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Point/Counterpoint – Another surgeon’s error – Must you tell the patient?

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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.

Wavebreak Media/Thinkstock

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.

Dr. Susan D. Moffatt-Bruce

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).

 

 

Dr. Chadrick E. Denlinger

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.

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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.

Wavebreak Media/Thinkstock

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.

Dr. Susan D. Moffatt-Bruce

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).

 

 

Dr. Chadrick E. Denlinger

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.

Wavebreak Media/Thinkstock

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.

Dr. Susan D. Moffatt-Bruce

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).

 

 

Dr. Chadrick E. Denlinger

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.

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Minimalist transfemoral TAVR winning surgical converts

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SNOWMASS, COLO. – Familiarity with the option of minimalist transfemoral transcatheter aortic valve replacement is causing some top surgeons to broaden their use of nonsurgical valve replacement.

"This minimalist transfemoral TAVR is something we’ve done quite a lot of. As a surgeon, I sort of hate to say it, but this to me has made a huge difference in whether I make a patient surgical or transcatheter," Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.

Dr. Vinod H. Thourani

"It’s me and a cardiology resident doing a minimalist transfemoral TAVR in the cath lab in an awake patient with fentanyl and Versed [midazolam] and a 14- to 24-French sheath. There’s no incision and the patients don’t go to the ICU. Thirty to forty percent of them go straight to their private room after their valve is implanted, if their groin is okay in the postop cath lab area," explained Dr. Thourani, associate director of cardiothoracic surgery at Emory University, Atlanta.

In 200 patients who’ve undergone the procedure at the hands of Dr. Thourani and his Emory colleagues, there has been zero in-hospital mortality. Most patients are home in 2-3 days.

On the other hand, the surgical approach is seeing advances as well, he continued. One technologic development he’s particularly enthusiastic about is the surgical sutureless valve.

"This is a whole new class of valves. My cardiologists, when I call them and tell them I put a sutureless valve in their patient, have no clue what we’re talking about," according to the surgeon.

Two major U.S. clinical trials are ongoing for the investigational sutureless Sorin Perceval and Edwards Intuity valves. These truly sutureless valves are crimped. The surgeon performs an open sternotomy, cross clamps the aorta, makes an aortotomy, then telescopes the valve down through the aortotomy. The Intuity valve is deployed via a brief balloon inflation to size it properly. The Perceval valve contains nitinol, so all that the surgeon has to do is put warm saline on it and the valve starts working.

"On my last Edwards Intuity valve, just last week, the cross clamp time was 35 minutes. Just to give you some perspective, the cross clamp time for a stented valve is 60-65 minutes and about 90 minutes for a stentless valve," Dr. Thourani explained.

He serves as a consultant to Edwards Lifesciences, Sorin, and St. Jude Medical.

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SNOWMASS, COLO. – Familiarity with the option of minimalist transfemoral transcatheter aortic valve replacement is causing some top surgeons to broaden their use of nonsurgical valve replacement.

"This minimalist transfemoral TAVR is something we’ve done quite a lot of. As a surgeon, I sort of hate to say it, but this to me has made a huge difference in whether I make a patient surgical or transcatheter," Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.

Dr. Vinod H. Thourani

"It’s me and a cardiology resident doing a minimalist transfemoral TAVR in the cath lab in an awake patient with fentanyl and Versed [midazolam] and a 14- to 24-French sheath. There’s no incision and the patients don’t go to the ICU. Thirty to forty percent of them go straight to their private room after their valve is implanted, if their groin is okay in the postop cath lab area," explained Dr. Thourani, associate director of cardiothoracic surgery at Emory University, Atlanta.

In 200 patients who’ve undergone the procedure at the hands of Dr. Thourani and his Emory colleagues, there has been zero in-hospital mortality. Most patients are home in 2-3 days.

On the other hand, the surgical approach is seeing advances as well, he continued. One technologic development he’s particularly enthusiastic about is the surgical sutureless valve.

"This is a whole new class of valves. My cardiologists, when I call them and tell them I put a sutureless valve in their patient, have no clue what we’re talking about," according to the surgeon.

Two major U.S. clinical trials are ongoing for the investigational sutureless Sorin Perceval and Edwards Intuity valves. These truly sutureless valves are crimped. The surgeon performs an open sternotomy, cross clamps the aorta, makes an aortotomy, then telescopes the valve down through the aortotomy. The Intuity valve is deployed via a brief balloon inflation to size it properly. The Perceval valve contains nitinol, so all that the surgeon has to do is put warm saline on it and the valve starts working.

"On my last Edwards Intuity valve, just last week, the cross clamp time was 35 minutes. Just to give you some perspective, the cross clamp time for a stented valve is 60-65 minutes and about 90 minutes for a stentless valve," Dr. Thourani explained.

He serves as a consultant to Edwards Lifesciences, Sorin, and St. Jude Medical.

[email protected]

SNOWMASS, COLO. – Familiarity with the option of minimalist transfemoral transcatheter aortic valve replacement is causing some top surgeons to broaden their use of nonsurgical valve replacement.

"This minimalist transfemoral TAVR is something we’ve done quite a lot of. As a surgeon, I sort of hate to say it, but this to me has made a huge difference in whether I make a patient surgical or transcatheter," Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.

Dr. Vinod H. Thourani

"It’s me and a cardiology resident doing a minimalist transfemoral TAVR in the cath lab in an awake patient with fentanyl and Versed [midazolam] and a 14- to 24-French sheath. There’s no incision and the patients don’t go to the ICU. Thirty to forty percent of them go straight to their private room after their valve is implanted, if their groin is okay in the postop cath lab area," explained Dr. Thourani, associate director of cardiothoracic surgery at Emory University, Atlanta.

In 200 patients who’ve undergone the procedure at the hands of Dr. Thourani and his Emory colleagues, there has been zero in-hospital mortality. Most patients are home in 2-3 days.

On the other hand, the surgical approach is seeing advances as well, he continued. One technologic development he’s particularly enthusiastic about is the surgical sutureless valve.

"This is a whole new class of valves. My cardiologists, when I call them and tell them I put a sutureless valve in their patient, have no clue what we’re talking about," according to the surgeon.

