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Sneak Peek: Journal of Hospital Medicine – Sept. 2017

Article Type
Changed
Fri, 09/14/2018 - 11:57
A randomized controlled trial of a CPR decision support video for patients admitted to the general medicine service

 

BACKGROUND: Patient preferences regarding cardiopulmonary resuscitation (CPR) are important, especially during hospitalization when a patient’s health is changing, yet many patients are not adequately informed or involved in the decision-making process.

OBJECTIVES: We examined the effect of an informational video about CPR on hospitalized patients’ code status choices.

DESIGN: This was a prospective, randomized trial conducted at the Veteran’s Affairs Hospital in Minneapolis.

PARTICIPANTS: We enrolled 119 patients who were hospitalized on the general medicine service and at least 65 years old. The majority were men (97%) with a mean age of 75.

INTERVENTION: A video described code status choices: full code (CPR and intubation if required), do not resuscitate (DNR), and do not resuscitate/do not intubate (DNR/DNI). Participants were randomized to watch the video (n = 59) or usual care (n = 60).

MEASUREMENTS: The primary outcome was participants’ code status preferences. Secondary outcomes included a questionnaire designed to evaluate participants’ trust in their health care team and their knowledge and perceptions about CPR.

RESULTS: Participants who viewed the video were less likely to choose full code (37%), compared with participants in the usual-care group (71%), and were more likely to choose DNR/DNI (56% in the video group vs. 17% in the control group) (P < .00001). We did not see a difference in trust in their health care team or knowledge and perceptions about CPR as assessed by our questionnaire.

CONCLUSIONS: Hospitalized patients who watched a video about CPR and code status choices were less likely to choose full code and more likely to choose DNR/DNI.
 

Also in JHM this month

Influenza season hospitalization trends in Israel: A multi-year comparative analysis 2005/2006 through 2012/2013

AUTHORS: Aharona Glatman-Freedman, MD, MPH, Zalman Kaufman, MS, Yaniv Stein, BS, Hanna Sefty, MS, Hila Zadka, PhD, Barak Gordon, MD, MHA, Jill Meron, BSc, Ethel-Sherry Gordon, PhD, Rita Dichtiar, BSc, Ziona Haklai, MSc, Arnon Afek, MD, Tamy Shohat, MD, MPH



Appropriate reconciliation of cardiovascular medications after elective surgery and postdischarge acute hospital and ambulatory visits

AUTHORS: Jonathan S. Lee, MD, Ralph Gonzales, MD, MSPH, Eric Vittinghoff, PhD, Kitty K. Corbett, PhD, MPH, Kirsten E. Fleischmann, MD, Neil Sehgal, MD, MPH, Andrew D. Auerbach, MD, MPH



Patterns and appropriateness of thrombophilia testing in an academic medical center

AUTHORS: Nicholas Cox, PharmD, Stacy A. Johnson, MD, Sara Vazquez, PharmD, Ryan P. Fleming, PharmD, BCPS, Matthew T. Rondina, MD, David Kaplan, MD, Stephanie Chauv, PharmD, Gabriel V. Fontaine, PharmD, Scott M. Stevens, MD, Scott Woller, MD, Daniel M. Witt, PharmD, BCPS, FCCP



National trends (2007-2013) of Clostridium difficile infection in patients with septic shock: Impact on outcome

AUTHORS: Kshitij Chatterjee, MD, Abhinav Goyal, MD, Aditya Chada, MD, Krishna Siva Sai Kakkera, MD, Howard L Corwin, MD



Blood products provided to patients receiving inappropriate critical care

AUTHORS: Thanh H. Neville, MD, MSHS, Alyssa Ziman, MD, Neil S. Wenger, MD, MPH

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A randomized controlled trial of a CPR decision support video for patients admitted to the general medicine service
A randomized controlled trial of a CPR decision support video for patients admitted to the general medicine service

 

BACKGROUND: Patient preferences regarding cardiopulmonary resuscitation (CPR) are important, especially during hospitalization when a patient’s health is changing, yet many patients are not adequately informed or involved in the decision-making process.

OBJECTIVES: We examined the effect of an informational video about CPR on hospitalized patients’ code status choices.

DESIGN: This was a prospective, randomized trial conducted at the Veteran’s Affairs Hospital in Minneapolis.

PARTICIPANTS: We enrolled 119 patients who were hospitalized on the general medicine service and at least 65 years old. The majority were men (97%) with a mean age of 75.

INTERVENTION: A video described code status choices: full code (CPR and intubation if required), do not resuscitate (DNR), and do not resuscitate/do not intubate (DNR/DNI). Participants were randomized to watch the video (n = 59) or usual care (n = 60).

MEASUREMENTS: The primary outcome was participants’ code status preferences. Secondary outcomes included a questionnaire designed to evaluate participants’ trust in their health care team and their knowledge and perceptions about CPR.

RESULTS: Participants who viewed the video were less likely to choose full code (37%), compared with participants in the usual-care group (71%), and were more likely to choose DNR/DNI (56% in the video group vs. 17% in the control group) (P < .00001). We did not see a difference in trust in their health care team or knowledge and perceptions about CPR as assessed by our questionnaire.

CONCLUSIONS: Hospitalized patients who watched a video about CPR and code status choices were less likely to choose full code and more likely to choose DNR/DNI.
 

Also in JHM this month

Influenza season hospitalization trends in Israel: A multi-year comparative analysis 2005/2006 through 2012/2013

AUTHORS: Aharona Glatman-Freedman, MD, MPH, Zalman Kaufman, MS, Yaniv Stein, BS, Hanna Sefty, MS, Hila Zadka, PhD, Barak Gordon, MD, MHA, Jill Meron, BSc, Ethel-Sherry Gordon, PhD, Rita Dichtiar, BSc, Ziona Haklai, MSc, Arnon Afek, MD, Tamy Shohat, MD, MPH



Appropriate reconciliation of cardiovascular medications after elective surgery and postdischarge acute hospital and ambulatory visits

AUTHORS: Jonathan S. Lee, MD, Ralph Gonzales, MD, MSPH, Eric Vittinghoff, PhD, Kitty K. Corbett, PhD, MPH, Kirsten E. Fleischmann, MD, Neil Sehgal, MD, MPH, Andrew D. Auerbach, MD, MPH



Patterns and appropriateness of thrombophilia testing in an academic medical center

AUTHORS: Nicholas Cox, PharmD, Stacy A. Johnson, MD, Sara Vazquez, PharmD, Ryan P. Fleming, PharmD, BCPS, Matthew T. Rondina, MD, David Kaplan, MD, Stephanie Chauv, PharmD, Gabriel V. Fontaine, PharmD, Scott M. Stevens, MD, Scott Woller, MD, Daniel M. Witt, PharmD, BCPS, FCCP



National trends (2007-2013) of Clostridium difficile infection in patients with septic shock: Impact on outcome

AUTHORS: Kshitij Chatterjee, MD, Abhinav Goyal, MD, Aditya Chada, MD, Krishna Siva Sai Kakkera, MD, Howard L Corwin, MD



Blood products provided to patients receiving inappropriate critical care

AUTHORS: Thanh H. Neville, MD, MSHS, Alyssa Ziman, MD, Neil S. Wenger, MD, MPH

 

BACKGROUND: Patient preferences regarding cardiopulmonary resuscitation (CPR) are important, especially during hospitalization when a patient’s health is changing, yet many patients are not adequately informed or involved in the decision-making process.

OBJECTIVES: We examined the effect of an informational video about CPR on hospitalized patients’ code status choices.

DESIGN: This was a prospective, randomized trial conducted at the Veteran’s Affairs Hospital in Minneapolis.

PARTICIPANTS: We enrolled 119 patients who were hospitalized on the general medicine service and at least 65 years old. The majority were men (97%) with a mean age of 75.

INTERVENTION: A video described code status choices: full code (CPR and intubation if required), do not resuscitate (DNR), and do not resuscitate/do not intubate (DNR/DNI). Participants were randomized to watch the video (n = 59) or usual care (n = 60).

MEASUREMENTS: The primary outcome was participants’ code status preferences. Secondary outcomes included a questionnaire designed to evaluate participants’ trust in their health care team and their knowledge and perceptions about CPR.

RESULTS: Participants who viewed the video were less likely to choose full code (37%), compared with participants in the usual-care group (71%), and were more likely to choose DNR/DNI (56% in the video group vs. 17% in the control group) (P < .00001). We did not see a difference in trust in their health care team or knowledge and perceptions about CPR as assessed by our questionnaire.

CONCLUSIONS: Hospitalized patients who watched a video about CPR and code status choices were less likely to choose full code and more likely to choose DNR/DNI.
 

Also in JHM this month

Influenza season hospitalization trends in Israel: A multi-year comparative analysis 2005/2006 through 2012/2013

AUTHORS: Aharona Glatman-Freedman, MD, MPH, Zalman Kaufman, MS, Yaniv Stein, BS, Hanna Sefty, MS, Hila Zadka, PhD, Barak Gordon, MD, MHA, Jill Meron, BSc, Ethel-Sherry Gordon, PhD, Rita Dichtiar, BSc, Ziona Haklai, MSc, Arnon Afek, MD, Tamy Shohat, MD, MPH



Appropriate reconciliation of cardiovascular medications after elective surgery and postdischarge acute hospital and ambulatory visits

AUTHORS: Jonathan S. Lee, MD, Ralph Gonzales, MD, MSPH, Eric Vittinghoff, PhD, Kitty K. Corbett, PhD, MPH, Kirsten E. Fleischmann, MD, Neil Sehgal, MD, MPH, Andrew D. Auerbach, MD, MPH



Patterns and appropriateness of thrombophilia testing in an academic medical center

AUTHORS: Nicholas Cox, PharmD, Stacy A. Johnson, MD, Sara Vazquez, PharmD, Ryan P. Fleming, PharmD, BCPS, Matthew T. Rondina, MD, David Kaplan, MD, Stephanie Chauv, PharmD, Gabriel V. Fontaine, PharmD, Scott M. Stevens, MD, Scott Woller, MD, Daniel M. Witt, PharmD, BCPS, FCCP



National trends (2007-2013) of Clostridium difficile infection in patients with septic shock: Impact on outcome

AUTHORS: Kshitij Chatterjee, MD, Abhinav Goyal, MD, Aditya Chada, MD, Krishna Siva Sai Kakkera, MD, Howard L Corwin, MD



Blood products provided to patients receiving inappropriate critical care

AUTHORS: Thanh H. Neville, MD, MSHS, Alyssa Ziman, MD, Neil S. Wenger, MD, MPH

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HM17 session summary: The hospitalist’s role in the opioid epidemic

Article Type
Changed
Fri, 09/14/2018 - 11:59

 

Presenters

Shoshana J. Herzig, MD, MPH, and Hillary J. Mosher, MFA, MD, FHM

Summary

The growth in opiate prescribing and associated increases in adverse events has created unique challenges for hospitalists, including how best to assess pain and opiate use disorders and how to safely prescribe opiates during hospitalization and at discharge.

These challenges are compounded by patient and system factors and a paucity of evidence-based guidelines to help guide safe administration of opiates in hospitalized patients. This can mean frustration for hospitalists and harm for patients.

Dr. Sarah Stella
The presenters, both hospitalists with expertise in the use of opiates and treatment of opiate use disorders in hospitalized patients, reviewed existing literature and guidelines on this topic. They highlighted the important role hospitalists’ can play in curbing the opioid epidemic and provided practical tips for safe prescribing and stewardship.

Key takeaways for HM

  • When assessing patients’ pain, it is crucial to differentiate between acute and chronic pain (or both) and whether it is nociceptive or neuropathic. Misclassification of pain contributes to inappropriate exposure and escalation of opiate therapy during hospitalization.
  • Always consider nonopioid analgesics such as NSAIDs first and pair them with opiates. Studies in a variety of conditions have demonstrated that these are equally, if not more, effective, even for severe pain, such as with renal colic. Reserve opiates for moderate to severe pain.
  • Always assess whether the benefits of initiating or continuing opioid therapy outweigh the risks for individual patients. There is no validated tool to predict risk for adverse events and/or opioid abuse disorder but a careful review of patient history can identify established risk factors (such as a history of mental illness or substance abuse disorders, renal impairment, or other comorbidities). In addition, nearly all states now have Prescription Drug Monitoring Programs, and hospitalists should consult these routinely when prescribing opiates.
  • Always clearly discuss expectations and risks of opioid therapy, including the potential for development of opioid use disorders with hospitalized patients prior to initiation. Emphasize pain reduction rather than elimination and focus on functional goals such as improved mobility. Also, set expectations for stepping down treatment up front.
  • Use the lowest effective dose of immediate-release opioids (preferably oral route) for shortest duration possible. Long acting opiates are associated with increased risk of adverse events, and their initiation should generally be avoided in hospitalized patients with noncancer pain.
  • Minimize risk by avoiding concurrent administration of other medications with sedative properties, especially benzodiazepines, which have been found to significantly increase the risk of adverse events, including overdose.
  • Recognize that chronic opioid use often begins with treatment of acute pain during hospitalization. Adopt best practice for discharge, including prescribing shorter courses whenever possible, discussing initiation, and changes or modifications in opiate therapy with patients’ primary care provider, and ensure timely postdischarge follow-up. Also consider coprescription of naloxone at discharge for higher risk patients.

