Can public reporting improve pediatric heart surgery?

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Wed, 01/02/2019 - 09:51

 

Public reporting of cardiac surgery outcomes has been a disruptive force in cardiology, and especially daunting in pediatric cardiac surgery because of low case volumes and rare mortality. To ensure that public reporting achieves its original goals – providing transparency to the patient care process, holding providers accountable, informing decision making for health care consumers, reducing costs, encouraging more efficient use of health system resources, and improving patient care and outcomes – further study that includes use of appropriate risk adjustment is needed, according to commentaries in the April issue of the Journal of Thoracic and Cardiovascular Surgery.

The journal asked two groups to provide perspective on a study Adam D. DeVore, MD, of Duke University in Durham, N.C., and his coauthors published last year (J Am Coll Cardiol. 2016 Mar 1;67:963-72). The study analyzed Medicare claims data from 2006 to 2012 for 37,829 hospitalizations for heart attack, 100,189 for heart failure (HF), and 79,076 for pneumonia. Dr. DeVore and his colleagues found readmission rates for the three conditions did not significantly improve after public reporting protocols were implemented in 2009. However, the study did show a significant decrease in ED visits and observation stays for those with HF: from 2.3% to –0.8% for the former (P = .007); and from 15% to 4% for the latter (P = .04).

Dr. J. William Gaynor
In their perspective, J. William Gaynor, MD, of the Children’s Hospital of Philadelphia and his coauthors cited four areas that require further study to validate the effectiveness of public reporting:

• The metrics must be accurate, reliably discern hospital quality, and account for high-risk cases without penalizing hospitals. “In pediatric cardiac surgery, this can be particularly challenging, owing to the very wide heterogeneity of disease and variability in case mix and volumes across centers,” Dr. Gaynor and his coauthors wrote. While methodology for case mix and patient characteristics have improved in recent years, further improvement is needed.

• Metrics must be clearly reported and easy for stakeholders to interpret. “This is critical if the data are to be used to steer patients toward higher-performing centers and/or to provide incentives for hospitals with lower performance to make improvements,” the researchers said.

• Regional reporting or a methodology that indicates where a hospital ranks within larger categories deserve further investigation as tools to help families choose a high-performing center, “ideally based on geography and on the particular type and complexity of disease,” Dr. Gaynor and his coauthors stated (J Thorac Cardiovasc Surg. 2017 Apr;153:904-7).

• Indirect standardization, a statistical methodology used to calculate risk-adjusted performance, could help consumers to interpret hospital performance more easily. This methodology might help classify a hospital with a low-complexity population as a high performer. “Developing better methods to convey this information to consumers is vital,” according to the researchers.

The perspective acknowledged several reports of an unintended consequence of public reporting: surgeons and centers avoiding higher-risk cases to skew their performance scores higher, thus restricting access to care. However, in a separate perspective on Dr. DeVore’s study, James S. Tweddell, MD, of Cincinnati Children’s Hospital Medical Center, and his coauthors, questioned the quality of the evidence on which Dr. Gaynor and his colleagues based their conclusion of risk aversion and limited access to care: a newspaper report from the United Kingdom.

Dr. James S. Tweddell
Dr. Tweddell and his coauthors cited a New York state study (Ann Thorac Surg. 1999 Oct;68:1195-1200) that suggested “risk-averse behavior may not be all bad,” and “if not for public reporting, these less-qualified individuals would have been willing to take on high-risk cases” (J Thorac Cardiovasc Surg. 2017 Apr;153:908-11).

Dr. Tweddell and his coauthors noted, “The predominance of data suggest an overall beneficial impact of public reporting.” They cited a trial that showed a decrease in heart attack–related deaths after public reporting had been implemented (JAMA. 2009 Dec 2;302:2330-7); a 2012 Agency for Healthcare Research and Quality systemic review (Evidence Report No. 208) that showed that research on harm is limited, and most studies do not confirm potential harm; and a meta-analysis that found a 15% reduction in adverse events associated with public reporting (BMC Health Serv Res. 2016;16:296).

“Appropriate risk adjustment is critical to achieve effective and fair transparency, but there is little objective data of harm associated with public reporting,” Dr. Tweddell and his coauthors concluded. While examination of public reporting must continue, they said, “these efforts are likely to result in minor course changes and the effort to inform and educate our patients and their families must continue.”

Ds. Gaynor, Dr. Tweddell, and their coauthors reported having no financial disclosures.
 

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Public reporting of cardiac surgery outcomes has been a disruptive force in cardiology, and especially daunting in pediatric cardiac surgery because of low case volumes and rare mortality. To ensure that public reporting achieves its original goals – providing transparency to the patient care process, holding providers accountable, informing decision making for health care consumers, reducing costs, encouraging more efficient use of health system resources, and improving patient care and outcomes – further study that includes use of appropriate risk adjustment is needed, according to commentaries in the April issue of the Journal of Thoracic and Cardiovascular Surgery.

The journal asked two groups to provide perspective on a study Adam D. DeVore, MD, of Duke University in Durham, N.C., and his coauthors published last year (J Am Coll Cardiol. 2016 Mar 1;67:963-72). The study analyzed Medicare claims data from 2006 to 2012 for 37,829 hospitalizations for heart attack, 100,189 for heart failure (HF), and 79,076 for pneumonia. Dr. DeVore and his colleagues found readmission rates for the three conditions did not significantly improve after public reporting protocols were implemented in 2009. However, the study did show a significant decrease in ED visits and observation stays for those with HF: from 2.3% to –0.8% for the former (P = .007); and from 15% to 4% for the latter (P = .04).

Dr. J. William Gaynor
In their perspective, J. William Gaynor, MD, of the Children’s Hospital of Philadelphia and his coauthors cited four areas that require further study to validate the effectiveness of public reporting:

• The metrics must be accurate, reliably discern hospital quality, and account for high-risk cases without penalizing hospitals. “In pediatric cardiac surgery, this can be particularly challenging, owing to the very wide heterogeneity of disease and variability in case mix and volumes across centers,” Dr. Gaynor and his coauthors wrote. While methodology for case mix and patient characteristics have improved in recent years, further improvement is needed.

• Metrics must be clearly reported and easy for stakeholders to interpret. “This is critical if the data are to be used to steer patients toward higher-performing centers and/or to provide incentives for hospitals with lower performance to make improvements,” the researchers said.

• Regional reporting or a methodology that indicates where a hospital ranks within larger categories deserve further investigation as tools to help families choose a high-performing center, “ideally based on geography and on the particular type and complexity of disease,” Dr. Gaynor and his coauthors stated (J Thorac Cardiovasc Surg. 2017 Apr;153:904-7).

• Indirect standardization, a statistical methodology used to calculate risk-adjusted performance, could help consumers to interpret hospital performance more easily. This methodology might help classify a hospital with a low-complexity population as a high performer. “Developing better methods to convey this information to consumers is vital,” according to the researchers.

The perspective acknowledged several reports of an unintended consequence of public reporting: surgeons and centers avoiding higher-risk cases to skew their performance scores higher, thus restricting access to care. However, in a separate perspective on Dr. DeVore’s study, James S. Tweddell, MD, of Cincinnati Children’s Hospital Medical Center, and his coauthors, questioned the quality of the evidence on which Dr. Gaynor and his colleagues based their conclusion of risk aversion and limited access to care: a newspaper report from the United Kingdom.

Dr. James S. Tweddell
Dr. Tweddell and his coauthors cited a New York state study (Ann Thorac Surg. 1999 Oct;68:1195-1200) that suggested “risk-averse behavior may not be all bad,” and “if not for public reporting, these less-qualified individuals would have been willing to take on high-risk cases” (J Thorac Cardiovasc Surg. 2017 Apr;153:908-11).

Dr. Tweddell and his coauthors noted, “The predominance of data suggest an overall beneficial impact of public reporting.” They cited a trial that showed a decrease in heart attack–related deaths after public reporting had been implemented (JAMA. 2009 Dec 2;302:2330-7); a 2012 Agency for Healthcare Research and Quality systemic review (Evidence Report No. 208) that showed that research on harm is limited, and most studies do not confirm potential harm; and a meta-analysis that found a 15% reduction in adverse events associated with public reporting (BMC Health Serv Res. 2016;16:296).

“Appropriate risk adjustment is critical to achieve effective and fair transparency, but there is little objective data of harm associated with public reporting,” Dr. Tweddell and his coauthors concluded. While examination of public reporting must continue, they said, “these efforts are likely to result in minor course changes and the effort to inform and educate our patients and their families must continue.”

Ds. Gaynor, Dr. Tweddell, and their coauthors reported having no financial disclosures.
 

 

Public reporting of cardiac surgery outcomes has been a disruptive force in cardiology, and especially daunting in pediatric cardiac surgery because of low case volumes and rare mortality. To ensure that public reporting achieves its original goals – providing transparency to the patient care process, holding providers accountable, informing decision making for health care consumers, reducing costs, encouraging more efficient use of health system resources, and improving patient care and outcomes – further study that includes use of appropriate risk adjustment is needed, according to commentaries in the April issue of the Journal of Thoracic and Cardiovascular Surgery.

The journal asked two groups to provide perspective on a study Adam D. DeVore, MD, of Duke University in Durham, N.C., and his coauthors published last year (J Am Coll Cardiol. 2016 Mar 1;67:963-72). The study analyzed Medicare claims data from 2006 to 2012 for 37,829 hospitalizations for heart attack, 100,189 for heart failure (HF), and 79,076 for pneumonia. Dr. DeVore and his colleagues found readmission rates for the three conditions did not significantly improve after public reporting protocols were implemented in 2009. However, the study did show a significant decrease in ED visits and observation stays for those with HF: from 2.3% to –0.8% for the former (P = .007); and from 15% to 4% for the latter (P = .04).

Dr. J. William Gaynor
In their perspective, J. William Gaynor, MD, of the Children’s Hospital of Philadelphia and his coauthors cited four areas that require further study to validate the effectiveness of public reporting:

• The metrics must be accurate, reliably discern hospital quality, and account for high-risk cases without penalizing hospitals. “In pediatric cardiac surgery, this can be particularly challenging, owing to the very wide heterogeneity of disease and variability in case mix and volumes across centers,” Dr. Gaynor and his coauthors wrote. While methodology for case mix and patient characteristics have improved in recent years, further improvement is needed.

• Metrics must be clearly reported and easy for stakeholders to interpret. “This is critical if the data are to be used to steer patients toward higher-performing centers and/or to provide incentives for hospitals with lower performance to make improvements,” the researchers said.

• Regional reporting or a methodology that indicates where a hospital ranks within larger categories deserve further investigation as tools to help families choose a high-performing center, “ideally based on geography and on the particular type and complexity of disease,” Dr. Gaynor and his coauthors stated (J Thorac Cardiovasc Surg. 2017 Apr;153:904-7).

• Indirect standardization, a statistical methodology used to calculate risk-adjusted performance, could help consumers to interpret hospital performance more easily. This methodology might help classify a hospital with a low-complexity population as a high performer. “Developing better methods to convey this information to consumers is vital,” according to the researchers.

The perspective acknowledged several reports of an unintended consequence of public reporting: surgeons and centers avoiding higher-risk cases to skew their performance scores higher, thus restricting access to care. However, in a separate perspective on Dr. DeVore’s study, James S. Tweddell, MD, of Cincinnati Children’s Hospital Medical Center, and his coauthors, questioned the quality of the evidence on which Dr. Gaynor and his colleagues based their conclusion of risk aversion and limited access to care: a newspaper report from the United Kingdom.

Dr. James S. Tweddell
Dr. Tweddell and his coauthors cited a New York state study (Ann Thorac Surg. 1999 Oct;68:1195-1200) that suggested “risk-averse behavior may not be all bad,” and “if not for public reporting, these less-qualified individuals would have been willing to take on high-risk cases” (J Thorac Cardiovasc Surg. 2017 Apr;153:908-11).

Dr. Tweddell and his coauthors noted, “The predominance of data suggest an overall beneficial impact of public reporting.” They cited a trial that showed a decrease in heart attack–related deaths after public reporting had been implemented (JAMA. 2009 Dec 2;302:2330-7); a 2012 Agency for Healthcare Research and Quality systemic review (Evidence Report No. 208) that showed that research on harm is limited, and most studies do not confirm potential harm; and a meta-analysis that found a 15% reduction in adverse events associated with public reporting (BMC Health Serv Res. 2016;16:296).

“Appropriate risk adjustment is critical to achieve effective and fair transparency, but there is little objective data of harm associated with public reporting,” Dr. Tweddell and his coauthors concluded. While examination of public reporting must continue, they said, “these efforts are likely to result in minor course changes and the effort to inform and educate our patients and their families must continue.”

Ds. Gaynor, Dr. Tweddell, and their coauthors reported having no financial disclosures.
 

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FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY

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Key clinical point: Public reporting of outcomes in cardiac surgery in children requires further investigation but has also been associated with improved outcomes.

Major finding: Emergency department visits for patients with heart failure declined from 2.3% before public reporting to –0.8% after implementation, and observation stays declined from 15.1% to 4.1%.

Data source: Analysis of Medicare claims data from 2006 to 2012 for 271,094 patients discharged after hospitalization for heart attack, heart failure or pneumonia. 

Disclosures: Dr. Gaynor and Dr. Tweddell had no financial relationships to disclose.

AATS publishes guidelines for infective endocarditis

Putting guidelines in context
Article Type
Changed
Tue, 12/04/2018 - 13:31

 

Infective endocarditis (IE) is a devastating complication of heart valve disease that, left untreated, can be fatal. Management requires a multidisciplinary approach, and many of the respective medical societies that represent the participating specialties have developed guidelines. Now, the American Association for Thoracic Surgery has published “Consensus Guidelines for the Surgical Treatment of Infective Endocarditis” to guide thoracic and cardiovascular surgeons in making decisions of when to operate in cases of IE (J Thorac Cardiovasc Surg. 2017 Jan 24. doi: 10.1016/j.jtcvs.2016.09.093).

Dr. Gösta B. Pettersson
“These guidelines describe diagnosis, indications, timing, surgical treatment and perioperative care for patients with infective endocarditis, and early surgeon involvement in team decision-making,” Gösta B. Pettersson, MD, PhD, of the Cleveland Clinic and his coauthors said.

The rationale for developing the guidelines is a growing prevalence of IE, including in patients with normal valves and no previous diagnosis of heart disease. “These new AATS consensus guidelines primarily address questions related to active and suspected active IE affective valves and intracardiac structures,” Dr. Pettersson and his coauthors said. The AATS guidelines for infective endocarditis address complications including risk of embolism and the timing of surgery in patients with neurological complications, while acknowledging the the need for additional research into these topics.*  “It is understood that surgery is beneficial only if the patient’s complications and other comorbidities do not preclude survival and meaningful recovery,” the guideline authors said.

The guidelines confirm the team approach for managing patients with IE. The team should include cardiology, infectious disease, cardiac surgery, and other specialties needed to handle IE-related complications (class of recommendation [COR] I, level of evidence [LOE] B). Before surgery, the surgeon should know the patient is on effective antimicrobial therapy (COR I, LOE B). Transesophageal echocardiography (TEE) is indicated to yield the clearest understanding of the pathology (COR I, LOE B).

Dr. Pettersson and the guideline writing team also clarified indications for surgery in patients with IE. They include when valve dysfunction causes heart failure (COR I, LOE B); when, after a full course of antibiotics, the patient has signs of heart block, annular or aortic abscess or destructive penetrating lesions (COR I, LOE B); and in the setting of recurrent emboli and persistent vegetations despite appropriate antibiotic therapy (COR IIA, LOE B).

The guideline writers acknowledged potential disagreement between the AATS guidelines and those of the American College of Cardiology/American Heart Association with regard to early surgery in IE. Debate surrounds whether to operate early or wait for symptoms of heart failure to manifest in patients with native valve endocarditis (NVE). The AATS guideline authors cite work by Duk-Hyun Kang, MD, PhD, and coauthors in South Korea (N Engl J Med. 2012;366;2466-73) and others advocating for early surgery. “For this reason, once a surgical indication is evident, surgery should not be delayed,” Dr. Pettersson and his coauthors said.

Several conditions can influence the timing of surgery. Patients with cerebral mycotic aneurysm should be managed closely with neurology or neurosurgery (COR I, LOE C). Patients with a recent intracranial hemorrhage should wait at least 3 weeks for surgery (COR IIA, LOE B), but those with nonhemorrhagic strokes could go in for urgent surgery (COR IIA, LOE B). Brain imaging is indicated for IE patients with neurological symptoms (COR I, LOE B), but anticoagulation management requires a nuanced approach that takes all risks and benefits into consideration (COR I, LOE C).