Two major U.S. clinical trials are ongoing for the investigational sutureless Sorin Perceval and Edwards Intuity valves. These truly sutureless valves are crimped. The surgeon performs an open sternotomy, cross clamps the aorta, makes an aortotomy, then telescopes the valve down through the aortotomy. The Intuity valve is deployed via a brief balloon inflation to size it properly. The Perceval valve contains nitinol, so all that the surgeon has to do is put warm saline on it and the valve starts working.

"On my last Edwards Intuity valve, just last week, the cross clamp time was 35 minutes. Just to give you some perspective, the cross clamp time for a stented valve is 60-65 minutes and about 90 minutes for a stentless valve," Dr. Thourani explained.

He serves as a consultant to Edwards Lifesciences, Sorin, and St. Jude Medical.

[email protected]

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INR inadequate to determine coagulopathy, thrombelastography preferred

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The international normalized ratio (INR) plays a major role in clinical decision-making, based upon the Model for End-Stage Liver Disease score and international guidelines, but it is unreliable in determining a patient’s need for fresh frozen plasma (FFP) and should not be used to estimate coagulopathy risk, according to a recent study.

Instead, thrombelastography’s (TEG) ability to measure clotting in real time makes it a superior assay for determining coagulopathy risk and reducing unnecessary FFP transfusions, the researchers found.

Originally developed to guide warfarin dosing needs, the INR only identifies deficiencies in several specific procoagulant factors in the extrinsic pathway, ignoring anticoagulant factors and intrinsic pathway procoagulant factors which together may balance out the extrinsic pathway abnormalities.

"Evidence-based research does not justify reliance on the INR to determine the need for FFP transfusion in hemodynamically stable patients," wrote Dr. Sean P. McCully and his colleagues at Oregon Health & Science University, Portland, in the December issue of the Journal of Trauma and Acute Care Surgery.

Dr. Sean P. McCully

"Transfusion of FFP should be limited to bleeding patients with evidence of coagulopathy or stable patients with evidence of a hypocoagulable state on TEG who are at risk for bleeding," they wrote (J. Trauma Acute Care Surg. 2013;75:947-53 [doi:10.1097/TA.0b013e3182a9676c]).

McCully’s team used three coagulation assay methods on blood samples before and after FFP transfer from 106 hemodynamically stable trauma (35%) and surgical (65%) patients. The patients, 59% males, ranged in age from 16 to 92 years (median age, 60 years) and were assessed from February 2010 through August 2012.

Patients were excluded if they had received a massive transfusion or had taken antiplatelet agents within 10 days of admission. Overall, 262 U of fresh frozen plasma were transfused, with patients receiving from 1-4 U each.

The three methods included TEG, clotting factor activity levels, and a collection of conventional coagulation tests that included INR values. While the median INR dropped from 1.87 before FFP transfusion to a still elevated 1.53 after transfusion (P less than .001), TEG values remained in the normal range with little change before and after transfusion. The researchers found all procoagulant factor activities to exceed 30% of normal values preceding transfusions.

The overall coagulation index, calculated from the four main TEG assay variables, was -0.1 before transfusion and -0.4 after (P less than.05). The R value, representing soluble clotting factor activity with the number of minutes to initial fibrin formation, went from 7.2 before transfusion to 6.9 afterward. K time represents a combination of soluble factor activity and fibrin cross-linking, measured at 1.7 minutes before transfusion and 1.6 minutes after.

Values for alpha-angle, the rate of clot strengthening, were 66.7 degrees before transfusion and 66.5 after. Clot strength measured by maximum amplitude of tracing, representing platelet function, went from 66.1 mm before to 66.6 mm after transfusion. Clot lysis at 30 minutes, assessing fibrinolysis, was 0.2% before and 0.3% after transfusion.

Among the other conventional coagulation tests, small changes were seen: a slight reduction in partial thromboplastin time but remaining within normal range before and after transfusion, decreases in hematocrit and platelet counts and increases in D-dimer and fibrinogen levels.

The clotting factors assay revealed median values within the normal range before and after transfusion for factors VIII, IX, XI and XII (intrinsic pathway), but median values for factors II, V and X (common pathway) were below normal range before and after FFP transfer.

The below-normal factor VII median values (extrinsic pathway) before and after transfusion corresponded with the abnormal INR values but were sufficient to maintain hemostasis.

"Our data suggest that an isolated abnormal INR does not reflect coagulopathy," the researchers wrote.

"Despite transfusion-related changes, TEG continued to reflect normal coagulation in a setting without clinical evidence of bleeding," the researchers wrote. "Based on a normal TEG and functional intrinsic pathway, we believe these patients had the potential to form a robust clot and should not have received FFP."

The researchers cited past research finding that anywhere from 10% to 73% of FFP transfusions are inappropriately administered. FFP transfusion complication risks can include acute lung injury, transfusion-associated circulatory overload, anaphylactic reactions, and infections transmission.

The study was limited by the lack of a control group who did not receive FFP, the determination of the bleeding events retrospectively instead of prospectively, and lack of indications for FFP transfusion from the treatment teams.

The study was funded by Dr. Schreiber within the Trauma Research Institute of Oregon. The authors reported no conflicts of interest.

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The international normalized ratio (INR) plays a major role in clinical decision-making, based upon the Model for End-Stage Liver Disease score and international guidelines, but it is unreliable in determining a patient’s need for fresh frozen plasma (FFP) and should not be used to estimate coagulopathy risk, according to a recent study.

Instead, thrombelastography’s (TEG) ability to measure clotting in real time makes it a superior assay for determining coagulopathy risk and reducing unnecessary FFP transfusions, the researchers found.

Originally developed to guide warfarin dosing needs, the INR only identifies deficiencies in several specific procoagulant factors in the extrinsic pathway, ignoring anticoagulant factors and intrinsic pathway procoagulant factors which together may balance out the extrinsic pathway abnormalities.

"Evidence-based research does not justify reliance on the INR to determine the need for FFP transfusion in hemodynamically stable patients," wrote Dr. Sean P. McCully and his colleagues at Oregon Health & Science University, Portland, in the December issue of the Journal of Trauma and Acute Care Surgery.