Dr. Stella is a hospitalist in Denver and an editorial board member of The Hospitalist.

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Meeting/Event

 

Presenters

Shoshana J. Herzig, MD, MPH, and Hillary J. Mosher, MFA, MD, FHM

Summary

The growth in opiate prescribing and associated increases in adverse events has created unique challenges for hospitalists, including how best to assess pain and opiate use disorders and how to safely prescribe opiates during hospitalization and at discharge.

These challenges are compounded by patient and system factors and a paucity of evidence-based guidelines to help guide safe administration of opiates in hospitalized patients. This can mean frustration for hospitalists and harm for patients.

Dr. Sarah Stella
The presenters, both hospitalists with expertise in the use of opiates and treatment of opiate use disorders in hospitalized patients, reviewed existing literature and guidelines on this topic. They highlighted the important role hospitalists’ can play in curbing the opioid epidemic and provided practical tips for safe prescribing and stewardship.

Key takeaways for HM

  • When assessing patients’ pain, it is crucial to differentiate between acute and chronic pain (or both) and whether it is nociceptive or neuropathic. Misclassification of pain contributes to inappropriate exposure and escalation of opiate therapy during hospitalization.
  • Always consider nonopioid analgesics such as NSAIDs first and pair them with opiates. Studies in a variety of conditions have demonstrated that these are equally, if not more, effective, even for severe pain, such as with renal colic. Reserve opiates for moderate to severe pain.
  • Always assess whether the benefits of initiating or continuing opioid therapy outweigh the risks for individual patients. There is no validated tool to predict risk for adverse events and/or opioid abuse disorder but a careful review of patient history can identify established risk factors (such as a history of mental illness or substance abuse disorders, renal impairment, or other comorbidities). In addition, nearly all states now have Prescription Drug Monitoring Programs, and hospitalists should consult these routinely when prescribing opiates.
  • Always clearly discuss expectations and risks of opioid therapy, including the potential for development of opioid use disorders with hospitalized patients prior to initiation. Emphasize pain reduction rather than elimination and focus on functional goals such as improved mobility. Also, set expectations for stepping down treatment up front.
  • Use the lowest effective dose of immediate-release opioids (preferably oral route) for shortest duration possible. Long acting opiates are associated with increased risk of adverse events, and their initiation should generally be avoided in hospitalized patients with noncancer pain.
  • Minimize risk by avoiding concurrent administration of other medications with sedative properties, especially benzodiazepines, which have been found to significantly increase the risk of adverse events, including overdose.
  • Recognize that chronic opioid use often begins with treatment of acute pain during hospitalization. Adopt best practice for discharge, including prescribing shorter courses whenever possible, discussing initiation, and changes or modifications in opiate therapy with patients’ primary care provider, and ensure timely postdischarge follow-up. Also consider coprescription of naloxone at discharge for higher risk patients.

Dr. Stella is a hospitalist in Denver and an editorial board member of The Hospitalist.

 

Presenters

Shoshana J. Herzig, MD, MPH, and Hillary J. Mosher, MFA, MD, FHM

Summary

The growth in opiate prescribing and associated increases in adverse events has created unique challenges for hospitalists, including how best to assess pain and opiate use disorders and how to safely prescribe opiates during hospitalization and at discharge.

These challenges are compounded by patient and system factors and a paucity of evidence-based guidelines to help guide safe administration of opiates in hospitalized patients. This can mean frustration for hospitalists and harm for patients.

Dr. Sarah Stella
The presenters, both hospitalists with expertise in the use of opiates and treatment of opiate use disorders in hospitalized patients, reviewed existing literature and guidelines on this topic. They highlighted the important role hospitalists’ can play in curbing the opioid epidemic and provided practical tips for safe prescribing and stewardship.

Key takeaways for HM

  • When assessing patients’ pain, it is crucial to differentiate between acute and chronic pain (or both) and whether it is nociceptive or neuropathic. Misclassification of pain contributes to inappropriate exposure and escalation of opiate therapy during hospitalization.
  • Always consider nonopioid analgesics such as NSAIDs first and pair them with opiates. Studies in a variety of conditions have demonstrated that these are equally, if not more, effective, even for severe pain, such as with renal colic. Reserve opiates for moderate to severe pain.
  • Always assess whether the benefits of initiating or continuing opioid therapy outweigh the risks for individual patients. There is no validated tool to predict risk for adverse events and/or opioid abuse disorder but a careful review of patient history can identify established risk factors (such as a history of mental illness or substance abuse disorders, renal impairment, or other comorbidities). In addition, nearly all states now have Prescription Drug Monitoring Programs, and hospitalists should consult these routinely when prescribing opiates.
  • Always clearly discuss expectations and risks of opioid therapy, including the potential for development of opioid use disorders with hospitalized patients prior to initiation. Emphasize pain reduction rather than elimination and focus on functional goals such as improved mobility. Also, set expectations for stepping down treatment up front.
  • Use the lowest effective dose of immediate-release opioids (preferably oral route) for shortest duration possible. Long acting opiates are associated with increased risk of adverse events, and their initiation should generally be avoided in hospitalized patients with noncancer pain.
  • Minimize risk by avoiding concurrent administration of other medications with sedative properties, especially benzodiazepines, which have been found to significantly increase the risk of adverse events, including overdose.
  • Recognize that chronic opioid use often begins with treatment of acute pain during hospitalization. Adopt best practice for discharge, including prescribing shorter courses whenever possible, discussing initiation, and changes or modifications in opiate therapy with patients’ primary care provider, and ensure timely postdischarge follow-up. Also consider coprescription of naloxone at discharge for higher risk patients.

Dr. Stella is a hospitalist in Denver and an editorial board member of The Hospitalist.

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Elimination of urine culture screening prior to elective joint arthroplasty

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Changed
Fri, 09/14/2018 - 12:00

 

Clinical question: What is the clinical impact of implementing a policy to no longer process urine specimens for perioperative screening in patients undergoing elective joint arthroplasty (EJA)?

Background: Despite prior studies indicating the lack of clinical benefit, preoperative urine cultures are still frequently obtained in patients undergoing EJA in attempts to reduce the risk of periprosthetic joint infections (PJI).

Study Design: Time series analysis.

Setting: Holland Orthopedic and Arthritic Center (HOAC) of Sunnybrook Health Sciences Centre.

Synopsis: After a multidisciplinary meeting, obtaining routine urine culture screening was removed from the preoperative order set. A time series analysis was performed to review the frequency of screening urine cultures obtained and processed, the number of patients treated for asymptomatic bacteriuria (ASB), and the incidence of PJI before and after the new policy was implemented. After the policy change, only 129 screening urine cultures were obtained prior to 1,891 EJAs (7 per 100 EJA; 95% CI 6-8; P less than .0001) which is a drastic decrease from the 3,069 screening urine cultures obtained prior to 3,523 EJAs (87 per 100 EJA; 95% CI, 86-88) before the policy change. Prior to the policy change, of the 352 positive urine cultures, 43 received perioperative treatment for ASB, and PJI incidence was 1/3523 (0.03%; 95% CI, 0.001-02). After the policy change, no perioperative antibiotics were prescribed for ASB, and PJI rate did not significantly change at 3/1891 (0.2%; 95% CI, 0.05-0.5; P = .1).

The study was limited by its low power to detect for small differences in rates because of its small PJI rate occurrence.

Bottom Line: A multidisciplinary approach in eliminating routine urine screening prior to EJA resulted in a decrease of urine cultures obtained and a decrease in treatment for asymptomatic bacteriuria, with no significant change in PJI rate. This change in clinical practice is supported by current evidence and has a significant impact on cost savings.

References: Lamb MJ, Baillie L, Pajak D, et al. “Elimination of Screening Urine Cultures Prior to Elective Joint Arthroplasty.”

Dr. Libot is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.

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Clinical question: What is the clinical impact of implementing a policy to no longer process urine specimens for perioperative screening in patients undergoing elective joint arthroplasty (EJA)?

Background: Despite prior studies indicating the lack of clinical benefit, preoperative urine cultures are still frequently obtained in patients undergoing EJA in attempts to reduce the risk of periprosthetic joint infections (PJI).

Study Design: Time series analysis.

Setting: Holland Orthopedic and Arthritic Center (HOAC) of Sunnybrook Health Sciences Centre.

Synopsis: After a multidisciplinary meeting, obtaining routine urine culture screening was removed from the preoperative order set. A time series analysis was performed to review the frequency of screening urine cultures obtained and processed, the number of patients treated for asymptomatic bacteriuria (ASB), and the incidence of PJI before and after the new policy was implemented. After the policy change, only 129 screening urine cultures were obtained prior to 1,891 EJAs (7 per 100 EJA; 95% CI 6-8; P less than .0001) which is a drastic decrease from the 3,069 screening urine cultures obtained prior to 3,523 EJAs (87 per 100 EJA; 95% CI, 86-88) before the policy change. Prior to the policy change, of the 352 positive urine cultures, 43 received perioperative treatment for ASB, and PJI incidence was 1/3523 (0.03%; 95% CI, 0.001-02). After the policy change, no perioperative antibiotics were prescribed for ASB, and PJI rate did not significantly change at 3/1891 (0.2%; 95% CI, 0.05-0.5; P = .1).

The study was limited by its low power to detect for small differences in rates because of its small PJI rate occurrence.

Bottom Line: A multidisciplinary approach in eliminating routine urine screening prior to EJA resulted in a decrease of urine cultures obtained and a decrease in treatment for asymptomatic bacteriuria, with no significant change in PJI rate. This change in clinical practice is supported by current evidence and has a significant impact on cost savings.

References: Lamb MJ, Baillie L, Pajak D, et al. “Elimination of Screening Urine Cultures Prior to Elective Joint Arthroplasty.”

Dr. Libot is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.

 

Clinical question: What is the clinical impact of implementing a policy to no longer process urine specimens for perioperative screening in patients undergoing elective joint arthroplasty (EJA)?

Background: Despite prior studies indicating the lack of clinical benefit, preoperative urine cultures are still frequently obtained in patients undergoing EJA in attempts to reduce the risk of periprosthetic joint infections (PJI).

Study Design: Time series analysis.

Setting: Holland Orthopedic and Arthritic Center (HOAC) of Sunnybrook Health Sciences Centre.

Synopsis: After a multidisciplinary meeting, obtaining routine urine culture screening was removed from the preoperative order set. A time series analysis was performed to review the frequency of screening urine cultures obtained and processed, the number of patients treated for asymptomatic bacteriuria (ASB), and the incidence of PJI before and after the new policy was implemented. After the policy change, only 129 screening urine cultures were obtained prior to 1,891 EJAs (7 per 100 EJA; 95% CI 6-8; P less than .0001) which is a drastic decrease from the 3,069 screening urine cultures obtained prior to 3,523 EJAs (87 per 100 EJA; 95% CI, 86-88) before the policy change. Prior to the policy change, of the 352 positive urine cultures, 43 received perioperative treatment for ASB, and PJI incidence was 1/3523 (0.03%; 95% CI, 0.001-02). After the policy change, no perioperative antibiotics were prescribed for ASB, and PJI rate did not significantly change at 3/1891 (0.2%; 95% CI, 0.05-0.5; P = .1).

The study was limited by its low power to detect for small differences in rates because of its small PJI rate occurrence.

Bottom Line: A multidisciplinary approach in eliminating routine urine screening prior to EJA resulted in a decrease of urine cultures obtained and a decrease in treatment for asymptomatic bacteriuria, with no significant change in PJI rate. This change in clinical practice is supported by current evidence and has a significant impact on cost savings.

References: Lamb MJ, Baillie L, Pajak D, et al. “Elimination of Screening Urine Cultures Prior to Elective Joint Arthroplasty.”

Dr. Libot is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.

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Risks are reduced when angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers are held before noncardiac surgery

Article Type
Changed
Fri, 09/14/2018 - 12:00

 

Clinical question: Is withholding angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARBs) prior to noncardiac surgery associated with a lower risk of a 30-day composite outcome of all-cause death, myocardial injury after noncardiac surgery, and stroke when compared with continuing them on the day of surgery?

Background: The current American College of Cardiology/American Heart Association guidelines recommend continuing ACEI and ARBs for noncardiac surgery. However, many clinicians, including anesthesiologists, withhold these medications to prevent intraoperative hypotension. Because of the lack of strong evidence regarding clinical outcomes, the decision to withhold ACEI and ARBs prior to noncardiac surgery is currently dictated by physician preference and local policy.

Study Design: Prospective cohort study.

Setting: Analysis sample from the VISION study (Vascular Events in Noncardiac Surgery Patients Cohort Evaluation), which included 12 centers in eight countries.