Key steps during surgery involve mandatory intraoperative TEE (COR I, LOE B), median sternotomy with few exceptions (COR I, LOE B), and radical debridement and removal of all infected and necrotic tissue (COR I, LOE B). The writers also provided four guidelines for reconstruction and valve replacement:

  • Repair when possible for patients with NVE (COR I, LOE B).
  • When replacement is indicated, the surgeon should base valve choice on normal criteria – age, life expectancy, comorbidities, and expected compliance with anticoagulation (COR I, LOE B).
  • Avoid use of mechanical valves in patients with intracranial bleeding or who have had a major stroke (COR IIA, LOE C).
  • In patients with invasive disease and deconstruction, reconstruction should depend on the involved valve, severity of destruction, and available options for cardiac reconstruction (COR I, LOE B).

The AATS guidelines also challenge conventional thinking on the practice of soaking a gel-impregnated graft with antimicrobials targeting a specific organism. “We found no evidence to support this practice,” Dr. Pettersson and his coauthors said (COR IIB, LOE B). They came to the same conclusion with regard to the use of local antimicrobials or antiseptics during irrigation after debridement and local injection of antimicrobials around the infected area (COR I, LOE C).

The guidelines provide direction on a host of other surgical issues in IE: use of aortic valve grafts; when to remove or replace noninfected grafts; when to remove pacemakers; the role of drainage; postoperative management; follow-up; and additional screening. They also shed insight into what the guideline authors call “residual controversies,” including surgery for injection drug users (use “all available resources and options for drug rehabilitation”) and dialysis patients (“it is reasonable to offer surgery when the additional burden of comorbidities is not overwhelming”). They also acknowledge seven different scenarios that lack clear evidence for intervention but require the surgeon to determine the need for surgery, ranging from timing of surgery for IE in patients with neurologic complications to how to treat patients with functional valve issues after being cured of IE.

The guideline writers acknowledged that institutional funds supported the work. Dr. Pettersson had no financial relationships to disclose.

*Correction 5/172017: It was incorrectly stated that these complications were not addressed in the guidelines due to lack of evidence

Body

 

Whether they’re intended to or not, guidelines like the AATS Consensus Guidelines for the Surgical Treatment of Infected Endocarditis “can evolve into hard and fast principles, sometimes leading to incorrect decision making and even creating medicolegal problems for treating physicians,” Gus J. Vlahakes, MD, of Harvard Medical School and Massachusetts General Hospital, Boston, said in his invited commentary (J Thorac Cardiovasc Surg. 2016 Nov 3. doi: 10.1016/j.jtcvs.2016.10.041).

Guidelines cannot “integrate all the necessary considerations,” Dr. Vlahakes said, so surgeons should view them as “a set of general principles to guide decision making.” In IE, that means having an experienced cardiac surgeon who can apply the guidelines on a case-by-case basis and a multidisciplinary team that includes an infectious disease specialist, he said. The surgeon must participate in preoperative management.

Gus J. Vlahakes, MD
In cases of IE caused by intravenous drug use, the multidisciplinary team should include an infectious disease specialist and a “contract” with the patient, Dr. Vlahakes said. “If there is recurrent intravenous drug abuse and new IE, it should be made clear to the patient after recovery from an operation that there may not be another operation offered,” he said. That may provide incentive for the patient to remain “clean.”

Dr. Vlahakes had no relevant financial disclosures.

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Whether they’re intended to or not, guidelines like the AATS Consensus Guidelines for the Surgical Treatment of Infected Endocarditis “can evolve into hard and fast principles, sometimes leading to incorrect decision making and even creating medicolegal problems for treating physicians,” Gus J. Vlahakes, MD, of Harvard Medical School and Massachusetts General Hospital, Boston, said in his invited commentary (J Thorac Cardiovasc Surg. 2016 Nov 3. doi: 10.1016/j.jtcvs.2016.10.041).

Guidelines cannot “integrate all the necessary considerations,” Dr. Vlahakes said, so surgeons should view them as “a set of general principles to guide decision making.” In IE, that means having an experienced cardiac surgeon who can apply the guidelines on a case-by-case basis and a multidisciplinary team that includes an infectious disease specialist, he said. The surgeon must participate in preoperative management.

Gus J. Vlahakes, MD
In cases of IE caused by intravenous drug use, the multidisciplinary team should include an infectious disease specialist and a “contract” with the patient, Dr. Vlahakes said. “If there is recurrent intravenous drug abuse and new IE, it should be made clear to the patient after recovery from an operation that there may not be another operation offered,” he said. That may provide incentive for the patient to remain “clean.”

Dr. Vlahakes had no relevant financial disclosures.

Body

 

Whether they’re intended to or not, guidelines like the AATS Consensus Guidelines for the Surgical Treatment of Infected Endocarditis “can evolve into hard and fast principles, sometimes leading to incorrect decision making and even creating medicolegal problems for treating physicians,” Gus J. Vlahakes, MD, of Harvard Medical School and Massachusetts General Hospital, Boston, said in his invited commentary (J Thorac Cardiovasc Surg. 2016 Nov 3. doi: 10.1016/j.jtcvs.2016.10.041).

Guidelines cannot “integrate all the necessary considerations,” Dr. Vlahakes said, so surgeons should view them as “a set of general principles to guide decision making.” In IE, that means having an experienced cardiac surgeon who can apply the guidelines on a case-by-case basis and a multidisciplinary team that includes an infectious disease specialist, he said. The surgeon must participate in preoperative management.

Gus J. Vlahakes, MD
In cases of IE caused by intravenous drug use, the multidisciplinary team should include an infectious disease specialist and a “contract” with the patient, Dr. Vlahakes said. “If there is recurrent intravenous drug abuse and new IE, it should be made clear to the patient after recovery from an operation that there may not be another operation offered,” he said. That may provide incentive for the patient to remain “clean.”

Dr. Vlahakes had no relevant financial disclosures.

Title
Putting guidelines in context
Putting guidelines in context

 

Infective endocarditis (IE) is a devastating complication of heart valve disease that, left untreated, can be fatal. Management requires a multidisciplinary approach, and many of the respective medical societies that represent the participating specialties have developed guidelines. Now, the American Association for Thoracic Surgery has published “Consensus Guidelines for the Surgical Treatment of Infective Endocarditis” to guide thoracic and cardiovascular surgeons in making decisions of when to operate in cases of IE (J Thorac Cardiovasc Surg. 2017 Jan 24. doi: 10.1016/j.jtcvs.2016.09.093).

Dr. Gösta B. Pettersson
“These guidelines describe diagnosis, indications, timing, surgical treatment and perioperative care for patients with infective endocarditis, and early surgeon involvement in team decision-making,” Gösta B. Pettersson, MD, PhD, of the Cleveland Clinic and his coauthors said.

The rationale for developing the guidelines is a growing prevalence of IE, including in patients with normal valves and no previous diagnosis of heart disease. “These new AATS consensus guidelines primarily address questions related to active and suspected active IE affective valves and intracardiac structures,” Dr. Pettersson and his coauthors said. The AATS guidelines for infective endocarditis address complications including risk of embolism and the timing of surgery in patients with neurological complications, while acknowledging the the need for additional research into these topics.*  “It is understood that surgery is beneficial only if the patient’s complications and other comorbidities do not preclude survival and meaningful recovery,” the guideline authors said.

The guidelines confirm the team approach for managing patients with IE. The team should include cardiology, infectious disease, cardiac surgery, and other specialties needed to handle IE-related complications (class of recommendation [COR] I, level of evidence [LOE] B). Before surgery, the surgeon should know the patient is on effective antimicrobial therapy (COR I, LOE B). Transesophageal echocardiography (TEE) is indicated to yield the clearest understanding of the pathology (COR I, LOE B).

Dr. Pettersson and the guideline writing team also clarified indications for surgery in patients with IE. They include when valve dysfunction causes heart failure (COR I, LOE B); when, after a full course of antibiotics, the patient has signs of heart block, annular or aortic abscess or destructive penetrating lesions (COR I, LOE B); and in the setting of recurrent emboli and persistent vegetations despite appropriate antibiotic therapy (COR IIA, LOE B).

The guideline writers acknowledged potential disagreement between the AATS guidelines and those of the American College of Cardiology/American Heart Association with regard to early surgery in IE. Debate surrounds whether to operate early or wait for symptoms of heart failure to manifest in patients with native valve endocarditis (NVE). The AATS guideline authors cite work by Duk-Hyun Kang, MD, PhD, and coauthors in South Korea (N Engl J Med. 2012;366;2466-73) and others advocating for early surgery. “For this reason, once a surgical indication is evident, surgery should not be delayed,” Dr. Pettersson and his coauthors said.

Several conditions can influence the timing of surgery. Patients with cerebral mycotic aneurysm should be managed closely with neurology or neurosurgery (COR I, LOE C). Patients with a recent intracranial hemorrhage should wait at least 3 weeks for surgery (COR IIA, LOE B), but those with nonhemorrhagic strokes could go in for urgent surgery (COR IIA, LOE B). Brain imaging is indicated for IE patients with neurological symptoms (COR I, LOE B), but anticoagulation management requires a nuanced approach that takes all risks and benefits into consideration (COR I, LOE C).

Key steps during surgery involve mandatory intraoperative TEE (COR I, LOE B), median sternotomy with few exceptions (COR I, LOE B), and radical debridement and removal of all infected and necrotic tissue (COR I, LOE B). The writers also provided four guidelines for reconstruction and valve replacement:

  • Repair when possible for patients with NVE (COR I, LOE B).
  • When replacement is indicated, the surgeon should base valve choice on normal criteria – age, life expectancy, comorbidities, and expected compliance with anticoagulation (COR I, LOE B).
  • Avoid use of mechanical valves in patients with intracranial bleeding or who have had a major stroke (COR IIA, LOE C).
  • In patients with invasive disease and deconstruction, reconstruction should depend on the involved valve, severity of destruction, and available options for cardiac reconstruction (COR I, LOE B).

The AATS guidelines also challenge conventional thinking on the practice of soaking a gel-impregnated graft with antimicrobials targeting a specific organism. “We found no evidence to support this practice,” Dr. Pettersson and his coauthors said (COR IIB, LOE B). They came to the same conclusion with regard to the use of local antimicrobials or antiseptics during irrigation after debridement and local injection of antimicrobials around the infected area (COR I, LOE C).

The guidelines provide direction on a host of other surgical issues in IE: use of aortic valve grafts; when to remove or replace noninfected grafts; when to remove pacemakers; the role of drainage; postoperative management; follow-up; and additional screening. They also shed insight into what the guideline authors call “residual controversies,” including surgery for injection drug users (use “all available resources and options for drug rehabilitation”) and dialysis patients (“it is reasonable to offer surgery when the additional burden of comorbidities is not overwhelming”). They also acknowledge seven different scenarios that lack clear evidence for intervention but require the surgeon to determine the need for surgery, ranging from timing of surgery for IE in patients with neurologic complications to how to treat patients with functional valve issues after being cured of IE.

The guideline writers acknowledged that institutional funds supported the work. Dr. Pettersson had no financial relationships to disclose.

*Correction 5/172017: It was incorrectly stated that these complications were not addressed in the guidelines due to lack of evidence

 

Infective endocarditis (IE) is a devastating complication of heart valve disease that, left untreated, can be fatal. Management requires a multidisciplinary approach, and many of the respective medical societies that represent the participating specialties have developed guidelines. Now, the American Association for Thoracic Surgery has published “Consensus Guidelines for the Surgical Treatment of Infective Endocarditis” to guide thoracic and cardiovascular surgeons in making decisions of when to operate in cases of IE (J Thorac Cardiovasc Surg. 2017 Jan 24. doi: 10.1016/j.jtcvs.2016.09.093).

Dr. Gösta B. Pettersson
“These guidelines describe diagnosis, indications, timing, surgical treatment and perioperative care for patients with infective endocarditis, and early surgeon involvement in team decision-making,” Gösta B. Pettersson, MD, PhD, of the Cleveland Clinic and his coauthors said.

The rationale for developing the guidelines is a growing prevalence of IE, including in patients with normal valves and no previous diagnosis of heart disease. “These new AATS consensus guidelines primarily address questions related to active and suspected active IE affective valves and intracardiac structures,” Dr. Pettersson and his coauthors said. The AATS guidelines for infective endocarditis address complications including risk of embolism and the timing of surgery in patients with neurological complications, while acknowledging the the need for additional research into these topics.*  “It is understood that surgery is beneficial only if the patient’s complications and other comorbidities do not preclude survival and meaningful recovery,” the guideline authors said.

The guidelines confirm the team approach for managing patients with IE. The team should include cardiology, infectious disease, cardiac surgery, and other specialties needed to handle IE-related complications (class of recommendation [COR] I, level of evidence [LOE] B). Before surgery, the surgeon should know the patient is on effective antimicrobial therapy (COR I, LOE B). Transesophageal echocardiography (TEE) is indicated to yield the clearest understanding of the pathology (COR I, LOE B).

Dr. Pettersson and the guideline writing team also clarified indications for surgery in patients with IE. They include when valve dysfunction causes heart failure (COR I, LOE B); when, after a full course of antibiotics, the patient has signs of heart block, annular or aortic abscess or destructive penetrating lesions (COR I, LOE B); and in the setting of recurrent emboli and persistent vegetations despite appropriate antibiotic therapy (COR IIA, LOE B).

The guideline writers acknowledged potential disagreement between the AATS guidelines and those of the American College of Cardiology/American Heart Association with regard to early surgery in IE. Debate surrounds whether to operate early or wait for symptoms of heart failure to manifest in patients with native valve endocarditis (NVE). The AATS guideline authors cite work by Duk-Hyun Kang, MD, PhD, and coauthors in South Korea (N Engl J Med. 2012;366;2466-73) and others advocating for early surgery. “For this reason, once a surgical indication is evident, surgery should not be delayed,” Dr. Pettersson and his coauthors said.

Several conditions can influence the timing of surgery. Patients with cerebral mycotic aneurysm should be managed closely with neurology or neurosurgery (COR I, LOE C). Patients with a recent intracranial hemorrhage should wait at least 3 weeks for surgery (COR IIA, LOE B), but those with nonhemorrhagic strokes could go in for urgent surgery (COR IIA, LOE B). Brain imaging is indicated for IE patients with neurological symptoms (COR I, LOE B), but anticoagulation management requires a nuanced approach that takes all risks and benefits into consideration (COR I, LOE C).

Key steps during surgery involve mandatory intraoperative TEE (COR I, LOE B), median sternotomy with few exceptions (COR I, LOE B), and radical debridement and removal of all infected and necrotic tissue (COR I, LOE B). The writers also provided four guidelines for reconstruction and valve replacement:

  • Repair when possible for patients with NVE (COR I, LOE B).
  • When replacement is indicated, the surgeon should base valve choice on normal criteria – age, life expectancy, comorbidities, and expected compliance with anticoagulation (COR I, LOE B).
  • Avoid use of mechanical valves in patients with intracranial bleeding or who have had a major stroke (COR IIA, LOE C).
  • In patients with invasive disease and deconstruction, reconstruction should depend on the involved valve, severity of destruction, and available options for cardiac reconstruction (COR I, LOE B).

The AATS guidelines also challenge conventional thinking on the practice of soaking a gel-impregnated graft with antimicrobials targeting a specific organism. “We found no evidence to support this practice,” Dr. Pettersson and his coauthors said (COR IIB, LOE B). They came to the same conclusion with regard to the use of local antimicrobials or antiseptics during irrigation after debridement and local injection of antimicrobials around the infected area (COR I, LOE C).

The guidelines provide direction on a host of other surgical issues in IE: use of aortic valve grafts; when to remove or replace noninfected grafts; when to remove pacemakers; the role of drainage; postoperative management; follow-up; and additional screening. They also shed insight into what the guideline authors call “residual controversies,” including surgery for injection drug users (use “all available resources and options for drug rehabilitation”) and dialysis patients (“it is reasonable to offer surgery when the additional burden of comorbidities is not overwhelming”). They also acknowledge seven different scenarios that lack clear evidence for intervention but require the surgeon to determine the need for surgery, ranging from timing of surgery for IE in patients with neurologic complications to how to treat patients with functional valve issues after being cured of IE.

The guideline writers acknowledged that institutional funds supported the work. Dr. Pettersson had no financial relationships to disclose.

*Correction 5/172017: It was incorrectly stated that these complications were not addressed in the guidelines due to lack of evidence

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Key clinical point: The American Association for Thoracic Surgery charged a committee of eight members to author “Consensus Guidelines: Surgical Treatment of Infective Endocarditis.”

