CTs for patients who are at high risk.
Such a screening program, if it were applied using strict criteria, "would avert 12,000 lung cancer deaths today," he asserted.
Adding measurement of VOCs in exhaled breath to the screening protocol could result in fewer invasive procedures for abnormal screening results, and VOC measurement could thus prove to be a simple, straight-forward cost-saving measure, Dr. Varghese added.
Dr. Eric Gartman, FCCP, comments: Current lung cancer screening recommendations remain quite controversial, and no matter one’s stance on the data, it would have to be agreed upon that further guidance on the appropriate screening population and further reduction in CT false positives are needed. In the near future, biomarker and exhaled breath phenotypes will dramatically change our screening for lung cancer and lead to earlier diagnoses.
Major finding: Finding three or more specific carbonyl VOCs in exhaled breath was 95% predictive of lung cancer, while no elevation was 80% predictive of benign nodules.
Data source: An analysis of VOCs in the exhaled breath of 151 patients with suspicious lung lesions.
Disclosures: Dr. Bousamra reported having no disclosures.
Point/Counterpoint – Another surgeon’s error – Must you tell the patient?
POINT: Surgeons have a duty to tell patients when a medical error has been made by a physician colleague.
Surgeons have a moral and ethical obligation to inform a patient when a medical error has occurred, including cases when the error was made by another surgeon.
Principles that support complete and honest disclosure to the patient and/or the patient’s family in such cases include professional obligation on the part of both the surgeon who made the error and the surgeon who discovered the error, the integrity of both surgeons, the patient’s right to informed care throughout the continuum of care, and the patient’s right to informed consent.
With respect to the first, the American Medical Association’s code of ethics provides a framework for disclosure; it clearly states that situations occur in which a patient experiences significant complications that may have resulted from a physician’s mistake or judgment and that the physician is ethically required to inform the patient of all facts necessary to ensure understanding of the error that occurred.
The American College of Physicians’ ethics manual also states that physicians should disclose to patients information about procedural or judgment errors made during the course of care, as long as that information is pertinent and material to the patient’s well-being.
Errors do not necessarily imply negligence or unethical behavior, but failure to disclose may.
As for patients’ rights, I think that patients are entitled to honest information. They shouldn’t bear the burden of determining how they came to be in another surgeon’s care.
Patients with complications may have impactful financial burdens that result from the additional treatment that is needed, and without all pertinent information, they may have difficulty understanding the benefits, such as deferment of payments, to which they are entitled.
The patient must also be kept informed as to the long-term care plan, and honest and timely disclosure will facilitate moving beyond blame and toward patient advocacy.
The patient is entitled to informed consent, and this requires an understanding of the conditions under which they arrived in another surgeon’s care. If a second procedure is required, the patient must be made aware of potential complications – including how the effects of the initial error might impact outcomes.
Although surgeons have an ethical obligation to disclose errors made by another surgeon, this is admittedly a difficult task. Pressures from society and medical professionals can make disclosure difficult, but the benefits of disclosure are very real; studies show that open, honest communication improves patient satisfaction, strengthens the physician-patient relationship, and can ultimately improve outcomes.
Disclosure also has the potential to improve the well-being of the surgeons involved, through relieving feelings of guilt, and satisfying the need to fulfill one’s obligations. Furthermore, data suggest that error disclosure reduces long-term litigation and costs. Admittedly, however, there are little data on how disclosure of another surgeon’s errors ultimately reduces litigation and costs.
Ultimately, supporting a just culture allows us to emphasize the importance of disclosing errors and to be accountable in setting a standard that involves exploring errors rather than ignoring them; it must be remembered, though, that this process of disclosure involves obtaining facts to help both surgeons and patients understand what truly happened.
Surgeon-to-surgeon discussions can be productive and can facilitate disclosure. However, if the doctor who made the error declines to be part of the disclosure process, one still has an obligation to disclose the error and to answer the patient’s questions honestly.
This approach requires a commitment to support surgeons in their efforts to promote transparency, and it requires a clear understanding of our obligations and the role of disclosure during training; we need to engage medical students and residents in the very important role of health care advocacy.
Dr. Bruce is an associate professor at the Ohio State University, Columbus.
COUNTERPOINT: Surgeons are not required to inform a patient of another physician’s possible error.
Surgeons do not have an obligation to disclose to a patient another surgeon’s possible medical error.
A consensus has been reached in medicine about our ethical duty to inform patients about our own medical errors. Although nondisclosure has previously been rationalized by concerns about invoking anxiety or confusion in the patient, this approach has largely been discredited; disclosure preserves patient trust and bolsters the physician-patient relationship.
However, it is an entirely different story when it comes to disclosing another surgeon’s mistake – a situation that is quite common. A recent survey showed that two-thirds of respondents had encountered a similar dilemma in the past 6 months (Qual. Saf. Health Care 2009;18:209-12).
The approach that physicians have previously taken when faced with this dilemma is an important measure of what they believe represents an ethical or just response. A poll of many of my colleagues across the country and at my own institution suggests that the preferred approach is to provide appropriate care for the patient and to answer their questions honestly, but to not proactively disclose the perceived medical error.
In fact, this was the preferred approach of every surgeon who responded.
A recent article in the New England Journal of Medicine addressed this very topic. The authors noted that there is little guidance available regarding the reporting of another physician’s error (2013;369:1752-7).
Among the challenges inherent in disclosing another’s mistake is the difficulty in determining exactly what happened. Uncertainty inevitably exists regarding the conversations that took place between the patient and the surgeon, and also about what actually defines a medical error. Incidents regarded as medical errors may comprise a large spectrum, ranging from "not what I would have done – but within the standard of care," to "blatant negligence."
Several studies suggest that highly trained physicians and surgeons routinely disagree about whether negligence has occurred in a given case. In one study, two reviewers disagreed 38% of the time as to whether appropriate care was provided.
Physicians have difficulty judging if the standard of care has been met. Therefore, it is not acceptable for each of us to assume we are the medical expert capable of rendering an opinion of whether previous care was appropriate and informing patients of our opinion.
Physicians overwhelmingly report that in the event they are responsible for a medical error discovered by another physician, they would prefer that the physician come to them first to discuss the matter. In fact, 93% of 400 respondents in one survey reported this preference.
The most acceptable approach when dealing with a peer’s medical error is to discuss the error with the responsible physician and to encourage the physician to disclose any error with the patient.
If there is disagreement as to whether an error occurred, institutional guidance should be applied. Only a collaborative approach can appropriately meet the needs of the patient and family after harmful medical errors.
Dr. Chadrick E. Denlinger is an associate professor at the Medical University of South Carolina, Charleston.
POINT: Surgeons have a duty to tell patients when a medical error has been made by a physician colleague.
Surgeons have a moral and ethical obligation to inform a patient when a medical error has occurred, including cases when the error was made by another surgeon.
Principles that support complete and honest disclosure to the patient and/or the patient’s family in such cases include professional obligation on the part of both the surgeon who made the error and the surgeon who discovered the error, the integrity of both surgeons, the patient’s right to informed care throughout the continuum of care, and the patient’s right to informed consent.
With respect to the first, the American Medical Association’s code of ethics provides a framework for disclosure; it clearly states that situations occur in which a patient experiences significant complications that may have resulted from a physician’s mistake or judgment and that the physician is ethically required to inform the patient of all facts necessary to ensure understanding of the error that occurred.
The American College of Physicians’ ethics manual also states that physicians should disclose to patients information about procedural or judgment errors made during the course of care, as long as that information is pertinent and material to the patient’s well-being.
Errors do not necessarily imply negligence or unethical behavior, but failure to disclose may.
As for patients’ rights, I think that patients are entitled to honest information. They shouldn’t bear the burden of determining how they came to be in another surgeon’s care.
Patients with complications may have impactful financial burdens that result from the additional treatment that is needed, and without all pertinent information, they may have difficulty understanding the benefits, such as deferment of payments, to which they are entitled.
The patient must also be kept informed as to the long-term care plan, and honest and timely disclosure will facilitate moving beyond blame and toward patient advocacy.
The patient is entitled to informed consent, and this requires an understanding of the conditions under which they arrived in another surgeon’s care. If a second procedure is required, the patient must be made aware of potential complications – including how the effects of the initial error might impact outcomes.
Although surgeons have an ethical obligation to disclose errors made by another surgeon, this is admittedly a difficult task. Pressures from society and medical professionals can make disclosure difficult, but the benefits of disclosure are very real; studies show that open, honest communication improves patient satisfaction, strengthens the physician-patient relationship, and can ultimately improve outcomes.
Disclosure also has the potential to improve the well-being of the surgeons involved, through relieving feelings of guilt, and satisfying the need to fulfill one’s obligations. Furthermore, data suggest that error disclosure reduces long-term litigation and costs. Admittedly, however, there are little data on how disclosure of another surgeon’s errors ultimately reduces litigation and costs.
Ultimately, supporting a just culture allows us to emphasize the importance of disclosing errors and to be accountable in setting a standard that involves exploring errors rather than ignoring them; it must be remembered, though, that this process of disclosure involves obtaining facts to help both surgeons and patients understand what truly happened.
Surgeon-to-surgeon discussions can be productive and can facilitate disclosure. However, if the doctor who made the error declines to be part of the disclosure process, one still has an obligation to disclose the error and to answer the patient’s questions honestly.
This approach requires a commitment to support surgeons in their efforts to promote transparency, and it requires a clear understanding of our obligations and the role of disclosure during training; we need to engage medical students and residents in the very important role of health care advocacy.
Dr. Bruce is an associate professor at the Ohio State University, Columbus.
COUNTERPOINT: Surgeons are not required to inform a patient of another physician’s possible error.
Surgeons do not have an obligation to disclose to a patient another surgeon’s possible medical error.
A consensus has been reached in medicine about our ethical duty to inform patients about our own medical errors. Although nondisclosure has previously been rationalized by concerns about invoking anxiety or confusion in the patient, this approach has largely been discredited; disclosure preserves patient trust and bolsters the physician-patient relationship.
However, it is an entirely different story when it comes to disclosing another surgeon’s mistake – a situation that is quite common. A recent survey showed that two-thirds of respondents had encountered a similar dilemma in the past 6 months (Qual. Saf. Health Care 2009;18:209-12).
The approach that physicians have previously taken when faced with this dilemma is an important measure of what they believe represents an ethical or just response. A poll of many of my colleagues across the country and at my own institution suggests that the preferred approach is to provide appropriate care for the patient and to answer their questions honestly, but to not proactively disclose the perceived medical error.
In fact, this was the preferred approach of every surgeon who responded.