Dr. Sean P. McCully

"Transfusion of FFP should be limited to bleeding patients with evidence of coagulopathy or stable patients with evidence of a hypocoagulable state on TEG who are at risk for bleeding," they wrote (J. Trauma Acute Care Surg. 2013;75:947-53 [doi:10.1097/TA.0b013e3182a9676c]).

McCully’s team used three coagulation assay methods on blood samples before and after FFP transfer from 106 hemodynamically stable trauma (35%) and surgical (65%) patients. The patients, 59% males, ranged in age from 16 to 92 years (median age, 60 years) and were assessed from February 2010 through August 2012.

Patients were excluded if they had received a massive transfusion or had taken antiplatelet agents within 10 days of admission. Overall, 262 U of fresh frozen plasma were transfused, with patients receiving from 1-4 U each.

The three methods included TEG, clotting factor activity levels, and a collection of conventional coagulation tests that included INR values. While the median INR dropped from 1.87 before FFP transfusion to a still elevated 1.53 after transfusion (P less than .001), TEG values remained in the normal range with little change before and after transfusion. The researchers found all procoagulant factor activities to exceed 30% of normal values preceding transfusions.

The overall coagulation index, calculated from the four main TEG assay variables, was -0.1 before transfusion and -0.4 after (P less than.05). The R value, representing soluble clotting factor activity with the number of minutes to initial fibrin formation, went from 7.2 before transfusion to 6.9 afterward. K time represents a combination of soluble factor activity and fibrin cross-linking, measured at 1.7 minutes before transfusion and 1.6 minutes after.

Values for alpha-angle, the rate of clot strengthening, were 66.7 degrees before transfusion and 66.5 after. Clot strength measured by maximum amplitude of tracing, representing platelet function, went from 66.1 mm before to 66.6 mm after transfusion. Clot lysis at 30 minutes, assessing fibrinolysis, was 0.2% before and 0.3% after transfusion.

Among the other conventional coagulation tests, small changes were seen: a slight reduction in partial thromboplastin time but remaining within normal range before and after transfusion, decreases in hematocrit and platelet counts and increases in D-dimer and fibrinogen levels.

The clotting factors assay revealed median values within the normal range before and after transfusion for factors VIII, IX, XI and XII (intrinsic pathway), but median values for factors II, V and X (common pathway) were below normal range before and after FFP transfer.

The below-normal factor VII median values (extrinsic pathway) before and after transfusion corresponded with the abnormal INR values but were sufficient to maintain hemostasis.

"Our data suggest that an isolated abnormal INR does not reflect coagulopathy," the researchers wrote.

"Despite transfusion-related changes, TEG continued to reflect normal coagulation in a setting without clinical evidence of bleeding," the researchers wrote. "Based on a normal TEG and functional intrinsic pathway, we believe these patients had the potential to form a robust clot and should not have received FFP."

The researchers cited past research finding that anywhere from 10% to 73% of FFP transfusions are inappropriately administered. FFP transfusion complication risks can include acute lung injury, transfusion-associated circulatory overload, anaphylactic reactions, and infections transmission.

The study was limited by the lack of a control group who did not receive FFP, the determination of the bleeding events retrospectively instead of prospectively, and lack of indications for FFP transfusion from the treatment teams.

The study was funded by Dr. Schreiber within the Trauma Research Institute of Oregon. The authors reported no conflicts of interest.

The international normalized ratio (INR) plays a major role in clinical decision-making, based upon the Model for End-Stage Liver Disease score and international guidelines, but it is unreliable in determining a patient’s need for fresh frozen plasma (FFP) and should not be used to estimate coagulopathy risk, according to a recent study.

Instead, thrombelastography’s (TEG) ability to measure clotting in real time makes it a superior assay for determining coagulopathy risk and reducing unnecessary FFP transfusions, the researchers found.

Originally developed to guide warfarin dosing needs, the INR only identifies deficiencies in several specific procoagulant factors in the extrinsic pathway, ignoring anticoagulant factors and intrinsic pathway procoagulant factors which together may balance out the extrinsic pathway abnormalities.

"Evidence-based research does not justify reliance on the INR to determine the need for FFP transfusion in hemodynamically stable patients," wrote Dr. Sean P. McCully and his colleagues at Oregon Health & Science University, Portland, in the December issue of the Journal of Trauma and Acute Care Surgery.

Dr. Sean P. McCully

"Transfusion of FFP should be limited to bleeding patients with evidence of coagulopathy or stable patients with evidence of a hypocoagulable state on TEG who are at risk for bleeding," they wrote (J. Trauma Acute Care Surg. 2013;75:947-53 [doi:10.1097/TA.0b013e3182a9676c]).

McCully’s team used three coagulation assay methods on blood samples before and after FFP transfer from 106 hemodynamically stable trauma (35%) and surgical (65%) patients. The patients, 59% males, ranged in age from 16 to 92 years (median age, 60 years) and were assessed from February 2010 through August 2012.

Patients were excluded if they had received a massive transfusion or had taken antiplatelet agents within 10 days of admission. Overall, 262 U of fresh frozen plasma were transfused, with patients receiving from 1-4 U each.

The three methods included TEG, clotting factor activity levels, and a collection of conventional coagulation tests that included INR values. While the median INR dropped from 1.87 before FFP transfusion to a still elevated 1.53 after transfusion (P less than .001), TEG values remained in the normal range with little change before and after transfusion. The researchers found all procoagulant factor activities to exceed 30% of normal values preceding transfusions.

The overall coagulation index, calculated from the four main TEG assay variables, was -0.1 before transfusion and -0.4 after (P less than.05). The R value, representing soluble clotting factor activity with the number of minutes to initial fibrin formation, went from 7.2 before transfusion to 6.9 afterward. K time represents a combination of soluble factor activity and fibrin cross-linking, measured at 1.7 minutes before transfusion and 1.6 minutes after.

Values for alpha-angle, the rate of clot strengthening, were 66.7 degrees before transfusion and 66.5 after. Clot strength measured by maximum amplitude of tracing, representing platelet function, went from 66.1 mm before to 66.6 mm after transfusion. Clot lysis at 30 minutes, assessing fibrinolysis, was 0.2% before and 0.3% after transfusion.

