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Half of outpatient antibiotics prescribed with no infectious disease code
based on a review of more than half a million outpatient prescriptions to more than a quarter million patients at 514 clinics around Chicago.
The researchers looked to see if prescriptions had an ICD-10 code that indicated an antibiotic; they were liberal in their approach, considering over 21,000 codes to at least possibly signal the need for an antibiotic.
Almost half the time, there was nothing in the codes related to bacterial infection: 29% of scripts were written in connection with codes for high blood pressure, annual visits, and other noninfectious disorders; 17% of prescriptions were written with no diagnosis code at all.
The study is likely the largest to date to look at outpatient antibiotic prescribing patterns in the United States, and the findings are worrisome. “Nearly half the time, clinicians have either a bad reason for prescribing antibiotics, or don’t provide a reason at all. When you consider about 80% of antibiotics are prescribed on an outpatient basis, that’s a concern,” lead investigator Jeffrey A. Linder, MD, MPH, chief of the division of general internal medicine and geriatrics at Northwestern University, Chicago, said in a written statement.
“At busy clinics, sadly, the most efficient thing to do is just call in an antibiotic prescription. We need to dig into the data more, but we believe there is a lot of antibiotic prescribing for colds, the flu, and non-specific symptoms such as just not feeling well,” he said.
With all the concern in recent years about overuse, it’s hard to imagine that prescribers are still being free and easy with antibiotics, and Dr. Linder’s study will certainly have its skeptics.
Sloppy record keeping could be one explanation for the findings. A patient could really have needed an antibiotic, but it just wasn’t captured in coding. There are also valid reasons for prescribing antibiotics over the phone, such as acne and recurrent UTIs.
Dr. Linder, however, thinks it’s more than that. He explained his study, its implications, and the next steps in an interview at ID Week, an annual scientific meeting on infectious diseases.
The 2,413 prescribers in the study included physicians, surgeons, residents, fellows, nurse practitioners, and physician assistants in general and specialty practices. Patients were a mean of 43 years old: 60% were women and 75% were white. The most common antibiotic classes were penicillins, macrolides, and cephalosporins. Prescriptions were written from November 2015 through October 2017.
The work was funded by the Agency for Healthcare Research and Quality. Dr. Linder did not have any disclosures.
SOURCE: Linder JA et al. ID Week 2018 abstract 1632.
based on a review of more than half a million outpatient prescriptions to more than a quarter million patients at 514 clinics around Chicago.
The researchers looked to see if prescriptions had an ICD-10 code that indicated an antibiotic; they were liberal in their approach, considering over 21,000 codes to at least possibly signal the need for an antibiotic.
Almost half the time, there was nothing in the codes related to bacterial infection: 29% of scripts were written in connection with codes for high blood pressure, annual visits, and other noninfectious disorders; 17% of prescriptions were written with no diagnosis code at all.
The study is likely the largest to date to look at outpatient antibiotic prescribing patterns in the United States, and the findings are worrisome. “Nearly half the time, clinicians have either a bad reason for prescribing antibiotics, or don’t provide a reason at all. When you consider about 80% of antibiotics are prescribed on an outpatient basis, that’s a concern,” lead investigator Jeffrey A. Linder, MD, MPH, chief of the division of general internal medicine and geriatrics at Northwestern University, Chicago, said in a written statement.
“At busy clinics, sadly, the most efficient thing to do is just call in an antibiotic prescription. We need to dig into the data more, but we believe there is a lot of antibiotic prescribing for colds, the flu, and non-specific symptoms such as just not feeling well,” he said.
With all the concern in recent years about overuse, it’s hard to imagine that prescribers are still being free and easy with antibiotics, and Dr. Linder’s study will certainly have its skeptics.
Sloppy record keeping could be one explanation for the findings. A patient could really have needed an antibiotic, but it just wasn’t captured in coding. There are also valid reasons for prescribing antibiotics over the phone, such as acne and recurrent UTIs.
Dr. Linder, however, thinks it’s more than that. He explained his study, its implications, and the next steps in an interview at ID Week, an annual scientific meeting on infectious diseases.
The 2,413 prescribers in the study included physicians, surgeons, residents, fellows, nurse practitioners, and physician assistants in general and specialty practices. Patients were a mean of 43 years old: 60% were women and 75% were white. The most common antibiotic classes were penicillins, macrolides, and cephalosporins. Prescriptions were written from November 2015 through October 2017.
The work was funded by the Agency for Healthcare Research and Quality. Dr. Linder did not have any disclosures.
SOURCE: Linder JA et al. ID Week 2018 abstract 1632.
based on a review of more than half a million outpatient prescriptions to more than a quarter million patients at 514 clinics around Chicago.
The researchers looked to see if prescriptions had an ICD-10 code that indicated an antibiotic; they were liberal in their approach, considering over 21,000 codes to at least possibly signal the need for an antibiotic.
Almost half the time, there was nothing in the codes related to bacterial infection: 29% of scripts were written in connection with codes for high blood pressure, annual visits, and other noninfectious disorders; 17% of prescriptions were written with no diagnosis code at all.
The study is likely the largest to date to look at outpatient antibiotic prescribing patterns in the United States, and the findings are worrisome. “Nearly half the time, clinicians have either a bad reason for prescribing antibiotics, or don’t provide a reason at all. When you consider about 80% of antibiotics are prescribed on an outpatient basis, that’s a concern,” lead investigator Jeffrey A. Linder, MD, MPH, chief of the division of general internal medicine and geriatrics at Northwestern University, Chicago, said in a written statement.
“At busy clinics, sadly, the most efficient thing to do is just call in an antibiotic prescription. We need to dig into the data more, but we believe there is a lot of antibiotic prescribing for colds, the flu, and non-specific symptoms such as just not feeling well,” he said.
With all the concern in recent years about overuse, it’s hard to imagine that prescribers are still being free and easy with antibiotics, and Dr. Linder’s study will certainly have its skeptics.
Sloppy record keeping could be one explanation for the findings. A patient could really have needed an antibiotic, but it just wasn’t captured in coding. There are also valid reasons for prescribing antibiotics over the phone, such as acne and recurrent UTIs.
Dr. Linder, however, thinks it’s more than that. He explained his study, its implications, and the next steps in an interview at ID Week, an annual scientific meeting on infectious diseases.
The 2,413 prescribers in the study included physicians, surgeons, residents, fellows, nurse practitioners, and physician assistants in general and specialty practices. Patients were a mean of 43 years old: 60% were women and 75% were white. The most common antibiotic classes were penicillins, macrolides, and cephalosporins. Prescriptions were written from November 2015 through October 2017.
The work was funded by the Agency for Healthcare Research and Quality. Dr. Linder did not have any disclosures.
SOURCE: Linder JA et al. ID Week 2018 abstract 1632.
REPORTING FROM ID WEEK 2018
Admission eosinopenia predicted severe CDI outcomes
For patients with even in the absence of hypotension and tachycardia, researchers wrote in JAMA Surgery.
“In animal models, peripheral eosinopenia is a biologically plausible predictive factor for adverse outcomes, and human data from this study indicate that this frequent addition to an admission complete blood cell count is an inexpensive, widely available risk index in the treatment of C. difficile infection,” wrote Audrey S. Kulaylat, MD, of Penn State University, Hershey, and her associates.