A recent article in the New England Journal of Medicine addressed this very topic. The authors noted that there is little guidance available regarding the reporting of another physician’s error (2013;369:1752-7).
Among the challenges inherent in disclosing another’s mistake is the difficulty in determining exactly what happened. Uncertainty inevitably exists regarding the conversations that took place between the patient and the surgeon, and also about what actually defines a medical error. Incidents regarded as medical errors may comprise a large spectrum, ranging from "not what I would have done – but within the standard of care," to "blatant negligence."
Several studies suggest that highly trained physicians and surgeons routinely disagree about whether negligence has occurred in a given case. In one study, two reviewers disagreed 38% of the time as to whether appropriate care was provided.
Physicians have difficulty judging if the standard of care has been met. Therefore, it is not acceptable for each of us to assume we are the medical expert capable of rendering an opinion of whether previous care was appropriate and informing patients of our opinion.
Physicians overwhelmingly report that in the event they are responsible for a medical error discovered by another physician, they would prefer that the physician come to them first to discuss the matter. In fact, 93% of 400 respondents in one survey reported this preference.
The most acceptable approach when dealing with a peer’s medical error is to discuss the error with the responsible physician and to encourage the physician to disclose any error with the patient.
If there is disagreement as to whether an error occurred, institutional guidance should be applied. Only a collaborative approach can appropriately meet the needs of the patient and family after harmful medical errors.
Dr. Chadrick E. Denlinger is an associate professor at the Medical University of South Carolina, Charleston.
POINT: Surgeons have a duty to tell patients when a medical error has been made by a physician colleague.
Surgeons have a moral and ethical obligation to inform a patient when a medical error has occurred, including cases when the error was made by another surgeon.
Principles that support complete and honest disclosure to the patient and/or the patient’s family in such cases include professional obligation on the part of both the surgeon who made the error and the surgeon who discovered the error, the integrity of both surgeons, the patient’s right to informed care throughout the continuum of care, and the patient’s right to informed consent.
With respect to the first, the American Medical Association’s code of ethics provides a framework for disclosure; it clearly states that situations occur in which a patient experiences significant complications that may have resulted from a physician’s mistake or judgment and that the physician is ethically required to inform the patient of all facts necessary to ensure understanding of the error that occurred.
The American College of Physicians’ ethics manual also states that physicians should disclose to patients information about procedural or judgment errors made during the course of care, as long as that information is pertinent and material to the patient’s well-being.
Errors do not necessarily imply negligence or unethical behavior, but failure to disclose may.
As for patients’ rights, I think that patients are entitled to honest information. They shouldn’t bear the burden of determining how they came to be in another surgeon’s care.
Patients with complications may have impactful financial burdens that result from the additional treatment that is needed, and without all pertinent information, they may have difficulty understanding the benefits, such as deferment of payments, to which they are entitled.
The patient must also be kept informed as to the long-term care plan, and honest and timely disclosure will facilitate moving beyond blame and toward patient advocacy.
The patient is entitled to informed consent, and this requires an understanding of the conditions under which they arrived in another surgeon’s care. If a second procedure is required, the patient must be made aware of potential complications – including how the effects of the initial error might impact outcomes.
Although surgeons have an ethical obligation to disclose errors made by another surgeon, this is admittedly a difficult task. Pressures from society and medical professionals can make disclosure difficult, but the benefits of disclosure are very real; studies show that open, honest communication improves patient satisfaction, strengthens the physician-patient relationship, and can ultimately improve outcomes.
Disclosure also has the potential to improve the well-being of the surgeons involved, through relieving feelings of guilt, and satisfying the need to fulfill one’s obligations. Furthermore, data suggest that error disclosure reduces long-term litigation and costs. Admittedly, however, there are little data on how disclosure of another surgeon’s errors ultimately reduces litigation and costs.
Ultimately, supporting a just culture allows us to emphasize the importance of disclosing errors and to be accountable in setting a standard that involves exploring errors rather than ignoring them; it must be remembered, though, that this process of disclosure involves obtaining facts to help both surgeons and patients understand what truly happened.
Surgeon-to-surgeon discussions can be productive and can facilitate disclosure. However, if the doctor who made the error declines to be part of the disclosure process, one still has an obligation to disclose the error and to answer the patient’s questions honestly.
This approach requires a commitment to support surgeons in their efforts to promote transparency, and it requires a clear understanding of our obligations and the role of disclosure during training; we need to engage medical students and residents in the very important role of health care advocacy.
Dr. Bruce is an associate professor at the Ohio State University, Columbus.
COUNTERPOINT: Surgeons are not required to inform a patient of another physician’s possible error.
Surgeons do not have an obligation to disclose to a patient another surgeon’s possible medical error.
A consensus has been reached in medicine about our ethical duty to inform patients about our own medical errors. Although nondisclosure has previously been rationalized by concerns about invoking anxiety or confusion in the patient, this approach has largely been discredited; disclosure preserves patient trust and bolsters the physician-patient relationship.
However, it is an entirely different story when it comes to disclosing another surgeon’s mistake – a situation that is quite common. A recent survey showed that two-thirds of respondents had encountered a similar dilemma in the past 6 months (Qual. Saf. Health Care 2009;18:209-12).
The approach that physicians have previously taken when faced with this dilemma is an important measure of what they believe represents an ethical or just response. A poll of many of my colleagues across the country and at my own institution suggests that the preferred approach is to provide appropriate care for the patient and to answer their questions honestly, but to not proactively disclose the perceived medical error.
In fact, this was the preferred approach of every surgeon who responded.
A recent article in the New England Journal of Medicine addressed this very topic. The authors noted that there is little guidance available regarding the reporting of another physician’s error (2013;369:1752-7).
Among the challenges inherent in disclosing another’s mistake is the difficulty in determining exactly what happened. Uncertainty inevitably exists regarding the conversations that took place between the patient and the surgeon, and also about what actually defines a medical error. Incidents regarded as medical errors may comprise a large spectrum, ranging from "not what I would have done – but within the standard of care," to "blatant negligence."
Several studies suggest that highly trained physicians and surgeons routinely disagree about whether negligence has occurred in a given case. In one study, two reviewers disagreed 38% of the time as to whether appropriate care was provided.
Physicians have difficulty judging if the standard of care has been met. Therefore, it is not acceptable for each of us to assume we are the medical expert capable of rendering an opinion of whether previous care was appropriate and informing patients of our opinion.
Physicians overwhelmingly report that in the event they are responsible for a medical error discovered by another physician, they would prefer that the physician come to them first to discuss the matter. In fact, 93% of 400 respondents in one survey reported this preference.
The most acceptable approach when dealing with a peer’s medical error is to discuss the error with the responsible physician and to encourage the physician to disclose any error with the patient.
If there is disagreement as to whether an error occurred, institutional guidance should be applied. Only a collaborative approach can appropriately meet the needs of the patient and family after harmful medical errors.
Dr. Chadrick E. Denlinger is an associate professor at the Medical University of South Carolina, Charleston.
Prior resection poses certain risks in lung transplantation
ORLANDO – Prior lung resection is associated with increased early mortality and with a more than twofold increased risk of renal failure requiring dialysis in lung transplant recipients, data from the United Network for Organ Sharing suggest.
Prior resection is not, however, associated with increased long-term mortality, prolonged hospital length of stay, or airway dehiscence, Dr. Asvin M. Ganapathi reported at the annual meeting of the Society of Thoracic Surgeons.
Of 15,300 adult lung transplant recipients in the UNOS database who received lungs between October 1999 and December 2011, 80 had a prior lobectomy and 22 had a prior pneumonectomy. After 3:1 propensity matching based on 17 recipient variables known to affect perioperative morbidity and mortality, 90-day mortality in 306 nonresection patients was 5.8%, compared with 13.9% in the 102 with prior resection. Renal failure requiring dialysis occurred in 6.6% and 13.9% of patients in the groups, respectively, said Dr. Ganapathi of the anesthesiology division of Duke University, Durham, N.C.
Hospital length of stay longer than 25 days was required in 36.9% and 36.4% of the nonresection and resection groups, respectively, and airway dehiscence occurred in 1.3% and 2%, he said.
Survival at 1 and 5 years was 83.6% and 48.4% in the nonresection group, and 78.9% and 45.6% in the prior-resection group.
A subanalysis comparing the prior-lobectomy patients with patients with no prior resection revealed no differences between the two groups in any of the examined outcomes, although there was a trend toward increased 90-day mortality in the lobectomy patient, and a more than twofold increase in renal failure requiring dialysis. A subanalysis comparing those with prior pneumonectomy with those with no prior resection showed a significantly greater need for dialysis in the pneumonectomy patients (8.9% vs. 3.8%), and a trend toward increased 90-day mortality in the pneumonectomy patients, but no differences in the other examined outcomes.
The propensity-matched groups were similar with respect to recipient, donor, and operative characteristics. There were 10 double and 12 single lung transplants after pneumonectomy, and 51 double and 29 single transplants after lobectomy.
Lung transplantation provides a durable, efficacious treatment for end-stage lung disease, but indications for transplant can vary, and as a result, a select group of patients may have had prior lung resection for treatment of their underlying disease, Dr. Ganapathi said.
Both lobectomy and pneumonectomy are known to cause anatomic changes such as mediastinal shift and vascular abnormalities.
"As such, a history of previous lung resection may affect selection of donor organs and increase the difficulty of transplantation," he said.
In fact, historically, prior thoracic surgery was considered a relative contraindication to lung transplantation because of increased risk of poor outcomes, but recent case reports and single-institution case series – though limited by small patient numbers and the inclusion of both major and minor thoracic procedures ranging from chest tube insertion to pneumonectomy – have suggested that transplantation is feasible in these patients, he said.
Studies specifically looking at lung transplant after resection are lacking; the largest series involved pneumonectomy and included only 14 patients, he said.
The current findings suggest that prior resection should not preclude lung transplantation.
Notable limits of the study include its retrospective design, which may have introduced unexpected bias into the analysis; the fact that the analysis is limited to the variable collected for the UNOS database; and the number of patients with prior resection, although this may be secondary to underreporting of prior thoracic procedures in the UNOS candidate registration form or a result of data being collected only from 1999 onward.
Other variables that may have been of interest for the current analysis were knowledge of laterality of prior resection, time from resection to treatment, days of postoperative ventilator use, and operative time, Dr. Ganapathi noted. Specifically, in cases of single lung transplant, the issue of laterality would be of great interest, he said.