Major finding: Patients with infective endocarditis need early input from the responsible cardiac surgeon, who must also lead the care team in evaluation, decision- making, and ultimately carrying out surgery as needed.

Data source: The writing committee followed Institute of Medicine standards for clinical practice guidelines, invited comment from a group of 12 multidisciplinary specialists and reviewed 288 articles in drafting the guidelines.

Disclosures: Institutional funds supported the work. Dr. Pettersson and his coauthors had no financial relationships to disclose.

Time to reexamine surgery for nonlocalized bronchiectasis

‘Important contribution,’ but ...
Article Type
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Wed, 01/02/2019 - 09:51

 

Nonlocalized bronchiectasis is becoming more common in developing countries and has been difficult to treat. While surgery for localized bronchiectasis has been proven, its role in nonlocalized disease is less established; researchers from China are advocating for a reexamination of surgical resection in this disease based on results of a small cohort study at their academic center.

“Lobectomy for the predominant lesion is a safe procedure in the surgical treatment of nonlocalized bronchiectasis and leads to significant relief of symptoms with good rates of satisfaction,” Jie Dai, PhD, of Shanghai (China) Pulmonary Hospital Tongji University and his coauthors reported in the Journal of Thoracic and Cardiovascular Surgery (2017 Apr;153:979-85).

The researchers reviewed the medical records of 37 consecutive patients – 10 men and 27 women – with nonlocalized bronchiectasis who had lobectomies via thoracotomies during 2010-2013. Twenty-three patients (62.2%) were symptom free after surgery and 10 (27%) reported that their symptoms had improved. Four (10.8%) said their symptoms either did not improve or worsened, but three of them also had chronic occlusive pulmonary disease. There were no deaths, and the morbidity rate was 21.6%.

The researchers used three criteria to select candidates for surgery: persistent symptoms despite medical treatment; an identifiable predominant lesion; and cardiopulmonary function compatible with anesthetic risk. Average age was 54.5 years and more than half (19) had no smoking history.

The surgical technique involved a posterolateral thoracotomy and a double-lumen endotracheal tube to avoid contamination of the opposite side of the lung during surgery. Surgery avoided excessive bronchial dissection and preserved peribronchial tissues. Extrapleural dissection avoided spillage of lung contents into the pleural space.

Treatment of the hilum followed an order from the pulmonary artery to the pulmonary vein and then to the bronchus. An ultrasonic device helped isolate and then ligate or sever distorted bronchial arteries. A mechanical stapler was used to close the bronchial stump. Reinforcement involved an intercostal muscle flap in 16 cases and a pedicled parietal pleural flap in 21. If any sign of pleural infection appeared after hemostasis, pleural space irrigation with 0.5% neomycin (500 mg/L) was initiated. Two chest drains were placed at the bronchial stump, and the bronchial suture checked with bronchoscopy. Airway secretions were removed, and pathology confirmed bronchiectasis all specimens.

The frequency of acute infection and hemoptysis decreased significantly at 1 year postoperatively, from 5.3% to 1.8% and 4.9% to 1.1%, respectively, (P less than .01 for both). Daily sputum volume decreased an average of 26.3 mL (P less than .01) and sputum cultures became sterile in 13 (35%) of patients (P less than .01).

Previously, surgery for nonlocalized bronchiectasis had been reserved for life-threatening symptoms only, but Dr. Dai and his coauthors fashioned their study on previous studies of lobectomy that included patients with nonlocalized bronchiectasis (Br J Surg. 2005;92:836-9; Ann Thorac Surg. 2003;75:382-7).

Two major complications occurred in the Shanghai cohort: empyema and persistent air leak, both of which were managed without a reoperation and had been reported in previous series. Dr. Dai and his coauthors have adopted protocols to reduce complications, among them, requiring that patients have sputum output greater than 20 mL/day with little purulence and no engorgement or edema in the tunica mucosa bronchiorum on bronchoscopy.

But the researchers are not ready to extend surgery as a blanket indication for nonlocalized bronchiectasis. “It is worth mentioning that the surgical benefit is limited to patients who have only one predominant area of bronchiectatic disease that can be localized by CT instead of those with diffuse bronchiectasis,” they wrote. “The ideal surgical candidate has a heterogeneous distribution of diseased areas.”

The investigators pointed out that the study was limited by its small size and lack of information on etiologies of disease.

Dr. Dai and his coauthors had no financial relationships to disclose.
 

Body

 

The study by Dr. Dai and his coauthors “is an important contribution to the literature” despite its limitations, Steven Milman, MD, and Thomas Ng, MD, of Brown University, Providence, R.I., said in their invited commentary (J Thorac Cardiovasc Surg. 2017 Apr;153:986). However, they added, “Several important points need to be stressed.”

Among those points: The researchers studied a “highly selected group” of young patients with good pulmonary functions; mean follow-up was short (15 months); the etiology of bronchiectasis was unknown; and lobectomy was not the optimal treatment for nonlocalized bronchiectasis. “It must be remembered that these patients first failed medical therapy and that the study population received lobectomy due to the extent of the dominant disease and not as routine treatment,” Dr. Milman and Dr. Ng wrote.

To validate the findings, Dr. Milman and Dr. Ng said, not only do more patients need to be studied with longer follow-up but future investigators also should study minimally invasive approaches to see if that would improve the outcomes.

Dr. Milman and Dr. Ng had no financial relationships to disclose.

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The study by Dr. Dai and his coauthors “is an important contribution to the literature” despite its limitations, Steven Milman, MD, and Thomas Ng, MD, of Brown University, Providence, R.I., said in their invited commentary (J Thorac Cardiovasc Surg. 2017 Apr;153:986). However, they added, “Several important points need to be stressed.”

Among those points: The researchers studied a “highly selected group” of young patients with good pulmonary functions; mean follow-up was short (15 months); the etiology of bronchiectasis was unknown; and lobectomy was not the optimal treatment for nonlocalized bronchiectasis. “It must be remembered that these patients first failed medical therapy and that the study population received lobectomy due to the extent of the dominant disease and not as routine treatment,” Dr. Milman and Dr. Ng wrote.

To validate the findings, Dr. Milman and Dr. Ng said, not only do more patients need to be studied with longer follow-up but future investigators also should study minimally invasive approaches to see if that would improve the outcomes.

Dr. Milman and Dr. Ng had no financial relationships to disclose.

Body

 

The study by Dr. Dai and his coauthors “is an important contribution to the literature” despite its limitations, Steven Milman, MD, and Thomas Ng, MD, of Brown University, Providence, R.I., said in their invited commentary (J Thorac Cardiovasc Surg. 2017 Apr;153:986). However, they added, “Several important points need to be stressed.”

Among those points: The researchers studied a “highly selected group” of young patients with good pulmonary functions; mean follow-up was short (15 months); the etiology of bronchiectasis was unknown; and lobectomy was not the optimal treatment for nonlocalized bronchiectasis. “It must be remembered that these patients first failed medical therapy and that the study population received lobectomy due to the extent of the dominant disease and not as routine treatment,” Dr. Milman and Dr. Ng wrote.

To validate the findings, Dr. Milman and Dr. Ng said, not only do more patients need to be studied with longer follow-up but future investigators also should study minimally invasive approaches to see if that would improve the outcomes.

Dr. Milman and Dr. Ng had no financial relationships to disclose.

Title
‘Important contribution,’ but ...
‘Important contribution,’ but ...

 

Nonlocalized bronchiectasis is becoming more common in developing countries and has been difficult to treat. While surgery for localized bronchiectasis has been proven, its role in nonlocalized disease is less established; researchers from China are advocating for a reexamination of surgical resection in this disease based on results of a small cohort study at their academic center.

“Lobectomy for the predominant lesion is a safe procedure in the surgical treatment of nonlocalized bronchiectasis and leads to significant relief of symptoms with good rates of satisfaction,” Jie Dai, PhD, of Shanghai (China) Pulmonary Hospital Tongji University and his coauthors reported in the Journal of Thoracic and Cardiovascular Surgery (2017 Apr;153:979-85).

The researchers reviewed the medical records of 37 consecutive patients – 10 men and 27 women – with nonlocalized bronchiectasis who had lobectomies via thoracotomies during 2010-2013. Twenty-three patients (62.2%) were symptom free after surgery and 10 (27%) reported that their symptoms had improved. Four (10.8%) said their symptoms either did not improve or worsened, but three of them also had chronic occlusive pulmonary disease. There were no deaths, and the morbidity rate was 21.6%.

The researchers used three criteria to select candidates for surgery: persistent symptoms despite medical treatment; an identifiable predominant lesion; and cardiopulmonary function compatible with anesthetic risk. Average age was 54.5 years and more than half (19) had no smoking history.

The surgical technique involved a posterolateral thoracotomy and a double-lumen endotracheal tube to avoid contamination of the opposite side of the lung during surgery. Surgery avoided excessive bronchial dissection and preserved peribronchial tissues. Extrapleural dissection avoided spillage of lung contents into the pleural space.

Treatment of the hilum followed an order from the pulmonary artery to the pulmonary vein and then to the bronchus. An ultrasonic device helped isolate and then ligate or sever distorted bronchial arteries. A mechanical stapler was used to close the bronchial stump. Reinforcement involved an intercostal muscle flap in 16 cases and a pedicled parietal pleural flap in 21. If any sign of pleural infection appeared after hemostasis, pleural space irrigation with 0.5% neomycin (500 mg/L) was initiated. Two chest drains were placed at the bronchial stump, and the bronchial suture checked with bronchoscopy. Airway secretions were removed, and pathology confirmed bronchiectasis all specimens.

The frequency of acute infection and hemoptysis decreased significantly at 1 year postoperatively, from 5.3% to 1.8% and 4.9% to 1.1%, respectively, (P less than .01 for both). Daily sputum volume decreased an average of 26.3 mL (P less than .01) and sputum cultures became sterile in 13 (35%) of patients (P less than .01).

Previously, surgery for nonlocalized bronchiectasis had been reserved for life-threatening symptoms only, but Dr. Dai and his coauthors fashioned their study on previous studies of lobectomy that included patients with nonlocalized bronchiectasis (Br J Surg. 2005;92:836-9; Ann Thorac Surg. 2003;75:382-7).

Two major complications occurred in the Shanghai cohort: empyema and persistent air leak, both of which were managed without a reoperation and had been reported in previous series. Dr. Dai and his coauthors have adopted protocols to reduce complications, among them, requiring that patients have sputum output greater than 20 mL/day with little purulence and no engorgement or edema in the tunica mucosa bronchiorum on bronchoscopy.

But the researchers are not ready to extend surgery as a blanket indication for nonlocalized bronchiectasis. “It is worth mentioning that the surgical benefit is limited to patients who have only one predominant area of bronchiectatic disease that can be localized by CT instead of those with diffuse bronchiectasis,” they wrote. “The ideal surgical candidate has a heterogeneous distribution of diseased areas.”

The investigators pointed out that the study was limited by its small size and lack of information on etiologies of disease.

Dr. Dai and his coauthors had no financial relationships to disclose.
 

 

Nonlocalized bronchiectasis is becoming more common in developing countries and has been difficult to treat. While surgery for localized bronchiectasis has been proven, its role in nonlocalized disease is less established; researchers from China are advocating for a reexamination of surgical resection in this disease based on results of a small cohort study at their academic center.

“Lobectomy for the predominant lesion is a safe procedure in the surgical treatment of nonlocalized bronchiectasis and leads to significant relief of symptoms with good rates of satisfaction,” Jie Dai, PhD, of Shanghai (China) Pulmonary Hospital Tongji University and his coauthors reported in the Journal of Thoracic and Cardiovascular Surgery (2017 Apr;153:979-85).

The researchers reviewed the medical records of 37 consecutive patients – 10 men and 27 women – with nonlocalized bronchiectasis who had lobectomies via thoracotomies during 2010-2013. Twenty-three patients (62.2%) were symptom free after surgery and 10 (27%) reported that their symptoms had improved. Four (10.8%) said their symptoms either did not improve or worsened, but three of them also had chronic occlusive pulmonary disease. There were no deaths, and the morbidity rate was 21.6%.

The researchers used three criteria to select candidates for surgery: persistent symptoms despite medical treatment; an identifiable predominant lesion; and cardiopulmonary function compatible with anesthetic risk. Average age was 54.5 years and more than half (19) had no smoking history.

The surgical technique involved a posterolateral thoracotomy and a double-lumen endotracheal tube to avoid contamination of the opposite side of the lung during surgery. Surgery avoided excessive bronchial dissection and preserved peribronchial tissues. Extrapleural dissection avoided spillage of lung contents into the pleural space.

Treatment of the hilum followed an order from the pulmonary artery to the pulmonary vein and then to the bronchus. An ultrasonic device helped isolate and then ligate or sever distorted bronchial arteries. A mechanical stapler was used to close the bronchial stump. Reinforcement involved an intercostal muscle flap in 16 cases and a pedicled parietal pleural flap in 21. If any sign of pleural infection appeared after hemostasis, pleural space irrigation with 0.5% neomycin (500 mg/L) was initiated. Two chest drains were placed at the bronchial stump, and the bronchial suture checked with bronchoscopy. Airway secretions were removed, and pathology confirmed bronchiectasis all specimens.

The frequency of acute infection and hemoptysis decreased significantly at 1 year postoperatively, from 5.3% to 1.8% and 4.9% to 1.1%, respectively, (P less than .01 for both). Daily sputum volume decreased an average of 26.3 mL (P less than .01) and sputum cultures became sterile in 13 (35%) of patients (P less than .01).

Previously, surgery for nonlocalized bronchiectasis had been reserved for life-threatening symptoms only, but Dr. Dai and his coauthors fashioned their study on previous studies of lobectomy that included patients with nonlocalized bronchiectasis (Br J Surg. 2005;92:836-9; Ann Thorac Surg. 2003;75:382-7).

Two major complications occurred in the Shanghai cohort: empyema and persistent air leak, both of which were managed without a reoperation and had been reported in previous series. Dr. Dai and his coauthors have adopted protocols to reduce complications, among them, requiring that patients have sputum output greater than 20 mL/day with little purulence and no engorgement or edema in the tunica mucosa bronchiorum on bronchoscopy.

But the researchers are not ready to extend surgery as a blanket indication for nonlocalized bronchiectasis. “It is worth mentioning that the surgical benefit is limited to patients who have only one predominant area of bronchiectatic disease that can be localized by CT instead of those with diffuse bronchiectasis,” they wrote. “The ideal surgical candidate has a heterogeneous distribution of diseased areas.”

The investigators pointed out that the study was limited by its small size and lack of information on etiologies of disease.

Dr. Dai and his coauthors had no financial relationships to disclose.
 

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Key clinical point: Lobectomy for nonlocalized bronchiectasis can improve symptoms significantly.

Major finding: Among 37 patients who had lobectomy, 62.2% were asymptomatic after surgery.

Data source: Single-center retrospective review of 37 patients who had lobectomy for nonlocalized bronchiectasis from January 2010 to December 2013.

Disclosure: Dr. Dai and his coauthors had no financial relationships to disclose.

Can high hematocrit predict early shunt thrombosis?

Is this a slow-moving train?
Article Type
Changed
Tue, 02/14/2023 - 13:06

 

Shunt occlusion has been a well-documented cause of shunt failure in newborns who have had systemic to pulmonary shunt placement, and little has been known about why shunts occlude. However, researchers have reported in a small retrospective study that higher postoperative hematocrit levels immediately after surgery may be predictors of shunt occlusion.

Reporting in the April 2017 issue of The Journal of Thoracic and Cardiovascular Surgery, Brett R. Anderson, MD, of New York-Presbyterian/Morgan Stanley Children’s Hospital, Columbia University Medical Center in New York, and coauthors, found that every 5-point increase in postoperative hematocrit more than doubled an infant’s odds of having early shunt occlusion (J Thorac Cardiovasc Surg. 2017;153:947-55).

“Beginning in the latter half of 2014, we noticed an increase in the incidence of early shunt occlusions in our neonatal cardiac intensive care unit,” Dr. Anderson and coauthors said. So they conducted a retrospective chart review of 80 infants who had undergone systemic to pulmonary shunt placement from January 2010 to July 2015, hypothesizing that increased hematocrit in the early postoperative period might have caused early shunt occlusion. They investigated the association between the first postoperative hematocrit and early shunt occlusion and in-hospital mortality in these patients.