Synopsis: A sample analysis was performed on 14,687 patients from the VISION study, who were at least 45 years old and undergoing noncardiac surgery and who required an overnight hospital admission. A total of 4,802 patients were taking ACEI/ARBs at baseline, and, for 1,245 (25.9%) of those patients, ACEI/ARBs were withheld at least 24 hours before surgery. Using multivariable regression models, the authors found that patients for whom ACEI/ARBs were withheld were less likely to suffer from the primary composite outcome of 30-day all-cause death, myocardial injury after noncardiac surgery, and stroke (12% vs 12.9%; adjusted relative risk, 0.82; 95% confidence interval, 0.7-0.96; P = .01). Withholding ACEI/ARBs prior to surgery was also associated with less risk of clinically important intraoperative hypotension, while the risk of postoperative hypotension was similar between the two groups.

Given that this was an observational study, analysis is limited because of the inability to account for every potential confounding factor.

Bottom Line: The study suggests a lower risk of postoperative death, stroke, and myocardial injury in patients for whom ACEI/ARBs were withheld prior to noncardiac surgery. A large randomized trial is needed to confirm the findings suggested by this analysis.

Citation: Roshanov PS, Rochwerg B, Patel A, et al. Withholding versus continuing angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers before noncardiac surgery.” Anesthesiology. 2017 Jan;126(1):16-27.
 

Dr. Libot is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.

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Clinical question: Is withholding angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARBs) prior to noncardiac surgery associated with a lower risk of a 30-day composite outcome of all-cause death, myocardial injury after noncardiac surgery, and stroke when compared with continuing them on the day of surgery?

Background: The current American College of Cardiology/American Heart Association guidelines recommend continuing ACEI and ARBs for noncardiac surgery. However, many clinicians, including anesthesiologists, withhold these medications to prevent intraoperative hypotension. Because of the lack of strong evidence regarding clinical outcomes, the decision to withhold ACEI and ARBs prior to noncardiac surgery is currently dictated by physician preference and local policy.

Study Design: Prospective cohort study.

Setting: Analysis sample from the VISION study (Vascular Events in Noncardiac Surgery Patients Cohort Evaluation), which included 12 centers in eight countries.

Synopsis: A sample analysis was performed on 14,687 patients from the VISION study, who were at least 45 years old and undergoing noncardiac surgery and who required an overnight hospital admission. A total of 4,802 patients were taking ACEI/ARBs at baseline, and, for 1,245 (25.9%) of those patients, ACEI/ARBs were withheld at least 24 hours before surgery. Using multivariable regression models, the authors found that patients for whom ACEI/ARBs were withheld were less likely to suffer from the primary composite outcome of 30-day all-cause death, myocardial injury after noncardiac surgery, and stroke (12% vs 12.9%; adjusted relative risk, 0.82; 95% confidence interval, 0.7-0.96; P = .01). Withholding ACEI/ARBs prior to surgery was also associated with less risk of clinically important intraoperative hypotension, while the risk of postoperative hypotension was similar between the two groups.

Given that this was an observational study, analysis is limited because of the inability to account for every potential confounding factor.

Bottom Line: The study suggests a lower risk of postoperative death, stroke, and myocardial injury in patients for whom ACEI/ARBs were withheld prior to noncardiac surgery. A large randomized trial is needed to confirm the findings suggested by this analysis.

Citation: Roshanov PS, Rochwerg B, Patel A, et al. Withholding versus continuing angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers before noncardiac surgery.” Anesthesiology. 2017 Jan;126(1):16-27.
 

Dr. Libot is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.

 

Clinical question: Is withholding angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARBs) prior to noncardiac surgery associated with a lower risk of a 30-day composite outcome of all-cause death, myocardial injury after noncardiac surgery, and stroke when compared with continuing them on the day of surgery?

Background: The current American College of Cardiology/American Heart Association guidelines recommend continuing ACEI and ARBs for noncardiac surgery. However, many clinicians, including anesthesiologists, withhold these medications to prevent intraoperative hypotension. Because of the lack of strong evidence regarding clinical outcomes, the decision to withhold ACEI and ARBs prior to noncardiac surgery is currently dictated by physician preference and local policy.

Study Design: Prospective cohort study.

Setting: Analysis sample from the VISION study (Vascular Events in Noncardiac Surgery Patients Cohort Evaluation), which included 12 centers in eight countries.

Synopsis: A sample analysis was performed on 14,687 patients from the VISION study, who were at least 45 years old and undergoing noncardiac surgery and who required an overnight hospital admission. A total of 4,802 patients were taking ACEI/ARBs at baseline, and, for 1,245 (25.9%) of those patients, ACEI/ARBs were withheld at least 24 hours before surgery. Using multivariable regression models, the authors found that patients for whom ACEI/ARBs were withheld were less likely to suffer from the primary composite outcome of 30-day all-cause death, myocardial injury after noncardiac surgery, and stroke (12% vs 12.9%; adjusted relative risk, 0.82; 95% confidence interval, 0.7-0.96; P = .01). Withholding ACEI/ARBs prior to surgery was also associated with less risk of clinically important intraoperative hypotension, while the risk of postoperative hypotension was similar between the two groups.

Given that this was an observational study, analysis is limited because of the inability to account for every potential confounding factor.

Bottom Line: The study suggests a lower risk of postoperative death, stroke, and myocardial injury in patients for whom ACEI/ARBs were withheld prior to noncardiac surgery. A large randomized trial is needed to confirm the findings suggested by this analysis.

Citation: Roshanov PS, Rochwerg B, Patel A, et al. Withholding versus continuing angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers before noncardiac surgery.” Anesthesiology. 2017 Jan;126(1):16-27.
 

Dr. Libot is assistant professor in the division of hospital medicine, Loyola University Chicago, Maywood, Ill.

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Perioperative infliximab does not increase serious infection risk

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Administration of infliximab within 4 weeks of elective knee or hip arthroplasty did not have any significant effect on patients’ risk of serious infection after surgery, whereas the use of glucocorticoids increased that risk, in an analysis of a Medicare claims database.

“This increased risk with glucocorticoids has been suggested by previous studies [and] although this risk may be related in part to increased disease severity among glucocorticoid treated patients, a direct medication effect is likely. [These data suggest] that prolonged interruptions in infliximab therapy prior to surgery may be counterproductive if higher dose glucocorticoid therapy is used in substitution,” wrote the authors of the new study, led by Michael D. George, MD, of the University of Pennsylvania in Philadelphia.

Dr. George and his colleagues examined data from the U.S. Medicare claims system on 4,288 elective knee or hip arthroplasties in individuals with rheumatoid arthritis, inflammatory bowel disease, psoriasis, psoriatic arthritis, or ankylosing spondylitis who received infliximab within 6 months prior to the operation during 2007-2013 (Arthritis Care Res. 2017 Jan 27. doi: 10.1002/acr.23209).

The patients had to have received infliximab at least three times within a year of their procedure to establish that they were receiving stable therapy over a long-term period. The investigators also looked at oral prednisone, prednisolone, and methylprednisolone prescriptions and used data on average dosing to determine how much was administered to each subject.

“Although previous studies have treated TNF stopping vs. not stopping as a dichotomous exposure based on an arbitrary (and variable) stopping definition, in this study the primary analysis evaluated stop timing as a more general categorical exposure using 4-week intervals (half the standard rheumatoid arthritis dosing interval) to allow better assessment of the optimal stop timing,” the authors explained.

Stopping infliximab within 4 weeks of the operation did not significantly influence the rate of serious infection within 30 days (adjusted odds ratio, 0.90; 95% CI, 0.60-1.34) and neither did stopping within 4-8 weeks (OR, 0.95; 95% CI, 0.62-1.36) when compared against stopping 8-12 weeks before surgery. Of the 4,288 arthroplasties, 270 serious infections (6.3%) occurred within 30 days of the operation.

There also was no significant difference between stopping within 4 weeks and 8-12 weeks in the rate of prosthetic joint infection within 1 year of the operation (hazard ratio, 0.98; 95% CI, 0.52-1.87). Overall, prosthetic joint infection occurred 2.9 times per 100 person-years.

However, glucocorticoid doses of more than 10 mg per day were risky. The odds for a serious infection within 30 days after surgery more than doubled with that level of use (OR, 2.11; 95% CI, 1.30-3.40), while the risk for a prosthetic joint infection within 1 year of the surgery also rose significantly (HR, 2.70; 95% CI, 1.30-5.60).

Dr. Susan M. Goodman
In an interview, Susan M. Goodman, MD, a rheumatologist at the Hospital for Special Surgery in New York, lauded the study and spoke about the importance of its findings.

“This is a very well done paper that adds important observational data to our understanding of perioperative medication risk,” Dr. Goodman said.

But the study results will not, at least initially, bring about any changes to the proposed guidelines for perioperative management of patients taking antirheumatic drugs that were described at the 2016 annual meeting of the American College of Rheumatology, she said.

“We were aware of the abstract, which was also presented at the ACR last fall at the time the current perioperative medication management guidelines were presented, and it won’t change guidelines at this point,” said Dr. Goodman, who is one of the lead authors of the proposed guidelines. “[But] I think [the study] could provide important background information to use in a randomized clinical trial to compare infection on [and] not on TNF inhibitors.”

The proposed guidelines conditionally recommend that all biologics should be withheld prior to surgery in patients with inflammatory arthritis, that surgery should be planned for the end of the dosing cycle, and that current daily doses of glucocorticoids, rather than supraphysiologic doses, should be continued in adults with rheumatoid arthritis, lupus, or inflammatory arthritis.

The National Institutes of Health, the Rheumatology Research Foundation, and the Department of Veterans Affairs funded the study. Dr. George did not report any relevant financial disclosures. Two coauthors disclosed receiving research grants or consulting fees from pharmaceutical companies for unrelated work.

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Administration of infliximab within 4 weeks of elective knee or hip arthroplasty did not have any significant effect on patients’ risk of serious infection after surgery, whereas the use of glucocorticoids increased that risk, in an analysis of a Medicare claims database.

“This increased risk with glucocorticoids has been suggested by previous studies [and] although this risk may be related in part to increased disease severity among glucocorticoid treated patients, a direct medication effect is likely. [These data suggest] that prolonged interruptions in infliximab therapy prior to surgery may be counterproductive if higher dose glucocorticoid therapy is used in substitution,” wrote the authors of the new study, led by Michael D. George, MD, of the University of Pennsylvania in Philadelphia.

Dr. George and his colleagues examined data from the U.S. Medicare claims system on 4,288 elective knee or hip arthroplasties in individuals with rheumatoid arthritis, inflammatory bowel disease, psoriasis, psoriatic arthritis, or ankylosing spondylitis who received infliximab within 6 months prior to the operation during 2007-2013 (Arthritis Care Res. 2017 Jan 27. doi: 10.1002/acr.23209).

The patients had to have received infliximab at least three times within a year of their procedure to establish that they were receiving stable therapy over a long-term period. The investigators also looked at oral prednisone, prednisolone, and methylprednisolone prescriptions and used data on average dosing to determine how much was administered to each subject.

“Although previous studies have treated TNF stopping vs. not stopping as a dichotomous exposure based on an arbitrary (and variable) stopping definition, in this study the primary analysis evaluated stop timing as a more general categorical exposure using 4-week intervals (half the standard rheumatoid arthritis dosing interval) to allow better assessment of the optimal stop timing,” the authors explained.

Stopping infliximab within 4 weeks of the operation did not significantly influence the rate of serious infection within 30 days (adjusted odds ratio, 0.90; 95% CI, 0.60-1.34) and neither did stopping within 4-8 weeks (OR, 0.95; 95% CI, 0.62-1.36) when compared against stopping 8-12 weeks before surgery. Of the 4,288 arthroplasties, 270 serious infections (6.3%) occurred within 30 days of the operation.

There also was no significant difference between stopping within 4 weeks and 8-12 weeks in the rate of prosthetic joint infection within 1 year of the operation (hazard ratio, 0.98; 95% CI, 0.52-1.87). Overall, prosthetic joint infection occurred 2.9 times per 100 person-years.

However, glucocorticoid doses of more than 10 mg per day were risky. The odds for a serious infection within 30 days after surgery more than doubled with that level of use (OR, 2.11; 95% CI, 1.30-3.40), while the risk for a prosthetic joint infection within 1 year of the surgery also rose significantly (HR, 2.70; 95% CI, 1.30-5.60).

Dr. Susan M. Goodman
In an interview, Susan M. Goodman, MD, a rheumatologist at the Hospital for Special Surgery in New York, lauded the study and spoke about the importance of its findings.

“This is a very well done paper that adds important observational data to our understanding of perioperative medication risk,” Dr. Goodman said.

But the study results will not, at least initially, bring about any changes to the proposed guidelines for perioperative management of patients taking antirheumatic drugs that were described at the 2016 annual meeting of the American College of Rheumatology, she said.

“We were aware of the abstract, which was also presented at the ACR last fall at the time the current perioperative medication management guidelines were presented, and it won’t change guidelines at this point,” said Dr. Goodman, who is one of the lead authors of the proposed guidelines. “[But] I think [the study] could provide important background information to use in a randomized clinical trial to compare infection on [and] not on TNF inhibitors.”

The proposed guidelines conditionally recommend that all biologics should be withheld prior to surgery in patients with inflammatory arthritis, that surgery should be planned for the end of the dosing cycle, and that current daily doses of glucocorticoids, rather than supraphysiologic doses, should be continued in adults with rheumatoid arthritis, lupus, or inflammatory arthritis.