In their cohort study of 2,065 patients admitted to two tertiary referral centers with C. difficile infection, undetectable eosinophil counts at hospital admission were associated with significantly increased odds of in-hospital mortality in both a training dataset (odds ratio, 2.01; 95% confidence interval, 1.08-3.73; P = .03) and a validation dataset (OR, 2.26; 95% CI, 1.33-3.83; P = .002). Undetectable eosinophil counts also were associated with elevated odds of severe disease requiring intensive care, vasopressor use, and emergency total colectomy. Besides eosinopenia, significant predictors of mortality included having more comorbidities and lower systolic blood pressure at admission. Strikingly, when patients had no initial hypotension or tachycardia, an undetectable eosinophil count was the only identifiable predictor of in-hospital death (OR, 5.76; 95% CI, 1.99-16.64). An elevated white blood cell count was not a significant predictor of mortality in this subgroup.
Dr. Kulaylat and her associates are studying the microbiome in C. difficile infection. Their work has identified a host immune reaction marked by an “exaggerated inflammasome response” and peripheral eosinopenia, they explained. Two recent murine models have produced similar results.
Admission eosinophil counts “allow for an immediate assessment of mortality risk at admission that is inexpensive and part of a differential for a standard complete blood count available at any hospital,” they concluded. They are now prospectively evaluating a prognostic score for C. difficile infection that includes eosinopenia and other easily discernible admission factors. The National Institutes of Health supported the work. The researchers reported having no conflicts of interest.
SOURCE: Kulaylat AS et al. JAMA Surg. 2018 Sep 12. doi: 10.1001/jamasurg.2018.3174.
For patients with even in the absence of hypotension and tachycardia, researchers wrote in JAMA Surgery.
“In animal models, peripheral eosinopenia is a biologically plausible predictive factor for adverse outcomes, and human data from this study indicate that this frequent addition to an admission complete blood cell count is an inexpensive, widely available risk index in the treatment of C. difficile infection,” wrote Audrey S. Kulaylat, MD, of Penn State University, Hershey, and her associates.
In their cohort study of 2,065 patients admitted to two tertiary referral centers with C. difficile infection, undetectable eosinophil counts at hospital admission were associated with significantly increased odds of in-hospital mortality in both a training dataset (odds ratio, 2.01; 95% confidence interval, 1.08-3.73; P = .03) and a validation dataset (OR, 2.26; 95% CI, 1.33-3.83; P = .002). Undetectable eosinophil counts also were associated with elevated odds of severe disease requiring intensive care, vasopressor use, and emergency total colectomy. Besides eosinopenia, significant predictors of mortality included having more comorbidities and lower systolic blood pressure at admission. Strikingly, when patients had no initial hypotension or tachycardia, an undetectable eosinophil count was the only identifiable predictor of in-hospital death (OR, 5.76; 95% CI, 1.99-16.64). An elevated white blood cell count was not a significant predictor of mortality in this subgroup.
Dr. Kulaylat and her associates are studying the microbiome in C. difficile infection. Their work has identified a host immune reaction marked by an “exaggerated inflammasome response” and peripheral eosinopenia, they explained. Two recent murine models have produced similar results.
Admission eosinophil counts “allow for an immediate assessment of mortality risk at admission that is inexpensive and part of a differential for a standard complete blood count available at any hospital,” they concluded. They are now prospectively evaluating a prognostic score for C. difficile infection that includes eosinopenia and other easily discernible admission factors. The National Institutes of Health supported the work. The researchers reported having no conflicts of interest.
SOURCE: Kulaylat AS et al. JAMA Surg. 2018 Sep 12. doi: 10.1001/jamasurg.2018.3174.
For patients with even in the absence of hypotension and tachycardia, researchers wrote in JAMA Surgery.
“In animal models, peripheral eosinopenia is a biologically plausible predictive factor for adverse outcomes, and human data from this study indicate that this frequent addition to an admission complete blood cell count is an inexpensive, widely available risk index in the treatment of C. difficile infection,” wrote Audrey S. Kulaylat, MD, of Penn State University, Hershey, and her associates.
In their cohort study of 2,065 patients admitted to two tertiary referral centers with C. difficile infection, undetectable eosinophil counts at hospital admission were associated with significantly increased odds of in-hospital mortality in both a training dataset (odds ratio, 2.01; 95% confidence interval, 1.08-3.73; P = .03) and a validation dataset (OR, 2.26; 95% CI, 1.33-3.83; P = .002). Undetectable eosinophil counts also were associated with elevated odds of severe disease requiring intensive care, vasopressor use, and emergency total colectomy. Besides eosinopenia, significant predictors of mortality included having more comorbidities and lower systolic blood pressure at admission. Strikingly, when patients had no initial hypotension or tachycardia, an undetectable eosinophil count was the only identifiable predictor of in-hospital death (OR, 5.76; 95% CI, 1.99-16.64). An elevated white blood cell count was not a significant predictor of mortality in this subgroup.
Dr. Kulaylat and her associates are studying the microbiome in C. difficile infection. Their work has identified a host immune reaction marked by an “exaggerated inflammasome response” and peripheral eosinopenia, they explained. Two recent murine models have produced similar results.
Admission eosinophil counts “allow for an immediate assessment of mortality risk at admission that is inexpensive and part of a differential for a standard complete blood count available at any hospital,” they concluded. They are now prospectively evaluating a prognostic score for C. difficile infection that includes eosinopenia and other easily discernible admission factors. The National Institutes of Health supported the work. The researchers reported having no conflicts of interest.
SOURCE: Kulaylat AS et al. JAMA Surg. 2018 Sep 12. doi: 10.1001/jamasurg.2018.3174.
FROM JAMA SURGERY
Key clinical point: Undetectable peripheral eosinophils predicted severe outcomes in patients admitted with Clostridium difficile infection.
Major finding: In the training and validation datasets, odds of in-hospital mortality were 2.01 (95% CI, 1.08-3.73) and 2.26 (95% CI, 1.33-3.83), respectively.
Study details: Two-hospital cohort study of 2,065 patients admitted with C. difficile infection.
Disclosures: The National Institutes of Health supported the work. The researchers reported having no conflicts of interest.
Source: Kulaylat A et al. JAMA Surg. 2018 Sep 12. doi: 10.1001/jamasurg.2018.3174.
Resident participation in surgery is safe for patients, study shows
Despite concerns that resident involvement in operations might pose a risk to the patient, the inclusion of general surgery residents in high-risk surgery cases does not negatively impact outcomes, according to a database study of more than 25,000 patients.
Adrienne N. Cobb, MD, of Loyola University Medical Center, Maywood, Ill., and her colleagues used the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database (2005-2012) to identify all patients undergoing any of six high-risk procedures on an elective basis.
Dr. Cobb and her colleagues compared outcomes for 25,363 patients who had procedures with and without resident participation: 4,018 and 21,345 patients, respectively. They also evaluated selected outcomes by postgraduate year (PGY). Junior residents were considered as PGY 1-2, senior residents were considered PGY 3, 4, and 5, and participants were considered fellows if they were PGY 6 or higher, according to their report published in the Journal of Surgical Research.