Five patients (6.3%) experienced early shunt occlusion – that is, within 24 hours of placement (actually, within 10 hours of placement). Overall, 12 infants (15%) experienced shunt occlusion. The physicians at New York-Presbyterian do not administer anticoagulation in these patients during the first 12 hours after shunt placement.

The median initial postoperative hematocrit was 41.7%, with a range of 31.7%-55.8%. The survival analysis the researchers performed found that for every 5 additional percentage points, the hazard ratio for early shunt occlusion was 2.7 (P = .007) and 1.74 for any shunt occlusion (P less than .001). Incidentally, four cases of early shunt occlusion occurred in the later study period after 2014, during which the average first postoperative hematocrit was significantly higher than in the pre-2014 study period, 45.3% vs. 41.5% (P = .21), and the odds of early shunt occlusion were 16 times higher (P less than .001). Dr. Anderson and coauthors said the possible explanation for this variation was a switch to a new point-of-care analyzer in 2013.

With regard to mortality, six infants overall (7.4%) died before discharge, and four (5%) within 30 days of shunt placement. No infants with early shunt occlusion died, although two with late shunt occlusion died. Increased inotrope score and first postoperative arterial oxygen tension were the only factors associated with increased mortality. “No significant association was identified between hematocrit and 30-day mortality,” Dr. Anderson and coauthors said.

In the first 24 hours after surgery, 11 infants (13.8%) received packed red blood cell (PRBC) transfusions, seven (8.8%) received platelets, and four (5%) received fresh frozen plasma/cryoprecipitate. Higher postoperative PRBC transfusion volumes were associated with increased odds of mortality (P = .001), but none of these factors were significantly associated with early shunt occlusion.

Dr. Anderson and coauthors acknowledged that shunt occlusion is a “vexing problem” in infants with cyanotic heart disease. While other researchers studied postoperative hematocrit levels and possible associations with outcomes, including shunt occlusion and mortality, the New York-Presbyterian investigators said this is the first study of the first postoperative hematocrit.

Dr. Anderson and coauthors said their findings raise the question about the ideal perioperative prophylactic antithrombotic therapy in these patients. These researchers initiate aspirin therapy 12 hours after surgery if hemostasis is established.

As a result of this study, Dr. Anderson and coauthors instituted a number of practice changes at their center. They include:

• Cardiac anesthesiologists have been asked not to transfuse shunted neonates with hematocrit level of greater than or equal to 35%, and hematocrits are then immediately repeated when a patient returns to the cardiac ICU.

• Patients with hematocrits greater than or equal to 55% get partial exchange transfusions.

• An individualized approach for patients with lower hematocrits who are more cyanotic than expected. This includes a diagnostic echocardiogram, nitric oxide, oxygen and heparin, escalated inotropic support if necessary and sometimes a cautious approach to transfusions if symptoms do not resolve and an acute shunt occlusion if not likely.

Dr. Anderson and coauthors acknowledged limits to their study, most notably its retrospective nature and a small population at a single center, and that large investigations are needed to validate their findings.

Dr. Anderson disclosed receiving salary support from the National Center for Advancing Translational Sciences. Coauthor Jennifer M. Duchon, MDCM, MPH, receives salary support from the National Institute of Allergy and Infectious Disease. The remaining coauthors had no financial relationships to disclose.

Body

 

In her invited commentary, Nancy S. Ghanayem, MD, of the Medical College of Wisconsin, gives credit to Dr. Anderson and coauthors for introducing the notion that high initial postoperative hematocrit may increase the risk of early shunt thrombosis in newborns, but with a caveat: “we remain somewhat hesitant regarding wholesale acceptance of the validity of the conclusions for several reasons” (J Thorac Cardiovasc Surg. 2017;153:956).

Those reasons include the low number of reported events, failure to list the actual hematocrits of the five patients who experienced early shunt occlusion and the lack of hemodynamic data – the latter of which she called “a significant limitation.”

A patient with low cardiac output, especially one who is cyanotic or has a single ventricle, is at higher risk for thrombosis and more likely to be transfused, “which in this case would potentially be masked by the method of comparing transfused volumes,” Dr. Ghanayem said. The inotrope score, while useful, is not a surrogate for actual cardiac output. She asks, “Accordingly, is early shunt occlusion due predominantly to passenger (corpuscular) overload or to a slow-moving train?”

Dr. Ghanayem had no financial relationships to disclose.

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In her invited commentary, Nancy S. Ghanayem, MD, of the Medical College of Wisconsin, gives credit to Dr. Anderson and coauthors for introducing the notion that high initial postoperative hematocrit may increase the risk of early shunt thrombosis in newborns, but with a caveat: “we remain somewhat hesitant regarding wholesale acceptance of the validity of the conclusions for several reasons” (J Thorac Cardiovasc Surg. 2017;153:956).

Those reasons include the low number of reported events, failure to list the actual hematocrits of the five patients who experienced early shunt occlusion and the lack of hemodynamic data – the latter of which she called “a significant limitation.”

A patient with low cardiac output, especially one who is cyanotic or has a single ventricle, is at higher risk for thrombosis and more likely to be transfused, “which in this case would potentially be masked by the method of comparing transfused volumes,” Dr. Ghanayem said. The inotrope score, while useful, is not a surrogate for actual cardiac output. She asks, “Accordingly, is early shunt occlusion due predominantly to passenger (corpuscular) overload or to a slow-moving train?”

Dr. Ghanayem had no financial relationships to disclose.

Body

 

In her invited commentary, Nancy S. Ghanayem, MD, of the Medical College of Wisconsin, gives credit to Dr. Anderson and coauthors for introducing the notion that high initial postoperative hematocrit may increase the risk of early shunt thrombosis in newborns, but with a caveat: “we remain somewhat hesitant regarding wholesale acceptance of the validity of the conclusions for several reasons” (J Thorac Cardiovasc Surg. 2017;153:956).

Those reasons include the low number of reported events, failure to list the actual hematocrits of the five patients who experienced early shunt occlusion and the lack of hemodynamic data – the latter of which she called “a significant limitation.”

A patient with low cardiac output, especially one who is cyanotic or has a single ventricle, is at higher risk for thrombosis and more likely to be transfused, “which in this case would potentially be masked by the method of comparing transfused volumes,” Dr. Ghanayem said. The inotrope score, while useful, is not a surrogate for actual cardiac output. She asks, “Accordingly, is early shunt occlusion due predominantly to passenger (corpuscular) overload or to a slow-moving train?”

Dr. Ghanayem had no financial relationships to disclose.

Title
Is this a slow-moving train?
Is this a slow-moving train?

 

Shunt occlusion has been a well-documented cause of shunt failure in newborns who have had systemic to pulmonary shunt placement, and little has been known about why shunts occlude. However, researchers have reported in a small retrospective study that higher postoperative hematocrit levels immediately after surgery may be predictors of shunt occlusion.

Reporting in the April 2017 issue of The Journal of Thoracic and Cardiovascular Surgery, Brett R. Anderson, MD, of New York-Presbyterian/Morgan Stanley Children’s Hospital, Columbia University Medical Center in New York, and coauthors, found that every 5-point increase in postoperative hematocrit more than doubled an infant’s odds of having early shunt occlusion (J Thorac Cardiovasc Surg. 2017;153:947-55).

“Beginning in the latter half of 2014, we noticed an increase in the incidence of early shunt occlusions in our neonatal cardiac intensive care unit,” Dr. Anderson and coauthors said. So they conducted a retrospective chart review of 80 infants who had undergone systemic to pulmonary shunt placement from January 2010 to July 2015, hypothesizing that increased hematocrit in the early postoperative period might have caused early shunt occlusion. They investigated the association between the first postoperative hematocrit and early shunt occlusion and in-hospital mortality in these patients.

Five patients (6.3%) experienced early shunt occlusion – that is, within 24 hours of placement (actually, within 10 hours of placement). Overall, 12 infants (15%) experienced shunt occlusion. The physicians at New York-Presbyterian do not administer anticoagulation in these patients during the first 12 hours after shunt placement.

The median initial postoperative hematocrit was 41.7%, with a range of 31.7%-55.8%. The survival analysis the researchers performed found that for every 5 additional percentage points, the hazard ratio for early shunt occlusion was 2.7 (P = .007) and 1.74 for any shunt occlusion (P less than .001). Incidentally, four cases of early shunt occlusion occurred in the later study period after 2014, during which the average first postoperative hematocrit was significantly higher than in the pre-2014 study period, 45.3% vs. 41.5% (P = .21), and the odds of early shunt occlusion were 16 times higher (P less than .001). Dr. Anderson and coauthors said the possible explanation for this variation was a switch to a new point-of-care analyzer in 2013.

With regard to mortality, six infants overall (7.4%) died before discharge, and four (5%) within 30 days of shunt placement. No infants with early shunt occlusion died, although two with late shunt occlusion died. Increased inotrope score and first postoperative arterial oxygen tension were the only factors associated with increased mortality. “No significant association was identified between hematocrit and 30-day mortality,” Dr. Anderson and coauthors said.

In the first 24 hours after surgery, 11 infants (13.8%) received packed red blood cell (PRBC) transfusions, seven (8.8%) received platelets, and four (5%) received fresh frozen plasma/cryoprecipitate. Higher postoperative PRBC transfusion volumes were associated with increased odds of mortality (P = .001), but none of these factors were significantly associated with early shunt occlusion.

Dr. Anderson and coauthors acknowledged that shunt occlusion is a “vexing problem” in infants with cyanotic heart disease. While other researchers studied postoperative hematocrit levels and possible associations with outcomes, including shunt occlusion and mortality, the New York-Presbyterian investigators said this is the first study of the first postoperative hematocrit.

Dr. Anderson and coauthors said their findings raise the question about the ideal perioperative prophylactic antithrombotic therapy in these patients. These researchers initiate aspirin therapy 12 hours after surgery if hemostasis is established.

As a result of this study, Dr. Anderson and coauthors instituted a number of practice changes at their center. They include:

• Cardiac anesthesiologists have been asked not to transfuse shunted neonates with hematocrit level of greater than or equal to 35%, and hematocrits are then immediately repeated when a patient returns to the cardiac ICU.

• Patients with hematocrits greater than or equal to 55% get partial exchange transfusions.

• An individualized approach for patients with lower hematocrits who are more cyanotic than expected. This includes a diagnostic echocardiogram, nitric oxide, oxygen and heparin, escalated inotropic support if necessary and sometimes a cautious approach to transfusions if symptoms do not resolve and an acute shunt occlusion if not likely.

Dr. Anderson and coauthors acknowledged limits to their study, most notably its retrospective nature and a small population at a single center, and that large investigations are needed to validate their findings.

Dr. Anderson disclosed receiving salary support from the National Center for Advancing Translational Sciences. Coauthor Jennifer M. Duchon, MDCM, MPH, receives salary support from the National Institute of Allergy and Infectious Disease. The remaining coauthors had no financial relationships to disclose.

 

Shunt occlusion has been a well-documented cause of shunt failure in newborns who have had systemic to pulmonary shunt placement, and little has been known about why shunts occlude. However, researchers have reported in a small retrospective study that higher postoperative hematocrit levels immediately after surgery may be predictors of shunt occlusion.

Reporting in the April 2017 issue of The Journal of Thoracic and Cardiovascular Surgery, Brett R. Anderson, MD, of New York-Presbyterian/Morgan Stanley Children’s Hospital, Columbia University Medical Center in New York, and coauthors, found that every 5-point increase in postoperative hematocrit more than doubled an infant’s odds of having early shunt occlusion (J Thorac Cardiovasc Surg. 2017;153:947-55).

“Beginning in the latter half of 2014, we noticed an increase in the incidence of early shunt occlusions in our neonatal cardiac intensive care unit,” Dr. Anderson and coauthors said. So they conducted a retrospective chart review of 80 infants who had undergone systemic to pulmonary shunt placement from January 2010 to July 2015, hypothesizing that increased hematocrit in the early postoperative period might have caused early shunt occlusion. They investigated the association between the first postoperative hematocrit and early shunt occlusion and in-hospital mortality in these patients.

Five patients (6.3%) experienced early shunt occlusion – that is, within 24 hours of placement (actually, within 10 hours of placement). Overall, 12 infants (15%) experienced shunt occlusion. The physicians at New York-Presbyterian do not administer anticoagulation in these patients during the first 12 hours after shunt placement.

The median initial postoperative hematocrit was 41.7%, with a range of 31.7%-55.8%. The survival analysis the researchers performed found that for every 5 additional percentage points, the hazard ratio for early shunt occlusion was 2.7 (P = .007) and 1.74 for any shunt occlusion (P less than .001). Incidentally, four cases of early shunt occlusion occurred in the later study period after 2014, during which the average first postoperative hematocrit was significantly higher than in the pre-2014 study period, 45.3% vs. 41.5% (P = .21), and the odds of early shunt occlusion were 16 times higher (P less than .001). Dr. Anderson and coauthors said the possible explanation for this variation was a switch to a new point-of-care analyzer in 2013.

With regard to mortality, six infants overall (7.4%) died before discharge, and four (5%) within 30 days of shunt placement. No infants with early shunt occlusion died, although two with late shunt occlusion died. Increased inotrope score and first postoperative arterial oxygen tension were the only factors associated with increased mortality. “No significant association was identified between hematocrit and 30-day mortality,” Dr. Anderson and coauthors said.

In the first 24 hours after surgery, 11 infants (13.8%) received packed red blood cell (PRBC) transfusions, seven (8.8%) received platelets, and four (5%) received fresh frozen plasma/cryoprecipitate. Higher postoperative PRBC transfusion volumes were associated with increased odds of mortality (P = .001), but none of these factors were significantly associated with early shunt occlusion.

Dr. Anderson and coauthors acknowledged that shunt occlusion is a “vexing problem” in infants with cyanotic heart disease. While other researchers studied postoperative hematocrit levels and possible associations with outcomes, including shunt occlusion and mortality, the New York-Presbyterian investigators said this is the first study of the first postoperative hematocrit.

Dr. Anderson and coauthors said their findings raise the question about the ideal perioperative prophylactic antithrombotic therapy in these patients. These researchers initiate aspirin therapy 12 hours after surgery if hemostasis is established.

As a result of this study, Dr. Anderson and coauthors instituted a number of practice changes at their center. They include:

• Cardiac anesthesiologists have been asked not to transfuse shunted neonates with hematocrit level of greater than or equal to 35%, and hematocrits are then immediately repeated when a patient returns to the cardiac ICU.

• Patients with hematocrits greater than or equal to 55% get partial exchange transfusions.

• An individualized approach for patients with lower hematocrits who are more cyanotic than expected. This includes a diagnostic echocardiogram, nitric oxide, oxygen and heparin, escalated inotropic support if necessary and sometimes a cautious approach to transfusions if symptoms do not resolve and an acute shunt occlusion if not likely.

Dr. Anderson and coauthors acknowledged limits to their study, most notably its retrospective nature and a small population at a single center, and that large investigations are needed to validate their findings.

Dr. Anderson disclosed receiving salary support from the National Center for Advancing Translational Sciences. Coauthor Jennifer M. Duchon, MDCM, MPH, receives salary support from the National Institute of Allergy and Infectious Disease. The remaining coauthors had no financial relationships to disclose.

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Key clinical point: Higher hematocrit levels have been associated with early shunt occlusion in newborns having systemic to pulmonary artery shunt placement.

Major finding: For every 5 additional percentage points of hematocrit, an infant’s odds of early shunt occlusion more than doubled (odds ratio, 2.70; P = .009).

Data source: Retrospective study of all newborns who underwent primary systemic to pulmonary artery shunt placement from January 2010 to July 2015 at a single center.

Disclosure: Dr. Anderson receives salary support from the National Center for Advancing Translational Sciences. Coauthor Jennifer M. Duchon, MDCM, MPH, receives salary support from the National Institute of Allergy and Infectious Disease. The remaining coauthors had no financial relationships to disclose.

Same-day discharge for lap hiatal procedures found feasible, safe

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– Selected patients who need operations, such as paraesophageal hernia repair and Heller myotomy, for benign hiatal diseases can have laparoscopic outpatient procedures with outcomes comparable with those of inpatients, a Canadian retrospective cohort study found.

“When comparing planned day-case patients with those who had planned admissions, we found that postoperative complication was the only statistically significant different outcome. Our data show same-day discharge resulted in no postoperative mortality, and no difference in postoperative morbidity, emergency room visits, and readmissions compared to traditional inpatient care,” said Juan Carlos Molina, MD, of McGill University Health Centre in Montreal, reporting the study results at the annual meeting of the American Society of Gastrointestinal and Endoscopic Surgeons.