The National Institutes of Health, the Rheumatology Research Foundation, and the Department of Veterans Affairs funded the study. Dr. George did not report any relevant financial disclosures. Two coauthors disclosed receiving research grants or consulting fees from pharmaceutical companies for unrelated work.

 

Administration of infliximab within 4 weeks of elective knee or hip arthroplasty did not have any significant effect on patients’ risk of serious infection after surgery, whereas the use of glucocorticoids increased that risk, in an analysis of a Medicare claims database.

“This increased risk with glucocorticoids has been suggested by previous studies [and] although this risk may be related in part to increased disease severity among glucocorticoid treated patients, a direct medication effect is likely. [These data suggest] that prolonged interruptions in infliximab therapy prior to surgery may be counterproductive if higher dose glucocorticoid therapy is used in substitution,” wrote the authors of the new study, led by Michael D. George, MD, of the University of Pennsylvania in Philadelphia.

Dr. George and his colleagues examined data from the U.S. Medicare claims system on 4,288 elective knee or hip arthroplasties in individuals with rheumatoid arthritis, inflammatory bowel disease, psoriasis, psoriatic arthritis, or ankylosing spondylitis who received infliximab within 6 months prior to the operation during 2007-2013 (Arthritis Care Res. 2017 Jan 27. doi: 10.1002/acr.23209).

The patients had to have received infliximab at least three times within a year of their procedure to establish that they were receiving stable therapy over a long-term period. The investigators also looked at oral prednisone, prednisolone, and methylprednisolone prescriptions and used data on average dosing to determine how much was administered to each subject.

“Although previous studies have treated TNF stopping vs. not stopping as a dichotomous exposure based on an arbitrary (and variable) stopping definition, in this study the primary analysis evaluated stop timing as a more general categorical exposure using 4-week intervals (half the standard rheumatoid arthritis dosing interval) to allow better assessment of the optimal stop timing,” the authors explained.

Stopping infliximab within 4 weeks of the operation did not significantly influence the rate of serious infection within 30 days (adjusted odds ratio, 0.90; 95% CI, 0.60-1.34) and neither did stopping within 4-8 weeks (OR, 0.95; 95% CI, 0.62-1.36) when compared against stopping 8-12 weeks before surgery. Of the 4,288 arthroplasties, 270 serious infections (6.3%) occurred within 30 days of the operation.

There also was no significant difference between stopping within 4 weeks and 8-12 weeks in the rate of prosthetic joint infection within 1 year of the operation (hazard ratio, 0.98; 95% CI, 0.52-1.87). Overall, prosthetic joint infection occurred 2.9 times per 100 person-years.

However, glucocorticoid doses of more than 10 mg per day were risky. The odds for a serious infection within 30 days after surgery more than doubled with that level of use (OR, 2.11; 95% CI, 1.30-3.40), while the risk for a prosthetic joint infection within 1 year of the surgery also rose significantly (HR, 2.70; 95% CI, 1.30-5.60).

Dr. Susan M. Goodman
In an interview, Susan M. Goodman, MD, a rheumatologist at the Hospital for Special Surgery in New York, lauded the study and spoke about the importance of its findings.

“This is a very well done paper that adds important observational data to our understanding of perioperative medication risk,” Dr. Goodman said.

But the study results will not, at least initially, bring about any changes to the proposed guidelines for perioperative management of patients taking antirheumatic drugs that were described at the 2016 annual meeting of the American College of Rheumatology, she said.

“We were aware of the abstract, which was also presented at the ACR last fall at the time the current perioperative medication management guidelines were presented, and it won’t change guidelines at this point,” said Dr. Goodman, who is one of the lead authors of the proposed guidelines. “[But] I think [the study] could provide important background information to use in a randomized clinical trial to compare infection on [and] not on TNF inhibitors.”

The proposed guidelines conditionally recommend that all biologics should be withheld prior to surgery in patients with inflammatory arthritis, that surgery should be planned for the end of the dosing cycle, and that current daily doses of glucocorticoids, rather than supraphysiologic doses, should be continued in adults with rheumatoid arthritis, lupus, or inflammatory arthritis.

The National Institutes of Health, the Rheumatology Research Foundation, and the Department of Veterans Affairs funded the study. Dr. George did not report any relevant financial disclosures. Two coauthors disclosed receiving research grants or consulting fees from pharmaceutical companies for unrelated work.

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Key clinical point: Administering glucocorticoids, but not infliximab, within 4 weeks of elective knee or hip replacement yields higher risk of serious infection after surgery.

Major finding: Subjects on glucocorticoids had an OR of 2.11 (95% CI 1.30-3.40) for serious infection within 30 days and an HR of 2.70 (95% CI 1.30-5.60) for prosthetic joint infection within 1 year.

Data source: Retrospective cohort study of 4,288 elective knee and hip arthroplasties in Medicare patients with rheumatoid arthritis, inflammatory bowel disease, psoriasis, psoriatic arthritis, or ankylosing spondylitis during 2007-2013.

Disclosures: The National Institutes of Health, the Rheumatology Research Foundation, and the Department of Veterans Affairs funded the study. Dr. George did not report any relevant financial disclosures. Two coauthors disclosed receiving research grants or consulting fees from pharmaceutical companies for unrelated work.

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Evidence suggests fondaparinux is more effective than LMWH in prevention of VTE and total DVT in the postoperative setting

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Clinical question: How do pentasaccharides compare to other anticoagulants in postoperative venous thromboembolism prevention?

Background: Venous thromboembolism (VTE) remains a leading cause of preventable hospital related death. Pentasaccharides selectively inhibit factor Xa to inhibit clotting and exhibit a lower risk of heparin induced thrombocytopenia (HIT) compared to low molecular weight heparin (LMWH) and unfractionated heparin. We lack a formal recommendation regarding the pentasaccharides superiority or inferiority, relative to other anticoagulants, in the perioperative setting.

Study design: Cochrane review.

Setting: Hospital and outpatient.

Synopsis: Authors searched randomized controlled trials involving pentasaccharides versus other VTE prophylaxis to obtain 25 studies totaling 21,004 subjects undergoing orthopedic, abdominal, cardiac bypass, thoracic, and bariatric surgery; hospitalized patients, immobilized patients, and those with superficial venous thrombosis. Selected studies pertained to fondaparinux and VTE prevention. Fondaparinux was superior to placebo in prevention of DVT and VTE. Compared to LMWH, fondaparinux reduced total VTE (RR, 0.55, 95% CI, 0.42-0.73) and DVT (RR, 0.54, 95% CI, 0.40-0.71), but carried a higher rate of major bleeding compared to placebo (RR, 2.56, 95% CI, 1.48-4.44) and LMWH (RR, 1.38, 95% CI, 1.09-1.75). The all cause death and major adverse events for fondaparinux versus placebo and LMWH were not statistically significant. Limitations of this review include the predominance of orthopedic patients, variable duration of treatment, and low-moderate quality data.

Bottom line: Fondaparinux demonstrates better perioperative total VTE and DVT reduction compared to LMWH, but it increases the incidence of major bleeding.

Reference: Dong K, Song Y, Li X, Ding J, Gao Z, Lu D, Zhu Y. Pentasaccharides for the prevention of venous thromboembolism. Cochrane Database Syst Rev. 2016 Oct 31;10:CD005134.

Dr. Coleman is an assistant professor of clinical medicine at Cooper Medical School at Rowan University. She works as a hospitalist at Cooper University Hospital in Camden, N.J.

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Clinical question: How do pentasaccharides compare to other anticoagulants in postoperative venous thromboembolism prevention?

Background: Venous thromboembolism (VTE) remains a leading cause of preventable hospital related death. Pentasaccharides selectively inhibit factor Xa to inhibit clotting and exhibit a lower risk of heparin induced thrombocytopenia (HIT) compared to low molecular weight heparin (LMWH) and unfractionated heparin. We lack a formal recommendation regarding the pentasaccharides superiority or inferiority, relative to other anticoagulants, in the perioperative setting.

Study design: Cochrane review.

Setting: Hospital and outpatient.

Synopsis: Authors searched randomized controlled trials involving pentasaccharides versus other VTE prophylaxis to obtain 25 studies totaling 21,004 subjects undergoing orthopedic, abdominal, cardiac bypass, thoracic, and bariatric surgery; hospitalized patients, immobilized patients, and those with superficial venous thrombosis. Selected studies pertained to fondaparinux and VTE prevention. Fondaparinux was superior to placebo in prevention of DVT and VTE. Compared to LMWH, fondaparinux reduced total VTE (RR, 0.55, 95% CI, 0.42-0.73) and DVT (RR, 0.54, 95% CI, 0.40-0.71), but carried a higher rate of major bleeding compared to placebo (RR, 2.56, 95% CI, 1.48-4.44) and LMWH (RR, 1.38, 95% CI, 1.09-1.75). The all cause death and major adverse events for fondaparinux versus placebo and LMWH were not statistically significant. Limitations of this review include the predominance of orthopedic patients, variable duration of treatment, and low-moderate quality data.

Bottom line: Fondaparinux demonstrates better perioperative total VTE and DVT reduction compared to LMWH, but it increases the incidence of major bleeding.

Reference: Dong K, Song Y, Li X, Ding J, Gao Z, Lu D, Zhu Y. Pentasaccharides for the prevention of venous thromboembolism. Cochrane Database Syst Rev. 2016 Oct 31;10:CD005134.

Dr. Coleman is an assistant professor of clinical medicine at Cooper Medical School at Rowan University. She works as a hospitalist at Cooper University Hospital in Camden, N.J.

 

Clinical question: How do pentasaccharides compare to other anticoagulants in postoperative venous thromboembolism prevention?

Background: Venous thromboembolism (VTE) remains a leading cause of preventable hospital related death. Pentasaccharides selectively inhibit factor Xa to inhibit clotting and exhibit a lower risk of heparin induced thrombocytopenia (HIT) compared to low molecular weight heparin (LMWH) and unfractionated heparin. We lack a formal recommendation regarding the pentasaccharides superiority or inferiority, relative to other anticoagulants, in the perioperative setting.

Study design: Cochrane review.

Setting: Hospital and outpatient.

Synopsis: Authors searched randomized controlled trials involving pentasaccharides versus other VTE prophylaxis to obtain 25 studies totaling 21,004 subjects undergoing orthopedic, abdominal, cardiac bypass, thoracic, and bariatric surgery; hospitalized patients, immobilized patients, and those with superficial venous thrombosis. Selected studies pertained to fondaparinux and VTE prevention. Fondaparinux was superior to placebo in prevention of DVT and VTE. Compared to LMWH, fondaparinux reduced total VTE (RR, 0.55, 95% CI, 0.42-0.73) and DVT (RR, 0.54, 95% CI, 0.40-0.71), but carried a higher rate of major bleeding compared to placebo (RR, 2.56, 95% CI, 1.48-4.44) and LMWH (RR, 1.38, 95% CI, 1.09-1.75). The all cause death and major adverse events for fondaparinux versus placebo and LMWH were not statistically significant. Limitations of this review include the predominance of orthopedic patients, variable duration of treatment, and low-moderate quality data.

Bottom line: Fondaparinux demonstrates better perioperative total VTE and DVT reduction compared to LMWH, but it increases the incidence of major bleeding.

Reference: Dong K, Song Y, Li X, Ding J, Gao Z, Lu D, Zhu Y. Pentasaccharides for the prevention of venous thromboembolism. Cochrane Database Syst Rev. 2016 Oct 31;10:CD005134.

Dr. Coleman is an assistant professor of clinical medicine at Cooper Medical School at Rowan University. She works as a hospitalist at Cooper University Hospital in Camden, N.J.

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DVT prophylaxis not needed after casting

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Clinical question: Is DVT prophylaxis necessary with lower leg casting or after knee arthroscopy?

Background: Patients who undergo immobilization from casting or knee arthroscopic surgery are thought to be at increased risk for venous thromboembolism (VTE). Most patients who undergo orthopedic procedures receive thromboprophylaxis but controversy exists surrounding its use in low limb casting or knee arthroscopic surgery. Prior studies did not establish consensus because of methodologic weaknesses.

Study design: Two parallel randomized-controlled, open-label trials with blinded outcome (POD-KAST for knee arthroscopy and POD-CAST for casting lower leg.

Setting: International (32 pediatric intensive care units across Asia, Australia, Europe, and North America).

Dr. Elizabeth Cerceo


Synopsis: Patients were randomly assigned to receive either a prophylactic dose of low-molecular-weight heparin (either for the 8 days after arthroscopy or for the duration of casting-related immobilization) or no anticoagulant therapy. The primary outcomes were the cumulative incidences of symptomatic venous thromboembolism (VTE) and major bleeding within 3 months after the procedure. For the 1,543 patients undergoing knee arthroscopy, VTE occurred in 0.7% of the treatment group and 0.4% of the control group (relative risk, 1.6; 95% confidence interval [CI], 0.4-6.8; absolute difference in risk, 0.3 percentage points; 95% CI, −0.6 to 1.2) and major bleeding was seen in 0.1% of both groups.

For the 1,519 patients undergoing knee arthroscopy, VTE occurred in 1.4% of the treatment group and 1.8% of the control group (relative risk, 0.8; 95% CI, 0.3-1.7; absolute difference in risk, −0.4 percentage points; 95% CI, −1.8 to 1.0) and no episodes of major bleeding were reported in either group.