The six procedures assessed were esophagectomy (1,233 patients), open abdominal aortic aneurysm repair (162), laparoscopic paraesophageal resection with Nissen fundoplication (2,316), pancreaticoduodenectomy (Whipple, 10,309), abdominoperineal resection (2,003), and hepatectomy (9,329).
The primary outcome of the study was 30-day mortality with the exposure being resident involvement. Secondary outcomes that had complications included superficial and deep surgical site infection, wound disruption, bleeding requiring transfusion, return to the operating room, pneumonia, unplanned reintubation, pulmonary embolism, acute renal failure, stroke, MI, sepsis, urinary tract infection (UTI), and deep vein thrombosis, operative time, and length of stay.
In both univariate and multivariate analysis, there were no significant differences in mortality between patients who did or did not have procedures in which resident participation at any level of training was involved.
Overall, resident participation did increase the odds of a prolonged operative time (odds ratio, 1.5; 95% confidence interval, 1.1-2.1). Only abdominal perineal resection showed an increased odds risk of having a prolonged operation when residents were involved (OR, 4.3; 95% CI, 1.1-4.8). With regard to these results, the authors commented: “We assert that the additional time spent with trainees in the OR is integral to the production of confident and competent surgeons and does not lead to poorer outcomes for patients. It may, however, lead to increasing costs for the hospital and the patient.”
When risk-adjusted odds were calculated for all the other secondary outcomes and postoperative outcomes tested, UTI was the only one to show a negative impact when residents were involved (OR, 2.3; 95% CI, 1.1-4.8).
The study limitations include the age of the data and the limited number of procedures evaluated, and thus might not be generalizable to a more modern era and other procedures, according to the authors.
“Apart from UTI rates, resident participation did not significantly increase patient morbidity or mortality. Residents should continue to be given active and engaging roles in the OR, even in the most challenging cases,” Dr. Cobb and her colleagues concluded.
The study was funded by the National Institutes of Health. The authors reported that they had no disclosures.
SOURCE: Cobb AN et al. J Surg Res. 2018 Dec; 232:308-17.
Despite concerns that resident involvement in operations might pose a risk to the patient, the inclusion of general surgery residents in high-risk surgery cases does not negatively impact outcomes, according to a database study of more than 25,000 patients.
Adrienne N. Cobb, MD, of Loyola University Medical Center, Maywood, Ill., and her colleagues used the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database (2005-2012) to identify all patients undergoing any of six high-risk procedures on an elective basis.
Dr. Cobb and her colleagues compared outcomes for 25,363 patients who had procedures with and without resident participation: 4,018 and 21,345 patients, respectively. They also evaluated selected outcomes by postgraduate year (PGY). Junior residents were considered as PGY 1-2, senior residents were considered PGY 3, 4, and 5, and participants were considered fellows if they were PGY 6 or higher, according to their report published in the Journal of Surgical Research.
The six procedures assessed were esophagectomy (1,233 patients), open abdominal aortic aneurysm repair (162), laparoscopic paraesophageal resection with Nissen fundoplication (2,316), pancreaticoduodenectomy (Whipple, 10,309), abdominoperineal resection (2,003), and hepatectomy (9,329).
The primary outcome of the study was 30-day mortality with the exposure being resident involvement. Secondary outcomes that had complications included superficial and deep surgical site infection, wound disruption, bleeding requiring transfusion, return to the operating room, pneumonia, unplanned reintubation, pulmonary embolism, acute renal failure, stroke, MI, sepsis, urinary tract infection (UTI), and deep vein thrombosis, operative time, and length of stay.
In both univariate and multivariate analysis, there were no significant differences in mortality between patients who did or did not have procedures in which resident participation at any level of training was involved.
Overall, resident participation did increase the odds of a prolonged operative time (odds ratio, 1.5; 95% confidence interval, 1.1-2.1). Only abdominal perineal resection showed an increased odds risk of having a prolonged operation when residents were involved (OR, 4.3; 95% CI, 1.1-4.8). With regard to these results, the authors commented: “We assert that the additional time spent with trainees in the OR is integral to the production of confident and competent surgeons and does not lead to poorer outcomes for patients. It may, however, lead to increasing costs for the hospital and the patient.”
When risk-adjusted odds were calculated for all the other secondary outcomes and postoperative outcomes tested, UTI was the only one to show a negative impact when residents were involved (OR, 2.3; 95% CI, 1.1-4.8).
The study limitations include the age of the data and the limited number of procedures evaluated, and thus might not be generalizable to a more modern era and other procedures, according to the authors.
“Apart from UTI rates, resident participation did not significantly increase patient morbidity or mortality. Residents should continue to be given active and engaging roles in the OR, even in the most challenging cases,” Dr. Cobb and her colleagues concluded.
The study was funded by the National Institutes of Health. The authors reported that they had no disclosures.
SOURCE: Cobb AN et al. J Surg Res. 2018 Dec; 232:308-17.
Despite concerns that resident involvement in operations might pose a risk to the patient, the inclusion of general surgery residents in high-risk surgery cases does not negatively impact outcomes, according to a database study of more than 25,000 patients.
Adrienne N. Cobb, MD, of Loyola University Medical Center, Maywood, Ill., and her colleagues used the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database (2005-2012) to identify all patients undergoing any of six high-risk procedures on an elective basis.
Dr. Cobb and her colleagues compared outcomes for 25,363 patients who had procedures with and without resident participation: 4,018 and 21,345 patients, respectively. They also evaluated selected outcomes by postgraduate year (PGY). Junior residents were considered as PGY 1-2, senior residents were considered PGY 3, 4, and 5, and participants were considered fellows if they were PGY 6 or higher, according to their report published in the Journal of Surgical Research.
The six procedures assessed were esophagectomy (1,233 patients), open abdominal aortic aneurysm repair (162), laparoscopic paraesophageal resection with Nissen fundoplication (2,316), pancreaticoduodenectomy (Whipple, 10,309), abdominoperineal resection (2,003), and hepatectomy (9,329).
The primary outcome of the study was 30-day mortality with the exposure being resident involvement. Secondary outcomes that had complications included superficial and deep surgical site infection, wound disruption, bleeding requiring transfusion, return to the operating room, pneumonia, unplanned reintubation, pulmonary embolism, acute renal failure, stroke, MI, sepsis, urinary tract infection (UTI), and deep vein thrombosis, operative time, and length of stay.
In both univariate and multivariate analysis, there were no significant differences in mortality between patients who did or did not have procedures in which resident participation at any level of training was involved.
Overall, resident participation did increase the odds of a prolonged operative time (odds ratio, 1.5; 95% confidence interval, 1.1-2.1). Only abdominal perineal resection showed an increased odds risk of having a prolonged operation when residents were involved (OR, 4.3; 95% CI, 1.1-4.8). With regard to these results, the authors commented: “We assert that the additional time spent with trainees in the OR is integral to the production of confident and competent surgeons and does not lead to poorer outcomes for patients. It may, however, lead to increasing costs for the hospital and the patient.”
When risk-adjusted odds were calculated for all the other secondary outcomes and postoperative outcomes tested, UTI was the only one to show a negative impact when residents were involved (OR, 2.3; 95% CI, 1.1-4.8).