Dr. Juan Carlos Molina
Postoperative complications were actually lower in the outpatient group, 9.2% vs. 19%, and the majority of them were minor. “This is expected because the less complicated cases were planned as day cases, especially in the beginning of the study,” Dr. Molina said.

The McGill researchers analyzed outcomes for 261 patients who had laparoscopic hiatal procedures from April 2011 to August 2016 – 163 as inpatients, 98 as outpatients, whom the study called planned day-case patients. The outpatient cohort consisted of younger patients (aged 60 vs. 66 years), but otherwise demographics between the two cohorts were similar. Discharge requirements after same-day hiatal procedures were the same as those for other outpatient procedures, Dr. Molina said.

The procedures included primary or revisional paraesophageal hernia repair (PEHR) in 123 (47.1%) patients; Heller myotomy in 94 (36%), 9 of which also underwent resection of an epiphrenic diverticulum; and Nissen fundoplication for gastroesophageal reflux disease in 44 (16.9%), of which 20 (45.5%) had a concomitant type I hiatal hernia. Among PEHR patients, 90% were at least type III.

“We include complex cases, such as revisional surgery, massive paraesophageal hernias, patients who had previous treatments for achalasia before surgery, or concurrent epiphrenic diverticulum resection,” Dr. Molina said. “To our knowledge, this report is the first to describe successful outpatient surgery in these complex patients, with comparable outcomes to admitted patients and to those described for more well-established outpatient procedures.”

The overall success rate of planned day surgery was 81.6%. Of the 18 unplanned admissions, patient preference to stay in the hospital and pain were the most common factors. Dr. Molina-Franjola said, “We identified factors that might be predictors of unplanned admission, and we found that female [sex], intraoperative complication, postoperative complications, and procedure performed in the afternoon were significant risk factors.”

Women accounted for 94.4% of the unplanned admissions after outpatient surgery, and PEHR/fundoplication represented 72.2% of unplanned admissions. No day-case patients with unplanned admission group required a reoperation within 30 days, although one who did not have an unplanned admission did.

With time, the share of outpatient procedures increased, Dr. Molina said. “In 2011, around 10% of procedures were day-case and that increased progressively to 67% in 2016,” he said.

Dr. Molina said that patients were sent home with antinauseates and instructions to call immediately if nausea or vomiting ensued. About 5% of outpatients returned for reflux, nausea, or vomiting, he said.

Dr. Molina reported having no financial disclosures.
 

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– Selected patients who need operations, such as paraesophageal hernia repair and Heller myotomy, for benign hiatal diseases can have laparoscopic outpatient procedures with outcomes comparable with those of inpatients, a Canadian retrospective cohort study found.

“When comparing planned day-case patients with those who had planned admissions, we found that postoperative complication was the only statistically significant different outcome. Our data show same-day discharge resulted in no postoperative mortality, and no difference in postoperative morbidity, emergency room visits, and readmissions compared to traditional inpatient care,” said Juan Carlos Molina, MD, of McGill University Health Centre in Montreal, reporting the study results at the annual meeting of the American Society of Gastrointestinal and Endoscopic Surgeons.

Dr. Juan Carlos Molina
Postoperative complications were actually lower in the outpatient group, 9.2% vs. 19%, and the majority of them were minor. “This is expected because the less complicated cases were planned as day cases, especially in the beginning of the study,” Dr. Molina said.

The McGill researchers analyzed outcomes for 261 patients who had laparoscopic hiatal procedures from April 2011 to August 2016 – 163 as inpatients, 98 as outpatients, whom the study called planned day-case patients. The outpatient cohort consisted of younger patients (aged 60 vs. 66 years), but otherwise demographics between the two cohorts were similar. Discharge requirements after same-day hiatal procedures were the same as those for other outpatient procedures, Dr. Molina said.

The procedures included primary or revisional paraesophageal hernia repair (PEHR) in 123 (47.1%) patients; Heller myotomy in 94 (36%), 9 of which also underwent resection of an epiphrenic diverticulum; and Nissen fundoplication for gastroesophageal reflux disease in 44 (16.9%), of which 20 (45.5%) had a concomitant type I hiatal hernia. Among PEHR patients, 90% were at least type III.

“We include complex cases, such as revisional surgery, massive paraesophageal hernias, patients who had previous treatments for achalasia before surgery, or concurrent epiphrenic diverticulum resection,” Dr. Molina said. “To our knowledge, this report is the first to describe successful outpatient surgery in these complex patients, with comparable outcomes to admitted patients and to those described for more well-established outpatient procedures.”

The overall success rate of planned day surgery was 81.6%. Of the 18 unplanned admissions, patient preference to stay in the hospital and pain were the most common factors. Dr. Molina-Franjola said, “We identified factors that might be predictors of unplanned admission, and we found that female [sex], intraoperative complication, postoperative complications, and procedure performed in the afternoon were significant risk factors.”

Women accounted for 94.4% of the unplanned admissions after outpatient surgery, and PEHR/fundoplication represented 72.2% of unplanned admissions. No day-case patients with unplanned admission group required a reoperation within 30 days, although one who did not have an unplanned admission did.

With time, the share of outpatient procedures increased, Dr. Molina said. “In 2011, around 10% of procedures were day-case and that increased progressively to 67% in 2016,” he said.

Dr. Molina said that patients were sent home with antinauseates and instructions to call immediately if nausea or vomiting ensued. About 5% of outpatients returned for reflux, nausea, or vomiting, he said.

Dr. Molina reported having no financial disclosures.
 

 

– Selected patients who need operations, such as paraesophageal hernia repair and Heller myotomy, for benign hiatal diseases can have laparoscopic outpatient procedures with outcomes comparable with those of inpatients, a Canadian retrospective cohort study found.

“When comparing planned day-case patients with those who had planned admissions, we found that postoperative complication was the only statistically significant different outcome. Our data show same-day discharge resulted in no postoperative mortality, and no difference in postoperative morbidity, emergency room visits, and readmissions compared to traditional inpatient care,” said Juan Carlos Molina, MD, of McGill University Health Centre in Montreal, reporting the study results at the annual meeting of the American Society of Gastrointestinal and Endoscopic Surgeons.

Dr. Juan Carlos Molina
Postoperative complications were actually lower in the outpatient group, 9.2% vs. 19%, and the majority of them were minor. “This is expected because the less complicated cases were planned as day cases, especially in the beginning of the study,” Dr. Molina said.

The McGill researchers analyzed outcomes for 261 patients who had laparoscopic hiatal procedures from April 2011 to August 2016 – 163 as inpatients, 98 as outpatients, whom the study called planned day-case patients. The outpatient cohort consisted of younger patients (aged 60 vs. 66 years), but otherwise demographics between the two cohorts were similar. Discharge requirements after same-day hiatal procedures were the same as those for other outpatient procedures, Dr. Molina said.

The procedures included primary or revisional paraesophageal hernia repair (PEHR) in 123 (47.1%) patients; Heller myotomy in 94 (36%), 9 of which also underwent resection of an epiphrenic diverticulum; and Nissen fundoplication for gastroesophageal reflux disease in 44 (16.9%), of which 20 (45.5%) had a concomitant type I hiatal hernia. Among PEHR patients, 90% were at least type III.

“We include complex cases, such as revisional surgery, massive paraesophageal hernias, patients who had previous treatments for achalasia before surgery, or concurrent epiphrenic diverticulum resection,” Dr. Molina said. “To our knowledge, this report is the first to describe successful outpatient surgery in these complex patients, with comparable outcomes to admitted patients and to those described for more well-established outpatient procedures.”

The overall success rate of planned day surgery was 81.6%. Of the 18 unplanned admissions, patient preference to stay in the hospital and pain were the most common factors. Dr. Molina-Franjola said, “We identified factors that might be predictors of unplanned admission, and we found that female [sex], intraoperative complication, postoperative complications, and procedure performed in the afternoon were significant risk factors.”

Women accounted for 94.4% of the unplanned admissions after outpatient surgery, and PEHR/fundoplication represented 72.2% of unplanned admissions. No day-case patients with unplanned admission group required a reoperation within 30 days, although one who did not have an unplanned admission did.

With time, the share of outpatient procedures increased, Dr. Molina said. “In 2011, around 10% of procedures were day-case and that increased progressively to 67% in 2016,” he said.

Dr. Molina said that patients were sent home with antinauseates and instructions to call immediately if nausea or vomiting ensued. About 5% of outpatients returned for reflux, nausea, or vomiting, he said.

Dr. Molina reported having no financial disclosures.
 

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Key clinical point: Same-day surgery for benign laparoscopic hiatal procedures have outcomes comparable with those of inpatient procedures.

Major finding: Postoperative complications were 9.2% for outpatient operations vs. 19% for inpatient, and 81.7% of patients who had same-day surgery did not have an unplanned admission.

Data source: Retrospective single-center study of 261 patients who had inpatient and outpatient laparoscopic hiatal procedures from April 2011 to August 2016.

Disclosures: Dr. Molina-Franjola reported having no financial disclosures.

Transanal TME comparable to open, lap approaches to rectal cancer

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– Transanal total mesorectal excision can consistently achieve good pathological results for obtaining specimens in rectal cancer, and overcome the shortcomings of the open and laparoscopic approaches to rectal cancer surgery, particularly in the distal part of the rectum where obtaining quality specimens can be technically challenging, researchers at the Hospital Clinic of Barcelona have found.

Reporting at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, Jacqueline van Laarhoven, MD, PhD, said, “Pathologically, transanal total mesorectal excision [TME] provides good results on integrity of the mesorectum, negative circumferential and distal resection margins, and lymph nodes per specimen.” This study represents the first results of a relatively large, single-institution cohort, Dr. van Laarhoven said.

Dr. Jacqueline van Laarhoven
Transanal TME has been performed at Hospital Clinic of Barcelona since 2009. Study coauthor Antonio M. Lacy, MD, PhD, and his team were the first to incorporate the procedure into standard practice. They’ve since introduced the Cecil procedure, a two-team hybrid approach that involves a laparoscopic team to perform the abdominal component and a second team working simultaneously to complete the TME transanally. Most procedures in this study were done by the Cecil procedure.

The study involved 187 patients with mid- or low-rectal cancer who had transanal TME from November 2011 to June 2016. Dr. van Laarhoven explained that obtaining high-quality specimens is an important prognostic factor for determining locoregional recurrence in rectal cancer. The study analyzed results of excised specimens in the mesorectum, circumferential and distal resected margins, and lymph nodes, and compared outcomes with those in two randomized clinical trials of both open and laparoscopic TME – the COLOR II (Lancet Oncol. 2013;14:210-8) and COREAN trials (Lancet Oncol. 2014;15:767-74) – where applicable.

In the Barcelona study population, 63.1% had tumors in the midrectum and 36.9% in the low rectum. Transanal TME yielded complete mesorectal quality in 95.7% of cases, almost-complete quality in 1.6% and incomplete in 1.1%, but comparison with COLOR II and COREAN trials was difficult because of differing inclusion criteria, Dr. van Laarhoven said.

Mean distal margin was 2.1 cm in midrectal cancer with a positive distal resection margin in 3.2%. In low-rectal cancer, the mean distal margin was 1.1 cm with a positive distal resection margin in 7.8%. Dr. van Laarhoven noted the overall circumferential resection margin (CRM) was 8.6% in this study, compared with 8.3% overall for the COREAN trial. As for COLOR II, the overall rate for positive CRM in mid- and low-rectal tumors was around 9%, Dr. van Laarhoven said, but in the open group the positive CRM was 3% in the midrectal excisions and 22% in low-rectal disease.

With regard to lymph nodes, the Barcelona study reported a median of 14 per specimen, with a range of 11 to 18, Dr. van Laarhoven said. However, in nonirradiated patients, the median was 15 per specimen. “This is consistent with the fact that neoadjuvant radiotherapy leads to a decrease in the lymph-node harvest,” she said. “These results are comparable to the COREAN and the COLOR II trials.”

Sixty-two percent of patients received neoadjuvant chemoradiotherapy, 3.2% received radiotherapy only, and 2.1% chemotherapy only.

On preoperative staging, 3.2% had T1 tumors, 20.3% T2, 67.9% T3, and 7.5% T4. The overall positive CRM (less than 1 mm) was 8.6% (including T4 tumors).

Postoperative pathological staging showed complete remission in 16% of patients, pT1 in 6.4%, pT2 in 28.9%, pT3 in 42.8%, pT4 in 2.7%, and pTis in 1.6%.

Dr. van Laarhoven commented, “As the quality of the surgical treatment is a surrogate marker for survival, transanal TME can be regarded as an oncologically safe method to treat patients with rectal cancer.”

Dr. van Laarhoven reported having no financial disclosures.

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– Transanal total mesorectal excision can consistently achieve good pathological results for obtaining specimens in rectal cancer, and overcome the shortcomings of the open and laparoscopic approaches to rectal cancer surgery, particularly in the distal part of the rectum where obtaining quality specimens can be technically challenging, researchers at the Hospital Clinic of Barcelona have found.

Reporting at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, Jacqueline van Laarhoven, MD, PhD, said, “Pathologically, transanal total mesorectal excision [TME] provides good results on integrity of the mesorectum, negative circumferential and distal resection margins, and lymph nodes per specimen.” This study represents the first results of a relatively large, single-institution cohort, Dr. van Laarhoven said.

Dr. Jacqueline van Laarhoven
Transanal TME has been performed at Hospital Clinic of Barcelona since 2009. Study coauthor Antonio M. Lacy, MD, PhD, and his team were the first to incorporate the procedure into standard practice. They’ve since introduced the Cecil procedure, a two-team hybrid approach that involves a laparoscopic team to perform the abdominal component and a second team working simultaneously to complete the TME transanally. Most procedures in this study were done by the Cecil procedure.

The study involved 187 patients with mid- or low-rectal cancer who had transanal TME from November 2011 to June 2016. Dr. van Laarhoven explained that obtaining high-quality specimens is an important prognostic factor for determining locoregional recurrence in rectal cancer. The study analyzed results of excised specimens in the mesorectum, circumferential and distal resected margins, and lymph nodes, and compared outcomes with those in two randomized clinical trials of both open and laparoscopic TME – the COLOR II (Lancet Oncol. 2013;14:210-8) and COREAN trials (Lancet Oncol. 2014;15:767-74) – where applicable.

In the Barcelona study population, 63.1% had tumors in the midrectum and 36.9% in the low rectum. Transanal TME yielded complete mesorectal quality in 95.7% of cases, almost-complete quality in 1.6% and incomplete in 1.1%, but comparison with COLOR II and COREAN trials was difficult because of differing inclusion criteria, Dr. van Laarhoven said.

Mean distal margin was 2.1 cm in midrectal cancer with a positive distal resection margin in 3.2%. In low-rectal cancer, the mean distal margin was 1.1 cm with a positive distal resection margin in 7.8%. Dr. van Laarhoven noted the overall circumferential resection margin (CRM) was 8.6% in this study, compared with 8.3% overall for the COREAN trial. As for COLOR II, the overall rate for positive CRM in mid- and low-rectal tumors was around 9%, Dr. van Laarhoven said, but in the open group the positive CRM was 3% in the midrectal excisions and 22% in low-rectal disease.

With regard to lymph nodes, the Barcelona study reported a median of 14 per specimen, with a range of 11 to 18, Dr. van Laarhoven said. However, in nonirradiated patients, the median was 15 per specimen. “This is consistent with the fact that neoadjuvant radiotherapy leads to a decrease in the lymph-node harvest,” she said. “These results are comparable to the COREAN and the COLOR II trials.”

Sixty-two percent of patients received neoadjuvant chemoradiotherapy, 3.2% received radiotherapy only, and 2.1% chemotherapy only.

On preoperative staging, 3.2% had T1 tumors, 20.3% T2, 67.9% T3, and 7.5% T4. The overall positive CRM (less than 1 mm) was 8.6% (including T4 tumors).

Postoperative pathological staging showed complete remission in 16% of patients, pT1 in 6.4%, pT2 in 28.9%, pT3 in 42.8%, pT4 in 2.7%, and pTis in 1.6%.

Dr. van Laarhoven commented, “As the quality of the surgical treatment is a surrogate marker for survival, transanal TME can be regarded as an oncologically safe method to treat patients with rectal cancer.”

Dr. van Laarhoven reported having no financial disclosures.

 

– Transanal total mesorectal excision can consistently achieve good pathological results for obtaining specimens in rectal cancer, and overcome the shortcomings of the open and laparoscopic approaches to rectal cancer surgery, particularly in the distal part of the rectum where obtaining quality specimens can be technically challenging, researchers at the Hospital Clinic of Barcelona have found.