"In conclusion, lung transplantation subsequent to previous major lung resection is associated with an increased risk of early mortality, but did not demonstrate any significant long-term survival differences. Additionally, prior major lung resection predisposes to increased morbidity in the form of renal failure requiring dialysis," he said. The increased rate of dialysis may be secondary to longer operative time, the need for cardiopulmonary bypass, or other unquantified factors, he added.
Careful, individualized preoperative recipient evaluation and technical planning are necessary to minimize these risks in the patients, he concluded.
Dr. Ganapathi reported having no relevant disclosures.
ORLANDO – Prior lung resection is associated with increased early mortality and with a more than twofold increased risk of renal failure requiring dialysis in lung transplant recipients, data from the United Network for Organ Sharing suggest.
Prior resection is not, however, associated with increased long-term mortality, prolonged hospital length of stay, or airway dehiscence, Dr. Asvin M. Ganapathi reported at the annual meeting of the Society of Thoracic Surgeons.
Of 15,300 adult lung transplant recipients in the UNOS database who received lungs between October 1999 and December 2011, 80 had a prior lobectomy and 22 had a prior pneumonectomy. After 3:1 propensity matching based on 17 recipient variables known to affect perioperative morbidity and mortality, 90-day mortality in 306 nonresection patients was 5.8%, compared with 13.9% in the 102 with prior resection. Renal failure requiring dialysis occurred in 6.6% and 13.9% of patients in the groups, respectively, said Dr. Ganapathi of the anesthesiology division of Duke University, Durham, N.C.
Hospital length of stay longer than 25 days was required in 36.9% and 36.4% of the nonresection and resection groups, respectively, and airway dehiscence occurred in 1.3% and 2%, he said.
Survival at 1 and 5 years was 83.6% and 48.4% in the nonresection group, and 78.9% and 45.6% in the prior-resection group.
A subanalysis comparing the prior-lobectomy patients with patients with no prior resection revealed no differences between the two groups in any of the examined outcomes, although there was a trend toward increased 90-day mortality in the lobectomy patient, and a more than twofold increase in renal failure requiring dialysis. A subanalysis comparing those with prior pneumonectomy with those with no prior resection showed a significantly greater need for dialysis in the pneumonectomy patients (8.9% vs. 3.8%), and a trend toward increased 90-day mortality in the pneumonectomy patients, but no differences in the other examined outcomes.
The propensity-matched groups were similar with respect to recipient, donor, and operative characteristics. There were 10 double and 12 single lung transplants after pneumonectomy, and 51 double and 29 single transplants after lobectomy.
Lung transplantation provides a durable, efficacious treatment for end-stage lung disease, but indications for transplant can vary, and as a result, a select group of patients may have had prior lung resection for treatment of their underlying disease, Dr. Ganapathi said.
Both lobectomy and pneumonectomy are known to cause anatomic changes such as mediastinal shift and vascular abnormalities.
"As such, a history of previous lung resection may affect selection of donor organs and increase the difficulty of transplantation," he said.
In fact, historically, prior thoracic surgery was considered a relative contraindication to lung transplantation because of increased risk of poor outcomes, but recent case reports and single-institution case series – though limited by small patient numbers and the inclusion of both major and minor thoracic procedures ranging from chest tube insertion to pneumonectomy – have suggested that transplantation is feasible in these patients, he said.
Studies specifically looking at lung transplant after resection are lacking; the largest series involved pneumonectomy and included only 14 patients, he said.
The current findings suggest that prior resection should not preclude lung transplantation.
Notable limits of the study include its retrospective design, which may have introduced unexpected bias into the analysis; the fact that the analysis is limited to the variable collected for the UNOS database; and the number of patients with prior resection, although this may be secondary to underreporting of prior thoracic procedures in the UNOS candidate registration form or a result of data being collected only from 1999 onward.
Other variables that may have been of interest for the current analysis were knowledge of laterality of prior resection, time from resection to treatment, days of postoperative ventilator use, and operative time, Dr. Ganapathi noted. Specifically, in cases of single lung transplant, the issue of laterality would be of great interest, he said.
"In conclusion, lung transplantation subsequent to previous major lung resection is associated with an increased risk of early mortality, but did not demonstrate any significant long-term survival differences. Additionally, prior major lung resection predisposes to increased morbidity in the form of renal failure requiring dialysis," he said. The increased rate of dialysis may be secondary to longer operative time, the need for cardiopulmonary bypass, or other unquantified factors, he added.
Careful, individualized preoperative recipient evaluation and technical planning are necessary to minimize these risks in the patients, he concluded.
Dr. Ganapathi reported having no relevant disclosures.
ORLANDO – Prior lung resection is associated with increased early mortality and with a more than twofold increased risk of renal failure requiring dialysis in lung transplant recipients, data from the United Network for Organ Sharing suggest.
Prior resection is not, however, associated with increased long-term mortality, prolonged hospital length of stay, or airway dehiscence, Dr. Asvin M. Ganapathi reported at the annual meeting of the Society of Thoracic Surgeons.
Of 15,300 adult lung transplant recipients in the UNOS database who received lungs between October 1999 and December 2011, 80 had a prior lobectomy and 22 had a prior pneumonectomy. After 3:1 propensity matching based on 17 recipient variables known to affect perioperative morbidity and mortality, 90-day mortality in 306 nonresection patients was 5.8%, compared with 13.9% in the 102 with prior resection. Renal failure requiring dialysis occurred in 6.6% and 13.9% of patients in the groups, respectively, said Dr. Ganapathi of the anesthesiology division of Duke University, Durham, N.C.
Hospital length of stay longer than 25 days was required in 36.9% and 36.4% of the nonresection and resection groups, respectively, and airway dehiscence occurred in 1.3% and 2%, he said.
Survival at 1 and 5 years was 83.6% and 48.4% in the nonresection group, and 78.9% and 45.6% in the prior-resection group.
A subanalysis comparing the prior-lobectomy patients with patients with no prior resection revealed no differences between the two groups in any of the examined outcomes, although there was a trend toward increased 90-day mortality in the lobectomy patient, and a more than twofold increase in renal failure requiring dialysis. A subanalysis comparing those with prior pneumonectomy with those with no prior resection showed a significantly greater need for dialysis in the pneumonectomy patients (8.9% vs. 3.8%), and a trend toward increased 90-day mortality in the pneumonectomy patients, but no differences in the other examined outcomes.
The propensity-matched groups were similar with respect to recipient, donor, and operative characteristics. There were 10 double and 12 single lung transplants after pneumonectomy, and 51 double and 29 single transplants after lobectomy.
Lung transplantation provides a durable, efficacious treatment for end-stage lung disease, but indications for transplant can vary, and as a result, a select group of patients may have had prior lung resection for treatment of their underlying disease, Dr. Ganapathi said.
Both lobectomy and pneumonectomy are known to cause anatomic changes such as mediastinal shift and vascular abnormalities.
"As such, a history of previous lung resection may affect selection of donor organs and increase the difficulty of transplantation," he said.
In fact, historically, prior thoracic surgery was considered a relative contraindication to lung transplantation because of increased risk of poor outcomes, but recent case reports and single-institution case series – though limited by small patient numbers and the inclusion of both major and minor thoracic procedures ranging from chest tube insertion to pneumonectomy – have suggested that transplantation is feasible in these patients, he said.
Studies specifically looking at lung transplant after resection are lacking; the largest series involved pneumonectomy and included only 14 patients, he said.
The current findings suggest that prior resection should not preclude lung transplantation.
Notable limits of the study include its retrospective design, which may have introduced unexpected bias into the analysis; the fact that the analysis is limited to the variable collected for the UNOS database; and the number of patients with prior resection, although this may be secondary to underreporting of prior thoracic procedures in the UNOS candidate registration form or a result of data being collected only from 1999 onward.
Other variables that may have been of interest for the current analysis were knowledge of laterality of prior resection, time from resection to treatment, days of postoperative ventilator use, and operative time, Dr. Ganapathi noted. Specifically, in cases of single lung transplant, the issue of laterality would be of great interest, he said.
"In conclusion, lung transplantation subsequent to previous major lung resection is associated with an increased risk of early mortality, but did not demonstrate any significant long-term survival differences. Additionally, prior major lung resection predisposes to increased morbidity in the form of renal failure requiring dialysis," he said. The increased rate of dialysis may be secondary to longer operative time, the need for cardiopulmonary bypass, or other unquantified factors, he added.
Careful, individualized preoperative recipient evaluation and technical planning are necessary to minimize these risks in the patients, he concluded.
Dr. Ganapathi reported having no relevant disclosures.
AT THE STS ANNUAL MEETING
Major finding: Survival at 1 and 5 years was 83.6% and 48.4%, respectively, in the nonresection group, and 78.9% and 45.6% in the prior-resection group.
Data source: An analysis of data from more than 15,000 patients in the United Network of Organ Sharing database.
Disclosures: Dr. Ganapathi reported having no relevant disclosures.
Registry data reveal risk factors for lung retransplantation
ORLANDO – Age and increased lung allocation score are among factors associated with risk of lung retransplantation, according to an analysis of data from the United Network for Organ Sharing.
Of 24,194 consecutive patients who underwent lung transplantation between 1987 and 2012 and who were included in the nationwide registry, 941 (3.9%) underwent retransplantation. Age over 40 years, increased lung allocation score, increased percentage decline in forced ventilatory capacity (FVC), and readmission to the intensive care unit each were associated with retransplantation (odds ratios, 2.26, 0.98, 0.99, and 2.27, respectively), Dr. J. Awori Hayanga reported at the annual meeting of the Society of Thoracic Surgeons.
The current findings could allow for better prediction of graft failure and the need for retransplantation, and could help guide immunosuppression protocols and donor selection, he said. This is important, because although the overall volume of retransplantation remains less than 5%, the number of such procedures is steadily increasing, with up to 100 now performed each year.
"Following the introduction of the lung allocation score, the waiting time decreased, and the volume, perhaps predictably, increased by almost 60% with this increased emphasis on clinical acuity. The relative paucity of donors nevertheless engenders a considerable amount of scrutiny," Dr. Hayanga said. "Contention exists between the utilitarian view, where allocation prioritizes recipients in most need, versus the egalitarian view that seeks to provide equal opportunity to all those in need," he explained.
While this ethical argument is "tempered somewhat by steadily improving outcomes," retransplantations still remain inferior to primary transplantations, carrying a 30% overall increased risk of death. Prior to this study, the risk factors for retransplantation were poorly characterized in the literature.
The study also showed that donor factors associated with retransplantation included smoking history and body mass index less than 18.5 kg/m2 (OR, 1.47 and 1.68, respectively). One transplant-related factor – increased graft ischemic time – was also associated with retransplantation (OR, 0.91), said Dr. Hayanga of the University of Pittsburgh.