The study limitations include the age of the data and the limited number of procedures evaluated, and thus might not be generalizable to a more modern era and other procedures, according to the authors.
“Apart from UTI rates, resident participation did not significantly increase patient morbidity or mortality. Residents should continue to be given active and engaging roles in the OR, even in the most challenging cases,” Dr. Cobb and her colleagues concluded.
The study was funded by the National Institutes of Health. The authors reported that they had no disclosures.
SOURCE: Cobb AN et al. J Surg Res. 2018 Dec; 232:308-17.
FROM THE JOURNAL OF SURGICAL RESEARCH
Key clinical point: Resident participation in surgery during training was safe for the patients involved.
Major finding: UTI was the only secondary outcome to show a negative impact when residents were involved in surgery (OR, 2.3; 95% CI, 1.1-4.8).
Study details: A retrospective database analysis of six complex procedures involving more than 25,000 surgeries during 2005-2012.
Disclosures: The authors reported that they had no disclosures.
Source: Cobb AN et al. J Surg Res 2018 Dec;232:308-17.
Five-year follow-up confirms safety of antibiotics for uncomplicated appendicitis
Longer-term outcomes of treating uncomplicated acute appendicitis with antibiotics suggest it is a feasible alternative to appendectomy.
Researchers have presented the 5-year follow-up data from the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotic therapy in 530 patients.
They found that 39.1% (100) of the 257 patients randomized to antibiotic therapy – 3 days of intravenous ertapenem followed by 7 days of oral levofloxacin and metronidazole – experienced a recurrence of appendicitis within 5 years and subsequently had surgery.
However the authors noted that seven of these patients were later found not to have appendicitis, so the true success rate for antibiotic treatment was actually 63.7%.
Seventy of the patients who experienced a recurrence underwent surgery in the first year after randomization, 17 in the second year, 3 in the third year, 5 in the fourth year, and the remaining 5 patients in the fifth year, the authors wrote in an article published in JAMA.
However the overall complication rate was similar in patients who were randomized to undergo appendectomy and in those who were initially randomized to the antibiotic group but later experienced a recurrence and underwent surgery.
“No patient initially treated with antibiotics, who ultimately developed recurrent appendicitis, had any complications related to the delay in surgery,” wrote Paulina Salminen, MD, from Turku (Finland) University Hospital and coauthors. “Nearly two-thirds of all patients who initially presented with uncomplicated appendicitis were successfully treated with antibiotics alone, and those who ultimately developed recurrent disease did not experience any adverse outcomes related to the delay in appendectomy.”
Of the 100 patients randomized to antibiotics who underwent appendectomy after a recurrence, 15 were operated on when they were first hospitalized at study admission.
The authors commented that the study design allowed for surgeons to exercise their clinical judgment in choosing when to perform an appendectomy on patients in the antibiotic group, because antibiotics alone was not considered acceptable treatment for appendicitis.
“This led to some patients undergoing appendectomy who did not have appendicitis or who might have been successfully treated with antibiotics or an another course of antibiotics,” they wrote. “Future studies should investigate protocols for further imaging or antibiotic treatment for patients who develop recurrent appendicitis after they were initially treated with antibiotics.”
In the recurrence group, the majority were found to have uncomplicated appendicitis, but complicated appendicitis was seen in two patients between 2 and 5 years after the index admission.
There was a significant 17.9% higher complication rate in the appendectomy group, compared with the antibiotic group – 24.4% versus 6.5% – at 5 years and two patients in the appendectomy group had severe complications requiring reoperation.
They suggested that the higher complication rate with surgery, which was mostly attributable to infections, could be reduced by the use of laparoscopic appendectomy, which is also associated with faster recovery.
The median length of hospital stay was 3 days for both the appendectomy group and the antibiotics-only group, but patients randomized to appendectomy took a median of 22 days of sick leave, compared with 11 days for those randomized to antibiotics (P less than .001).
In the absence of standard protocol on treating appendicitis with antibiotics, the authors noted that they took a conservative approach, using broad-spectrum antibiotics and keeping patients in hospital for 3 days for observation.
“The success of antibiotic treatment for appendicitis calls into question prior beliefs that appendicitis inevitably results in serious intra-abdominal infection if appendectomy is not performed.”
The study was supported by the Mary and Georg C. Ehrnrooth Foundation, the EVO Foundation, and Turku University. One author declared lecture fees from three pharmaceutical companies but no other conflicts of interest were declared.
SOURCE: Salminen P et al. JAMA 2018;320:1259-65. doi: 10.1001/jama.2018.13201.
“When the earlier results of the APPAC trial were published, showing that 73% of patients with uncomplicated acute appendicitis did not require surgery at 1 year of follow-up, critics raised concerns that many more of these patients would eventually require surgery,” wrote Edward H. Livingston, MD, deputy editor of JAMA in an accompanying editorial (JAMA 2018;320:1245-46).Surgeons have since been waiting until longer-term outcomes were known. These 5-year results are supportive of the antibiotics approach. “They show no increase in major complications in patients who experienced a recurrence and underwent appendectomy after initially being randomized to antibiotic therapy. They challenge the notion that uncomplicated acute appendicitis is a surgical emergency and show that nonsurgical treatment is a reasonable option,” Dr Livingston wrote.
He declared no conflicts of interest.
“When the earlier results of the APPAC trial were published, showing that 73% of patients with uncomplicated acute appendicitis did not require surgery at 1 year of follow-up, critics raised concerns that many more of these patients would eventually require surgery,” wrote Edward H. Livingston, MD, deputy editor of JAMA in an accompanying editorial (JAMA 2018;320:1245-46).Surgeons have since been waiting until longer-term outcomes were known. These 5-year results are supportive of the antibiotics approach. “They show no increase in major complications in patients who experienced a recurrence and underwent appendectomy after initially being randomized to antibiotic therapy. They challenge the notion that uncomplicated acute appendicitis is a surgical emergency and show that nonsurgical treatment is a reasonable option,” Dr Livingston wrote.
He declared no conflicts of interest.
“When the earlier results of the APPAC trial were published, showing that 73% of patients with uncomplicated acute appendicitis did not require surgery at 1 year of follow-up, critics raised concerns that many more of these patients would eventually require surgery,” wrote Edward H. Livingston, MD, deputy editor of JAMA in an accompanying editorial (JAMA 2018;320:1245-46).Surgeons have since been waiting until longer-term outcomes were known. These 5-year results are supportive of the antibiotics approach. “They show no increase in major complications in patients who experienced a recurrence and underwent appendectomy after initially being randomized to antibiotic therapy. They challenge the notion that uncomplicated acute appendicitis is a surgical emergency and show that nonsurgical treatment is a reasonable option,” Dr Livingston wrote.
He declared no conflicts of interest.
Longer-term outcomes of treating uncomplicated acute appendicitis with antibiotics suggest it is a feasible alternative to appendectomy.
Researchers have presented the 5-year follow-up data from the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotic therapy in 530 patients.
They found that 39.1% (100) of the 257 patients randomized to antibiotic therapy – 3 days of intravenous ertapenem followed by 7 days of oral levofloxacin and metronidazole – experienced a recurrence of appendicitis within 5 years and subsequently had surgery.