Bottom line: VTE prophylaxis either after arthroscopy or during immobilization from casting did not prevent DVT.

Citations: Van Adrichem RA, Nemeth B, Algra A, et al. Thromboprophylaxis after knee arthroscopy and low-leg casting. N Engl J Med. 2016 Dec 3. doi: 10.1056/NEJMoa1613303.
 

Dr. Cerceo is assistant professor in the division of hospital medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.

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Clinical question: Is DVT prophylaxis necessary with lower leg casting or after knee arthroscopy?

Background: Patients who undergo immobilization from casting or knee arthroscopic surgery are thought to be at increased risk for venous thromboembolism (VTE). Most patients who undergo orthopedic procedures receive thromboprophylaxis but controversy exists surrounding its use in low limb casting or knee arthroscopic surgery. Prior studies did not establish consensus because of methodologic weaknesses.

Study design: Two parallel randomized-controlled, open-label trials with blinded outcome (POD-KAST for knee arthroscopy and POD-CAST for casting lower leg.

Setting: International (32 pediatric intensive care units across Asia, Australia, Europe, and North America).

Dr. Elizabeth Cerceo


Synopsis: Patients were randomly assigned to receive either a prophylactic dose of low-molecular-weight heparin (either for the 8 days after arthroscopy or for the duration of casting-related immobilization) or no anticoagulant therapy. The primary outcomes were the cumulative incidences of symptomatic venous thromboembolism (VTE) and major bleeding within 3 months after the procedure. For the 1,543 patients undergoing knee arthroscopy, VTE occurred in 0.7% of the treatment group and 0.4% of the control group (relative risk, 1.6; 95% confidence interval [CI], 0.4-6.8; absolute difference in risk, 0.3 percentage points; 95% CI, −0.6 to 1.2) and major bleeding was seen in 0.1% of both groups.

For the 1,519 patients undergoing knee arthroscopy, VTE occurred in 1.4% of the treatment group and 1.8% of the control group (relative risk, 0.8; 95% CI, 0.3-1.7; absolute difference in risk, −0.4 percentage points; 95% CI, −1.8 to 1.0) and no episodes of major bleeding were reported in either group.

Bottom line: VTE prophylaxis either after arthroscopy or during immobilization from casting did not prevent DVT.

Citations: Van Adrichem RA, Nemeth B, Algra A, et al. Thromboprophylaxis after knee arthroscopy and low-leg casting. N Engl J Med. 2016 Dec 3. doi: 10.1056/NEJMoa1613303.
 

Dr. Cerceo is assistant professor in the division of hospital medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.

 

Clinical question: Is DVT prophylaxis necessary with lower leg casting or after knee arthroscopy?

Background: Patients who undergo immobilization from casting or knee arthroscopic surgery are thought to be at increased risk for venous thromboembolism (VTE). Most patients who undergo orthopedic procedures receive thromboprophylaxis but controversy exists surrounding its use in low limb casting or knee arthroscopic surgery. Prior studies did not establish consensus because of methodologic weaknesses.

Study design: Two parallel randomized-controlled, open-label trials with blinded outcome (POD-KAST for knee arthroscopy and POD-CAST for casting lower leg.

Setting: International (32 pediatric intensive care units across Asia, Australia, Europe, and North America).

Dr. Elizabeth Cerceo


Synopsis: Patients were randomly assigned to receive either a prophylactic dose of low-molecular-weight heparin (either for the 8 days after arthroscopy or for the duration of casting-related immobilization) or no anticoagulant therapy. The primary outcomes were the cumulative incidences of symptomatic venous thromboembolism (VTE) and major bleeding within 3 months after the procedure. For the 1,543 patients undergoing knee arthroscopy, VTE occurred in 0.7% of the treatment group and 0.4% of the control group (relative risk, 1.6; 95% confidence interval [CI], 0.4-6.8; absolute difference in risk, 0.3 percentage points; 95% CI, −0.6 to 1.2) and major bleeding was seen in 0.1% of both groups.

For the 1,519 patients undergoing knee arthroscopy, VTE occurred in 1.4% of the treatment group and 1.8% of the control group (relative risk, 0.8; 95% CI, 0.3-1.7; absolute difference in risk, −0.4 percentage points; 95% CI, −1.8 to 1.0) and no episodes of major bleeding were reported in either group.

Bottom line: VTE prophylaxis either after arthroscopy or during immobilization from casting did not prevent DVT.

Citations: Van Adrichem RA, Nemeth B, Algra A, et al. Thromboprophylaxis after knee arthroscopy and low-leg casting. N Engl J Med. 2016 Dec 3. doi: 10.1056/NEJMoa1613303.
 

Dr. Cerceo is assistant professor in the division of hospital medicine, and associate director of the internal medicine residency program at Cooper Medical School of Rowan University, Camden, N.J.

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TAVR concerns hinder use in younger, lower-risk patients

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– Despite increasing use of transcatheter aortic valve replacement for patients with severe aortic stenosis at intermediate risk for surgery, the procedure is meeting selected resistance because of ongoing concerns about the procedure’s limitations.

As more data emerge from randomized trials and registries, cardiologists and cardiothoracic surgeons see the choice between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) for patients at intermediate surgical risk as something to individualize based on factors that include age, the type of TAVR access possible (transfemoral or an alternative route), and of course, patient preference. An added variable is the constant stream of new data that keeps TAVR in flux, with improved and smaller valves and delivery systems coming onto the market that eclipse the experience and lessons learned from older TAVR systems.

In intermediate-risk patients, usually defined as those with a Society of Thoracic Surgeons (STS) mortality risk score of 4%-8%, “I think you can go either way,” said Frank W. Sellke, MD, at the American Heart Association scientific sessions.

“If a patient is 90 years old and can’t expect to live more than a couple of years, you use TAVR; but if the patient is 55 years old and can expect to live 30 years, I would recommend SAVR,” said Dr. Sellke, professor and chief of cardiothoracic surgery at Brown University in Providence, R.I.

He rattled off four things about TAVR that keep it from being for everyone: periprocedural vascular complications, higher rates of paravalvular leak than with surgery, leaflet thrombosis (a phenomenon with unclear clinical consequences), and undocumented long-term durability.

Dr. Sellke made these comments while discussing the report at the meeting on registry data collected from nearly 6,000 intermediate-risk patients who underwent TAVR or SAVR in Germany during January 2011 through December 2013 and assembled in the German Aortic Valve Registry. During that 3-year period, German TAVR patients could receive either the SAPIEN XT valve or the CoreValve, two TAVR systems that now have been superseded in both Europe and the United States by next-generation systems, SAPIEN 3 and Evolut R.

Limitations of a transthoracic approach

Another factor limiting TAVR is the endovascular approach. The best TAVR results by far have come from using a transfemoral approach for endovascular valve placement, but experts estimate that today at least 10% of patients considered for TAVR have a vascular anatomy that makes the transfemoral TAVR impossible. In the past, when such patients underwent TAVR, it was via either a transapical or transaortic approach (collectively called transthoracic), although additional endovascular entry sites are now being tested.

The limitations of transthoracic TAVR were underscored by results from a prespecified quality-of-life analysis done as part of the PARTNER 2 trial that compared the SAPIEN XT system with SAVR in intermediate-risk patients (N Engl J Med. 2016 April 27;374[17]:1609-20).

Mitchel L. Zoler/Frontline Medical News
Dr. David J. Cohen
“The most important finding was a significant interaction of health status and TAVR access site,” said David J. Cohen, MD, in presenting the findings at the Transcatheter Cardiovascular Therapeutics annual meeting in Washington. In PARTNER 2, of the 1,011 patients who underwent TAVR, 775 (77%) had their procedure via a transfemoral approach, and 236 (23%) had it by a transthoracic approach. At 1 month after treatment, the average overall summary score on the Kansas City Cardiomyopathy Questionnaire (KCCQ) had increased by 14 points among the transfemoral TAVR patients, compared with the randomized SAVR patients, a short-term gain in health status by the TAVR patients over the SAVR patients that was both statistically significant and highly clinically meaningful (a 5-point increase in KCCQ score is considered clinically meaningful), reported Dr. Cohen, director of cardiovascular research and an interventional cardiologist at St. Luke’s Health System in Kansas City, Mo.

In contrast, the patients in the study who had their TAVR done by a transthoracic route had a statistically nonsignificant incremental gain in their KCCQ score, compared with randomized SAVR patients, after 1 month, and their incremental rise in KCCQ score was not clinically meaningful.

The investigators measured KCCQ scores at both 1 and 2 years after treatment, and they were similar regardless of whether patients had undergone TAVR or SAVR in both the transfemoral and transthoracic subgroups. All the quality-of-life benefit from TAVR compared with SAVR occurred only during the first month (and possibly for a few additional months beyond that) and only in TAVR patients treated by the transfemoral route. Dr. Cohen stressed that the SAVR patients in both the transfemoral and transthoracic subgroups had very similar outcomes, showing that patient differences could not explain why the transfemoral patients received a much greater incremental benefit, compared with the SAVR patients, at 1 month than did the transthoracic patients.

“A transthoracic TAVR approach may not be preferable to SAVR, at least in the short to intermediate term,” said Dr. Cohen. “There is no benefit from TAVR, compared with SAVR, if you can’t do it transfemorally, although emerging evidence has suggested that other nontransfemoral approaches that stay out of the chest may provide benefit similar to transfemoral TAVR. The message is, stay out of the chest,” he concluded.

 

 

Mitchel L. Zoler/Frontline Medical News
Dr. Craig R. Smith
Clinicians had already begun to appreciate the limitations of transthoracic TAVR based on prior reports, noted Craig R. Smith, MD, professor and chairman of surgery at Columbia University Medical Center in New York. “Transapical and transaortic approaches are playing increasingly small roles,” he said in an interview during the American Heart Association meeting. “A strong argument can be made for using SAVR if the patient is not a candidate for transfemoral TAVR; it’s how patients are often triaged.”

Concerns about durability

The durability of TAVR valves is another concern that has recently been influencing patients as they decide between TAVR and SAVR, said Dr. Smith. “A lot of patients don’t want TAVR because of their concerns about its durability.” These patients usually cite evidence reported in May 2016 at the annual congress of the European Association of Percutaneous Cardiovascular Interventions in Paris by Danny Dvir, MD, on longer-term follow-up of 378 patients who underwent TAVR at either of two pioneering centers. A retrospective review suggested a valve degeneration rate of about 50% after 8 years, Dr. Dvir reported.

This report “has gotten a lot of penetration over the Internet, and a lot of patients don’t like the uncertainty” about TAVR durability that this report produced. “A lot of the time now, patients come in with a fixed idea of whether they want TAVR or SAVR,” Dr. Smith said.

Dr. Smith essentially agreed with Dr. Sellke on the current role for TAVR relative to SAVR in lower-risk patients.

“If the patient is clearly intermediate risk, with an STS mortality risk of more than 6% and is at least 80 years old, then they’ll have TAVR 99% of the time. But if it’s a 75 year old with an STS score of 3.2% and otherwise healthy, the best choice is not as clear.”

Another cardiothoracic surgeon with lots of TAVR experience, Michael J. Reardon, MD, has much more enthusiasm for TAVR. “In my practice, I use TAVR exclusively in patients at least 80 years old. I don‘t care how healthy they look,” said Dr. Reardon, professor of cardiovascular surgery at Houston Methodist. He acknowledged that broader use of TAVR for intermediate-risk patients is getting push back from other cardiothoracic surgeons.

Dr. Sellke is one such surgeon, and he called uncertain TAVR valve durability the deciding factor. “We need longer-term data on [TAVR] valve longevity before we routinely put them into intermediate- or low-risk patients,” he said during a panel discussion at the meeting.

Dr. Reardon highlighted that newer TAVR systems have been reducing problems such as paravalvular leaks and the need for pacemakers following placement of self-expanding TAVR valves. Despite these technical improvements, the final frontier for TAVR for lower-risk patients is valve durability, Dr. Reardon said in an interview.

“I’m convinced the durability is there, and that any 80-year-old patient who is anatomically suited for transfemoral TAVR should get it no matter now healthy they look. If their likely survival is 15 years or less, then they are reasonable candidates for TAVR.”

Dr. Sellke had no relevant disclosures. PARTNER 2 was funded by Edwards, the company that markets Sapient TAVR systems. Dr. Cohen had no relevant disclosures. Dr. Smith has been an investigator in the PARTNER studies. Dr. Reardon has been a consultant to Medtronic, the company that markets the CoreValve and Evolut R TAVR systems.

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– Despite increasing use of transcatheter aortic valve replacement for patients with severe aortic stenosis at intermediate risk for surgery, the procedure is meeting selected resistance because of ongoing concerns about the procedure’s limitations.

As more data emerge from randomized trials and registries, cardiologists and cardiothoracic surgeons see the choice between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) for patients at intermediate surgical risk as something to individualize based on factors that include age, the type of TAVR access possible (transfemoral or an alternative route), and of course, patient preference. An added variable is the constant stream of new data that keeps TAVR in flux, with improved and smaller valves and delivery systems coming onto the market that eclipse the experience and lessons learned from older TAVR systems.