Lung transplantation is a well-established therapeutic option for end-stage lung disease, but long-term outcomes are largely determined by chronic allograft failure – a diagnosis which constitutes "the most justifiable, evidence-driven indication for retransplantation," he said. Survival among patients who undergo retransplantation for this indication have nearly equivalent survival to those with a first transplant, he noted.
Conversely, "there are multiple observations in the literature of the dismal outcomes observed following retransplantation for primary graft failure and airway complications," he noted.
"We seek now to build and validate a risk scoring model to help predict the risk for chronic graft failures and for retransplantation, to enrich the dialogue, to improve immunosuppressive and selection protocols, and ultimately to provide evidence-based prognostic data," he said.
This study was funded by the Ruben J. Williams Foundation. Dr. Hayanga reported having no other disclosures.
ORLANDO – Age and increased lung allocation score are among factors associated with risk of lung retransplantation, according to an analysis of data from the United Network for Organ Sharing.
Of 24,194 consecutive patients who underwent lung transplantation between 1987 and 2012 and who were included in the nationwide registry, 941 (3.9%) underwent retransplantation. Age over 40 years, increased lung allocation score, increased percentage decline in forced ventilatory capacity (FVC), and readmission to the intensive care unit each were associated with retransplantation (odds ratios, 2.26, 0.98, 0.99, and 2.27, respectively), Dr. J. Awori Hayanga reported at the annual meeting of the Society of Thoracic Surgeons.
The current findings could allow for better prediction of graft failure and the need for retransplantation, and could help guide immunosuppression protocols and donor selection, he said. This is important, because although the overall volume of retransplantation remains less than 5%, the number of such procedures is steadily increasing, with up to 100 now performed each year.
"Following the introduction of the lung allocation score, the waiting time decreased, and the volume, perhaps predictably, increased by almost 60% with this increased emphasis on clinical acuity. The relative paucity of donors nevertheless engenders a considerable amount of scrutiny," Dr. Hayanga said. "Contention exists between the utilitarian view, where allocation prioritizes recipients in most need, versus the egalitarian view that seeks to provide equal opportunity to all those in need," he explained.
While this ethical argument is "tempered somewhat by steadily improving outcomes," retransplantations still remain inferior to primary transplantations, carrying a 30% overall increased risk of death. Prior to this study, the risk factors for retransplantation were poorly characterized in the literature.
The study also showed that donor factors associated with retransplantation included smoking history and body mass index less than 18.5 kg/m2 (OR, 1.47 and 1.68, respectively). One transplant-related factor – increased graft ischemic time – was also associated with retransplantation (OR, 0.91), said Dr. Hayanga of the University of Pittsburgh.
Lung transplantation is a well-established therapeutic option for end-stage lung disease, but long-term outcomes are largely determined by chronic allograft failure – a diagnosis which constitutes "the most justifiable, evidence-driven indication for retransplantation," he said. Survival among patients who undergo retransplantation for this indication have nearly equivalent survival to those with a first transplant, he noted.
Conversely, "there are multiple observations in the literature of the dismal outcomes observed following retransplantation for primary graft failure and airway complications," he noted.
"We seek now to build and validate a risk scoring model to help predict the risk for chronic graft failures and for retransplantation, to enrich the dialogue, to improve immunosuppressive and selection protocols, and ultimately to provide evidence-based prognostic data," he said.
This study was funded by the Ruben J. Williams Foundation. Dr. Hayanga reported having no other disclosures.
ORLANDO – Age and increased lung allocation score are among factors associated with risk of lung retransplantation, according to an analysis of data from the United Network for Organ Sharing.
Of 24,194 consecutive patients who underwent lung transplantation between 1987 and 2012 and who were included in the nationwide registry, 941 (3.9%) underwent retransplantation. Age over 40 years, increased lung allocation score, increased percentage decline in forced ventilatory capacity (FVC), and readmission to the intensive care unit each were associated with retransplantation (odds ratios, 2.26, 0.98, 0.99, and 2.27, respectively), Dr. J. Awori Hayanga reported at the annual meeting of the Society of Thoracic Surgeons.
The current findings could allow for better prediction of graft failure and the need for retransplantation, and could help guide immunosuppression protocols and donor selection, he said. This is important, because although the overall volume of retransplantation remains less than 5%, the number of such procedures is steadily increasing, with up to 100 now performed each year.
"Following the introduction of the lung allocation score, the waiting time decreased, and the volume, perhaps predictably, increased by almost 60% with this increased emphasis on clinical acuity. The relative paucity of donors nevertheless engenders a considerable amount of scrutiny," Dr. Hayanga said. "Contention exists between the utilitarian view, where allocation prioritizes recipients in most need, versus the egalitarian view that seeks to provide equal opportunity to all those in need," he explained.
While this ethical argument is "tempered somewhat by steadily improving outcomes," retransplantations still remain inferior to primary transplantations, carrying a 30% overall increased risk of death. Prior to this study, the risk factors for retransplantation were poorly characterized in the literature.
The study also showed that donor factors associated with retransplantation included smoking history and body mass index less than 18.5 kg/m2 (OR, 1.47 and 1.68, respectively). One transplant-related factor – increased graft ischemic time – was also associated with retransplantation (OR, 0.91), said Dr. Hayanga of the University of Pittsburgh.
Lung transplantation is a well-established therapeutic option for end-stage lung disease, but long-term outcomes are largely determined by chronic allograft failure – a diagnosis which constitutes "the most justifiable, evidence-driven indication for retransplantation," he said. Survival among patients who undergo retransplantation for this indication have nearly equivalent survival to those with a first transplant, he noted.
Conversely, "there are multiple observations in the literature of the dismal outcomes observed following retransplantation for primary graft failure and airway complications," he noted.
"We seek now to build and validate a risk scoring model to help predict the risk for chronic graft failures and for retransplantation, to enrich the dialogue, to improve immunosuppressive and selection protocols, and ultimately to provide evidence-based prognostic data," he said.
This study was funded by the Ruben J. Williams Foundation. Dr. Hayanga reported having no other disclosures.
AT THE STS ANNUAL MEETING
Major finding: Factors associated with retransplantation were age over 40, increased lung allocation score, increased percentage decline in forced ventilatory capacity, and ICU readmission (odds ratios, 2.26, 0.98, 0.99, and 2.27, respectively).
Data source: An analysis of data from 24,194 participants in the United Network for Organ Sharing registry.
Disclosures: This study was funded by the Ruben J. Williams Foundation. Dr. Hayanga reported having no other disclosures.
Later lung retransplant may boost survival
ORLANDO – Survival following repeat lung transplantation is similar to survival following initial lung transplantation when performed at least 90 days after the initial transplant, according to a review of data from the United Network for Organ Sharing registry.
However, survival in those retransplanted within 90 days of the primary transplant is severely diminished, Asishana A. Osho, a fourth-year medical student at Duke University, Durham, N.C., reported at the annual meeting of the Society of Thoracic Surgeons.
The outcomes of 9,270 primary lung transplant cases and 456 retransplant cases performed since implementation of the lung allocation score (LAS) show that overall 5-year survival was significantly better in the primary transplant patients (hazard ratio, 1.69). However, after 1:1 propensity matching, 5-year survival was similar for 429 primary transplant and 429 retransplant patients (HR, 1.01), and between 392 primary transplant patients and 392 matched late (after 90 days) retransplant patients (HR, 1.23).
Conversely, 5-year survival was significantly reduced for 51 early (within 90 days) retransplant patients, compared with 51 matched primary transplant patients (HR, 1.38), Mr. Osho said.
Patients included in the study were participants in the UNOS registry. The median age of those in the primary transplant group was 58 years, compared with 62 years for the early retransplantation group and 47 for the late retransplantation group. The median LAS were 38.9, 88.3, and 45.8 for the groups, respectively.
Bilateral transplantation was performed in 66.5% of cases.
The findings provide new information about the effects of retransplantation timing and have potential implications for clinical decision making, Mr. Osho said.
The frequency of lung retransplantation has increased over the past several years, probably because of the implementation of the LAS, and this increase has also been accompanied by an increase in survival among those undergoing a repeat transplantation, as is apparent when comparing survival curves before and after 2005, he noted.
The current results, however, show that the survival is diminished with early retransplantation. Patients also generally did worse if they were treated in the ICU before transplant, if they had a single vs. double lung transplant, or if they received the transplant for primary graft dysfunction vs. for bronchiolitis obliterans.
The diminished survival among those undergoing early retransplantation may be related to the stress of having two major procedures in close proximity, Mr. Osho said.
"An additional consideration is that patients who do poorly shortly after the first transplant may have certain traits that predispose them to doing poorly with subsequent procedures," he said.
Though limited by the fact that only patients who ultimately received lungs were included, and by the retrospective design (a factor somewhat mitigated by the use of propensity matching), the findings identify factors, including admission status, type of treatment, and transplant diagnosis that clinicians should be cognizant of before performing retransplantation, and they suggest that the utility of early repeat transplantation requires further examination, he concluded.
Mr. Osho reporting having no disclosures.
ORLANDO – Survival following repeat lung transplantation is similar to survival following initial lung transplantation when performed at least 90 days after the initial transplant, according to a review of data from the United Network for Organ Sharing registry.
However, survival in those retransplanted within 90 days of the primary transplant is severely diminished, Asishana A. Osho, a fourth-year medical student at Duke University, Durham, N.C., reported at the annual meeting of the Society of Thoracic Surgeons.
The outcomes of 9,270 primary lung transplant cases and 456 retransplant cases performed since implementation of the lung allocation score (LAS) show that overall 5-year survival was significantly better in the primary transplant patients (hazard ratio, 1.69). However, after 1:1 propensity matching, 5-year survival was similar for 429 primary transplant and 429 retransplant patients (HR, 1.01), and between 392 primary transplant patients and 392 matched late (after 90 days) retransplant patients (HR, 1.23).
Conversely, 5-year survival was significantly reduced for 51 early (within 90 days) retransplant patients, compared with 51 matched primary transplant patients (HR, 1.38), Mr. Osho said.
Patients included in the study were participants in the UNOS registry. The median age of those in the primary transplant group was 58 years, compared with 62 years for the early retransplantation group and 47 for the late retransplantation group. The median LAS were 38.9, 88.3, and 45.8 for the groups, respectively.
Bilateral transplantation was performed in 66.5% of cases.
The findings provide new information about the effects of retransplantation timing and have potential implications for clinical decision making, Mr. Osho said.