However the authors noted that seven of these patients were later found not to have appendicitis, so the true success rate for antibiotic treatment was actually 63.7%.
Seventy of the patients who experienced a recurrence underwent surgery in the first year after randomization, 17 in the second year, 3 in the third year, 5 in the fourth year, and the remaining 5 patients in the fifth year, the authors wrote in an article published in JAMA.
However the overall complication rate was similar in patients who were randomized to undergo appendectomy and in those who were initially randomized to the antibiotic group but later experienced a recurrence and underwent surgery.
“No patient initially treated with antibiotics, who ultimately developed recurrent appendicitis, had any complications related to the delay in surgery,” wrote Paulina Salminen, MD, from Turku (Finland) University Hospital and coauthors. “Nearly two-thirds of all patients who initially presented with uncomplicated appendicitis were successfully treated with antibiotics alone, and those who ultimately developed recurrent disease did not experience any adverse outcomes related to the delay in appendectomy.”
Of the 100 patients randomized to antibiotics who underwent appendectomy after a recurrence, 15 were operated on when they were first hospitalized at study admission.
The authors commented that the study design allowed for surgeons to exercise their clinical judgment in choosing when to perform an appendectomy on patients in the antibiotic group, because antibiotics alone was not considered acceptable treatment for appendicitis.
“This led to some patients undergoing appendectomy who did not have appendicitis or who might have been successfully treated with antibiotics or an another course of antibiotics,” they wrote. “Future studies should investigate protocols for further imaging or antibiotic treatment for patients who develop recurrent appendicitis after they were initially treated with antibiotics.”
In the recurrence group, the majority were found to have uncomplicated appendicitis, but complicated appendicitis was seen in two patients between 2 and 5 years after the index admission.
There was a significant 17.9% higher complication rate in the appendectomy group, compared with the antibiotic group – 24.4% versus 6.5% – at 5 years and two patients in the appendectomy group had severe complications requiring reoperation.
They suggested that the higher complication rate with surgery, which was mostly attributable to infections, could be reduced by the use of laparoscopic appendectomy, which is also associated with faster recovery.
The median length of hospital stay was 3 days for both the appendectomy group and the antibiotics-only group, but patients randomized to appendectomy took a median of 22 days of sick leave, compared with 11 days for those randomized to antibiotics (P less than .001).
In the absence of standard protocol on treating appendicitis with antibiotics, the authors noted that they took a conservative approach, using broad-spectrum antibiotics and keeping patients in hospital for 3 days for observation.
“The success of antibiotic treatment for appendicitis calls into question prior beliefs that appendicitis inevitably results in serious intra-abdominal infection if appendectomy is not performed.”
The study was supported by the Mary and Georg C. Ehrnrooth Foundation, the EVO Foundation, and Turku University. One author declared lecture fees from three pharmaceutical companies but no other conflicts of interest were declared.
SOURCE: Salminen P et al. JAMA 2018;320:1259-65. doi: 10.1001/jama.2018.13201.
Longer-term outcomes of treating uncomplicated acute appendicitis with antibiotics suggest it is a feasible alternative to appendectomy.
Researchers have presented the 5-year follow-up data from the Appendicitis Acuta (APPAC) multicenter randomized clinical trial comparing appendectomy with antibiotic therapy in 530 patients.
They found that 39.1% (100) of the 257 patients randomized to antibiotic therapy – 3 days of intravenous ertapenem followed by 7 days of oral levofloxacin and metronidazole – experienced a recurrence of appendicitis within 5 years and subsequently had surgery.
However the authors noted that seven of these patients were later found not to have appendicitis, so the true success rate for antibiotic treatment was actually 63.7%.
Seventy of the patients who experienced a recurrence underwent surgery in the first year after randomization, 17 in the second year, 3 in the third year, 5 in the fourth year, and the remaining 5 patients in the fifth year, the authors wrote in an article published in JAMA.
However the overall complication rate was similar in patients who were randomized to undergo appendectomy and in those who were initially randomized to the antibiotic group but later experienced a recurrence and underwent surgery.
“No patient initially treated with antibiotics, who ultimately developed recurrent appendicitis, had any complications related to the delay in surgery,” wrote Paulina Salminen, MD, from Turku (Finland) University Hospital and coauthors. “Nearly two-thirds of all patients who initially presented with uncomplicated appendicitis were successfully treated with antibiotics alone, and those who ultimately developed recurrent disease did not experience any adverse outcomes related to the delay in appendectomy.”
Of the 100 patients randomized to antibiotics who underwent appendectomy after a recurrence, 15 were operated on when they were first hospitalized at study admission.
The authors commented that the study design allowed for surgeons to exercise their clinical judgment in choosing when to perform an appendectomy on patients in the antibiotic group, because antibiotics alone was not considered acceptable treatment for appendicitis.
“This led to some patients undergoing appendectomy who did not have appendicitis or who might have been successfully treated with antibiotics or an another course of antibiotics,” they wrote. “Future studies should investigate protocols for further imaging or antibiotic treatment for patients who develop recurrent appendicitis after they were initially treated with antibiotics.”
In the recurrence group, the majority were found to have uncomplicated appendicitis, but complicated appendicitis was seen in two patients between 2 and 5 years after the index admission.
There was a significant 17.9% higher complication rate in the appendectomy group, compared with the antibiotic group – 24.4% versus 6.5% – at 5 years and two patients in the appendectomy group had severe complications requiring reoperation.
They suggested that the higher complication rate with surgery, which was mostly attributable to infections, could be reduced by the use of laparoscopic appendectomy, which is also associated with faster recovery.
The median length of hospital stay was 3 days for both the appendectomy group and the antibiotics-only group, but patients randomized to appendectomy took a median of 22 days of sick leave, compared with 11 days for those randomized to antibiotics (P less than .001).
In the absence of standard protocol on treating appendicitis with antibiotics, the authors noted that they took a conservative approach, using broad-spectrum antibiotics and keeping patients in hospital for 3 days for observation.
“The success of antibiotic treatment for appendicitis calls into question prior beliefs that appendicitis inevitably results in serious intra-abdominal infection if appendectomy is not performed.”
The study was supported by the Mary and Georg C. Ehrnrooth Foundation, the EVO Foundation, and Turku University. One author declared lecture fees from three pharmaceutical companies but no other conflicts of interest were declared.
SOURCE: Salminen P et al. JAMA 2018;320:1259-65. doi: 10.1001/jama.2018.13201.
FROM JAMA
Key clinical point: Antibiotics could be used as an alternative to surgery for uncomplicated acute appendicitis.
Major finding: Around two-thirds of patients with acute appendicitis treated with antibiotics only did not experience a recurrence in 5 years.
Study details: Randomized controlled study in 530 patients with uncomplicated acute appendicitis.
Disclosures: The study was supported by the Mary and Georg C. Ehrnrooth Foundation, the EVO Foundation, and Turku University. One author declared lecture fees from three pharmaceutical companies but no other conflicts of interest were declared.
Source: Salminen P et al. JAMA 2018;320:1259-65. doi: 10.1001/jama.2018.13201.