Reporting at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, Jacqueline van Laarhoven, MD, PhD, said, “Pathologically, transanal total mesorectal excision [TME] provides good results on integrity of the mesorectum, negative circumferential and distal resection margins, and lymph nodes per specimen.” This study represents the first results of a relatively large, single-institution cohort, Dr. van Laarhoven said.

Dr. Jacqueline van Laarhoven
Transanal TME has been performed at Hospital Clinic of Barcelona since 2009. Study coauthor Antonio M. Lacy, MD, PhD, and his team were the first to incorporate the procedure into standard practice. They’ve since introduced the Cecil procedure, a two-team hybrid approach that involves a laparoscopic team to perform the abdominal component and a second team working simultaneously to complete the TME transanally. Most procedures in this study were done by the Cecil procedure.

The study involved 187 patients with mid- or low-rectal cancer who had transanal TME from November 2011 to June 2016. Dr. van Laarhoven explained that obtaining high-quality specimens is an important prognostic factor for determining locoregional recurrence in rectal cancer. The study analyzed results of excised specimens in the mesorectum, circumferential and distal resected margins, and lymph nodes, and compared outcomes with those in two randomized clinical trials of both open and laparoscopic TME – the COLOR II (Lancet Oncol. 2013;14:210-8) and COREAN trials (Lancet Oncol. 2014;15:767-74) – where applicable.

In the Barcelona study population, 63.1% had tumors in the midrectum and 36.9% in the low rectum. Transanal TME yielded complete mesorectal quality in 95.7% of cases, almost-complete quality in 1.6% and incomplete in 1.1%, but comparison with COLOR II and COREAN trials was difficult because of differing inclusion criteria, Dr. van Laarhoven said.

Mean distal margin was 2.1 cm in midrectal cancer with a positive distal resection margin in 3.2%. In low-rectal cancer, the mean distal margin was 1.1 cm with a positive distal resection margin in 7.8%. Dr. van Laarhoven noted the overall circumferential resection margin (CRM) was 8.6% in this study, compared with 8.3% overall for the COREAN trial. As for COLOR II, the overall rate for positive CRM in mid- and low-rectal tumors was around 9%, Dr. van Laarhoven said, but in the open group the positive CRM was 3% in the midrectal excisions and 22% in low-rectal disease.

With regard to lymph nodes, the Barcelona study reported a median of 14 per specimen, with a range of 11 to 18, Dr. van Laarhoven said. However, in nonirradiated patients, the median was 15 per specimen. “This is consistent with the fact that neoadjuvant radiotherapy leads to a decrease in the lymph-node harvest,” she said. “These results are comparable to the COREAN and the COLOR II trials.”

Sixty-two percent of patients received neoadjuvant chemoradiotherapy, 3.2% received radiotherapy only, and 2.1% chemotherapy only.

On preoperative staging, 3.2% had T1 tumors, 20.3% T2, 67.9% T3, and 7.5% T4. The overall positive CRM (less than 1 mm) was 8.6% (including T4 tumors).

Postoperative pathological staging showed complete remission in 16% of patients, pT1 in 6.4%, pT2 in 28.9%, pT3 in 42.8%, pT4 in 2.7%, and pTis in 1.6%.

Dr. van Laarhoven commented, “As the quality of the surgical treatment is a surrogate marker for survival, transanal TME can be regarded as an oncologically safe method to treat patients with rectal cancer.”

Dr. van Laarhoven reported having no financial disclosures.

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Key clinical point: Transanal total mesorectal excision (TME) is a viable alternative to open or laparoscopic TME in cancers of the low and midrectum.

Major finding: Postoperative pathological staging showed complete remission in 16%, with pT1 in 6.4%, pT2 in 28.9%, pT3 in 42.8%, pT4 in 2.7%, and pTis in 1.6%.

Data source: Analysis of 187 patients prospectively enrolled in a standardized database who had transanal TME from November 2011 to June 2016 at a single center.

Disclosures: Dr. van Laarhoven reported having no financial disclosures.

Does laparoscopy have an advantage for emergency VHR?

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– The benefits of elective laparoscopic ventral hernia repair over the open approach have been well documented, but, when presented with emergency cases, surgeons still are about 10 times more likely to employ open surgery, possibly exposing patients to greater risk of complications, as well as longer hospital stays, according to an analysis of a national database.

“Despite the benefits of laparoscopic surgery, its utilization in ventral hernia repair (VHR) remains low,” said David Pechman, MD, MBA, of Mount Sinai Beth Israel Medical Center, New York, at the annual meeting of the American Society of Gastrointestinal and Endoscopic Surgeons. “This study suggests that utilization is further decreased in emergency cases. Relative to elective cases, emergency VHR is associated with markedly increased rates of morbidity, giving us more room to improve patient outcomes with the use of laparoscopy in these cases.”

Dr. David Pechman
The treatment algorithm for emergency VHR too frequently does not include consideration of a laparoscopic approach, Dr. Pechman said. “This may be due to laparoscopy being thought of as a luxury rather than a tool with which surgeons can optimize patient outcomes,” he said.

The study analyzed 330 emergency VHR operations in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database for 2012 and 2013. Thirty-two (9.3%) of those operations were performed laparoscopically, and the remainder were open. Because the sample size of laparoscopic operations was so small, drawing statistically significant conclusions from the findings is difficult without a larger, higher-powered study, Dr. Pechman said. “We do think that further research is warranted and believe that analysis of a larger sample would display that increased utilization of laparoscopy in emergency VHR could significantly improve outcomes.”

The analysis found significant differences in outcomes between the laparoscopic and the open operations for emergency VHR. Average hospital stay after laparoscopic emergency VHR was 2.8 days vs. 5.9 days for open VHR (P = .02). Surgical site infection rates were 0% vs. 7.7% (P = .15). Demographics between both laparoscopic and open groups were similar, Dr. Pechman said.

Session moderator E. Matthew Ritter, MD, of Walter Reed National Military Medical Center, Bethesda, Md., noted that the study conclusion is in line with the goals of SAGES’s minimally invasive surgery initiative to increase utilization of laparoscopy. When referring to the findings Dr. Pechman reported, Dr. Ritter said, “This is a remarkably low complication rate for a procedure that could seemingly have some benefit.”

Dr. Pechman’s response acknowledged the concerns of the surgeons doing the procedures: “A lot of this has to do with surgeon comfort and the preoperative decision-making, especially in an emergency setting.”

Dr. Pechman and coauthors reported no financial disclosures.

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– The benefits of elective laparoscopic ventral hernia repair over the open approach have been well documented, but, when presented with emergency cases, surgeons still are about 10 times more likely to employ open surgery, possibly exposing patients to greater risk of complications, as well as longer hospital stays, according to an analysis of a national database.

“Despite the benefits of laparoscopic surgery, its utilization in ventral hernia repair (VHR) remains low,” said David Pechman, MD, MBA, of Mount Sinai Beth Israel Medical Center, New York, at the annual meeting of the American Society of Gastrointestinal and Endoscopic Surgeons. “This study suggests that utilization is further decreased in emergency cases. Relative to elective cases, emergency VHR is associated with markedly increased rates of morbidity, giving us more room to improve patient outcomes with the use of laparoscopy in these cases.”

Dr. David Pechman
The treatment algorithm for emergency VHR too frequently does not include consideration of a laparoscopic approach, Dr. Pechman said. “This may be due to laparoscopy being thought of as a luxury rather than a tool with which surgeons can optimize patient outcomes,” he said.

The study analyzed 330 emergency VHR operations in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database for 2012 and 2013. Thirty-two (9.3%) of those operations were performed laparoscopically, and the remainder were open. Because the sample size of laparoscopic operations was so small, drawing statistically significant conclusions from the findings is difficult without a larger, higher-powered study, Dr. Pechman said. “We do think that further research is warranted and believe that analysis of a larger sample would display that increased utilization of laparoscopy in emergency VHR could significantly improve outcomes.”

The analysis found significant differences in outcomes between the laparoscopic and the open operations for emergency VHR. Average hospital stay after laparoscopic emergency VHR was 2.8 days vs. 5.9 days for open VHR (P = .02). Surgical site infection rates were 0% vs. 7.7% (P = .15). Demographics between both laparoscopic and open groups were similar, Dr. Pechman said.

Session moderator E. Matthew Ritter, MD, of Walter Reed National Military Medical Center, Bethesda, Md., noted that the study conclusion is in line with the goals of SAGES’s minimally invasive surgery initiative to increase utilization of laparoscopy. When referring to the findings Dr. Pechman reported, Dr. Ritter said, “This is a remarkably low complication rate for a procedure that could seemingly have some benefit.”

Dr. Pechman’s response acknowledged the concerns of the surgeons doing the procedures: “A lot of this has to do with surgeon comfort and the preoperative decision-making, especially in an emergency setting.”

Dr. Pechman and coauthors reported no financial disclosures.

– The benefits of elective laparoscopic ventral hernia repair over the open approach have been well documented, but, when presented with emergency cases, surgeons still are about 10 times more likely to employ open surgery, possibly exposing patients to greater risk of complications, as well as longer hospital stays, according to an analysis of a national database.

“Despite the benefits of laparoscopic surgery, its utilization in ventral hernia repair (VHR) remains low,” said David Pechman, MD, MBA, of Mount Sinai Beth Israel Medical Center, New York, at the annual meeting of the American Society of Gastrointestinal and Endoscopic Surgeons. “This study suggests that utilization is further decreased in emergency cases. Relative to elective cases, emergency VHR is associated with markedly increased rates of morbidity, giving us more room to improve patient outcomes with the use of laparoscopy in these cases.”

Dr. David Pechman
The treatment algorithm for emergency VHR too frequently does not include consideration of a laparoscopic approach, Dr. Pechman said. “This may be due to laparoscopy being thought of as a luxury rather than a tool with which surgeons can optimize patient outcomes,” he said.

The study analyzed 330 emergency VHR operations in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database for 2012 and 2013. Thirty-two (9.3%) of those operations were performed laparoscopically, and the remainder were open. Because the sample size of laparoscopic operations was so small, drawing statistically significant conclusions from the findings is difficult without a larger, higher-powered study, Dr. Pechman said. “We do think that further research is warranted and believe that analysis of a larger sample would display that increased utilization of laparoscopy in emergency VHR could significantly improve outcomes.”

The analysis found significant differences in outcomes between the laparoscopic and the open operations for emergency VHR. Average hospital stay after laparoscopic emergency VHR was 2.8 days vs. 5.9 days for open VHR (P = .02). Surgical site infection rates were 0% vs. 7.7% (P = .15). Demographics between both laparoscopic and open groups were similar, Dr. Pechman said.

Session moderator E. Matthew Ritter, MD, of Walter Reed National Military Medical Center, Bethesda, Md., noted that the study conclusion is in line with the goals of SAGES’s minimally invasive surgery initiative to increase utilization of laparoscopy. When referring to the findings Dr. Pechman reported, Dr. Ritter said, “This is a remarkably low complication rate for a procedure that could seemingly have some benefit.”

Dr. Pechman’s response acknowledged the concerns of the surgeons doing the procedures: “A lot of this has to do with surgeon comfort and the preoperative decision-making, especially in an emergency setting.”

Dr. Pechman and coauthors reported no financial disclosures.

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Key clinical point: Outcomes of laparoscopic ventral hernia repair (VHR) may be superior to those for open surgery in the emergency setting.

Major finding: Average hospital stay after laparoscopic emergency VHR was 2.8 days vs. 5.9 days for open surgery, and surgical site infection rates were 0% vs. 7.7%.

Data source: Analysis of 329 cases of emergency VHR enrolled in the American College of Surgeons National Surgical Quality Improvement Program in 2012 and 2013.

Disclosures: Dr. Pechman reported no financial disclosures.

Robot-assisted surgery: Twice the price

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– Robot-assisted operations for inguinal hernia repair (IHR) and cholecystectomy have grown steadily in recent years, but these procedures can be done equally well by traditional operations at a fraction of the cost, according to a study from Geisinger Medical Center in Pennsylvania.

Master Video/Shutterstock
Minimally invasive robotic surgery with the da Vinci Surgical System.
“Overall in either the inguinal hernia or cholecystectomy groups, the robotic surgery group had the highest cost total,” Dr. Vogels said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. “There was no outcome advantage for either the robotic inguinal hernia repair or robotic cholecystectomy in this study.” The outcomes the study measured were 30-day readmission and 30-day mortality. Demographics across all study groups were similar.

Dr. Vogels quoted statistics from the ECRI Institute that showed robotic surgery procedures have increased 178% between 2009 and 2014, and the two procedures the group studied are the most frequently performed robotic procedures.

Within the Geisinger system, the study found a 3:1 cost disparity for IHR: $6,292 total cost for hospital-based robotic surgery vs. $3,421 for ASC-based laparoscopy IHR and $1,853 for ASC-based open repair. For cholecystectomy, the disparity isn’t as wide – it’s 2:1 – but is still significant: Total costs for hospital-based robotic surgery are $6,057 vs. $3,443 for ASC-based cholecystectomy and $3,270 for hospital-based laparoscopic cholecystectomy (the study did not include any open cholecystectomies).

Total costs not only include costs for the procedure but also all related pre- and postoperative care. The cost analysis did not account for the cost of the robot, including maintenance contracts, or costs for laparoscopic instruments. Variable costs also ranged from about $3,000 for robotic IHR to $942 for ASC open repair – which means the lowest per-procedure cost for the latter was around $900.

“Translating this into the fact that cholecystectomies and inguinal hernia repairs are the most often performed general surgery procedures, ambulatory surgery centers can save over $60 billion over the next 10 years in just overhead costs as well as increased efficiency,” Dr. Vogels said.

The study also found access issues depending on where patients had their operations. “As far as service and access in our institution alone, we found that patients going to the main hospital spent as much as two times longer getting these procedures done as compared to the ambulatory surgery centers,” Dr. Vogels said.

Robotic procedures also required longer operative times, the study found – an average of 109 minutes for IHR vs. about an hour for ASC procedures and hospital-based open surgery (but averaging 78 minutes for in-hospital laparoscopy); and 73 minutes for robotic cholecystectomy, 60 minutes for hospital laparoscopy, and 45 minutes for ASC laparoscopy.

Robotic session moderator Dmitry Oleynikov, MD, FACS, of the University of Nebraska Medical Center, Omaha, asked Dr. Vogels if putting a robotic platform in an ambulatory surgery setting would make it more cost effective.

That’s not practical from a cost or efficiency perspective, she said.

“When you look at the cost of the ASCs, specifically in the hernia group, the lowest-cost hernia repair is about $800; with the robot it’s going to be significantly higher than that, up to three times higher than that,” Dr. Vogels replied. “Then you’re also changing all those simple ambulatory surgery procedures to more involved robotic procedures, so it’s hard to justify doing that in the ASC.”

Dr. Vogels and her coauthors had no relevant financial disclosures.

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– Robot-assisted operations for inguinal hernia repair (IHR) and cholecystectomy have grown steadily in recent years, but these procedures can be done equally well by traditional operations at a fraction of the cost, according to a study from Geisinger Medical Center in Pennsylvania.

Master Video/Shutterstock
Minimally invasive robotic surgery with the da Vinci Surgical System.
“Overall in either the inguinal hernia or cholecystectomy groups, the robotic surgery group had the highest cost total,” Dr. Vogels said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. “There was no outcome advantage for either the robotic inguinal hernia repair or robotic cholecystectomy in this study.” The outcomes the study measured were 30-day readmission and 30-day mortality. Demographics across all study groups were similar.

Dr. Vogels quoted statistics from the ECRI Institute that showed robotic surgery procedures have increased 178% between 2009 and 2014, and the two procedures the group studied are the most frequently performed robotic procedures.

Within the Geisinger system, the study found a 3:1 cost disparity for IHR: $6,292 total cost for hospital-based robotic surgery vs. $3,421 for ASC-based laparoscopy IHR and $1,853 for ASC-based open repair. For cholecystectomy, the disparity isn’t as wide – it’s 2:1 – but is still significant: Total costs for hospital-based robotic surgery are $6,057 vs. $3,443 for ASC-based cholecystectomy and $3,270 for hospital-based laparoscopic cholecystectomy (the study did not include any open cholecystectomies).

Total costs not only include costs for the procedure but also all related pre- and postoperative care. The cost analysis did not account for the cost of the robot, including maintenance contracts, or costs for laparoscopic instruments. Variable costs also ranged from about $3,000 for robotic IHR to $942 for ASC open repair – which means the lowest per-procedure cost for the latter was around $900.