The frequency of lung retransplantation has increased over the past several years, probably because of the implementation of the LAS, and this increase has also been accompanied by an increase in survival among those undergoing a repeat transplantation, as is apparent when comparing survival curves before and after 2005, he noted.
The current results, however, show that the survival is diminished with early retransplantation. Patients also generally did worse if they were treated in the ICU before transplant, if they had a single vs. double lung transplant, or if they received the transplant for primary graft dysfunction vs. for bronchiolitis obliterans.
The diminished survival among those undergoing early retransplantation may be related to the stress of having two major procedures in close proximity, Mr. Osho said.
"An additional consideration is that patients who do poorly shortly after the first transplant may have certain traits that predispose them to doing poorly with subsequent procedures," he said.
Though limited by the fact that only patients who ultimately received lungs were included, and by the retrospective design (a factor somewhat mitigated by the use of propensity matching), the findings identify factors, including admission status, type of treatment, and transplant diagnosis that clinicians should be cognizant of before performing retransplantation, and they suggest that the utility of early repeat transplantation requires further examination, he concluded.
Mr. Osho reporting having no disclosures.
ORLANDO – Survival following repeat lung transplantation is similar to survival following initial lung transplantation when performed at least 90 days after the initial transplant, according to a review of data from the United Network for Organ Sharing registry.
However, survival in those retransplanted within 90 days of the primary transplant is severely diminished, Asishana A. Osho, a fourth-year medical student at Duke University, Durham, N.C., reported at the annual meeting of the Society of Thoracic Surgeons.
The outcomes of 9,270 primary lung transplant cases and 456 retransplant cases performed since implementation of the lung allocation score (LAS) show that overall 5-year survival was significantly better in the primary transplant patients (hazard ratio, 1.69). However, after 1:1 propensity matching, 5-year survival was similar for 429 primary transplant and 429 retransplant patients (HR, 1.01), and between 392 primary transplant patients and 392 matched late (after 90 days) retransplant patients (HR, 1.23).
Conversely, 5-year survival was significantly reduced for 51 early (within 90 days) retransplant patients, compared with 51 matched primary transplant patients (HR, 1.38), Mr. Osho said.
Patients included in the study were participants in the UNOS registry. The median age of those in the primary transplant group was 58 years, compared with 62 years for the early retransplantation group and 47 for the late retransplantation group. The median LAS were 38.9, 88.3, and 45.8 for the groups, respectively.
Bilateral transplantation was performed in 66.5% of cases.
The findings provide new information about the effects of retransplantation timing and have potential implications for clinical decision making, Mr. Osho said.
The frequency of lung retransplantation has increased over the past several years, probably because of the implementation of the LAS, and this increase has also been accompanied by an increase in survival among those undergoing a repeat transplantation, as is apparent when comparing survival curves before and after 2005, he noted.
The current results, however, show that the survival is diminished with early retransplantation. Patients also generally did worse if they were treated in the ICU before transplant, if they had a single vs. double lung transplant, or if they received the transplant for primary graft dysfunction vs. for bronchiolitis obliterans.
The diminished survival among those undergoing early retransplantation may be related to the stress of having two major procedures in close proximity, Mr. Osho said.
"An additional consideration is that patients who do poorly shortly after the first transplant may have certain traits that predispose them to doing poorly with subsequent procedures," he said.
Though limited by the fact that only patients who ultimately received lungs were included, and by the retrospective design (a factor somewhat mitigated by the use of propensity matching), the findings identify factors, including admission status, type of treatment, and transplant diagnosis that clinicians should be cognizant of before performing retransplantation, and they suggest that the utility of early repeat transplantation requires further examination, he concluded.
Mr. Osho reporting having no disclosures.
AT THE STS ANNUAL MEETING
Major finding: Survival was significantly reduced for early (within 90 days) retransplant, compared with primary transplant (HR, 1.38).
Data source: A retrospective cohort study including 9,270 primary lung transplant patients and 456 retransplant patients.
Disclosures: Mr. Osho reported having no disclosures.
Esophagectomy treatment response nodes provide prognostic information
ORLANDO – Tumor response nodes obtained from patients who undergo esophagectomy for early-stage adenocarcinoma provide valuable prognostic information, according to Dr. Dylan Nieman.
Such nodes – lymph nodes with evidence of neoadjuvant treatment effect without residual cancer cells – may mark the prior spread of tumor, and should be counted as positive, Dr. Nieman of the University of Rochester (N.Y.) said at the annual meeting of the Society of Thoracic Surgeons.
The current practice of ignoring these nodes likely results in systematic pathologic understaging, he explained.
In 90 patients who underwent esophagectomy after neoadjuvant therapy for esophageal adenocarcinoma, the median number of nodes found per resection specimen was 18. A total of 100 tumor response nodes without viable malignant cells were identified in 38 (42%) of the patients.
The majority of the patients with treatment response nodes had only one node detected, Dr. Nieman said.
The median survival for the entire cohort was 55.6 months, and the 5-year survival was 35%. The median survival of patients with evidence of treatment response nodes was poorer, but not significantly different from those without treatment response nodes (45.9 vs. 55.6 months), he noted.
"However, for a subset of 62 patients classified as having limited or no nodal involvement – that is, AJCC N0 or N1 – the presence of treatment response nodes was associated with significantly poorer survival. This effect remained when adjusting for patient age and [American Joint Committee on Cancer] stage (hazard ratio, 2.7)," he said.
In a subset of 46 patients with pathologic AJCC stage 2B or less, the presence of treatment response nodes was still associated with poorer survival, even after adjustment for age and AJCC stage.
"To look at this a different way, if tumor response nodes were to be counted as positive, the nodal status of 29 of these patients would be upstaged. This includes 18 of 39 patients, or 46%, who were classified as node negative, and 8 of 23 patients, or 34%, who were classified as N1 by AJCC pathological assessment," he said.
The recategorization of those 29 patients resulted in better survival for the entire group, but particularly for those in the lowest-stage group, he noted.
When investigators modeled stage-adjusted survival, the counting of tumor response nodes as positive offered a better model fit, compared with following the current practice of ignoring tumor response nodes, he explained.
Patients included in the study were identified from a prospectively collected clinical database of esophagectomy patients, and were treated with neoadjuvant therapy for esophageal adenocarcinoma between 2006 and 2011. Most (82 of 90) were men. The patients had a mean age of 62 years, and were followed for a median of 27 months. Forty patients received preoperative chemotherapy, and 50 received preoperative chemoradiation.
In all cases, pathologic resection margins were negative.
On pathologic review, the majority had T3 tumors. More than 40% were staged as node negative, and more than two-thirds were staged with N0 or N1 disease.
"Prior to neoadjuvant therapy, all of these patients were clinically staged stage 2 or stage 3, but at the time of resection after neoadjuvant therapy, by AJCC staging, 24% of the patients were stage 0 or 1, 27% were stage 2, and almost half were stage 3," he said.
The findings are notable, because the current AJCC pathologic staging for esophageal adenocarcinoma is derived from the experience of patients undergoing esophagectomy alone. This approach has unclear relevance in patients who receive multimodality therapy, which has supplanted primary surgery as the standard of care for locoregionally advanced esophageal adenocarcinoma, he said.
"Future efforts at revising the staging system for esophageal adenocarcinoma should consider treatment response lymph nodes. ... We currently have pathological staging models that are of limited usefulness for our neoadjuvantly treated population. Perhaps consideration of these nodes can help improve that," he concluded.
Dr. Nieman reported having no financial disclosures.
ORLANDO – Tumor response nodes obtained from patients who undergo esophagectomy for early-stage adenocarcinoma provide valuable prognostic information, according to Dr. Dylan Nieman.
Such nodes – lymph nodes with evidence of neoadjuvant treatment effect without residual cancer cells – may mark the prior spread of tumor, and should be counted as positive, Dr. Nieman of the University of Rochester (N.Y.) said at the annual meeting of the Society of Thoracic Surgeons.
The current practice of ignoring these nodes likely results in systematic pathologic understaging, he explained.
In 90 patients who underwent esophagectomy after neoadjuvant therapy for esophageal adenocarcinoma, the median number of nodes found per resection specimen was 18. A total of 100 tumor response nodes without viable malignant cells were identified in 38 (42%) of the patients.
The majority of the patients with treatment response nodes had only one node detected, Dr. Nieman said.
The median survival for the entire cohort was 55.6 months, and the 5-year survival was 35%. The median survival of patients with evidence of treatment response nodes was poorer, but not significantly different from those without treatment response nodes (45.9 vs. 55.6 months), he noted.
"However, for a subset of 62 patients classified as having limited or no nodal involvement – that is, AJCC N0 or N1 – the presence of treatment response nodes was associated with significantly poorer survival. This effect remained when adjusting for patient age and [American Joint Committee on Cancer] stage (hazard ratio, 2.7)," he said.
In a subset of 46 patients with pathologic AJCC stage 2B or less, the presence of treatment response nodes was still associated with poorer survival, even after adjustment for age and AJCC stage.
"To look at this a different way, if tumor response nodes were to be counted as positive, the nodal status of 29 of these patients would be upstaged. This includes 18 of 39 patients, or 46%, who were classified as node negative, and 8 of 23 patients, or 34%, who were classified as N1 by AJCC pathological assessment," he said.
The recategorization of those 29 patients resulted in better survival for the entire group, but particularly for those in the lowest-stage group, he noted.
When investigators modeled stage-adjusted survival, the counting of tumor response nodes as positive offered a better model fit, compared with following the current practice of ignoring tumor response nodes, he explained.
Patients included in the study were identified from a prospectively collected clinical database of esophagectomy patients, and were treated with neoadjuvant therapy for esophageal adenocarcinoma between 2006 and 2011. Most (82 of 90) were men. The patients had a mean age of 62 years, and were followed for a median of 27 months. Forty patients received preoperative chemotherapy, and 50 received preoperative chemoradiation.
In all cases, pathologic resection margins were negative.
On pathologic review, the majority had T3 tumors. More than 40% were staged as node negative, and more than two-thirds were staged with N0 or N1 disease.
"Prior to neoadjuvant therapy, all of these patients were clinically staged stage 2 or stage 3, but at the time of resection after neoadjuvant therapy, by AJCC staging, 24% of the patients were stage 0 or 1, 27% were stage 2, and almost half were stage 3," he said.
The findings are notable, because the current AJCC pathologic staging for esophageal adenocarcinoma is derived from the experience of patients undergoing esophagectomy alone. This approach has unclear relevance in patients who receive multimodality therapy, which has supplanted primary surgery as the standard of care for locoregionally advanced esophageal adenocarcinoma, he said.