Partial nephrectomies on rise for early-stage RCC
SAN FRANCISCO – Partial nephrectomy for localized renal cell carcinomas (RCCs) is on the rise, but the procedure is still less commonly performed than radical nephrectomy and more commonly performed at high-volume surgical centers.
About half of localized renal tumors are excised through partial nephrectomy, based on results from a new analysis of The National Cancer Database. The study also indicated that patient mortality rates were lower at high volume centers, those in the top 10 percentile of treatment volume, said David Cahn, DO, who presented the results at the annual meeting of the American Urological Association.
The study looked at surgeries among 142,000 patients with pT1a-T2b RCCs (no involvement of lymph nodes or metastases) who underwent procedures during 2004-2014.
Overall, 41% of patients had partial nephrectomies, 58% had radical nephrectomies, and 1% received ablative therapy. The frequency of partial nephrectomies rose markedly over the course of the study, increasing from 24% of cases in 2004 to 53% in 2014. The vast majority of partial nephrectomies, 81%, were performed for pT1a tumors; 24% of pT1b tumors also were excised using partial nephrectomy.
Compared with the reference point of T1a tumors, T1b tumors (odds ratio, 0.22; P less than .0001), T2a (OR, 0.06; P less than .0001), and T2b tumors (OR, 0.03; P less than .0001) were progressively less likely to be treated with partial nephrectomy. A multivariate analysis showed that patients at a high volume center were significantly more likely to undergo partial nephrectomy (OR, 1.89; P less than .0001). Overall mortality was lower at high volume centers (hazard ratio, 0.92; P = .012).
“I think that regionalization of care has ... some benefits to patients, but it comes with many challenges as well. This study really did help show that increased numbers [of procedures performed] makes you more comfortable and willing to offer partial nephrectomy,” said Dr. Cahn, of Fox Chase Cancer Center, Philadelphia.
“Volume tends to show better outcomes. But the concern is: Are you overloading systems? Are you making patients travel farther, and how does that work in terms of follow-up care?” Dr. Cahn said. He cited the example of a patient who may have to travel several hours to get surgery but then returns home and develops a postoperative complication that must be treated in a different facility. That raises issues of transfer of medical records and coordination of care.
The solution, he said, is for some of the procedures and practices common at high-volume centers to be transferred to smaller centers. “For the routine partial nephrectomy ... we need to have well-trained physicians who can offer those all over the country. I think it’s too hard in terms of feasibility to push those patients just towards certain high volume centers.”
SOURCE: AUA Annual Meeting, Abstract PD07-04.
SAN FRANCISCO – Partial nephrectomy for localized renal cell carcinomas (RCCs) is on the rise, but the procedure is still less commonly performed than radical nephrectomy and more commonly performed at high-volume surgical centers.
About half of localized renal tumors are excised through partial nephrectomy, based on results from a new analysis of The National Cancer Database. The study also indicated that patient mortality rates were lower at high volume centers, those in the top 10 percentile of treatment volume, said David Cahn, DO, who presented the results at the annual meeting of the American Urological Association.
The study looked at surgeries among 142,000 patients with pT1a-T2b RCCs (no involvement of lymph nodes or metastases) who underwent procedures during 2004-2014.
Overall, 41% of patients had partial nephrectomies, 58% had radical nephrectomies, and 1% received ablative therapy. The frequency of partial nephrectomies rose markedly over the course of the study, increasing from 24% of cases in 2004 to 53% in 2014. The vast majority of partial nephrectomies, 81%, were performed for pT1a tumors; 24% of pT1b tumors also were excised using partial nephrectomy.
Compared with the reference point of T1a tumors, T1b tumors (odds ratio, 0.22; P less than .0001), T2a (OR, 0.06; P less than .0001), and T2b tumors (OR, 0.03; P less than .0001) were progressively less likely to be treated with partial nephrectomy. A multivariate analysis showed that patients at a high volume center were significantly more likely to undergo partial nephrectomy (OR, 1.89; P less than .0001). Overall mortality was lower at high volume centers (hazard ratio, 0.92; P = .012).
“I think that regionalization of care has ... some benefits to patients, but it comes with many challenges as well. This study really did help show that increased numbers [of procedures performed] makes you more comfortable and willing to offer partial nephrectomy,” said Dr. Cahn, of Fox Chase Cancer Center, Philadelphia.
“Volume tends to show better outcomes. But the concern is: Are you overloading systems? Are you making patients travel farther, and how does that work in terms of follow-up care?” Dr. Cahn said. He cited the example of a patient who may have to travel several hours to get surgery but then returns home and develops a postoperative complication that must be treated in a different facility. That raises issues of transfer of medical records and coordination of care.
The solution, he said, is for some of the procedures and practices common at high-volume centers to be transferred to smaller centers. “For the routine partial nephrectomy ... we need to have well-trained physicians who can offer those all over the country. I think it’s too hard in terms of feasibility to push those patients just towards certain high volume centers.”
SOURCE: AUA Annual Meeting, Abstract PD07-04.
SAN FRANCISCO – Partial nephrectomy for localized renal cell carcinomas (RCCs) is on the rise, but the procedure is still less commonly performed than radical nephrectomy and more commonly performed at high-volume surgical centers.
About half of localized renal tumors are excised through partial nephrectomy, based on results from a new analysis of The National Cancer Database. The study also indicated that patient mortality rates were lower at high volume centers, those in the top 10 percentile of treatment volume, said David Cahn, DO, who presented the results at the annual meeting of the American Urological Association.
The study looked at surgeries among 142,000 patients with pT1a-T2b RCCs (no involvement of lymph nodes or metastases) who underwent procedures during 2004-2014.
Overall, 41% of patients had partial nephrectomies, 58% had radical nephrectomies, and 1% received ablative therapy. The frequency of partial nephrectomies rose markedly over the course of the study, increasing from 24% of cases in 2004 to 53% in 2014. The vast majority of partial nephrectomies, 81%, were performed for pT1a tumors; 24% of pT1b tumors also were excised using partial nephrectomy.
Compared with the reference point of T1a tumors, T1b tumors (odds ratio, 0.22; P less than .0001), T2a (OR, 0.06; P less than .0001), and T2b tumors (OR, 0.03; P less than .0001) were progressively less likely to be treated with partial nephrectomy. A multivariate analysis showed that patients at a high volume center were significantly more likely to undergo partial nephrectomy (OR, 1.89; P less than .0001). Overall mortality was lower at high volume centers (hazard ratio, 0.92; P = .012).
“I think that regionalization of care has ... some benefits to patients, but it comes with many challenges as well. This study really did help show that increased numbers [of procedures performed] makes you more comfortable and willing to offer partial nephrectomy,” said Dr. Cahn, of Fox Chase Cancer Center, Philadelphia.
“Volume tends to show better outcomes. But the concern is: Are you overloading systems? Are you making patients travel farther, and how does that work in terms of follow-up care?” Dr. Cahn said. He cited the example of a patient who may have to travel several hours to get surgery but then returns home and develops a postoperative complication that must be treated in a different facility. That raises issues of transfer of medical records and coordination of care.