“Translating this into the fact that cholecystectomies and inguinal hernia repairs are the most often performed general surgery procedures, ambulatory surgery centers can save over $60 billion over the next 10 years in just overhead costs as well as increased efficiency,” Dr. Vogels said.

The study also found access issues depending on where patients had their operations. “As far as service and access in our institution alone, we found that patients going to the main hospital spent as much as two times longer getting these procedures done as compared to the ambulatory surgery centers,” Dr. Vogels said.

Robotic procedures also required longer operative times, the study found – an average of 109 minutes for IHR vs. about an hour for ASC procedures and hospital-based open surgery (but averaging 78 minutes for in-hospital laparoscopy); and 73 minutes for robotic cholecystectomy, 60 minutes for hospital laparoscopy, and 45 minutes for ASC laparoscopy.

Robotic session moderator Dmitry Oleynikov, MD, FACS, of the University of Nebraska Medical Center, Omaha, asked Dr. Vogels if putting a robotic platform in an ambulatory surgery setting would make it more cost effective.

That’s not practical from a cost or efficiency perspective, she said.

“When you look at the cost of the ASCs, specifically in the hernia group, the lowest-cost hernia repair is about $800; with the robot it’s going to be significantly higher than that, up to three times higher than that,” Dr. Vogels replied. “Then you’re also changing all those simple ambulatory surgery procedures to more involved robotic procedures, so it’s hard to justify doing that in the ASC.”

Dr. Vogels and her coauthors had no relevant financial disclosures.

 

– Robot-assisted operations for inguinal hernia repair (IHR) and cholecystectomy have grown steadily in recent years, but these procedures can be done equally well by traditional operations at a fraction of the cost, according to a study from Geisinger Medical Center in Pennsylvania.

Master Video/Shutterstock
Minimally invasive robotic surgery with the da Vinci Surgical System.
“Overall in either the inguinal hernia or cholecystectomy groups, the robotic surgery group had the highest cost total,” Dr. Vogels said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. “There was no outcome advantage for either the robotic inguinal hernia repair or robotic cholecystectomy in this study.” The outcomes the study measured were 30-day readmission and 30-day mortality. Demographics across all study groups were similar.

Dr. Vogels quoted statistics from the ECRI Institute that showed robotic surgery procedures have increased 178% between 2009 and 2014, and the two procedures the group studied are the most frequently performed robotic procedures.

Within the Geisinger system, the study found a 3:1 cost disparity for IHR: $6,292 total cost for hospital-based robotic surgery vs. $3,421 for ASC-based laparoscopy IHR and $1,853 for ASC-based open repair. For cholecystectomy, the disparity isn’t as wide – it’s 2:1 – but is still significant: Total costs for hospital-based robotic surgery are $6,057 vs. $3,443 for ASC-based cholecystectomy and $3,270 for hospital-based laparoscopic cholecystectomy (the study did not include any open cholecystectomies).

Total costs not only include costs for the procedure but also all related pre- and postoperative care. The cost analysis did not account for the cost of the robot, including maintenance contracts, or costs for laparoscopic instruments. Variable costs also ranged from about $3,000 for robotic IHR to $942 for ASC open repair – which means the lowest per-procedure cost for the latter was around $900.

“Translating this into the fact that cholecystectomies and inguinal hernia repairs are the most often performed general surgery procedures, ambulatory surgery centers can save over $60 billion over the next 10 years in just overhead costs as well as increased efficiency,” Dr. Vogels said.

The study also found access issues depending on where patients had their operations. “As far as service and access in our institution alone, we found that patients going to the main hospital spent as much as two times longer getting these procedures done as compared to the ambulatory surgery centers,” Dr. Vogels said.

Robotic procedures also required longer operative times, the study found – an average of 109 minutes for IHR vs. about an hour for ASC procedures and hospital-based open surgery (but averaging 78 minutes for in-hospital laparoscopy); and 73 minutes for robotic cholecystectomy, 60 minutes for hospital laparoscopy, and 45 minutes for ASC laparoscopy.

Robotic session moderator Dmitry Oleynikov, MD, FACS, of the University of Nebraska Medical Center, Omaha, asked Dr. Vogels if putting a robotic platform in an ambulatory surgery setting would make it more cost effective.

That’s not practical from a cost or efficiency perspective, she said.

“When you look at the cost of the ASCs, specifically in the hernia group, the lowest-cost hernia repair is about $800; with the robot it’s going to be significantly higher than that, up to three times higher than that,” Dr. Vogels replied. “Then you’re also changing all those simple ambulatory surgery procedures to more involved robotic procedures, so it’s hard to justify doing that in the ASC.”

Dr. Vogels and her coauthors had no relevant financial disclosures.

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Key clinical point: Outcomes for robot-assisted inguinal hernia repair and cholecystectomy are similar to those for outpatient open and laparoscopic procedures.

Major finding: Robotic IHR costs up to three times more than open outpatient surgery, and robotic cholecystectomy costs twice as much as outpatient surgery.

Data source: Study of 1,971 in-hospital robotic, laparoscopic, and open procedures, and outpatient laparoscopic and open operations done from 2007 to 2016 at Geisinger Medical Center.

Disclosures: Dr. Vogels and coauthors reported having no financial disclosures.

Robotics: General surgery goes its own way

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HOUSTON – Subspecialties such as urology and gynecology have seen a steady increase in robot-assisted surgery and an offsetting decline in open procedures, but in general surgery, robot-assisted procedures seem to be making gains at the expense of laparoscopy, according to researchers from the University of Nebraska.

Dr. Priscila Rodrigues Armijo


This shift to RAS rather than laparoscopy could have significant implications because RAS is significantly more costly than laparoscopy, Dr. Armijo said. “In our study, the open procedures were the most expensive, followed by the robot-assisted surgeries and then laparoscopy,” she said. Median direct costs were $14,364 for open procedures, $11,376 for RAS and $7,945 for laparoscopy.

The Nebraska study retrospectively analyzed five different general surgery procedures: colectomy, cholecystectomy, and bariatric procedures in addition to VHR and IHR. The researchers analyzed 857,468 operations entered into the University HealthSystem Consortium Clinical Database Resource Manager from October 2008 to September 2015.

Dr. Armijo explained that the goal was to study trends in general surgery because while several studies have examined trends in urologic and gynecologic surgery, few studies have done so in general surgery.

All but the hernia repair procedures followed the trends seen in other subspecialties, Dr. Armijo said. Over the study period, the share of all minimally invasive surgeries that were RAS increased from fewer than 1% to about 7%, she said. In these procedures, RAS increased dramatically: from 0.4% to 8% in colectomy; 0.2 to 1.8% in cholecystectomy; and 0.6% to 5.4% in bariatric surgery.

“There was a significant increase in minimally invasive utilizations over time, and robotic surgery increased disproportionately compared to the laparoscope counterpart,” Dr. Armijo said. “And although we cannot prove where those patients are coming from, we believe that, especially for inguinal and ventral hernia repairs, they are coming from laparoscopic surgeons who now are adopting robotic techniques and not from open surgeons switching to the robotic approach.”

In 7 years, the study showed a significant decrease in the share of open procedures in colectomy (from 71.8% to 61.9%), cholecystectomy (35.7% to 27.1%), and bariatric surgery (20.1% to 10.1%), but an increase in both laparoscopic and RAS approaches in these surgeries.

However, in IHR, open procedures held steady at around 84% through the study period, while laparoscopic procedures declined from 12.6% to 10.8% and RAS jumped 3.1% to 4.5%. For VHR, the share of open procedures actually jumped from 80.9% to 85.2%, while the proportion of laparoscopic procedures fell from 18.9% to 11.9% and RAS operations jumped more than tenfold, from 0.2% to 2.9%.

“For ventral hernia repair there was a significant decrease in the laparoscopic approach with a significant increase in both open and robotic procedures, which may be due to new open techniques, including component separation, that have been shown to be more durable as a repair,” Dr. Armijo said. “In addition, those repair techniques are more easily performed with the robotic approach. Laparoscopic surgeons are finding that robotic technology is enabling them to execute surgical tasks, such as suturing mesh.”

Coauthor Dmitry Oleynikov, MD, FACS, disclosed he is a stockholder in Virtual Incision Corp. Dr. Armijo and other coauthors had no financial relationships to disclose.

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HOUSTON – Subspecialties such as urology and gynecology have seen a steady increase in robot-assisted surgery and an offsetting decline in open procedures, but in general surgery, robot-assisted procedures seem to be making gains at the expense of laparoscopy, according to researchers from the University of Nebraska.

Dr. Priscila Rodrigues Armijo


This shift to RAS rather than laparoscopy could have significant implications because RAS is significantly more costly than laparoscopy, Dr. Armijo said. “In our study, the open procedures were the most expensive, followed by the robot-assisted surgeries and then laparoscopy,” she said. Median direct costs were $14,364 for open procedures, $11,376 for RAS and $7,945 for laparoscopy.

The Nebraska study retrospectively analyzed five different general surgery procedures: colectomy, cholecystectomy, and bariatric procedures in addition to VHR and IHR. The researchers analyzed 857,468 operations entered into the University HealthSystem Consortium Clinical Database Resource Manager from October 2008 to September 2015.

Dr. Armijo explained that the goal was to study trends in general surgery because while several studies have examined trends in urologic and gynecologic surgery, few studies have done so in general surgery.

All but the hernia repair procedures followed the trends seen in other subspecialties, Dr. Armijo said. Over the study period, the share of all minimally invasive surgeries that were RAS increased from fewer than 1% to about 7%, she said. In these procedures, RAS increased dramatically: from 0.4% to 8% in colectomy; 0.2 to 1.8% in cholecystectomy; and 0.6% to 5.4% in bariatric surgery.

“There was a significant increase in minimally invasive utilizations over time, and robotic surgery increased disproportionately compared to the laparoscope counterpart,” Dr. Armijo said. “And although we cannot prove where those patients are coming from, we believe that, especially for inguinal and ventral hernia repairs, they are coming from laparoscopic surgeons who now are adopting robotic techniques and not from open surgeons switching to the robotic approach.”

In 7 years, the study showed a significant decrease in the share of open procedures in colectomy (from 71.8% to 61.9%), cholecystectomy (35.7% to 27.1%), and bariatric surgery (20.1% to 10.1%), but an increase in both laparoscopic and RAS approaches in these surgeries.

However, in IHR, open procedures held steady at around 84% through the study period, while laparoscopic procedures declined from 12.6% to 10.8% and RAS jumped 3.1% to 4.5%. For VHR, the share of open procedures actually jumped from 80.9% to 85.2%, while the proportion of laparoscopic procedures fell from 18.9% to 11.9% and RAS operations jumped more than tenfold, from 0.2% to 2.9%.

“For ventral hernia repair there was a significant decrease in the laparoscopic approach with a significant increase in both open and robotic procedures, which may be due to new open techniques, including component separation, that have been shown to be more durable as a repair,” Dr. Armijo said. “In addition, those repair techniques are more easily performed with the robotic approach. Laparoscopic surgeons are finding that robotic technology is enabling them to execute surgical tasks, such as suturing mesh.”

Coauthor Dmitry Oleynikov, MD, FACS, disclosed he is a stockholder in Virtual Incision Corp. Dr. Armijo and other coauthors had no financial relationships to disclose.

 

HOUSTON – Subspecialties such as urology and gynecology have seen a steady increase in robot-assisted surgery and an offsetting decline in open procedures, but in general surgery, robot-assisted procedures seem to be making gains at the expense of laparoscopy, according to researchers from the University of Nebraska.

Dr. Priscila Rodrigues Armijo


This shift to RAS rather than laparoscopy could have significant implications because RAS is significantly more costly than laparoscopy, Dr. Armijo said. “In our study, the open procedures were the most expensive, followed by the robot-assisted surgeries and then laparoscopy,” she said. Median direct costs were $14,364 for open procedures, $11,376 for RAS and $7,945 for laparoscopy.

The Nebraska study retrospectively analyzed five different general surgery procedures: colectomy, cholecystectomy, and bariatric procedures in addition to VHR and IHR. The researchers analyzed 857,468 operations entered into the University HealthSystem Consortium Clinical Database Resource Manager from October 2008 to September 2015.

Dr. Armijo explained that the goal was to study trends in general surgery because while several studies have examined trends in urologic and gynecologic surgery, few studies have done so in general surgery.

All but the hernia repair procedures followed the trends seen in other subspecialties, Dr. Armijo said. Over the study period, the share of all minimally invasive surgeries that were RAS increased from fewer than 1% to about 7%, she said. In these procedures, RAS increased dramatically: from 0.4% to 8% in colectomy; 0.2 to 1.8% in cholecystectomy; and 0.6% to 5.4% in bariatric surgery.

“There was a significant increase in minimally invasive utilizations over time, and robotic surgery increased disproportionately compared to the laparoscope counterpart,” Dr. Armijo said. “And although we cannot prove where those patients are coming from, we believe that, especially for inguinal and ventral hernia repairs, they are coming from laparoscopic surgeons who now are adopting robotic techniques and not from open surgeons switching to the robotic approach.”

In 7 years, the study showed a significant decrease in the share of open procedures in colectomy (from 71.8% to 61.9%), cholecystectomy (35.7% to 27.1%), and bariatric surgery (20.1% to 10.1%), but an increase in both laparoscopic and RAS approaches in these surgeries.

However, in IHR, open procedures held steady at around 84% through the study period, while laparoscopic procedures declined from 12.6% to 10.8% and RAS jumped 3.1% to 4.5%. For VHR, the share of open procedures actually jumped from 80.9% to 85.2%, while the proportion of laparoscopic procedures fell from 18.9% to 11.9% and RAS operations jumped more than tenfold, from 0.2% to 2.9%.

“For ventral hernia repair there was a significant decrease in the laparoscopic approach with a significant increase in both open and robotic procedures, which may be due to new open techniques, including component separation, that have been shown to be more durable as a repair,” Dr. Armijo said. “In addition, those repair techniques are more easily performed with the robotic approach. Laparoscopic surgeons are finding that robotic technology is enabling them to execute surgical tasks, such as suturing mesh.”

Coauthor Dmitry Oleynikov, MD, FACS, disclosed he is a stockholder in Virtual Incision Corp. Dr. Armijo and other coauthors had no financial relationships to disclose.

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Key clinical point: In inguinal and ventral hernia repair, laparoscopic surgeons are more likely than are open surgery counterparts to move to surgical robot.

Major finding: Over the 7-year study period, the share of open ventral hernia repair procedures increased from 80.9% to 85.2%, while the proportion of laparoscopic procedures fell from 18.9% to 11.9% and RAS operations increased from 0.2% to 2.9%.

Data source: Multicenter, retrospective study of 857,468 general surgery procedures from 2008 to 2015 in the University HealthSystem Consortium Clinical Database Resource Manager.

Disclosures: Dr. Armijo reported having no financial disclosures. Coauthor Dmitry Oleynikov, MD, disclosed stock holding in Virtual Incision Corp.
 

Observation works for most smaller splanchnic artery aneurysms

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– Guidelines for the management of splanchnic artery aneurysms have been hard to come by because of their rarity, but investigators at Massachusetts General Hospital and Harvard Medical School, both in Boston, have surveyed their 20-year experience to conclude that surveillance is appropriate for most cases of aneurysms smaller than 25 mm, and selective open or endovascular repair is indicated for larger lesions, depending on their location.

“Most of the small splanchnic artery aneurysms (SAAs) of less than 25 mm did not grow or rupture over time and can be observed with axial imaging every 3 years,” Mark F. Conrad, MD, reported at a symposium on vascular surgery sponsored by Northwestern University.

Dr. Mark Conrad
Dr. Conrad, director of clinical research in the division of vascular and endovascular surgery at Massachusetts General Hospital, reported on his institution’s outcomes for intervention and observation based on 264 SAAs in 250 patients treated or observed from 1994 to 2014 – 166 patients (176 SAAs) monitored with surveillance imaging and 84 (88 SAAs) undergoing early repair. The overall 5-year survival was 86%. “There was no difference in the intervention group vs. the observation group, but again, intervention was selected based on size of the aneurysm,” Dr. Conrad said.

The predominant sites of aneurysm were the splenic artery (95, 36%) and the celiac artery (78, 30%), followed by the hepatic artery (34, 13%), pancreaticoduodenal artery (PDA; 25, 9.6%), superior mesenteric artery (SMA; 17, 6%), gastroduodenal artery (GDA; 11, 4%), jejunal artery (3, 1%) and inferior mesenteric artery (1, 0.4%).