In intermediate-risk patients, usually defined as those with a Society of Thoracic Surgeons (STS) mortality risk score of 4%-8%, “I think you can go either way,” said Frank W. Sellke, MD, at the American Heart Association scientific sessions.

“If a patient is 90 years old and can’t expect to live more than a couple of years, you use TAVR; but if the patient is 55 years old and can expect to live 30 years, I would recommend SAVR,” said Dr. Sellke, professor and chief of cardiothoracic surgery at Brown University in Providence, R.I.

He rattled off four things about TAVR that keep it from being for everyone: periprocedural vascular complications, higher rates of paravalvular leak than with surgery, leaflet thrombosis (a phenomenon with unclear clinical consequences), and undocumented long-term durability.

Dr. Sellke made these comments while discussing the report at the meeting on registry data collected from nearly 6,000 intermediate-risk patients who underwent TAVR or SAVR in Germany during January 2011 through December 2013 and assembled in the German Aortic Valve Registry. During that 3-year period, German TAVR patients could receive either the SAPIEN XT valve or the CoreValve, two TAVR systems that now have been superseded in both Europe and the United States by next-generation systems, SAPIEN 3 and Evolut R.

Limitations of a transthoracic approach

Another factor limiting TAVR is the endovascular approach. The best TAVR results by far have come from using a transfemoral approach for endovascular valve placement, but experts estimate that today at least 10% of patients considered for TAVR have a vascular anatomy that makes the transfemoral TAVR impossible. In the past, when such patients underwent TAVR, it was via either a transapical or transaortic approach (collectively called transthoracic), although additional endovascular entry sites are now being tested.

The limitations of transthoracic TAVR were underscored by results from a prespecified quality-of-life analysis done as part of the PARTNER 2 trial that compared the SAPIEN XT system with SAVR in intermediate-risk patients (N Engl J Med. 2016 April 27;374[17]:1609-20).

Mitchel L. Zoler/Frontline Medical News
Dr. David J. Cohen
“The most important finding was a significant interaction of health status and TAVR access site,” said David J. Cohen, MD, in presenting the findings at the Transcatheter Cardiovascular Therapeutics annual meeting in Washington. In PARTNER 2, of the 1,011 patients who underwent TAVR, 775 (77%) had their procedure via a transfemoral approach, and 236 (23%) had it by a transthoracic approach. At 1 month after treatment, the average overall summary score on the Kansas City Cardiomyopathy Questionnaire (KCCQ) had increased by 14 points among the transfemoral TAVR patients, compared with the randomized SAVR patients, a short-term gain in health status by the TAVR patients over the SAVR patients that was both statistically significant and highly clinically meaningful (a 5-point increase in KCCQ score is considered clinically meaningful), reported Dr. Cohen, director of cardiovascular research and an interventional cardiologist at St. Luke’s Health System in Kansas City, Mo.

In contrast, the patients in the study who had their TAVR done by a transthoracic route had a statistically nonsignificant incremental gain in their KCCQ score, compared with randomized SAVR patients, after 1 month, and their incremental rise in KCCQ score was not clinically meaningful.

The investigators measured KCCQ scores at both 1 and 2 years after treatment, and they were similar regardless of whether patients had undergone TAVR or SAVR in both the transfemoral and transthoracic subgroups. All the quality-of-life benefit from TAVR compared with SAVR occurred only during the first month (and possibly for a few additional months beyond that) and only in TAVR patients treated by the transfemoral route. Dr. Cohen stressed that the SAVR patients in both the transfemoral and transthoracic subgroups had very similar outcomes, showing that patient differences could not explain why the transfemoral patients received a much greater incremental benefit, compared with the SAVR patients, at 1 month than did the transthoracic patients.

“A transthoracic TAVR approach may not be preferable to SAVR, at least in the short to intermediate term,” said Dr. Cohen. “There is no benefit from TAVR, compared with SAVR, if you can’t do it transfemorally, although emerging evidence has suggested that other nontransfemoral approaches that stay out of the chest may provide benefit similar to transfemoral TAVR. The message is, stay out of the chest,” he concluded.

 

 

Mitchel L. Zoler/Frontline Medical News
Dr. Craig R. Smith
Clinicians had already begun to appreciate the limitations of transthoracic TAVR based on prior reports, noted Craig R. Smith, MD, professor and chairman of surgery at Columbia University Medical Center in New York. “Transapical and transaortic approaches are playing increasingly small roles,” he said in an interview during the American Heart Association meeting. “A strong argument can be made for using SAVR if the patient is not a candidate for transfemoral TAVR; it’s how patients are often triaged.”

Concerns about durability

The durability of TAVR valves is another concern that has recently been influencing patients as they decide between TAVR and SAVR, said Dr. Smith. “A lot of patients don’t want TAVR because of their concerns about its durability.” These patients usually cite evidence reported in May 2016 at the annual congress of the European Association of Percutaneous Cardiovascular Interventions in Paris by Danny Dvir, MD, on longer-term follow-up of 378 patients who underwent TAVR at either of two pioneering centers. A retrospective review suggested a valve degeneration rate of about 50% after 8 years, Dr. Dvir reported.

This report “has gotten a lot of penetration over the Internet, and a lot of patients don’t like the uncertainty” about TAVR durability that this report produced. “A lot of the time now, patients come in with a fixed idea of whether they want TAVR or SAVR,” Dr. Smith said.

Dr. Smith essentially agreed with Dr. Sellke on the current role for TAVR relative to SAVR in lower-risk patients.

“If the patient is clearly intermediate risk, with an STS mortality risk of more than 6% and is at least 80 years old, then they’ll have TAVR 99% of the time. But if it’s a 75 year old with an STS score of 3.2% and otherwise healthy, the best choice is not as clear.”

Another cardiothoracic surgeon with lots of TAVR experience, Michael J. Reardon, MD, has much more enthusiasm for TAVR. “In my practice, I use TAVR exclusively in patients at least 80 years old. I don‘t care how healthy they look,” said Dr. Reardon, professor of cardiovascular surgery at Houston Methodist. He acknowledged that broader use of TAVR for intermediate-risk patients is getting push back from other cardiothoracic surgeons.

Dr. Sellke is one such surgeon, and he called uncertain TAVR valve durability the deciding factor. “We need longer-term data on [TAVR] valve longevity before we routinely put them into intermediate- or low-risk patients,” he said during a panel discussion at the meeting.

Dr. Reardon highlighted that newer TAVR systems have been reducing problems such as paravalvular leaks and the need for pacemakers following placement of self-expanding TAVR valves. Despite these technical improvements, the final frontier for TAVR for lower-risk patients is valve durability, Dr. Reardon said in an interview.

“I’m convinced the durability is there, and that any 80-year-old patient who is anatomically suited for transfemoral TAVR should get it no matter now healthy they look. If their likely survival is 15 years or less, then they are reasonable candidates for TAVR.”

Dr. Sellke had no relevant disclosures. PARTNER 2 was funded by Edwards, the company that markets Sapient TAVR systems. Dr. Cohen had no relevant disclosures. Dr. Smith has been an investigator in the PARTNER studies. Dr. Reardon has been a consultant to Medtronic, the company that markets the CoreValve and Evolut R TAVR systems.

 

– Despite increasing use of transcatheter aortic valve replacement for patients with severe aortic stenosis at intermediate risk for surgery, the procedure is meeting selected resistance because of ongoing concerns about the procedure’s limitations.

As more data emerge from randomized trials and registries, cardiologists and cardiothoracic surgeons see the choice between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) for patients at intermediate surgical risk as something to individualize based on factors that include age, the type of TAVR access possible (transfemoral or an alternative route), and of course, patient preference. An added variable is the constant stream of new data that keeps TAVR in flux, with improved and smaller valves and delivery systems coming onto the market that eclipse the experience and lessons learned from older TAVR systems.

In intermediate-risk patients, usually defined as those with a Society of Thoracic Surgeons (STS) mortality risk score of 4%-8%, “I think you can go either way,” said Frank W. Sellke, MD, at the American Heart Association scientific sessions.

“If a patient is 90 years old and can’t expect to live more than a couple of years, you use TAVR; but if the patient is 55 years old and can expect to live 30 years, I would recommend SAVR,” said Dr. Sellke, professor and chief of cardiothoracic surgery at Brown University in Providence, R.I.

He rattled off four things about TAVR that keep it from being for everyone: periprocedural vascular complications, higher rates of paravalvular leak than with surgery, leaflet thrombosis (a phenomenon with unclear clinical consequences), and undocumented long-term durability.

Dr. Sellke made these comments while discussing the report at the meeting on registry data collected from nearly 6,000 intermediate-risk patients who underwent TAVR or SAVR in Germany during January 2011 through December 2013 and assembled in the German Aortic Valve Registry. During that 3-year period, German TAVR patients could receive either the SAPIEN XT valve or the CoreValve, two TAVR systems that now have been superseded in both Europe and the United States by next-generation systems, SAPIEN 3 and Evolut R.

Limitations of a transthoracic approach

Another factor limiting TAVR is the endovascular approach. The best TAVR results by far have come from using a transfemoral approach for endovascular valve placement, but experts estimate that today at least 10% of patients considered for TAVR have a vascular anatomy that makes the transfemoral TAVR impossible. In the past, when such patients underwent TAVR, it was via either a transapical or transaortic approach (collectively called transthoracic), although additional endovascular entry sites are now being tested.

The limitations of transthoracic TAVR were underscored by results from a prespecified quality-of-life analysis done as part of the PARTNER 2 trial that compared the SAPIEN XT system with SAVR in intermediate-risk patients (N Engl J Med. 2016 April 27;374[17]:1609-20).

Mitchel L. Zoler/Frontline Medical News
Dr. David J. Cohen
“The most important finding was a significant interaction of health status and TAVR access site,” said David J. Cohen, MD, in presenting the findings at the Transcatheter Cardiovascular Therapeutics annual meeting in Washington. In PARTNER 2, of the 1,011 patients who underwent TAVR, 775 (77%) had their procedure via a transfemoral approach, and 236 (23%) had it by a transthoracic approach. At 1 month after treatment, the average overall summary score on the Kansas City Cardiomyopathy Questionnaire (KCCQ) had increased by 14 points among the transfemoral TAVR patients, compared with the randomized SAVR patients, a short-term gain in health status by the TAVR patients over the SAVR patients that was both statistically significant and highly clinically meaningful (a 5-point increase in KCCQ score is considered clinically meaningful), reported Dr. Cohen, director of cardiovascular research and an interventional cardiologist at St. Luke’s Health System in Kansas City, Mo.

In contrast, the patients in the study who had their TAVR done by a transthoracic route had a statistically nonsignificant incremental gain in their KCCQ score, compared with randomized SAVR patients, after 1 month, and their incremental rise in KCCQ score was not clinically meaningful.

The investigators measured KCCQ scores at both 1 and 2 years after treatment, and they were similar regardless of whether patients had undergone TAVR or SAVR in both the transfemoral and transthoracic subgroups. All the quality-of-life benefit from TAVR compared with SAVR occurred only during the first month (and possibly for a few additional months beyond that) and only in TAVR patients treated by the transfemoral route. Dr. Cohen stressed that the SAVR patients in both the transfemoral and transthoracic subgroups had very similar outcomes, showing that patient differences could not explain why the transfemoral patients received a much greater incremental benefit, compared with the SAVR patients, at 1 month than did the transthoracic patients.

“A transthoracic TAVR approach may not be preferable to SAVR, at least in the short to intermediate term,” said Dr. Cohen. “There is no benefit from TAVR, compared with SAVR, if you can’t do it transfemorally, although emerging evidence has suggested that other nontransfemoral approaches that stay out of the chest may provide benefit similar to transfemoral TAVR. The message is, stay out of the chest,” he concluded.

 

 

Mitchel L. Zoler/Frontline Medical News
Dr. Craig R. Smith
Clinicians had already begun to appreciate the limitations of transthoracic TAVR based on prior reports, noted Craig R. Smith, MD, professor and chairman of surgery at Columbia University Medical Center in New York. “Transapical and transaortic approaches are playing increasingly small roles,” he said in an interview during the American Heart Association meeting. “A strong argument can be made for using SAVR if the patient is not a candidate for transfemoral TAVR; it’s how patients are often triaged.”

Concerns about durability

The durability of TAVR valves is another concern that has recently been influencing patients as they decide between TAVR and SAVR, said Dr. Smith. “A lot of patients don’t want TAVR because of their concerns about its durability.” These patients usually cite evidence reported in May 2016 at the annual congress of the European Association of Percutaneous Cardiovascular Interventions in Paris by Danny Dvir, MD, on longer-term follow-up of 378 patients who underwent TAVR at either of two pioneering centers. A retrospective review suggested a valve degeneration rate of about 50% after 8 years, Dr. Dvir reported.

This report “has gotten a lot of penetration over the Internet, and a lot of patients don’t like the uncertainty” about TAVR durability that this report produced. “A lot of the time now, patients come in with a fixed idea of whether they want TAVR or SAVR,” Dr. Smith said.

Dr. Smith essentially agreed with Dr. Sellke on the current role for TAVR relative to SAVR in lower-risk patients.