The solution, he said, is for some of the procedures and practices common at high-volume centers to be transferred to smaller centers. “For the routine partial nephrectomy ... we need to have well-trained physicians who can offer those all over the country. I think it’s too hard in terms of feasibility to push those patients just towards certain high volume centers.”
SOURCE: AUA Annual Meeting, Abstract PD07-04.
REPORTING FROM THE AUA ANNUAL MEETING
Key clinical point: Many patients who could undergo partial nephrectomy are still receiving radical nephrectomies.
Major finding: In 2014, 53% of patients with pT1a or pT1b RCC underwent partial nephrectomy.
Study details: Retrospective analysis of 142,000 patients.
Disclosures: The study was funded internally. Dr. Cahn reports having no relevant financial disclosures.
Source: Cahn D et al. AUA Annual Meeting, Abstract PD07-04.
Risk factors for postop cardiac events differ between vascular and general surgery
Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.
They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.
Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.
A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.
The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.
However, predictors of CEs risk between vascular and general surgery were significantly different.
For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.
For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.
The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.
“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.
They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”
Dr. Acheampong and his colleagues reported having no disclosures.
SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.
Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.
They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.
Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.
A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.
The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.
However, predictors of CEs risk between vascular and general surgery were significantly different.
For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.
For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.
The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.
“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.
They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”
Dr. Acheampong and his colleagues reported having no disclosures.
SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.
Predictive risk factors for cardiac events (CEs) after general and vascular surgery differed significantly, according to a large retrospective study. However, there was no significant difference seen in the overall incidence of CEs between the two types of surgery, reported Derrick Acheampong, MD, and his colleagues at the Icahn School of Medicine at Mount Sinai, New York.
They performed a retrospective data analysis of 8,441 adult patients at their large urban teaching hospital; these patients had undergone general or vascular surgery during 2013-2016 and, in the analysis, were grouped by whether they experienced postoperative CEs.
Univariate and multivariate analyses identified predictors of postoperative CE and the association of CEs with adverse postoperative outcomes. CEs were defined as myocardial infarction or cardiac arrest within the 30-day postoperative period.
A total of 157 patients (1.9%) experienced CEs after major general and vascular surgery, with no significant difference in incidence between the two types of surgery (P = .44), according to their report, published online in the Annals of Medicine and Surgery. CE-associated mortality among this group was high, at 55.4%.
The occurrence of a CE following surgery in both groups was significantly associated with increased mortality, as well as pulmonary, renal, and neurological complications, in addition to systemic sepsis, postoperative red blood cell transfusion, unplanned return to the operating room, and prolonged hospitalization, according to the researchers.
However, predictors of CEs risk between vascular and general surgery were significantly different.
For general surgery, American Society of Anesthesiologists (ASA) status greater than 3, dependent functional status, acute renal failure or dialysis, weight loss, creatinine greater than 1.2 mg/dL, international normalized ratio (INR) greater than 1.5, and partial thromboplastin time (PTT) less than 35 seconds were all unique independent predictors of postoperative CEs.
For vascular surgery, the unique significant predictors of postoperative CEs were age greater than 65 years, emergency surgery, diabetes, congestive heart failure, systemic sepsis, and operative time greater than 240 minutes.
The only common predictive risk factors for postoperative CEs for the two forms of surgery were hematocrit less than 34% and ventilator dependence.
“The present study corroborates reported studies that recommend separate predictive CE risk indices and risk stratification among different surgical specialties. Predictors for CE greatly differed between general and vascular surgery patients in our patient population,” the authors stated.
They concluded with the hope that their study “provides useful information to surgeons and allows for the necessary resources to be focused on identified at-risk patients to improve surgical outcomes.”
Dr. Acheampong and his colleagues reported having no disclosures.
SOURCE: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.
FROM ANNALS OF MEDICINE AND SURGERY
Key clinical point: There was a significant difference in predictive risk factors for postoperative cardiac events between vascular and general surgery.
Major finding: The 1.9% incidence of cardiac events following general or vascular surgery was associated with a mortality rate of 55%.
Study details: Retrospective study of 8,441 patients who underwent vascular or general surgery during 2013-2015.
Disclosures: The authors reported having no disclosures.
Source: Acheampong D et al. Ann Med Surg. 2018. doi: 10.1016/j.amsu.2018.08.001.
POEM effective for more than achalasia
.
The procedure was clinically successful and relieved chest pain in most patients, reported Mouen A. Khashab, MD, director of therapeutic endoscopy at Johns Hopkins Hospital in Baltimore.
POEM was introduced in 2008 as a less invasive alternative to laparoscopic Heller myotomy. During the procedure, submucosal tunneling is performed through the lower esophageal sphincter to the gastric cardia, thereby weakening the lower esophageal sphincter to allow passage of food.
POEM is clinically successful in 80%-90% of patients with achalasia. Although the procedure is regarded as safe and effective for achalasia, it has not been thoroughly researched for treatment of other esophageal motility disorders, including junction outflow obstruction (EGJOO), jackhammer esophagus (JE), or esophagogastric distal esophageal spasm (DES). EGJOO is similar to achalasia, but with peristalsis and a mean integrated relaxation pressure (IRP) greater than 15 mm Hg. Both JE and DES are spastic esophageal disorders. Patients with JE exhibit extreme esophageal hypercontractility, whereas patients with DES have a normal mean IRP and at least 20% premature contractions.
“The role POEM plays in management of these disorders is not clear, mainly due to scarcity of studies on this topic,” the authors wrote in Endoscopy International Open. “A previous multicenter study investigated the role of POEM in 73 patients with spastic esophageal disorders. However, the vast majority of patients (n = 54) in that study had type III (spastic) achalasia.” Since therapies such as botulinum toxin injections and calcium channel blockers are ineffective for many patients with nonachalasia esophageal motility disorders, “POEM is potentially an ideal treatment.”
The international, multicenter study involved 11 treatment centers and 50 patients. Patients with JE (n = 18), EGJOO (n = 15), and DES (n = 17) were included, each diagnosed according to the Chicago classification of esophageal motility disorders. Patients with type III achalasia were excluded.
Outcomes included technical success (completion of myotomy) and clinical success (Eckardt score at least 3 and symptom improvement). Prior to the procedure, the mean Eckardt score was 6.9 and chest pain was reported by almost three-quarters of the patients (72%).
Technical success was achieved in all patients. Myotomy thickness varied between cases; approximately half had a selective inner circular myotomy (48%), slightly less had a full-thickness myotomy (44%), and several were undefined (8%). Mean esophageal myotomy length was 12.5 cm and mean gastric myotomy length was 2.5 cm. Mean procedure time was approximately 90 minutes. Median duration of hospital stay was 2 days.
Nine adverse events (AEs) occurred in 8 patients, including submucosal hematoma, aspiration pneumonia, inadvertent mucosotomy, postprocedure pain, esophageal leak, bleed, and symptomatic capno-thorax/peritoneum.
“Although AEs occurred in 18% of patients,” the authors noted, “55.6% were rated as mild and 44.4% as moderate with no severe events. Most AEs can be managed intraprocedurally.”