Among the other conventional coagulation tests, small changes were seen: a slight reduction in partial thromboplastin time but remaining within normal range before and after transfusion, decreases in hematocrit and platelet counts and increases in D-dimer and fibrinogen levels.

The clotting factors assay revealed median values within the normal range before and after transfusion for factors VIII, IX, XI and XII (intrinsic pathway), but median values for factors II, V and X (common pathway) were below normal range before and after FFP transfer.

The below-normal factor VII median values (extrinsic pathway) before and after transfusion corresponded with the abnormal INR values but were sufficient to maintain hemostasis.

"Our data suggest that an isolated abnormal INR does not reflect coagulopathy," the researchers wrote.

"Despite transfusion-related changes, TEG continued to reflect normal coagulation in a setting without clinical evidence of bleeding," the researchers wrote. "Based on a normal TEG and functional intrinsic pathway, we believe these patients had the potential to form a robust clot and should not have received FFP."

The researchers cited past research finding that anywhere from 10% to 73% of FFP transfusions are inappropriately administered. FFP transfusion complication risks can include acute lung injury, transfusion-associated circulatory overload, anaphylactic reactions, and infections transmission.

The study was limited by the lack of a control group who did not receive FFP, the determination of the bleeding events retrospectively instead of prospectively, and lack of indications for FFP transfusion from the treatment teams.

The study was funded by Dr. Schreiber within the Trauma Research Institute of Oregon. The authors reported no conflicts of interest.

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Major Finding: Despite elevated international normalized ratio values before (1.87) and after (1.53) FFP transfusions in stable patients (P less than .001), thrombelastography values remained in normal range with an overall coagulation index of –0.1 before transfusion and –0.4 after (P less than .05).

Data Source: The findings are based on a prospective, observational study of 106 hemodynamically stable trauma and surgical patients who received FFP, enrolled from February 2010 through August 2012.

Disclosures: The study was funded by Dr. Schreiber within the Trauma Research Institute of Oregon. The authors reported no conflicts of interest.

Registry data reveal risk factors for lung retransplantation

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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.

Dr. J. Awori Hayanga

"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.

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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.

Dr. J. Awori Hayanga

"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.

Dr. J. Awori Hayanga

"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.

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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.

Bedside IVC filter placement safe in critically ill

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Bedside IVC filter placement safe in critically ill

PALM BEACH, FLA. – Bedside vena cava filter placement using intravascular ultrasound was a safe and effective option in critically ill patients, according to a retrospective study at the University of Alabama at Birmingham.

During a 5-year period, 98% of the filter placements were successful. Technical success also improved significantly, and the complication rates dropped, reported Dr. Roan J. Glocker during a presentation at the annual meeting of the Southern Association for Vascular Surgery.

Vena cava filters have been used for nearly 4 decades for the prevention of pulmonary embolism. Dr. Glocker said that the bedside methods of filter placement often eliminate the need to transport patients, who are often critically ill or injured. It also eliminates the need for an operating room or angiography usage and reduces the risk that may result from contrast administration and radiation.

In 2010, researchers at the University of Alabama first reported successful outcomes of an algorithm for bedside intravascular ultrasound (IVUS) guided inferior vena cava (IVC) filter placement. Dr. Glocker said that the team wanted to evaluate their experience over a longer period of time, and to determine whether the safety and efficacy of the procedure was sustainable and evaluate the complication rates.

Dr. Roan J. Glocker

Researchers conducted a retrospective review of 398 patients undergoing bedside IVUS-guided IVC filter placement from 2008 to 2012. Seventy-percent of the patients were male, with a mean age of 77 years old, ranging from 14 to 91 years old. Close to 80% were multitrauma patients. The most common indication for filter placement was VTE prophylaxis in multisystem injury.

Outcomes were analyzed at 30 days. The study had no control groups.

Results showed that the technical success was 98%. The optional filters – Gunther Tulip or Cook Celect – were used in 94% of the patients, and the Greenfield permanent filter was used in the rest.

In 97% of the cases, a single puncture technique was performed. Periprocedural complications occurred only 3% of the time. Thirty patients died within 30 days of filter placement; however, there were no deaths related to pulmonary embolism or filter-related problems, Dr. Glocker reported.

When researchers compared the first and last 100 procedures, the complication rates dropped from 7% to 2 % (P = .08), and the technical success improved significantly from 96% in the first 100 procedures to 100% in the last 100.

Although there has been little change in the basic design of the filters, there have been remarkable improvements in placement techniques, going from the operating room to the radiology suites, to the patient bedside, said Dr. Lazar J. Greenfield Sr., professor emeritus of surgery at the University of Michigan, Ann Arbor, and the inventor of the filter.

But a 2013 study showed that the use of vena cava filters varies widely among hospitals, and some experts say that there’s still not enough evidence about its effectiveness.

In 2010, the Food and Drug Administration issued safety concerns about leaving the filters in place for a long period of time. Currently, the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study, a 5-year, multispecialty, prospective trial, is examining the use of IVC filters by focusing on safety endpoints.

The procedure has a learning curve. The surgeon has to be familiar with the IVUS modality and should have a thorough understanding of deployment of each filter, Dr. Glocker said. He guesstimated that physicians should perform approximately 20-50 procedures to reach competency and start performing the procedure on their own.

Dr. Glocker and Dr. Greenfield had no disclosures.

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PALM BEACH, FLA. – Bedside vena cava filter placement using intravascular ultrasound was a safe and effective option in critically ill patients, according to a retrospective study at the University of Alabama at Birmingham.

During a 5-year period, 98% of the filter placements were successful. Technical success also improved significantly, and the complication rates dropped, reported Dr. Roan J. Glocker during a presentation at the annual meeting of the Southern Association for Vascular Surgery.

Vena cava filters have been used for nearly 4 decades for the prevention of pulmonary embolism. Dr. Glocker said that the bedside methods of filter placement often eliminate the need to transport patients, who are often critically ill or injured. It also eliminates the need for an operating room or angiography usage and reduces the risk that may result from contrast administration and radiation.