"Future efforts at revising the staging system for esophageal adenocarcinoma should consider treatment response lymph nodes. ... We currently have pathological staging models that are of limited usefulness for our neoadjuvantly treated population. Perhaps consideration of these nodes can help improve that," he concluded.
Dr. Nieman reported having no financial disclosures.
ORLANDO – Tumor response nodes obtained from patients who undergo esophagectomy for early-stage adenocarcinoma provide valuable prognostic information, according to Dr. Dylan Nieman.
Such nodes – lymph nodes with evidence of neoadjuvant treatment effect without residual cancer cells – may mark the prior spread of tumor, and should be counted as positive, Dr. Nieman of the University of Rochester (N.Y.) said at the annual meeting of the Society of Thoracic Surgeons.
The current practice of ignoring these nodes likely results in systematic pathologic understaging, he explained.
In 90 patients who underwent esophagectomy after neoadjuvant therapy for esophageal adenocarcinoma, the median number of nodes found per resection specimen was 18. A total of 100 tumor response nodes without viable malignant cells were identified in 38 (42%) of the patients.
The majority of the patients with treatment response nodes had only one node detected, Dr. Nieman said.
The median survival for the entire cohort was 55.6 months, and the 5-year survival was 35%. The median survival of patients with evidence of treatment response nodes was poorer, but not significantly different from those without treatment response nodes (45.9 vs. 55.6 months), he noted.
"However, for a subset of 62 patients classified as having limited or no nodal involvement – that is, AJCC N0 or N1 – the presence of treatment response nodes was associated with significantly poorer survival. This effect remained when adjusting for patient age and [American Joint Committee on Cancer] stage (hazard ratio, 2.7)," he said.
In a subset of 46 patients with pathologic AJCC stage 2B or less, the presence of treatment response nodes was still associated with poorer survival, even after adjustment for age and AJCC stage.
"To look at this a different way, if tumor response nodes were to be counted as positive, the nodal status of 29 of these patients would be upstaged. This includes 18 of 39 patients, or 46%, who were classified as node negative, and 8 of 23 patients, or 34%, who were classified as N1 by AJCC pathological assessment," he said.
The recategorization of those 29 patients resulted in better survival for the entire group, but particularly for those in the lowest-stage group, he noted.
When investigators modeled stage-adjusted survival, the counting of tumor response nodes as positive offered a better model fit, compared with following the current practice of ignoring tumor response nodes, he explained.
Patients included in the study were identified from a prospectively collected clinical database of esophagectomy patients, and were treated with neoadjuvant therapy for esophageal adenocarcinoma between 2006 and 2011. Most (82 of 90) were men. The patients had a mean age of 62 years, and were followed for a median of 27 months. Forty patients received preoperative chemotherapy, and 50 received preoperative chemoradiation.
In all cases, pathologic resection margins were negative.
On pathologic review, the majority had T3 tumors. More than 40% were staged as node negative, and more than two-thirds were staged with N0 or N1 disease.
"Prior to neoadjuvant therapy, all of these patients were clinically staged stage 2 or stage 3, but at the time of resection after neoadjuvant therapy, by AJCC staging, 24% of the patients were stage 0 or 1, 27% were stage 2, and almost half were stage 3," he said.
The findings are notable, because the current AJCC pathologic staging for esophageal adenocarcinoma is derived from the experience of patients undergoing esophagectomy alone. This approach has unclear relevance in patients who receive multimodality therapy, which has supplanted primary surgery as the standard of care for locoregionally advanced esophageal adenocarcinoma, he said.
"Future efforts at revising the staging system for esophageal adenocarcinoma should consider treatment response lymph nodes. ... We currently have pathological staging models that are of limited usefulness for our neoadjuvantly treated population. Perhaps consideration of these nodes can help improve that," he concluded.
Dr. Nieman reported having no financial disclosures.
AT THE STS ANNUAL MEETING
Major finding: In 62 patients classified as having limited or no nodal involvement, the presence of treatment response nodes was associated with significantly poorer survival (adjusted hazard ratio, 2.7).
Data source: A review of 90 prospectively collected cases.
Disclosures: Dr. Nieman reported having no financial disclosures.
Platelet-rich plasma reduces sternal wound infection risk
ORLANDO – The use of autologous platelet-rich plasma following cardiac surgery was associated with a significantly reduced incidence of sternal wound complications – and with a 50% reduction in the costs associated with such complications – in a study of 2,000 patients.
The findings suggest that routine use of platelet-rich plasma (PRP) should be considered for all patients undergoing sternotomy for cardiac surgical procedures, Dr. Amit N. Patel said at the annual meeting of the Society of Thoracic Surgeons.
Over a 7-year period, an initial 1,000 patients undergoing open cardiac operations requiring sternotomy received standard-of-care sternal closure, including preoperative antibiotic treatment and protocol-driven glycemic management. The second 1,000 patients received the same standard-of-care sternal closure plus PRP, which was applied to the sternum at the time of closure.
Compared with the control group, the patients who received PRP had a significantly reduced incidence of deep sternal wound infections (0.6% vs. 2.0%) and superficial wound drainage (2.0% vs. 8.0%), as well as a lower readmission rate (0.8% vs. 4.0%), said Dr. Patel of the University of Utah, Salt Lake City.
On multivariate analysis, the use of PRP was an independent predictor of a reduced incidence of deep sternal wound infection, he reported.
Furthermore, the total cost associated with caring for wound complications was reduced by about 50% in the PRP group ($593,791 vs. $1,256,960), he added.
The treatment and control groups were similar with respect to age, weight, diabetes, renal dysfunction, smoking status, and steroid use. However, the treatment group had more ventricular assist device implantations and open aortic operations. No complications associated with the use of PRP were reported.
Given the increased morbidity, mortality and costs associated with sternal wound complications following cardiac surgery, the findings have important implications for improving outcomes, Dr. Patel said, noting that the findings support those of several prior studies demonstrating that autologous platelet-rich plasma promotes successful wound healing through improved ossification.
"The problem is, how do you prepare it, how do you apply it, and how do you use it reproducibly?" he said.
In the current study, the Magellan Platelet Separator System was used, and it provided such reproducibility – at a cost of $385 per application, he noted.
Though limited by the single-center, nonrandomized, and nonblinded nature of the study, the findings are bolstered by the large sample size and the fact that the study was conducted at a tertiary referral center, he said.
"The overall potential of PRP in this large sample size was very positive," he concluded.
Dr. Patel reported having no disclosures.
ORLANDO – The use of autologous platelet-rich plasma following cardiac surgery was associated with a significantly reduced incidence of sternal wound complications – and with a 50% reduction in the costs associated with such complications – in a study of 2,000 patients.
The findings suggest that routine use of platelet-rich plasma (PRP) should be considered for all patients undergoing sternotomy for cardiac surgical procedures, Dr. Amit N. Patel said at the annual meeting of the Society of Thoracic Surgeons.
Over a 7-year period, an initial 1,000 patients undergoing open cardiac operations requiring sternotomy received standard-of-care sternal closure, including preoperative antibiotic treatment and protocol-driven glycemic management. The second 1,000 patients received the same standard-of-care sternal closure plus PRP, which was applied to the sternum at the time of closure.
Compared with the control group, the patients who received PRP had a significantly reduced incidence of deep sternal wound infections (0.6% vs. 2.0%) and superficial wound drainage (2.0% vs. 8.0%), as well as a lower readmission rate (0.8% vs. 4.0%), said Dr. Patel of the University of Utah, Salt Lake City.
On multivariate analysis, the use of PRP was an independent predictor of a reduced incidence of deep sternal wound infection, he reported.
Furthermore, the total cost associated with caring for wound complications was reduced by about 50% in the PRP group ($593,791 vs. $1,256,960), he added.
The treatment and control groups were similar with respect to age, weight, diabetes, renal dysfunction, smoking status, and steroid use. However, the treatment group had more ventricular assist device implantations and open aortic operations. No complications associated with the use of PRP were reported.
Given the increased morbidity, mortality and costs associated with sternal wound complications following cardiac surgery, the findings have important implications for improving outcomes, Dr. Patel said, noting that the findings support those of several prior studies demonstrating that autologous platelet-rich plasma promotes successful wound healing through improved ossification.
"The problem is, how do you prepare it, how do you apply it, and how do you use it reproducibly?" he said.
In the current study, the Magellan Platelet Separator System was used, and it provided such reproducibility – at a cost of $385 per application, he noted.
Though limited by the single-center, nonrandomized, and nonblinded nature of the study, the findings are bolstered by the large sample size and the fact that the study was conducted at a tertiary referral center, he said.
"The overall potential of PRP in this large sample size was very positive," he concluded.
Dr. Patel reported having no disclosures.
ORLANDO – The use of autologous platelet-rich plasma following cardiac surgery was associated with a significantly reduced incidence of sternal wound complications – and with a 50% reduction in the costs associated with such complications – in a study of 2,000 patients.
The findings suggest that routine use of platelet-rich plasma (PRP) should be considered for all patients undergoing sternotomy for cardiac surgical procedures, Dr. Amit N. Patel said at the annual meeting of the Society of Thoracic Surgeons.
Over a 7-year period, an initial 1,000 patients undergoing open cardiac operations requiring sternotomy received standard-of-care sternal closure, including preoperative antibiotic treatment and protocol-driven glycemic management. The second 1,000 patients received the same standard-of-care sternal closure plus PRP, which was applied to the sternum at the time of closure.
Compared with the control group, the patients who received PRP had a significantly reduced incidence of deep sternal wound infections (0.6% vs. 2.0%) and superficial wound drainage (2.0% vs. 8.0%), as well as a lower readmission rate (0.8% vs. 4.0%), said Dr. Patel of the University of Utah, Salt Lake City.
On multivariate analysis, the use of PRP was an independent predictor of a reduced incidence of deep sternal wound infection, he reported.
Furthermore, the total cost associated with caring for wound complications was reduced by about 50% in the PRP group ($593,791 vs. $1,256,960), he added.
The treatment and control groups were similar with respect to age, weight, diabetes, renal dysfunction, smoking status, and steroid use. However, the treatment group had more ventricular assist device implantations and open aortic operations. No complications associated with the use of PRP were reported.
Given the increased morbidity, mortality and costs associated with sternal wound complications following cardiac surgery, the findings have important implications for improving outcomes, Dr. Patel said, noting that the findings support those of several prior studies demonstrating that autologous platelet-rich plasma promotes successful wound healing through improved ossification.
"The problem is, how do you prepare it, how do you apply it, and how do you use it reproducibly?" he said.