“If the patient is clearly intermediate risk, with an STS mortality risk of more than 6% and is at least 80 years old, then they’ll have TAVR 99% of the time. But if it’s a 75 year old with an STS score of 3.2% and otherwise healthy, the best choice is not as clear.”

Another cardiothoracic surgeon with lots of TAVR experience, Michael J. Reardon, MD, has much more enthusiasm for TAVR. “In my practice, I use TAVR exclusively in patients at least 80 years old. I don‘t care how healthy they look,” said Dr. Reardon, professor of cardiovascular surgery at Houston Methodist. He acknowledged that broader use of TAVR for intermediate-risk patients is getting push back from other cardiothoracic surgeons.

Dr. Sellke is one such surgeon, and he called uncertain TAVR valve durability the deciding factor. “We need longer-term data on [TAVR] valve longevity before we routinely put them into intermediate- or low-risk patients,” he said during a panel discussion at the meeting.

Dr. Reardon highlighted that newer TAVR systems have been reducing problems such as paravalvular leaks and the need for pacemakers following placement of self-expanding TAVR valves. Despite these technical improvements, the final frontier for TAVR for lower-risk patients is valve durability, Dr. Reardon said in an interview.

“I’m convinced the durability is there, and that any 80-year-old patient who is anatomically suited for transfemoral TAVR should get it no matter now healthy they look. If their likely survival is 15 years or less, then they are reasonable candidates for TAVR.”

Dr. Sellke had no relevant disclosures. PARTNER 2 was funded by Edwards, the company that markets Sapient TAVR systems. Dr. Cohen had no relevant disclosures. Dr. Smith has been an investigator in the PARTNER studies. Dr. Reardon has been a consultant to Medtronic, the company that markets the CoreValve and Evolut R TAVR systems.

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EXPERT ANALYSIS FROM THE AHA SCIENTIFIC SESSIONS

Disallow All Ads

AGA Guideline: Preventing Crohn’s recurrence after resection

Article Type
Changed
Fri, 01/18/2019 - 16:24

Patients whose Crohn’s disease fully remits after resection should not wait for endoscopic recurrence to start tumor-necrosis-factor inhibitors or thiopurines, according to a new guideline from the American Gastroenterological Association.

Patients who are low risk or worried about side effects, however, “may reasonably select endoscopy-guided pharmacological treatment,” the guidelines state (doi: 10.1053/j.gastro.2016.10.038).

Dr. Geoffrey C. Nguyen
About half of patients need surgical resection within 10 years of a Crohn’s disease diagnosis, and about one in four of those who undergo surgery need another resection within 5 years, noted Geoffrey C. Nguyen, MD, PhD, of the University of Toronto, and his associates. Accordingly, they developed recommendations for preventing multiple surgeries in patients who have no evidence of disease after initial resection. Surgical recurrence was rare in the clinical trials these experts evaluated, so they used endoscopic recurrence as a proxy.

Early pharmacologic prophylaxis usually begins within 8 weeks of surgery, they noted. Whether this approach bests endoscopy-guided treatment is unclear: In one small trial (Gastroenterology. 2013;145[4]:766-74.e1), early azathioprine therapy failed to best endoscopy-guided therapy for preventing clinical or endoscopic recurrence.

Early prophylaxis, however, is usually reasonable because most Crohn’s patients who undergo surgery have at least one risk factor for recurrence, Dr. Nguyen and his associates emphasize. They suggest reserving endoscopy-guided therapy for patients who have real concerns about side effects and are at low risk, such as nonsmokers who were diagnosed within 10 years and have less than 10-20 cm of fibrostenotic disease.

For prophylaxis, a moderate amount of evidence supports anti–tumor necrosis factor (TNF) agents, thiopurines, or combined therapy over other agents, the guideline also states. In placebo-controlled clinical trials, anti-TNF therapy reduced the chances of clinical recurrence by 49% and endoscopic recurrence by 76%, while thiopurines cut these rates by 65% and 60%, respectively. Evidence favors anti-TNF agents over thiopurines for preventing recurrence, but it is of low quality, the guideline says. Furthermore, only indirect evidence supports combined therapy in patients at highest risk of recurrence.

Among the antibiotics, only nitroimidazoles such as metronidazole have been adequately studied, and they posted worse results than anti-TNF agents or thiopurines. Antibiotic therapy decreased the risk of endoscopic recurrence of Crohn’s disease by about 50%, but long-term use is associated with peripheral neuropathy and disease usually recurs within 2 years of stopping treatment. Accordingly, the guidelines suggest using a nitroimidazole for only 3-12 months, and only in lower-risk patients who are concerned about the adverse effects of anti-TNF agents and thiopurines.
 

 

The AGA made a conditional recommendation against the prophylactic use of budesonide, probiotics, and 5-aminosalicylates such as mesalamine. Only low-quality evidence supports their efficacy after resection, and by using these agents, clinicians may inadvertently boost the risk of recurrence by forgoing better therapies, the guideline states.

The initial endoscopy should be timed for 6-12 months after resection, regardless of whether patients are receiving pharmacologic prophylaxis, the guideline states. If there is endoscopic recurrence, then anti-TNF or thiopurine therapy should be started or optimized.

In the Postoperative Crohn’s Endoscopic Recurrence (POCER) trial, endoscopic monitoring and treatment escalation in the face of endoscopic recurrence cut the risk of subsequent clinical and endoscopic recurrence by about 18% and 27%, respectively, compared with continuing the original treatment regimen. Most patients received azathioprine or adalimumab with 3 months of metronidazole postoperatively, so “even [those] who were already on postoperative prophylaxis benefited from endoscopic monitoring with colonoscopy at 6-12 months,” the guideline notes. However, patients who elect early prophylaxis after resection can reasonably forego colonoscopy if endoscopic recurrence is unlikely to affect their treatment plan, the AGA states. The guideline strongly recommends ongoing surveillance endoscopies if patients decide against early postresection prophylaxis, but notes a lack of evidence on how far to space out these procedures.

None of the authors had relevant financial disclosures.

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Patients whose Crohn’s disease fully remits after resection should not wait for endoscopic recurrence to start tumor-necrosis-factor inhibitors or thiopurines, according to a new guideline from the American Gastroenterological Association.

Patients who are low risk or worried about side effects, however, “may reasonably select endoscopy-guided pharmacological treatment,” the guidelines state (doi: 10.1053/j.gastro.2016.10.038).

Dr. Geoffrey C. Nguyen
About half of patients need surgical resection within 10 years of a Crohn’s disease diagnosis, and about one in four of those who undergo surgery need another resection within 5 years, noted Geoffrey C. Nguyen, MD, PhD, of the University of Toronto, and his associates. Accordingly, they developed recommendations for preventing multiple surgeries in patients who have no evidence of disease after initial resection. Surgical recurrence was rare in the clinical trials these experts evaluated, so they used endoscopic recurrence as a proxy.

Early pharmacologic prophylaxis usually begins within 8 weeks of surgery, they noted. Whether this approach bests endoscopy-guided treatment is unclear: In one small trial (Gastroenterology. 2013;145[4]:766-74.e1), early azathioprine therapy failed to best endoscopy-guided therapy for preventing clinical or endoscopic recurrence.

Early prophylaxis, however, is usually reasonable because most Crohn’s patients who undergo surgery have at least one risk factor for recurrence, Dr. Nguyen and his associates emphasize. They suggest reserving endoscopy-guided therapy for patients who have real concerns about side effects and are at low risk, such as nonsmokers who were diagnosed within 10 years and have less than 10-20 cm of fibrostenotic disease.

For prophylaxis, a moderate amount of evidence supports anti–tumor necrosis factor (TNF) agents, thiopurines, or combined therapy over other agents, the guideline also states. In placebo-controlled clinical trials, anti-TNF therapy reduced the chances of clinical recurrence by 49% and endoscopic recurrence by 76%, while thiopurines cut these rates by 65% and 60%, respectively. Evidence favors anti-TNF agents over thiopurines for preventing recurrence, but it is of low quality, the guideline says. Furthermore, only indirect evidence supports combined therapy in patients at highest risk of recurrence.

Among the antibiotics, only nitroimidazoles such as metronidazole have been adequately studied, and they posted worse results than anti-TNF agents or thiopurines. Antibiotic therapy decreased the risk of endoscopic recurrence of Crohn’s disease by about 50%, but long-term use is associated with peripheral neuropathy and disease usually recurs within 2 years of stopping treatment. Accordingly, the guidelines suggest using a nitroimidazole for only 3-12 months, and only in lower-risk patients who are concerned about the adverse effects of anti-TNF agents and thiopurines.
 

 

The AGA made a conditional recommendation against the prophylactic use of budesonide, probiotics, and 5-aminosalicylates such as mesalamine. Only low-quality evidence supports their efficacy after resection, and by using these agents, clinicians may inadvertently boost the risk of recurrence by forgoing better therapies, the guideline states.

The initial endoscopy should be timed for 6-12 months after resection, regardless of whether patients are receiving pharmacologic prophylaxis, the guideline states. If there is endoscopic recurrence, then anti-TNF or thiopurine therapy should be started or optimized.

In the Postoperative Crohn’s Endoscopic Recurrence (POCER) trial, endoscopic monitoring and treatment escalation in the face of endoscopic recurrence cut the risk of subsequent clinical and endoscopic recurrence by about 18% and 27%, respectively, compared with continuing the original treatment regimen. Most patients received azathioprine or adalimumab with 3 months of metronidazole postoperatively, so “even [those] who were already on postoperative prophylaxis benefited from endoscopic monitoring with colonoscopy at 6-12 months,” the guideline notes. However, patients who elect early prophylaxis after resection can reasonably forego colonoscopy if endoscopic recurrence is unlikely to affect their treatment plan, the AGA states. The guideline strongly recommends ongoing surveillance endoscopies if patients decide against early postresection prophylaxis, but notes a lack of evidence on how far to space out these procedures.

None of the authors had relevant financial disclosures.

Patients whose Crohn’s disease fully remits after resection should not wait for endoscopic recurrence to start tumor-necrosis-factor inhibitors or thiopurines, according to a new guideline from the American Gastroenterological Association.

Patients who are low risk or worried about side effects, however, “may reasonably select endoscopy-guided pharmacological treatment,” the guidelines state (doi: 10.1053/j.gastro.2016.10.038).

Dr. Geoffrey C. Nguyen
About half of patients need surgical resection within 10 years of a Crohn’s disease diagnosis, and about one in four of those who undergo surgery need another resection within 5 years, noted Geoffrey C. Nguyen, MD, PhD, of the University of Toronto, and his associates. Accordingly, they developed recommendations for preventing multiple surgeries in patients who have no evidence of disease after initial resection. Surgical recurrence was rare in the clinical trials these experts evaluated, so they used endoscopic recurrence as a proxy.

Early pharmacologic prophylaxis usually begins within 8 weeks of surgery, they noted. Whether this approach bests endoscopy-guided treatment is unclear: In one small trial (Gastroenterology. 2013;145[4]:766-74.e1), early azathioprine therapy failed to best endoscopy-guided therapy for preventing clinical or endoscopic recurrence.

Early prophylaxis, however, is usually reasonable because most Crohn’s patients who undergo surgery have at least one risk factor for recurrence, Dr. Nguyen and his associates emphasize. They suggest reserving endoscopy-guided therapy for patients who have real concerns about side effects and are at low risk, such as nonsmokers who were diagnosed within 10 years and have less than 10-20 cm of fibrostenotic disease.

For prophylaxis, a moderate amount of evidence supports anti–tumor necrosis factor (TNF) agents, thiopurines, or combined therapy over other agents, the guideline also states. In placebo-controlled clinical trials, anti-TNF therapy reduced the chances of clinical recurrence by 49% and endoscopic recurrence by 76%, while thiopurines cut these rates by 65% and 60%, respectively. Evidence favors anti-TNF agents over thiopurines for preventing recurrence, but it is of low quality, the guideline says. Furthermore, only indirect evidence supports combined therapy in patients at highest risk of recurrence.

Among the antibiotics, only nitroimidazoles such as metronidazole have been adequately studied, and they posted worse results than anti-TNF agents or thiopurines. Antibiotic therapy decreased the risk of endoscopic recurrence of Crohn’s disease by about 50%, but long-term use is associated with peripheral neuropathy and disease usually recurs within 2 years of stopping treatment. Accordingly, the guidelines suggest using a nitroimidazole for only 3-12 months, and only in lower-risk patients who are concerned about the adverse effects of anti-TNF agents and thiopurines.
 

 

The AGA made a conditional recommendation against the prophylactic use of budesonide, probiotics, and 5-aminosalicylates such as mesalamine. Only low-quality evidence supports their efficacy after resection, and by using these agents, clinicians may inadvertently boost the risk of recurrence by forgoing better therapies, the guideline states.

The initial endoscopy should be timed for 6-12 months after resection, regardless of whether patients are receiving pharmacologic prophylaxis, the guideline states. If there is endoscopic recurrence, then anti-TNF or thiopurine therapy should be started or optimized.