In 2010, researchers at the University of Alabama first reported successful outcomes of an algorithm for bedside intravascular ultrasound (IVUS) guided inferior vena cava (IVC) filter placement. Dr. Glocker said that the team wanted to evaluate their experience over a longer period of time, and to determine whether the safety and efficacy of the procedure was sustainable and evaluate the complication rates.

Dr. Roan J. Glocker

Researchers conducted a retrospective review of 398 patients undergoing bedside IVUS-guided IVC filter placement from 2008 to 2012. Seventy-percent of the patients were male, with a mean age of 77 years old, ranging from 14 to 91 years old. Close to 80% were multitrauma patients. The most common indication for filter placement was VTE prophylaxis in multisystem injury.

Outcomes were analyzed at 30 days. The study had no control groups.

Results showed that the technical success was 98%. The optional filters – Gunther Tulip or Cook Celect – were used in 94% of the patients, and the Greenfield permanent filter was used in the rest.

In 97% of the cases, a single puncture technique was performed. Periprocedural complications occurred only 3% of the time. Thirty patients died within 30 days of filter placement; however, there were no deaths related to pulmonary embolism or filter-related problems, Dr. Glocker reported.

When researchers compared the first and last 100 procedures, the complication rates dropped from 7% to 2 % (P = .08), and the technical success improved significantly from 96% in the first 100 procedures to 100% in the last 100.

Although there has been little change in the basic design of the filters, there have been remarkable improvements in placement techniques, going from the operating room to the radiology suites, to the patient bedside, said Dr. Lazar J. Greenfield Sr., professor emeritus of surgery at the University of Michigan, Ann Arbor, and the inventor of the filter.

But a 2013 study showed that the use of vena cava filters varies widely among hospitals, and some experts say that there’s still not enough evidence about its effectiveness.

In 2010, the Food and Drug Administration issued safety concerns about leaving the filters in place for a long period of time. Currently, the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study, a 5-year, multispecialty, prospective trial, is examining the use of IVC filters by focusing on safety endpoints.

The procedure has a learning curve. The surgeon has to be familiar with the IVUS modality and should have a thorough understanding of deployment of each filter, Dr. Glocker said. He guesstimated that physicians should perform approximately 20-50 procedures to reach competency and start performing the procedure on their own.

Dr. Glocker and Dr. Greenfield had no disclosures.

[email protected]

On Twitter @naseemsmiller

PALM BEACH, FLA. – Bedside vena cava filter placement using intravascular ultrasound was a safe and effective option in critically ill patients, according to a retrospective study at the University of Alabama at Birmingham.

During a 5-year period, 98% of the filter placements were successful. Technical success also improved significantly, and the complication rates dropped, reported Dr. Roan J. Glocker during a presentation at the annual meeting of the Southern Association for Vascular Surgery.

Vena cava filters have been used for nearly 4 decades for the prevention of pulmonary embolism. Dr. Glocker said that the bedside methods of filter placement often eliminate the need to transport patients, who are often critically ill or injured. It also eliminates the need for an operating room or angiography usage and reduces the risk that may result from contrast administration and radiation.

In 2010, researchers at the University of Alabama first reported successful outcomes of an algorithm for bedside intravascular ultrasound (IVUS) guided inferior vena cava (IVC) filter placement. Dr. Glocker said that the team wanted to evaluate their experience over a longer period of time, and to determine whether the safety and efficacy of the procedure was sustainable and evaluate the complication rates.

Dr. Roan J. Glocker

Researchers conducted a retrospective review of 398 patients undergoing bedside IVUS-guided IVC filter placement from 2008 to 2012. Seventy-percent of the patients were male, with a mean age of 77 years old, ranging from 14 to 91 years old. Close to 80% were multitrauma patients. The most common indication for filter placement was VTE prophylaxis in multisystem injury.

Outcomes were analyzed at 30 days. The study had no control groups.

Results showed that the technical success was 98%. The optional filters – Gunther Tulip or Cook Celect – were used in 94% of the patients, and the Greenfield permanent filter was used in the rest.

In 97% of the cases, a single puncture technique was performed. Periprocedural complications occurred only 3% of the time. Thirty patients died within 30 days of filter placement; however, there were no deaths related to pulmonary embolism or filter-related problems, Dr. Glocker reported.

When researchers compared the first and last 100 procedures, the complication rates dropped from 7% to 2 % (P = .08), and the technical success improved significantly from 96% in the first 100 procedures to 100% in the last 100.

Although there has been little change in the basic design of the filters, there have been remarkable improvements in placement techniques, going from the operating room to the radiology suites, to the patient bedside, said Dr. Lazar J. Greenfield Sr., professor emeritus of surgery at the University of Michigan, Ann Arbor, and the inventor of the filter.

But a 2013 study showed that the use of vena cava filters varies widely among hospitals, and some experts say that there’s still not enough evidence about its effectiveness.

In 2010, the Food and Drug Administration issued safety concerns about leaving the filters in place for a long period of time. Currently, the PRESERVE (Predicting the Safety and Effectiveness of Inferior Vena Cava Filters) study, a 5-year, multispecialty, prospective trial, is examining the use of IVC filters by focusing on safety endpoints.

The procedure has a learning curve. The surgeon has to be familiar with the IVUS modality and should have a thorough understanding of deployment of each filter, Dr. Glocker said. He guesstimated that physicians should perform approximately 20-50 procedures to reach competency and start performing the procedure on their own.

Dr. Glocker and Dr. Greenfield had no disclosures.

[email protected]

On Twitter @naseemsmiller

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Major finding: When researchers compared the first and last 100 procedures, the complication rates dropped from 7% to 2 % (P = .08), and the technical success improved significantly from 96% in the first 100 procedures to 100% in the last 100.

Data source: A retrospective review of 398 patients undergoing bedside IVUS-guided IVC filter placement from 2008 to 2012

Disclosures: Dr. Glocker had no disclosures.

Later lung retransplant may boost survival

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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.

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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.

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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.

Platelet-rich plasma reduces sternal wound infection risk

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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.

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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.