In the current study, the Magellan Platelet Separator System was used, and it provided such reproducibility – at a cost of $385 per application, he noted.
Though limited by the single-center, nonrandomized, and nonblinded nature of the study, the findings are bolstered by the large sample size and the fact that the study was conducted at a tertiary referral center, he said.
"The overall potential of PRP in this large sample size was very positive," he concluded.
Dr. Patel reported having no disclosures.
AT THE STS ANNUAL MEETING
Major finding: PRP patients had a significantly reduced incidence of deep sternal wound infections (0.6% vs. 2.0%).
Data source: An observational study involving 2,000 patients who underwent sternotomy for cardiac surgical procedures at a single center.
Disclosures: Dr. Patel reported having no disclosures.
Novel procedure reduced need for aortic valve replacement in UAV patients
ORLANDO – A novel combination of aortic root remodeling and aortic valve bicuspidization helped prevent the need for surgery in young adult patients with unicuspid aortic valve anatomy and root dilatation, according to Dr. Diana Aicher.
Though unicuspid aortic valve (UAV) anatomy is rare, about 60% of affected patients require aortic valve surgery before 20 years of age owing to aneurysm of the aortic root. Aortic root remodeling and aortic valve bicuspidization allow for good aortic valve hemodynamic function, and in most patients with aortic regurgitation due to UAV and root aneurysm, the surgical procedure obviates the need for aortic valve replacement, Dr. Aicher reported at the annual meeting of the Society of Thoracic Surgeons.
Of 25 patients with aortic regurgitation due to UAV and aortic root dilatation who underwent the procedure between August 2001 and August 2012, 84% were free from reoperation and 91% were free from aortic valve replacement at 5 years of follow-up, said Dr. Aicher of Uniklinikum des Saarlandes, Homburg, Germany.
Intraoperative echocardiography revealed minimal (stage 1) aortic regurgitation in 8% of patients and no aortic regurgitation in 92% of patients. The systolic peak gradient was 14 mm Hg.
No early or late deaths occurred following surgery, and there was no bleeding or thromboembolism. One patient developed endocarditis during follow-up, which was treated with antibiotics and reoperation for aortic regurgitation 2 months later, Dr. Aicher noted.
Three other patients required reoperation; two had relevant recurrent aortic regurgitation due to suture dehiscence and were reoperated on between 16 and 32 months after the initial procedure. One patient received a biological aortic valve replacement.
Patients included in the study were adults aged 21-65 years (mean age, 37.5 years). All were followed echographically at 3, 6, and 12 months, and then at yearly intervals for up to 141 months (mean, 42 months).
The findings suggest that in patients with UAV who develop aortic root aneurysm, a combination of valve bicuspidization – a procedure developed by Dr. Aicher and her team several years ago – and root remodeling can be used to treat both defects with a satisfactory result, she said.
The procedure involves resection of the dilated aortic root tissue, leaving two tongues at 180-degree orientation for the commissures. A new commissure is then created opposite the normal one, and cusp tissue is augmented by autologous pericardial patches. Dilation of the basal ring was corrected by suture annuloplasty in 16 patients.
The findings indicate that "in the presence of UAV and aortic root dilatation, the concept of valve bicuspidization and root remodeling can be applied with satisfactory hemodynamic results. Additional stabilization of the atrioventricular junction by a circumferential annuloplasty is an important complement to the repair strategy," Dr. Aicher said.
"Our repair strategy is an alternative to the current standard of care," she concluded.
Dr. Aicher reported having no disclosures.
ORLANDO – A novel combination of aortic root remodeling and aortic valve bicuspidization helped prevent the need for surgery in young adult patients with unicuspid aortic valve anatomy and root dilatation, according to Dr. Diana Aicher.
Though unicuspid aortic valve (UAV) anatomy is rare, about 60% of affected patients require aortic valve surgery before 20 years of age owing to aneurysm of the aortic root. Aortic root remodeling and aortic valve bicuspidization allow for good aortic valve hemodynamic function, and in most patients with aortic regurgitation due to UAV and root aneurysm, the surgical procedure obviates the need for aortic valve replacement, Dr. Aicher reported at the annual meeting of the Society of Thoracic Surgeons.
Of 25 patients with aortic regurgitation due to UAV and aortic root dilatation who underwent the procedure between August 2001 and August 2012, 84% were free from reoperation and 91% were free from aortic valve replacement at 5 years of follow-up, said Dr. Aicher of Uniklinikum des Saarlandes, Homburg, Germany.
Intraoperative echocardiography revealed minimal (stage 1) aortic regurgitation in 8% of patients and no aortic regurgitation in 92% of patients. The systolic peak gradient was 14 mm Hg.
No early or late deaths occurred following surgery, and there was no bleeding or thromboembolism. One patient developed endocarditis during follow-up, which was treated with antibiotics and reoperation for aortic regurgitation 2 months later, Dr. Aicher noted.
Three other patients required reoperation; two had relevant recurrent aortic regurgitation due to suture dehiscence and were reoperated on between 16 and 32 months after the initial procedure. One patient received a biological aortic valve replacement.
Patients included in the study were adults aged 21-65 years (mean age, 37.5 years). All were followed echographically at 3, 6, and 12 months, and then at yearly intervals for up to 141 months (mean, 42 months).
The findings suggest that in patients with UAV who develop aortic root aneurysm, a combination of valve bicuspidization – a procedure developed by Dr. Aicher and her team several years ago – and root remodeling can be used to treat both defects with a satisfactory result, she said.
The procedure involves resection of the dilated aortic root tissue, leaving two tongues at 180-degree orientation for the commissures. A new commissure is then created opposite the normal one, and cusp tissue is augmented by autologous pericardial patches. Dilation of the basal ring was corrected by suture annuloplasty in 16 patients.
The findings indicate that "in the presence of UAV and aortic root dilatation, the concept of valve bicuspidization and root remodeling can be applied with satisfactory hemodynamic results. Additional stabilization of the atrioventricular junction by a circumferential annuloplasty is an important complement to the repair strategy," Dr. Aicher said.
"Our repair strategy is an alternative to the current standard of care," she concluded.
Dr. Aicher reported having no disclosures.
ORLANDO – A novel combination of aortic root remodeling and aortic valve bicuspidization helped prevent the need for surgery in young adult patients with unicuspid aortic valve anatomy and root dilatation, according to Dr. Diana Aicher.
Though unicuspid aortic valve (UAV) anatomy is rare, about 60% of affected patients require aortic valve surgery before 20 years of age owing to aneurysm of the aortic root. Aortic root remodeling and aortic valve bicuspidization allow for good aortic valve hemodynamic function, and in most patients with aortic regurgitation due to UAV and root aneurysm, the surgical procedure obviates the need for aortic valve replacement, Dr. Aicher reported at the annual meeting of the Society of Thoracic Surgeons.
Of 25 patients with aortic regurgitation due to UAV and aortic root dilatation who underwent the procedure between August 2001 and August 2012, 84% were free from reoperation and 91% were free from aortic valve replacement at 5 years of follow-up, said Dr. Aicher of Uniklinikum des Saarlandes, Homburg, Germany.
Intraoperative echocardiography revealed minimal (stage 1) aortic regurgitation in 8% of patients and no aortic regurgitation in 92% of patients. The systolic peak gradient was 14 mm Hg.
No early or late deaths occurred following surgery, and there was no bleeding or thromboembolism. One patient developed endocarditis during follow-up, which was treated with antibiotics and reoperation for aortic regurgitation 2 months later, Dr. Aicher noted.
Three other patients required reoperation; two had relevant recurrent aortic regurgitation due to suture dehiscence and were reoperated on between 16 and 32 months after the initial procedure. One patient received a biological aortic valve replacement.
Patients included in the study were adults aged 21-65 years (mean age, 37.5 years). All were followed echographically at 3, 6, and 12 months, and then at yearly intervals for up to 141 months (mean, 42 months).
The findings suggest that in patients with UAV who develop aortic root aneurysm, a combination of valve bicuspidization – a procedure developed by Dr. Aicher and her team several years ago – and root remodeling can be used to treat both defects with a satisfactory result, she said.
The procedure involves resection of the dilated aortic root tissue, leaving two tongues at 180-degree orientation for the commissures. A new commissure is then created opposite the normal one, and cusp tissue is augmented by autologous pericardial patches. Dilation of the basal ring was corrected by suture annuloplasty in 16 patients.
The findings indicate that "in the presence of UAV and aortic root dilatation, the concept of valve bicuspidization and root remodeling can be applied with satisfactory hemodynamic results. Additional stabilization of the atrioventricular junction by a circumferential annuloplasty is an important complement to the repair strategy," Dr. Aicher said.
"Our repair strategy is an alternative to the current standard of care," she concluded.
Dr. Aicher reported having no disclosures.
AT THE STS ANNUAL MEETING
Major finding: At 5 years of follow-up, 84% of patients with unicuspid aortic valve anatomy were free from reoperation and 91% were free from aortic valve replacement.
Data source: A review of 25 cases.
Disclosures: Dr. Aicher reported having no disclosures.
Compounds in exhaled breath could improve high-risk lung cancer screening
ORLANDO – The presence of certain carbonyl volatile organic compounds in exhaled breath can aid in the detection of early lung cancer, according to Dr. Michael Bousamra.
An analysis of volatile organic compounds (VOCs) in the exhaled breath of 10 lung cancer patients and 88 controls, including 45 smokers and 43 nonsmokers, identified four carbonyl VOCs that occurred significantly more often in the lung cancer patients’ breath samples than in the control samples: 2-butanone, 3-hydroxy-2-butanone, hydroxylacetaldehyde, and 4-hydroxyhexenal.
Further study of 151 patients with suspicious lung nodules found no single VOC marker that was independently predictive of lung cancer, but when the levels of three or more were elevated in a single patient, the sensitivity and specificity for lung cancer were 60% and 95.2%, respectively. When the levels of at least two of the VOCs were elevated, the sensitivity and specificity were 84.7% and 81%, respectively, and when at least one was elevated, the sensitivity and specificity were 93.8% and 45.2%, respectively.
The absence of VOC elevation was predictive of benign disease in 80% of cases, Dr. Bousamra of the University of Louisville, Ky., reported at the annual meeting of the Society of Thoracic Surgeons.
Notably, the concentrations of three of four VOCs in samples from lung cancer patients decreased to the level found in healthy controls after resection, he noted.
This finding "lends credence to the notion that these carbonyl markers really aren’t indicators of something other than cancer," he said.