In the Postoperative Crohn’s Endoscopic Recurrence (POCER) trial, endoscopic monitoring and treatment escalation in the face of endoscopic recurrence cut the risk of subsequent clinical and endoscopic recurrence by about 18% and 27%, respectively, compared with continuing the original treatment regimen. Most patients received azathioprine or adalimumab with 3 months of metronidazole postoperatively, so “even [those] who were already on postoperative prophylaxis benefited from endoscopic monitoring with colonoscopy at 6-12 months,” the guideline notes. However, patients who elect early prophylaxis after resection can reasonably forego colonoscopy if endoscopic recurrence is unlikely to affect their treatment plan, the AGA states. The guideline strongly recommends ongoing surveillance endoscopies if patients decide against early postresection prophylaxis, but notes a lack of evidence on how far to space out these procedures.

None of the authors had relevant financial disclosures.

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Study shows NJ tube and PEG-J on par for enteral nutrition, but each has complications

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Wed, 01/02/2019 - 09:44

 

CORONADO, CALIF. – Percutaneous gastrostomy with jejunal extension (PEG-J) is an appealing and effective method for delivery of enteral nutrition in necrotizing pancreatitis patients, without the mechanical issues and discomfort associated with nasojejunal (NJ) tube, results from a single-center retrospective study showed.

“The advantages of PEG-J route for enteral nutrition in necrotizing pancreatitis patients must be weighed carefully against the potentially severe complication profile,” study author Alexandra M. Roch, MD, said at the annual meeting of the Western Surgical Association.

Dr. Alexandra M. Roch

Historically, the preferred way to manage patients with necrotizing pancreatitis was via parenteral nutrition with a lack of pancreatic stimulation, said Dr. Roch, of the department of surgery at Indiana University, Indianapolis. However, parenteral nutrition is associated with increased permeability, a lack of peristaltic stimulation, changes in intestinal flora, and an increased risk of infection.

 


“More recently, enteral nutrition has been used, despite a potential for pancreatic stimulation,” she said. “From 16 randomized, controlled trials with 847 patients, it was associated with decreased mortality, decreased infectious complications, decreased length of hospital stay, and a trend toward decreased rate of organ failure. Based on those findings, enteral nutrition has become the standard of care in acute pancreatitis. The optimal enteral nutrition route, however, is still debated. The traditional route is the nasojejunal [NJ] tube. Its placement is noninvasive, but it is associated with discomfort for the patient, dislodgement in 16%-63% of cases, and potentially sinusitis. Conversely, percutaneous gastrostomy with jejunal extension [PEG-J] is beneficial for patient comfort but has the drawbacks of being an invasive procedure with the risk of cellulitis and more severe complications.”

The aim of the current study was to compare the safety and efficacy of NJ tube and PEG-J enteral nutrition delivery before surgical debridement in patients with necrotizing pancreatitis. Dr. Roch and her associates hypothesized that NJ tube and PEG-J would have a similar complication profile. They retrospectively reviewed the medical records of all patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015. Patients with exclusive total parenteral nutrition were excluded from the study, as were those who had incomplete data.

Dr. Roch reported results from 242 patients with a mean age of 54 years. More than half (64%) were men and the main etiology was biliary (47%), followed by alcohol (16%). The median duration of preoperative enteral nutrition was 29 days. Of the 242 patients, 187 had an NJ tube only, 25 had PEG-J only, and 30 patients had an NJ tube followed by PEG-J. More than half of PEG-Js were placed under fluoroscopic guidance, while the remaining 41% were placed endoscopically.

In terms of safety, patients in the NJ tube group had a significantly higher rate of all complications, compared with those in the PEG-J group (52% vs. 27%, respectively; P = .0015). Conversely, there was a significantly higher rate of serious complications among patients in the PEG-J group, compared with the NJ group (11% vs. 0%; P less than .0001). The researchers also found that compared with patients in the PEG-J group, those in the NJ group were more prone to mechanical complications such as difficulty to place (5% vs. 0%, respectively), replacement (30% vs. 5.5%), and repositioning (30% vs. 2%), while PEG-J patients were more prone to infectious complications such as skin infections/cellulitis (4% vs. 0%) and perforation/leakage/peritonitis (11% vs. 0%). When they limited the analysis to grade III or IV complications, the mechanism was always the same: early dislodgement from the GI tract. “The presentation ranged from asymptomatic patients to severe peritonitis,” Dr. Roch said. “Two patients out of the six with severe complications required emergent laparotomy.”

In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively). There were also no differences between the two groups in nutritional status when assessed by an increase of serum albumin (38% vs. 36%; P = .87), normalization of serum albumin (9% vs. 16%; P = .14), or in the prevalence of infected necrosis (53% vs. 49%; P = .64).

Dr. Roch acknowledged certain limitations of the study, including its single-center, retrospective design. “Furthermore, we are a tertiary care center, and most patients are referred to us late in the course of their disease,” she said. “Finally, no PEG-Js were placed outside of our institution, raising the question of a selection bias. She reported having no financial disclosures.

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CORONADO, CALIF. – Percutaneous gastrostomy with jejunal extension (PEG-J) is an appealing and effective method for delivery of enteral nutrition in necrotizing pancreatitis patients, without the mechanical issues and discomfort associated with nasojejunal (NJ) tube, results from a single-center retrospective study showed.

“The advantages of PEG-J route for enteral nutrition in necrotizing pancreatitis patients must be weighed carefully against the potentially severe complication profile,” study author Alexandra M. Roch, MD, said at the annual meeting of the Western Surgical Association.

Dr. Alexandra M. Roch

Historically, the preferred way to manage patients with necrotizing pancreatitis was via parenteral nutrition with a lack of pancreatic stimulation, said Dr. Roch, of the department of surgery at Indiana University, Indianapolis. However, parenteral nutrition is associated with increased permeability, a lack of peristaltic stimulation, changes in intestinal flora, and an increased risk of infection.

 


“More recently, enteral nutrition has been used, despite a potential for pancreatic stimulation,” she said. “From 16 randomized, controlled trials with 847 patients, it was associated with decreased mortality, decreased infectious complications, decreased length of hospital stay, and a trend toward decreased rate of organ failure. Based on those findings, enteral nutrition has become the standard of care in acute pancreatitis. The optimal enteral nutrition route, however, is still debated. The traditional route is the nasojejunal [NJ] tube. Its placement is noninvasive, but it is associated with discomfort for the patient, dislodgement in 16%-63% of cases, and potentially sinusitis. Conversely, percutaneous gastrostomy with jejunal extension [PEG-J] is beneficial for patient comfort but has the drawbacks of being an invasive procedure with the risk of cellulitis and more severe complications.”

The aim of the current study was to compare the safety and efficacy of NJ tube and PEG-J enteral nutrition delivery before surgical debridement in patients with necrotizing pancreatitis. Dr. Roch and her associates hypothesized that NJ tube and PEG-J would have a similar complication profile. They retrospectively reviewed the medical records of all patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015. Patients with exclusive total parenteral nutrition were excluded from the study, as were those who had incomplete data.

Dr. Roch reported results from 242 patients with a mean age of 54 years. More than half (64%) were men and the main etiology was biliary (47%), followed by alcohol (16%). The median duration of preoperative enteral nutrition was 29 days. Of the 242 patients, 187 had an NJ tube only, 25 had PEG-J only, and 30 patients had an NJ tube followed by PEG-J. More than half of PEG-Js were placed under fluoroscopic guidance, while the remaining 41% were placed endoscopically.

In terms of safety, patients in the NJ tube group had a significantly higher rate of all complications, compared with those in the PEG-J group (52% vs. 27%, respectively; P = .0015). Conversely, there was a significantly higher rate of serious complications among patients in the PEG-J group, compared with the NJ group (11% vs. 0%; P less than .0001). The researchers also found that compared with patients in the PEG-J group, those in the NJ group were more prone to mechanical complications such as difficulty to place (5% vs. 0%, respectively), replacement (30% vs. 5.5%), and repositioning (30% vs. 2%), while PEG-J patients were more prone to infectious complications such as skin infections/cellulitis (4% vs. 0%) and perforation/leakage/peritonitis (11% vs. 0%). When they limited the analysis to grade III or IV complications, the mechanism was always the same: early dislodgement from the GI tract. “The presentation ranged from asymptomatic patients to severe peritonitis,” Dr. Roch said. “Two patients out of the six with severe complications required emergent laparotomy.”

In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively). There were also no differences between the two groups in nutritional status when assessed by an increase of serum albumin (38% vs. 36%; P = .87), normalization of serum albumin (9% vs. 16%; P = .14), or in the prevalence of infected necrosis (53% vs. 49%; P = .64).

Dr. Roch acknowledged certain limitations of the study, including its single-center, retrospective design. “Furthermore, we are a tertiary care center, and most patients are referred to us late in the course of their disease,” she said. “Finally, no PEG-Js were placed outside of our institution, raising the question of a selection bias. She reported having no financial disclosures.

 

CORONADO, CALIF. – Percutaneous gastrostomy with jejunal extension (PEG-J) is an appealing and effective method for delivery of enteral nutrition in necrotizing pancreatitis patients, without the mechanical issues and discomfort associated with nasojejunal (NJ) tube, results from a single-center retrospective study showed.

“The advantages of PEG-J route for enteral nutrition in necrotizing pancreatitis patients must be weighed carefully against the potentially severe complication profile,” study author Alexandra M. Roch, MD, said at the annual meeting of the Western Surgical Association.

Dr. Alexandra M. Roch

Historically, the preferred way to manage patients with necrotizing pancreatitis was via parenteral nutrition with a lack of pancreatic stimulation, said Dr. Roch, of the department of surgery at Indiana University, Indianapolis. However, parenteral nutrition is associated with increased permeability, a lack of peristaltic stimulation, changes in intestinal flora, and an increased risk of infection.

 


“More recently, enteral nutrition has been used, despite a potential for pancreatic stimulation,” she said. “From 16 randomized, controlled trials with 847 patients, it was associated with decreased mortality, decreased infectious complications, decreased length of hospital stay, and a trend toward decreased rate of organ failure. Based on those findings, enteral nutrition has become the standard of care in acute pancreatitis. The optimal enteral nutrition route, however, is still debated. The traditional route is the nasojejunal [NJ] tube. Its placement is noninvasive, but it is associated with discomfort for the patient, dislodgement in 16%-63% of cases, and potentially sinusitis. Conversely, percutaneous gastrostomy with jejunal extension [PEG-J] is beneficial for patient comfort but has the drawbacks of being an invasive procedure with the risk of cellulitis and more severe complications.”

The aim of the current study was to compare the safety and efficacy of NJ tube and PEG-J enteral nutrition delivery before surgical debridement in patients with necrotizing pancreatitis. Dr. Roch and her associates hypothesized that NJ tube and PEG-J would have a similar complication profile. They retrospectively reviewed the medical records of all patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015. Patients with exclusive total parenteral nutrition were excluded from the study, as were those who had incomplete data.

Dr. Roch reported results from 242 patients with a mean age of 54 years. More than half (64%) were men and the main etiology was biliary (47%), followed by alcohol (16%). The median duration of preoperative enteral nutrition was 29 days. Of the 242 patients, 187 had an NJ tube only, 25 had PEG-J only, and 30 patients had an NJ tube followed by PEG-J. More than half of PEG-Js were placed under fluoroscopic guidance, while the remaining 41% were placed endoscopically.

In terms of safety, patients in the NJ tube group had a significantly higher rate of all complications, compared with those in the PEG-J group (52% vs. 27%, respectively; P = .0015). Conversely, there was a significantly higher rate of serious complications among patients in the PEG-J group, compared with the NJ group (11% vs. 0%; P less than .0001). The researchers also found that compared with patients in the PEG-J group, those in the NJ group were more prone to mechanical complications such as difficulty to place (5% vs. 0%, respectively), replacement (30% vs. 5.5%), and repositioning (30% vs. 2%), while PEG-J patients were more prone to infectious complications such as skin infections/cellulitis (4% vs. 0%) and perforation/leakage/peritonitis (11% vs. 0%). When they limited the analysis to grade III or IV complications, the mechanism was always the same: early dislodgement from the GI tract. “The presentation ranged from asymptomatic patients to severe peritonitis,” Dr. Roch said. “Two patients out of the six with severe complications required emergent laparotomy.”

In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively). There were also no differences between the two groups in nutritional status when assessed by an increase of serum albumin (38% vs. 36%; P = .87), normalization of serum albumin (9% vs. 16%; P = .14), or in the prevalence of infected necrosis (53% vs. 49%; P = .64).

Dr. Roch acknowledged certain limitations of the study, including its single-center, retrospective design. “Furthermore, we are a tertiary care center, and most patients are referred to us late in the course of their disease,” she said. “Finally, no PEG-Js were placed outside of our institution, raising the question of a selection bias. She reported having no financial disclosures.

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Key clinical point: In necrotizing pancreatitis, NJ tube and PEG-J both delivered enteral nutrition effectively.

Major finding: In terms of efficacy, the NJ and PEG-J groups were equivalent in achieving enteral nutrition (67% vs. 68%, respectively).

Data source: A retrospective review of 242 patients who underwent surgical debridement for necrotizing pancreatitis at Indiana University Medical Center between 2005 and 2015.

Disclosures: Dr. Roch reported having no financial disclosures.