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autologous platelet-rich plasma, cardiac surgery, sternal wound complications, platelet-rich plasma, PRP, sternotomy, cardiac surgical procedures, Dr. Amit N. Patel, annual meeting of the Society of Thoracic Surgeons, sternal closure,preoperative antibiotic treatment, protocol-driven glycemic management, standard-of-care sternal closure plus PRP,
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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

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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.

Dr. Diana Aicher

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.

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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.

Dr. Diana Aicher

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.

Dr. Diana Aicher

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.

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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.

Screening database shows ABI can be cost effective

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PALM BEACH, FLA. – The ankle-brachial index value is directly associated with the prevalence of carotid artery stenosis and with a history of coronary artery disease and cerebrovascular disease, according to analysis of more than 3.6 million records obtained from the private health screening company, Life Line Screening.

But what makes the study interesting is the database itself, and not so much the findings, which have been previously shown, commented Dr. Spence M. Taylor, president of the Greenville Health System Clinical University, Greenville, South Carolina.

Life Line Screening has mobile units, which travel to various locations and for a fee of more than $100, screen individuals, collecting nearly 300 data points per person. Meanwhile, the ankle-brachial index (ABI) costs less than $30 approximately. Yet, the test hasn’t become widely used, despite the evidence. Not much has changed since the 2001 PARTNERS study, which showed that the primary care physicians’ awareness of PAD diagnosis was "relatively low" (JAMA 2001;286:1317-24).

Dr. Mark A. Adelman

Results using the Life Line Screening’s large database may show the federal government that ABI can be cost effective, and getting them on board would popularize the screening tool, said Dr. Mark A. Adelman of the NYU Langone Medical Center, who presented his study at the Southern Association for Vascular Surgery annual meeting.

"Life Line is a huge paradox," said Dr. Taylor, senior associate dean of academic affairs at University of South Carolina, Greenville. It’s an operation that "we love to hate and hate to love," he added.

Dr. Adelman, the Frank J. Veith, M.D. Professor of Vascular and Endovascular Surgery and chief of vascular surgery at NYU Langone, and his colleagues analyzed data obtained from Life Line Screening, and found that individuals with an ABI between 0.41 and 0.60 had a 26.4% incidence of carotid artery stenosis (CAS), compared with individuals who had a normal ABI. The incidence increased to 35% for patients with ABI of 0.4 or less.

The majority of the abnormal ABI cases were between 0.81 and 0.90.

The analysis by Dr. Adelman and his colleagues also showed that individuals with PAD were more likely to be aged 70 years or older, male, and have modifiable risk factors, such as a history of smoking, hypertension, diabetes, and hypercholesterolemia, compared with non–PAD persons (P less than .001). (A comparison of Life Line’s database to one from the general population showed that the risk factors such as hypertension, hyperlipidemia, diabetes, and smoking were comparable.)

PAD subjects were also more likely to have CAS, prior stroke, prior transient ischemic attack, prior MI, and prior coronary revascularization, compared with those who didn’t have PAD (P less than .001). There was a significant correlation between decreasing ABI value and an increase in the prevalence of CAS, CAD, and cardiovascular disease (P less than .001).

In a separate study analyzing the same database, Dr. Adelman and his colleagues found that modifiable risk factors, such as hypertension and smoking, are associated with increased prevalence of peripheral vascular disease (J. Vasc. Surg. 2013;58:673-81).

Dr. Adelman said that screening for ABI could trigger other screening and lead to modification of risk factors that could affect better patient outcomes, changes in lifestyle, or changes in pharmacological management.

Dr. Adelman and Dr. Taylor had no disclosures.

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PALM BEACH, FLA. – The ankle-brachial index value is directly associated with the prevalence of carotid artery stenosis and with a history of coronary artery disease and cerebrovascular disease, according to analysis of more than 3.6 million records obtained from the private health screening company, Life Line Screening.

But what makes the study interesting is the database itself, and not so much the findings, which have been previously shown, commented Dr. Spence M. Taylor, president of the Greenville Health System Clinical University, Greenville, South Carolina.

Life Line Screening has mobile units, which travel to various locations and for a fee of more than $100, screen individuals, collecting nearly 300 data points per person. Meanwhile, the ankle-brachial index (ABI) costs less than $30 approximately. Yet, the test hasn’t become widely used, despite the evidence. Not much has changed since the 2001 PARTNERS study, which showed that the primary care physicians’ awareness of PAD diagnosis was "relatively low" (JAMA 2001;286:1317-24).

Dr. Mark A. Adelman

Results using the Life Line Screening’s large database may show the federal government that ABI can be cost effective, and getting them on board would popularize the screening tool, said Dr. Mark A. Adelman of the NYU Langone Medical Center, who presented his study at the Southern Association for Vascular Surgery annual meeting.

"Life Line is a huge paradox," said Dr. Taylor, senior associate dean of academic affairs at University of South Carolina, Greenville. It’s an operation that "we love to hate and hate to love," he added.

Dr. Adelman, the Frank J. Veith, M.D. Professor of Vascular and Endovascular Surgery and chief of vascular surgery at NYU Langone, and his colleagues analyzed data obtained from Life Line Screening, and found that individuals with an ABI between 0.41 and 0.60 had a 26.4% incidence of carotid artery stenosis (CAS), compared with individuals who had a normal ABI. The incidence increased to 35% for patients with ABI of 0.4 or less.

The majority of the abnormal ABI cases were between 0.81 and 0.90.

The analysis by Dr. Adelman and his colleagues also showed that individuals with PAD were more likely to be aged 70 years or older, male, and have modifiable risk factors, such as a history of smoking, hypertension, diabetes, and hypercholesterolemia, compared with non–PAD persons (P less than .001). (A comparison of Life Line’s database to one from the general population showed that the risk factors such as hypertension, hyperlipidemia, diabetes, and smoking were comparable.)

PAD subjects were also more likely to have CAS, prior stroke, prior transient ischemic attack, prior MI, and prior coronary revascularization, compared with those who didn’t have PAD (P less than .001). There was a significant correlation between decreasing ABI value and an increase in the prevalence of CAS, CAD, and cardiovascular disease (P less than .001).