Of the 151 patients studied, 109 were diagnosed with lung cancer and 42 with benign nodules. Of those with lung cancer, 1 had stage 0 disease, 47 had stage I, 18 had stage II, 26 had stage III, and 17 had stage IV.
The exhaled breath samples were collected using a 1-L Tedlar bag and were analyzed by investigators blinded to the preoperative diagnosis and pathology.
The findings suggest that these specific VOCs in exhaled breath could be used as an adjunct to computed tomography (CT) for the diagnosis of early lung cancer. In this study, the VOCs were also useful for distinguishing benign from malignant nodules, Dr. Bousamra noted. "When three or four carbonyl markers were elevated, the probability of cancer was very high; when no carbonyl markers – or even one – was elevated, associated pulmonary disease was likely benign. I think that clinical decision making could be assisted in these instances," he said.
Carbonyl VOC testing, however, is not quite ready for prime time, he noted.
Exhaled breath has long been considered a promising noninvasive tool for the diagnosis of early lung cancer, but studies conducted to date have failed to achieve clinical significance because of a lack of specificity and challenges associated with complex volatile mixtures.
Although the findings of the current study advance the possibility of using exhaled breath in lung cancer diagnosis and clinical decision making, the study was limited by an inadequate control group. In addition, further study is needed in patients with pulmonary nodules and benign pulmonary disease, as well as in patients following resection, Dr. Bousamra said.
The study also lacked a specific look at patients with chronic obstructive pulmonary disease and other interstitial lung disease common in patients with lung cancer, he noted.
He estimated, however, that VOC testing could be in place to help with the diagnosis of lung cancer within 2 years.
The possibilities for this testing are exciting, and the work of Dr. Bousamra and his colleagues represents a window into the future of lung cancer screening and diagnosis, according to the invited discussant, Dr. Tom Varghese Jr. of the University of Washington, Seattle.
Lung cancer is the leading cause of cancer deaths worldwide, with higher mortality than the next three leading causes of cancer death combined, Dr. Varghese said.
A large screening trial showed that using low-dose CT for screening could reduce mortality by 20% – a finding that led to the recent endorsement by the U.S. Preventive Services Task Force of low-dose screening CTs for high-risk patients.
Such screening, if applied using strict criteria, "would avert 12,000 lung cancer deaths today," he said.
Adding measurement of VOCs in exhaled breath to the screening protocol could result in fewer invasive procedures for abnormal screening results, and VOC measurement could thus prove to be a simple, straightforward cost-saving measure, Dr. Varghese added.
Dr. Bousamra reported having no disclosures.
ORLANDO – The presence of certain carbonyl volatile organic compounds in exhaled breath can aid in the detection of early lung cancer, according to Dr. Michael Bousamra.
An analysis of volatile organic compounds (VOCs) in the exhaled breath of 10 lung cancer patients and 88 controls, including 45 smokers and 43 nonsmokers, identified four carbonyl VOCs that occurred significantly more often in the lung cancer patients’ breath samples than in the control samples: 2-butanone, 3-hydroxy-2-butanone, hydroxylacetaldehyde, and 4-hydroxyhexenal.
Further study of 151 patients with suspicious lung nodules found no single VOC marker that was independently predictive of lung cancer, but when the levels of three or more were elevated in a single patient, the sensitivity and specificity for lung cancer were 60% and 95.2%, respectively. When the levels of at least two of the VOCs were elevated, the sensitivity and specificity were 84.7% and 81%, respectively, and when at least one was elevated, the sensitivity and specificity were 93.8% and 45.2%, respectively.
The absence of VOC elevation was predictive of benign disease in 80% of cases, Dr. Bousamra of the University of Louisville, Ky., reported at the annual meeting of the Society of Thoracic Surgeons.
Notably, the concentrations of three of four VOCs in samples from lung cancer patients decreased to the level found in healthy controls after resection, he noted.
This finding "lends credence to the notion that these carbonyl markers really aren’t indicators of something other than cancer," he said.
Of the 151 patients studied, 109 were diagnosed with lung cancer and 42 with benign nodules. Of those with lung cancer, 1 had stage 0 disease, 47 had stage I, 18 had stage II, 26 had stage III, and 17 had stage IV.
The exhaled breath samples were collected using a 1-L Tedlar bag and were analyzed by investigators blinded to the preoperative diagnosis and pathology.
The findings suggest that these specific VOCs in exhaled breath could be used as an adjunct to computed tomography (CT) for the diagnosis of early lung cancer. In this study, the VOCs were also useful for distinguishing benign from malignant nodules, Dr. Bousamra noted. "When three or four carbonyl markers were elevated, the probability of cancer was very high; when no carbonyl markers – or even one – was elevated, associated pulmonary disease was likely benign. I think that clinical decision making could be assisted in these instances," he said.
Carbonyl VOC testing, however, is not quite ready for prime time, he noted.
Exhaled breath has long been considered a promising noninvasive tool for the diagnosis of early lung cancer, but studies conducted to date have failed to achieve clinical significance because of a lack of specificity and challenges associated with complex volatile mixtures.
Although the findings of the current study advance the possibility of using exhaled breath in lung cancer diagnosis and clinical decision making, the study was limited by an inadequate control group. In addition, further study is needed in patients with pulmonary nodules and benign pulmonary disease, as well as in patients following resection, Dr. Bousamra said.
The study also lacked a specific look at patients with chronic obstructive pulmonary disease and other interstitial lung disease common in patients with lung cancer, he noted.
He estimated, however, that VOC testing could be in place to help with the diagnosis of lung cancer within 2 years.
The possibilities for this testing are exciting, and the work of Dr. Bousamra and his colleagues represents a window into the future of lung cancer screening and diagnosis, according to the invited discussant, Dr. Tom Varghese Jr. of the University of Washington, Seattle.
Lung cancer is the leading cause of cancer deaths worldwide, with higher mortality than the next three leading causes of cancer death combined, Dr. Varghese said.
A large screening trial showed that using low-dose CT for screening could reduce mortality by 20% – a finding that led to the recent endorsement by the U.S. Preventive Services Task Force of low-dose screening CTs for high-risk patients.
Such screening, if applied using strict criteria, "would avert 12,000 lung cancer deaths today," he said.
Adding measurement of VOCs in exhaled breath to the screening protocol could result in fewer invasive procedures for abnormal screening results, and VOC measurement could thus prove to be a simple, straightforward cost-saving measure, Dr. Varghese added.
Dr. Bousamra reported having no disclosures.
ORLANDO – The presence of certain carbonyl volatile organic compounds in exhaled breath can aid in the detection of early lung cancer, according to Dr. Michael Bousamra.
An analysis of volatile organic compounds (VOCs) in the exhaled breath of 10 lung cancer patients and 88 controls, including 45 smokers and 43 nonsmokers, identified four carbonyl VOCs that occurred significantly more often in the lung cancer patients’ breath samples than in the control samples: 2-butanone, 3-hydroxy-2-butanone, hydroxylacetaldehyde, and 4-hydroxyhexenal.
Further study of 151 patients with suspicious lung nodules found no single VOC marker that was independently predictive of lung cancer, but when the levels of three or more were elevated in a single patient, the sensitivity and specificity for lung cancer were 60% and 95.2%, respectively. When the levels of at least two of the VOCs were elevated, the sensitivity and specificity were 84.7% and 81%, respectively, and when at least one was elevated, the sensitivity and specificity were 93.8% and 45.2%, respectively.
The absence of VOC elevation was predictive of benign disease in 80% of cases, Dr. Bousamra of the University of Louisville, Ky., reported at the annual meeting of the Society of Thoracic Surgeons.
Notably, the concentrations of three of four VOCs in samples from lung cancer patients decreased to the level found in healthy controls after resection, he noted.
This finding "lends credence to the notion that these carbonyl markers really aren’t indicators of something other than cancer," he said.
Of the 151 patients studied, 109 were diagnosed with lung cancer and 42 with benign nodules. Of those with lung cancer, 1 had stage 0 disease, 47 had stage I, 18 had stage II, 26 had stage III, and 17 had stage IV.
The exhaled breath samples were collected using a 1-L Tedlar bag and were analyzed by investigators blinded to the preoperative diagnosis and pathology.
The findings suggest that these specific VOCs in exhaled breath could be used as an adjunct to computed tomography (CT) for the diagnosis of early lung cancer. In this study, the VOCs were also useful for distinguishing benign from malignant nodules, Dr. Bousamra noted. "When three or four carbonyl markers were elevated, the probability of cancer was very high; when no carbonyl markers – or even one – was elevated, associated pulmonary disease was likely benign. I think that clinical decision making could be assisted in these instances," he said.
Carbonyl VOC testing, however, is not quite ready for prime time, he noted.
Exhaled breath has long been considered a promising noninvasive tool for the diagnosis of early lung cancer, but studies conducted to date have failed to achieve clinical significance because of a lack of specificity and challenges associated with complex volatile mixtures.
Although the findings of the current study advance the possibility of using exhaled breath in lung cancer diagnosis and clinical decision making, the study was limited by an inadequate control group. In addition, further study is needed in patients with pulmonary nodules and benign pulmonary disease, as well as in patients following resection, Dr. Bousamra said.
The study also lacked a specific look at patients with chronic obstructive pulmonary disease and other interstitial lung disease common in patients with lung cancer, he noted.
He estimated, however, that VOC testing could be in place to help with the diagnosis of lung cancer within 2 years.
The possibilities for this testing are exciting, and the work of Dr. Bousamra and his colleagues represents a window into the future of lung cancer screening and diagnosis, according to the invited discussant, Dr. Tom Varghese Jr. of the University of Washington, Seattle.
Lung cancer is the leading cause of cancer deaths worldwide, with higher mortality than the next three leading causes of cancer death combined, Dr. Varghese said.
A large screening trial showed that using low-dose CT for screening could reduce mortality by 20% – a finding that led to the recent endorsement by the U.S. Preventive Services Task Force of low-dose screening CTs for high-risk patients.
Such screening, if applied using strict criteria, "would avert 12,000 lung cancer deaths today," he said.
Adding measurement of VOCs in exhaled breath to the screening protocol could result in fewer invasive procedures for abnormal screening results, and VOC measurement could thus prove to be a simple, straightforward cost-saving measure, Dr. Varghese added.
Dr. Bousamra reported having no disclosures.
AT THE STS ANNUAL MEETING
Major finding: Finding three or more specific carbonyl VOCs in exhaled breath was 95% predictive of lung cancer, while no elevation was 80% predictive of benign nodules.
Data source: An analysis of VOCs in the exhaled breath of 151 patients with suspicious lung lesions.
Disclosures: Dr. Bousamra reported having no disclosures.