Surveillance consisted of imaging every 3 years. Of the surveillance cohort, 138 patients had longer-term follow-up. The average aneurysm size was 16.3 mm, “so they’re small,” Dr. Conrad said. Of that whole group, only 12 (9%), of SAAs grew in size, and of those, 8 were 25 mm or smaller when they were identified; 8 of the 12 required repair. “The average time to repair was 2 years,” Dr. Conrad said. “There were no ruptures in the surveillance cohort.”

Among the early repair group, 13 (14.7%) had rupture upon presentation, 3 of which (23%) were pseudoaneurysms. The majority of aneurysms in this group were in either the splenic artery, PDA, or GDA. “Their average size was 31 mm – much larger than the patients that we watched,” he said. A total of 70% of all repairs were endovascular in nature, the remainder open, but endovascular comprised a higher percentage of rupture repairs: 10 (77%) vs. 3 (23%) that underwent open procedures.

The outcomes for endovascular and open repair were similar based on the small number of subjects, Dr. Conrad said: 30-day morbidity of 17% for endovascular repair and 22.2% for open; and 30-day mortality of 3.5% and 4.5%, respectively. However, for ruptured lesions, the outcomes were starkly significant: 54% morbidity and 8% mortality at 30 days.

The researchers performed a univariate analysis of predictors for aneurysm. They were aneurysm size with an odds ratio of 1.04 for every 1 mm of growth; PDA or GDA lesions with an OR of 11.2; and Ehlers-Danlos type IV syndrome with an OR of 32.5. The latter included all the three study patients with Ehlers-Danlos syndrome.

Among patients who had splenic SAAs, 99 (93%) were asymptomatic and 5 (5.3%) had pseudoaneurysm, and almost half (47) went into surveillance. Over a mean observation period of 35 months, six (12.8%) grew in size, comprising half of the growing SAAs in the observation group. Thirty-two had endovascular repair and four open repair, with a 30-day morbidity of 22% and 30-day mortality of 2.7%.

Celiac SAAs proved most problematic in terms of symptomatology; all 78 patients with this variant were asymptomatic, and 12 (15%) had dissection. Sixty patients went into surveillance with a mean time of 43 months, and three (5) had aneurysms that grew in size. Five had intervention, four with open repair, with 30-day morbidity of 20% and no 30-day mortality.

Hepatic SAAs affected 34 study subjects, 29 (85%) of whom were asymptomatic, 4 (15%) who had dissection, and 7 (21%) with pseudoaneurysm. Eleven entered surveillance for an average of 28 months, but none showed any aneurysmal growth. The 16 who had intervention were evenly split between open and endovascular repair with 30-day morbidity of 25% and 30-day morality of 12.5%.

The PDA and GDA aneurysms “are really interesting,” Dr. Conrad said. “I think they’re different in nature than the other aneurysms,” he said, noting that 12 (33%) of these aneurysms were symptomatic and 6 (17%) were pseudoaneurysms. Because of the high rate of rupture of PDA/GDA aneurysms, Dr. Conrad advised repair at diagnosis: “97% of these patients had a celiac stenosis, and of those, two-thirds were atherosclerosis related and one-third related to the median arcuate ligament compression.” The rupture rate was comparatively high – 20%. Twenty cases underwent endovascular repair with a 90% success rate while four cases had open repair. Thirty-day morbidity for intact lesions was 11% with no deaths, and 50% with 14% mortality rate for ruptured lesions.

Of the SMA aneurysms in the study population, only 17% were mycotic with the remainder asymptomatic, Dr. Conrad said. Nine underwent surveillance, with one growing in size over a mean observation period of 28 months, four had open repair, and two endovascular repair. Morbidity was 17% at 30 days with no deaths.

The guidelines Dr. Conrad and his group developed recommend treatment for symptomatic patients and a more nuanced approach for asymptomatic patients, depending on the location and size of SAA. All lesions 25 mm or smaller, except those of the PDA/GDA, can be observed with axial imaging every 3 years, he said; intervention is indicated for all larger lesions. Endovascular repair is in order for all splenic SAAs in pregnancy, liver transplantation, and pseudoaneurysm. For hepatic SAAs, open or endovascular repair is indicated for pseudoaneurysm, but open repair only is indicated for asymptomatic celiac SAAs with pseudoaneurysm. Endovascular intervention can address most SAA aneurysms of the PDA and GDA.

Dr. Conrad disclosed he is a consultant to Medtronic and Volcano and is a member of Bard’s clinical events committee.
 

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– Guidelines for the management of splanchnic artery aneurysms have been hard to come by because of their rarity, but investigators at Massachusetts General Hospital and Harvard Medical School, both in Boston, have surveyed their 20-year experience to conclude that surveillance is appropriate for most cases of aneurysms smaller than 25 mm, and selective open or endovascular repair is indicated for larger lesions, depending on their location.

“Most of the small splanchnic artery aneurysms (SAAs) of less than 25 mm did not grow or rupture over time and can be observed with axial imaging every 3 years,” Mark F. Conrad, MD, reported at a symposium on vascular surgery sponsored by Northwestern University.

Dr. Mark Conrad
Dr. Conrad, director of clinical research in the division of vascular and endovascular surgery at Massachusetts General Hospital, reported on his institution’s outcomes for intervention and observation based on 264 SAAs in 250 patients treated or observed from 1994 to 2014 – 166 patients (176 SAAs) monitored with surveillance imaging and 84 (88 SAAs) undergoing early repair. The overall 5-year survival was 86%. “There was no difference in the intervention group vs. the observation group, but again, intervention was selected based on size of the aneurysm,” Dr. Conrad said.

The predominant sites of aneurysm were the splenic artery (95, 36%) and the celiac artery (78, 30%), followed by the hepatic artery (34, 13%), pancreaticoduodenal artery (PDA; 25, 9.6%), superior mesenteric artery (SMA; 17, 6%), gastroduodenal artery (GDA; 11, 4%), jejunal artery (3, 1%) and inferior mesenteric artery (1, 0.4%).

Surveillance consisted of imaging every 3 years. Of the surveillance cohort, 138 patients had longer-term follow-up. The average aneurysm size was 16.3 mm, “so they’re small,” Dr. Conrad said. Of that whole group, only 12 (9%), of SAAs grew in size, and of those, 8 were 25 mm or smaller when they were identified; 8 of the 12 required repair. “The average time to repair was 2 years,” Dr. Conrad said. “There were no ruptures in the surveillance cohort.”

Among the early repair group, 13 (14.7%) had rupture upon presentation, 3 of which (23%) were pseudoaneurysms. The majority of aneurysms in this group were in either the splenic artery, PDA, or GDA. “Their average size was 31 mm – much larger than the patients that we watched,” he said. A total of 70% of all repairs were endovascular in nature, the remainder open, but endovascular comprised a higher percentage of rupture repairs: 10 (77%) vs. 3 (23%) that underwent open procedures.

The outcomes for endovascular and open repair were similar based on the small number of subjects, Dr. Conrad said: 30-day morbidity of 17% for endovascular repair and 22.2% for open; and 30-day mortality of 3.5% and 4.5%, respectively. However, for ruptured lesions, the outcomes were starkly significant: 54% morbidity and 8% mortality at 30 days.

The researchers performed a univariate analysis of predictors for aneurysm. They were aneurysm size with an odds ratio of 1.04 for every 1 mm of growth; PDA or GDA lesions with an OR of 11.2; and Ehlers-Danlos type IV syndrome with an OR of 32.5. The latter included all the three study patients with Ehlers-Danlos syndrome.

Among patients who had splenic SAAs, 99 (93%) were asymptomatic and 5 (5.3%) had pseudoaneurysm, and almost half (47) went into surveillance. Over a mean observation period of 35 months, six (12.8%) grew in size, comprising half of the growing SAAs in the observation group. Thirty-two had endovascular repair and four open repair, with a 30-day morbidity of 22% and 30-day mortality of 2.7%.

Celiac SAAs proved most problematic in terms of symptomatology; all 78 patients with this variant were asymptomatic, and 12 (15%) had dissection. Sixty patients went into surveillance with a mean time of 43 months, and three (5) had aneurysms that grew in size. Five had intervention, four with open repair, with 30-day morbidity of 20% and no 30-day mortality.

Hepatic SAAs affected 34 study subjects, 29 (85%) of whom were asymptomatic, 4 (15%) who had dissection, and 7 (21%) with pseudoaneurysm. Eleven entered surveillance for an average of 28 months, but none showed any aneurysmal growth. The 16 who had intervention were evenly split between open and endovascular repair with 30-day morbidity of 25% and 30-day morality of 12.5%.

The PDA and GDA aneurysms “are really interesting,” Dr. Conrad said. “I think they’re different in nature than the other aneurysms,” he said, noting that 12 (33%) of these aneurysms were symptomatic and 6 (17%) were pseudoaneurysms. Because of the high rate of rupture of PDA/GDA aneurysms, Dr. Conrad advised repair at diagnosis: “97% of these patients had a celiac stenosis, and of those, two-thirds were atherosclerosis related and one-third related to the median arcuate ligament compression.” The rupture rate was comparatively high – 20%. Twenty cases underwent endovascular repair with a 90% success rate while four cases had open repair. Thirty-day morbidity for intact lesions was 11% with no deaths, and 50% with 14% mortality rate for ruptured lesions.

Of the SMA aneurysms in the study population, only 17% were mycotic with the remainder asymptomatic, Dr. Conrad said. Nine underwent surveillance, with one growing in size over a mean observation period of 28 months, four had open repair, and two endovascular repair. Morbidity was 17% at 30 days with no deaths.

The guidelines Dr. Conrad and his group developed recommend treatment for symptomatic patients and a more nuanced approach for asymptomatic patients, depending on the location and size of SAA. All lesions 25 mm or smaller, except those of the PDA/GDA, can be observed with axial imaging every 3 years, he said; intervention is indicated for all larger lesions. Endovascular repair is in order for all splenic SAAs in pregnancy, liver transplantation, and pseudoaneurysm. For hepatic SAAs, open or endovascular repair is indicated for pseudoaneurysm, but open repair only is indicated for asymptomatic celiac SAAs with pseudoaneurysm. Endovascular intervention can address most SAA aneurysms of the PDA and GDA.

Dr. Conrad disclosed he is a consultant to Medtronic and Volcano and is a member of Bard’s clinical events committee.
 

 

– Guidelines for the management of splanchnic artery aneurysms have been hard to come by because of their rarity, but investigators at Massachusetts General Hospital and Harvard Medical School, both in Boston, have surveyed their 20-year experience to conclude that surveillance is appropriate for most cases of aneurysms smaller than 25 mm, and selective open or endovascular repair is indicated for larger lesions, depending on their location.

“Most of the small splanchnic artery aneurysms (SAAs) of less than 25 mm did not grow or rupture over time and can be observed with axial imaging every 3 years,” Mark F. Conrad, MD, reported at a symposium on vascular surgery sponsored by Northwestern University.

Dr. Mark Conrad
Dr. Conrad, director of clinical research in the division of vascular and endovascular surgery at Massachusetts General Hospital, reported on his institution’s outcomes for intervention and observation based on 264 SAAs in 250 patients treated or observed from 1994 to 2014 – 166 patients (176 SAAs) monitored with surveillance imaging and 84 (88 SAAs) undergoing early repair. The overall 5-year survival was 86%. “There was no difference in the intervention group vs. the observation group, but again, intervention was selected based on size of the aneurysm,” Dr. Conrad said.

The predominant sites of aneurysm were the splenic artery (95, 36%) and the celiac artery (78, 30%), followed by the hepatic artery (34, 13%), pancreaticoduodenal artery (PDA; 25, 9.6%), superior mesenteric artery (SMA; 17, 6%), gastroduodenal artery (GDA; 11, 4%), jejunal artery (3, 1%) and inferior mesenteric artery (1, 0.4%).

Surveillance consisted of imaging every 3 years. Of the surveillance cohort, 138 patients had longer-term follow-up. The average aneurysm size was 16.3 mm, “so they’re small,” Dr. Conrad said. Of that whole group, only 12 (9%), of SAAs grew in size, and of those, 8 were 25 mm or smaller when they were identified; 8 of the 12 required repair. “The average time to repair was 2 years,” Dr. Conrad said. “There were no ruptures in the surveillance cohort.”

Among the early repair group, 13 (14.7%) had rupture upon presentation, 3 of which (23%) were pseudoaneurysms. The majority of aneurysms in this group were in either the splenic artery, PDA, or GDA. “Their average size was 31 mm – much larger than the patients that we watched,” he said. A total of 70% of all repairs were endovascular in nature, the remainder open, but endovascular comprised a higher percentage of rupture repairs: 10 (77%) vs. 3 (23%) that underwent open procedures.

The outcomes for endovascular and open repair were similar based on the small number of subjects, Dr. Conrad said: 30-day morbidity of 17% for endovascular repair and 22.2% for open; and 30-day mortality of 3.5% and 4.5%, respectively. However, for ruptured lesions, the outcomes were starkly significant: 54% morbidity and 8% mortality at 30 days.

The researchers performed a univariate analysis of predictors for aneurysm. They were aneurysm size with an odds ratio of 1.04 for every 1 mm of growth; PDA or GDA lesions with an OR of 11.2; and Ehlers-Danlos type IV syndrome with an OR of 32.5. The latter included all the three study patients with Ehlers-Danlos syndrome.

Among patients who had splenic SAAs, 99 (93%) were asymptomatic and 5 (5.3%) had pseudoaneurysm, and almost half (47) went into surveillance. Over a mean observation period of 35 months, six (12.8%) grew in size, comprising half of the growing SAAs in the observation group. Thirty-two had endovascular repair and four open repair, with a 30-day morbidity of 22% and 30-day mortality of 2.7%.

Celiac SAAs proved most problematic in terms of symptomatology; all 78 patients with this variant were asymptomatic, and 12 (15%) had dissection. Sixty patients went into surveillance with a mean time of 43 months, and three (5) had aneurysms that grew in size. Five had intervention, four with open repair, with 30-day morbidity of 20% and no 30-day mortality.

Hepatic SAAs affected 34 study subjects, 29 (85%) of whom were asymptomatic, 4 (15%) who had dissection, and 7 (21%) with pseudoaneurysm. Eleven entered surveillance for an average of 28 months, but none showed any aneurysmal growth. The 16 who had intervention were evenly split between open and endovascular repair with 30-day morbidity of 25% and 30-day morality of 12.5%.

The PDA and GDA aneurysms “are really interesting,” Dr. Conrad said. “I think they’re different in nature than the other aneurysms,” he said, noting that 12 (33%) of these aneurysms were symptomatic and 6 (17%) were pseudoaneurysms. Because of the high rate of rupture of PDA/GDA aneurysms, Dr. Conrad advised repair at diagnosis: “97% of these patients had a celiac stenosis, and of those, two-thirds were atherosclerosis related and one-third related to the median arcuate ligament compression.” The rupture rate was comparatively high – 20%. Twenty cases underwent endovascular repair with a 90% success rate while four cases had open repair. Thirty-day morbidity for intact lesions was 11% with no deaths, and 50% with 14% mortality rate for ruptured lesions.

Of the SMA aneurysms in the study population, only 17% were mycotic with the remainder asymptomatic, Dr. Conrad said. Nine underwent surveillance, with one growing in size over a mean observation period of 28 months, four had open repair, and two endovascular repair. Morbidity was 17% at 30 days with no deaths.

The guidelines Dr. Conrad and his group developed recommend treatment for symptomatic patients and a more nuanced approach for asymptomatic patients, depending on the location and size of SAA. All lesions 25 mm or smaller, except those of the PDA/GDA, can be observed with axial imaging every 3 years, he said; intervention is indicated for all larger lesions. Endovascular repair is in order for all splenic SAAs in pregnancy, liver transplantation, and pseudoaneurysm. For hepatic SAAs, open or endovascular repair is indicated for pseudoaneurysm, but open repair only is indicated for asymptomatic celiac SAAs with pseudoaneurysm. Endovascular intervention can address most SAA aneurysms of the PDA and GDA.

Dr. Conrad disclosed he is a consultant to Medtronic and Volcano and is a member of Bard’s clinical events committee.
 

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Key clinical point: Surveillance imaging every three years may be adequate to manage splanchnic artery aneurysms (SAA) smaller than 25 mm, because they rarely expand significantly.

Major finding: In the surveillance group that had long-term follow-up, 9% had SAAs that grew in size.

Data source: Analysis of 250 patients with 264 SAAs during 1994-2014 in the Research Patient Data Registry at Massachusetts General Hospital.

Disclosures: Dr. Conrad disclosed he is a consultant to Medtronic and Volcano and is a member of Bard’s clinical events committee.