In a separate study analyzing the same database, Dr. Adelman and his colleagues found that modifiable risk factors, such as hypertension and smoking, are associated with increased prevalence of peripheral vascular disease (J. Vasc. Surg. 2013;58:673-81).

Dr. Adelman said that screening for ABI could trigger other screening and lead to modification of risk factors that could affect better patient outcomes, changes in lifestyle, or changes in pharmacological management.

Dr. Adelman and Dr. Taylor had no disclosures.

[email protected]

On Twitter @naseemsmiller

PALM BEACH, FLA. – The ankle-brachial index value is directly associated with the prevalence of carotid artery stenosis and with a history of coronary artery disease and cerebrovascular disease, according to analysis of more than 3.6 million records obtained from the private health screening company, Life Line Screening.

But what makes the study interesting is the database itself, and not so much the findings, which have been previously shown, commented Dr. Spence M. Taylor, president of the Greenville Health System Clinical University, Greenville, South Carolina.

Life Line Screening has mobile units, which travel to various locations and for a fee of more than $100, screen individuals, collecting nearly 300 data points per person. Meanwhile, the ankle-brachial index (ABI) costs less than $30 approximately. Yet, the test hasn’t become widely used, despite the evidence. Not much has changed since the 2001 PARTNERS study, which showed that the primary care physicians’ awareness of PAD diagnosis was "relatively low" (JAMA 2001;286:1317-24).

Dr. Mark A. Adelman

Results using the Life Line Screening’s large database may show the federal government that ABI can be cost effective, and getting them on board would popularize the screening tool, said Dr. Mark A. Adelman of the NYU Langone Medical Center, who presented his study at the Southern Association for Vascular Surgery annual meeting.

"Life Line is a huge paradox," said Dr. Taylor, senior associate dean of academic affairs at University of South Carolina, Greenville. It’s an operation that "we love to hate and hate to love," he added.

Dr. Adelman, the Frank J. Veith, M.D. Professor of Vascular and Endovascular Surgery and chief of vascular surgery at NYU Langone, and his colleagues analyzed data obtained from Life Line Screening, and found that individuals with an ABI between 0.41 and 0.60 had a 26.4% incidence of carotid artery stenosis (CAS), compared with individuals who had a normal ABI. The incidence increased to 35% for patients with ABI of 0.4 or less.

The majority of the abnormal ABI cases were between 0.81 and 0.90.

The analysis by Dr. Adelman and his colleagues also showed that individuals with PAD were more likely to be aged 70 years or older, male, and have modifiable risk factors, such as a history of smoking, hypertension, diabetes, and hypercholesterolemia, compared with non–PAD persons (P less than .001). (A comparison of Life Line’s database to one from the general population showed that the risk factors such as hypertension, hyperlipidemia, diabetes, and smoking were comparable.)

PAD subjects were also more likely to have CAS, prior stroke, prior transient ischemic attack, prior MI, and prior coronary revascularization, compared with those who didn’t have PAD (P less than .001). There was a significant correlation between decreasing ABI value and an increase in the prevalence of CAS, CAD, and cardiovascular disease (P less than .001).

In a separate study analyzing the same database, Dr. Adelman and his colleagues found that modifiable risk factors, such as hypertension and smoking, are associated with increased prevalence of peripheral vascular disease (J. Vasc. Surg. 2013;58:673-81).

Dr. Adelman said that screening for ABI could trigger other screening and lead to modification of risk factors that could affect better patient outcomes, changes in lifestyle, or changes in pharmacological management.

Dr. Adelman and Dr. Taylor had no disclosures.

[email protected]

On Twitter @naseemsmiller

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Major finding: Individuals with an ABI between 0.41 and 0.60 had a 26.4% incidence of CAS, compared with individuals who had a normal ABI. The incidence increased to 35% for patients with ABI of 0.4 or less.

Data source: 3.6 million records collected by Life Line Screening.

Disclosures: Dr. Adelman and Dr. Taylor had no disclosures.

Failure to rescue driving AAA repair mortality

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Failure to rescue driving AAA repair mortality

CHICAGO – Failure to rescue patients from major complications drives much of the variation in hospital mortality for abdominal aortic aneurysm repair, an award-winning study suggests.

"Careful attention to early recognition and management of postoperative complications could be the key to improving mortality," Dr. Seth Waits reported at the annual meeting of the Midwestern Vascular Surgical Society.

Failure to rescue (FTR), or death after a complication, is increasing being recognized as a source of differences in hospital mortality. A recent study reported that women who experienced a major complication after ovarian cancer treatment at a low-volume hospital were 48% more likely to die than were their counterparts at a high-volume hospital. Complication rates, long thought to be the culprit behind higher hospital mortality, were similar at the hospitals, while FTR rates were almost double at the low-volume hospitals (J. Clin. Oncol. 2012;30:3976-82).

For the current analysis, Dr. Waits and his colleagues at the University of Michigan Frankel Cardiovascular Center in Ann Arbor, calculated risk-adjusted mortality rates for 3,215 patients who underwent open or endovascular abdominal aortic aneurysm (AAA) repair at 40 hospitals participating in the Michigan Surgical Quality Collaborative between 2007 and 2012.

For 2,440 patients undergoing endovascular repair, hospital mortality ranged from a low of 0.07% to a high of 6.14%.

Though low- and high-mortality hospitals had similar major complication rates (11.6% vs. 10.6%), FTR rates were 45 times greater in high-mortality hospitals (0.83% vs. 37.5%), Dr. Waits reported.

For 775 patients who underwent open AAA repair, hospital mortality ranged from 4.5% to 16.4%.

Once again, despite low- and high-mortality hospitals having nearly identical complication rates (45.1% vs. 45.8%), but FTR rates were three times higher at the high-mortality hospitals (10.3% vs. 33%), he said.

An average of 2.85 and 2.66 severe complications occurred per FTR event for open and endovascular repair, respectively.

Transfusion was the most common postoperative complication leading to a FTR event for endovascular and open repair (5.8% and 29.8%, respectively), followed by prolonged intubation (2.4%; 18.2%) and reintubation (9.2%; 2%), according to the meeting’s best poster presentation.

No significant difference was seen in rupture/emergent repair between low- and high-mortality hospitals.

Dr. Waits called for preoperative identification of high-risk patients and use of FTR countermeasures, such as improved ICU admission, anesthesia alerts, and nurse/physician awareness to improve AAA mortality.

"Understanding the mechanisms that underlie failure to rescue offers the opportunity to move from a reactive to proactive approach in our management of complications following abdominal aortic aneurysm repair," he said in an interview.

Dr. Waits and his coauthors reported having no financial disclosures.

[email protected]

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CHICAGO – Failure to rescue patients from major complications drives much of the variation in hospital mortality for abdominal aortic aneurysm repair, an award-winning study suggests.

"Careful attention to early recognition and management of postoperative complications could be the key to improving mortality," Dr. Seth Waits reported at the annual meeting of the Midwestern Vascular Surgical Society.

Failure to rescue (FTR), or death after a complication, is increasing being recognized as a source of differences in hospital mortality. A recent study reported that women who experienced a major complication after ovarian cancer treatment at a low-volume hospital were 48% more likely to die than were their counterparts at a high-volume hospital. Complication rates, long thought to be the culprit behind higher hospital mortality, were similar at the hospitals, while FTR rates were almost double at the low-volume hospitals (J. Clin. Oncol. 2012;30:3976-82).

For the current analysis, Dr. Waits and his colleagues at the University of Michigan Frankel Cardiovascular Center in Ann Arbor, calculated risk-adjusted mortality rates for 3,215 patients who underwent open or endovascular abdominal aortic aneurysm (AAA) repair at 40 hospitals participating in the Michigan Surgical Quality Collaborative between 2007 and 2012.

For 2,440 patients undergoing endovascular repair, hospital mortality ranged from a low of 0.07% to a high of 6.14%.

Though low- and high-mortality hospitals had similar major complication rates (11.6% vs. 10.6%), FTR rates were 45 times greater in high-mortality hospitals (0.83% vs. 37.5%), Dr. Waits reported.

For 775 patients who underwent open AAA repair, hospital mortality ranged from 4.5% to 16.4%.

Once again, despite low- and high-mortality hospitals having nearly identical complication rates (45.1% vs. 45.8%), but FTR rates were three times higher at the high-mortality hospitals (10.3% vs. 33%), he said.

An average of 2.85 and 2.66 severe complications occurred per FTR event for open and endovascular repair, respectively.

Transfusion was the most common postoperative complication leading to a FTR event for endovascular and open repair (5.8% and 29.8%, respectively), followed by prolonged intubation (2.4%; 18.2%) and reintubation (9.2%; 2%), according to the meeting’s best poster presentation.

No significant difference was seen in rupture/emergent repair between low- and high-mortality hospitals.

Dr. Waits called for preoperative identification of high-risk patients and use of FTR countermeasures, such as improved ICU admission, anesthesia alerts, and nurse/physician awareness to improve AAA mortality.

"Understanding the mechanisms that underlie failure to rescue offers the opportunity to move from a reactive to proactive approach in our management of complications following abdominal aortic aneurysm repair," he said in an interview.

Dr. Waits and his coauthors reported having no financial disclosures.

[email protected]

CHICAGO – Failure to rescue patients from major complications drives much of the variation in hospital mortality for abdominal aortic aneurysm repair, an award-winning study suggests.

"Careful attention to early recognition and management of postoperative complications could be the key to improving mortality," Dr. Seth Waits reported at the annual meeting of the Midwestern Vascular Surgical Society.

Failure to rescue (FTR), or death after a complication, is increasing being recognized as a source of differences in hospital mortality. A recent study reported that women who experienced a major complication after ovarian cancer treatment at a low-volume hospital were 48% more likely to die than were their counterparts at a high-volume hospital. Complication rates, long thought to be the culprit behind higher hospital mortality, were similar at the hospitals, while FTR rates were almost double at the low-volume hospitals (J. Clin. Oncol. 2012;30:3976-82).

For the current analysis, Dr. Waits and his colleagues at the University of Michigan Frankel Cardiovascular Center in Ann Arbor, calculated risk-adjusted mortality rates for 3,215 patients who underwent open or endovascular abdominal aortic aneurysm (AAA) repair at 40 hospitals participating in the Michigan Surgical Quality Collaborative between 2007 and 2012.

For 2,440 patients undergoing endovascular repair, hospital mortality ranged from a low of 0.07% to a high of 6.14%.

Though low- and high-mortality hospitals had similar major complication rates (11.6% vs. 10.6%), FTR rates were 45 times greater in high-mortality hospitals (0.83% vs. 37.5%), Dr. Waits reported.

For 775 patients who underwent open AAA repair, hospital mortality ranged from 4.5% to 16.4%.

Once again, despite low- and high-mortality hospitals having nearly identical complication rates (45.1% vs. 45.8%), but FTR rates were three times higher at the high-mortality hospitals (10.3% vs. 33%), he said.

An average of 2.85 and 2.66 severe complications occurred per FTR event for open and endovascular repair, respectively.

Transfusion was the most common postoperative complication leading to a FTR event for endovascular and open repair (5.8% and 29.8%, respectively), followed by prolonged intubation (2.4%; 18.2%) and reintubation (9.2%; 2%), according to the meeting’s best poster presentation.

No significant difference was seen in rupture/emergent repair between low- and high-mortality hospitals.

Dr. Waits called for preoperative identification of high-risk patients and use of FTR countermeasures, such as improved ICU admission, anesthesia alerts, and nurse/physician awareness to improve AAA mortality.

"Understanding the mechanisms that underlie failure to rescue offers the opportunity to move from a reactive to proactive approach in our management of complications following abdominal aortic aneurysm repair," he said in an interview.

Dr. Waits and his coauthors reported having no financial disclosures.

[email protected]

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Major finding: FTR rates were 45 times higher in high AAA-mortality hospitals vs. low AAA-mortality hospitals (0.83% vs. 37.5%).

Data source: Retrospective study of 3,215 patients with abdominal aortic aneurysm repair.

Disclosures: Dr. Waits and his coauthors reported having no financial disclosures.