Median follow-up time was approximately 8 months, during which 42 patients (87.5%) achieved clinical success, with many dramatically improved; over half of the patients (52%) had Eckardt scores of 0 or 1. From the group of patients who had chest pain prior to the procedure, 87% had resolution of chest pain. Although reflux developed in almost a quarter of the patients (22.2%), this was successfully managed with proton pump inhibitors in all instances. Most patients (82.9%) who underwent postoperative manometry had resolution of preoperative abnormalities.
Subgroup analysis was also performed. Clinical success was achieved in 94.1% of patients with DES, 93.3% of patients with EGJOO, and 75.0% with JE. Collectively, the spastic disorders (DES/JE) had a lower numerical response than EGJOO. However, the authors noted that “the difference was not statistically significant (P = .41), likely a type II error due to the relatively small number of included patients.” In all subgroups, postprocedural mean Eckardt scores decreased to less than 2. Patients with EGJOO were most likely to achieve Eckardt scores of 0 or 1. AEs were similar between subgroups.
“Remarkably, chest pain improved in more than 85% of patients,” the authors wrote. “Chest pain is frequently the major presenting symptom in these disorders and is difficult to treat.”
“It is important to mention that a long esophageal myotomy is essential to ensure that proximal esophageal spasms are effectively covered and treated,” the authors wrote. “Mean length of esophageal myotomy in patients with DES and JE in the current study was about 14 cm, which is more than twice the length of a typical endoscopic or surgical myotomy performed in achalasia patients.”
Even with the need for an extended myotomy, “results from the current study along with published data suggest POEM as an effective technique” for nonachalasia esophageal motility disorders, the authors concluded.
Since retrospective studies are inherently limited by design, the authors encouraged randomized trials to clarify the primary role of POEM in the management of nonachalasia esophageal motility disorders.
The authors reported compensation from Olympus, Boston Scientific, and Cook Medical.
SOURCE: Khashab MA et al. Endosc Int Open. 2018 Aug 10. doi: 10.1055/a-0625-6288.
.
The procedure was clinically successful and relieved chest pain in most patients, reported Mouen A. Khashab, MD, director of therapeutic endoscopy at Johns Hopkins Hospital in Baltimore.
POEM was introduced in 2008 as a less invasive alternative to laparoscopic Heller myotomy. During the procedure, submucosal tunneling is performed through the lower esophageal sphincter to the gastric cardia, thereby weakening the lower esophageal sphincter to allow passage of food.
POEM is clinically successful in 80%-90% of patients with achalasia. Although the procedure is regarded as safe and effective for achalasia, it has not been thoroughly researched for treatment of other esophageal motility disorders, including junction outflow obstruction (EGJOO), jackhammer esophagus (JE), or esophagogastric distal esophageal spasm (DES). EGJOO is similar to achalasia, but with peristalsis and a mean integrated relaxation pressure (IRP) greater than 15 mm Hg. Both JE and DES are spastic esophageal disorders. Patients with JE exhibit extreme esophageal hypercontractility, whereas patients with DES have a normal mean IRP and at least 20% premature contractions.
“The role POEM plays in management of these disorders is not clear, mainly due to scarcity of studies on this topic,” the authors wrote in Endoscopy International Open. “A previous multicenter study investigated the role of POEM in 73 patients with spastic esophageal disorders. However, the vast majority of patients (n = 54) in that study had type III (spastic) achalasia.” Since therapies such as botulinum toxin injections and calcium channel blockers are ineffective for many patients with nonachalasia esophageal motility disorders, “POEM is potentially an ideal treatment.”
The international, multicenter study involved 11 treatment centers and 50 patients. Patients with JE (n = 18), EGJOO (n = 15), and DES (n = 17) were included, each diagnosed according to the Chicago classification of esophageal motility disorders. Patients with type III achalasia were excluded.
Outcomes included technical success (completion of myotomy) and clinical success (Eckardt score at least 3 and symptom improvement). Prior to the procedure, the mean Eckardt score was 6.9 and chest pain was reported by almost three-quarters of the patients (72%).
Technical success was achieved in all patients. Myotomy thickness varied between cases; approximately half had a selective inner circular myotomy (48%), slightly less had a full-thickness myotomy (44%), and several were undefined (8%). Mean esophageal myotomy length was 12.5 cm and mean gastric myotomy length was 2.5 cm. Mean procedure time was approximately 90 minutes. Median duration of hospital stay was 2 days.
Nine adverse events (AEs) occurred in 8 patients, including submucosal hematoma, aspiration pneumonia, inadvertent mucosotomy, postprocedure pain, esophageal leak, bleed, and symptomatic capno-thorax/peritoneum.
“Although AEs occurred in 18% of patients,” the authors noted, “55.6% were rated as mild and 44.4% as moderate with no severe events. Most AEs can be managed intraprocedurally.”
Median follow-up time was approximately 8 months, during which 42 patients (87.5%) achieved clinical success, with many dramatically improved; over half of the patients (52%) had Eckardt scores of 0 or 1. From the group of patients who had chest pain prior to the procedure, 87% had resolution of chest pain. Although reflux developed in almost a quarter of the patients (22.2%), this was successfully managed with proton pump inhibitors in all instances. Most patients (82.9%) who underwent postoperative manometry had resolution of preoperative abnormalities.
Subgroup analysis was also performed. Clinical success was achieved in 94.1% of patients with DES, 93.3% of patients with EGJOO, and 75.0% with JE. Collectively, the spastic disorders (DES/JE) had a lower numerical response than EGJOO. However, the authors noted that “the difference was not statistically significant (P = .41), likely a type II error due to the relatively small number of included patients.” In all subgroups, postprocedural mean Eckardt scores decreased to less than 2. Patients with EGJOO were most likely to achieve Eckardt scores of 0 or 1. AEs were similar between subgroups.
“Remarkably, chest pain improved in more than 85% of patients,” the authors wrote. “Chest pain is frequently the major presenting symptom in these disorders and is difficult to treat.”
“It is important to mention that a long esophageal myotomy is essential to ensure that proximal esophageal spasms are effectively covered and treated,” the authors wrote. “Mean length of esophageal myotomy in patients with DES and JE in the current study was about 14 cm, which is more than twice the length of a typical endoscopic or surgical myotomy performed in achalasia patients.”
Even with the need for an extended myotomy, “results from the current study along with published data suggest POEM as an effective technique” for nonachalasia esophageal motility disorders, the authors concluded.
Since retrospective studies are inherently limited by design, the authors encouraged randomized trials to clarify the primary role of POEM in the management of nonachalasia esophageal motility disorders.
The authors reported compensation from Olympus, Boston Scientific, and Cook Medical.
SOURCE: Khashab MA et al. Endosc Int Open. 2018 Aug 10. doi: 10.1055/a-0625-6288.
.
The procedure was clinically successful and relieved chest pain in most patients, reported Mouen A. Khashab, MD, director of therapeutic endoscopy at Johns Hopkins Hospital in Baltimore.
POEM was introduced in 2008 as a less invasive alternative to laparoscopic Heller myotomy. During the procedure, submucosal tunneling is performed through the lower esophageal sphincter to the gastric cardia, thereby weakening the lower esophageal sphincter to allow passage of food.
POEM is clinically successful in 80%-90% of patients with achalasia. Although the procedure is regarded as safe and effective for achalasia, it has not been thoroughly researched for treatment of other esophageal motility disorders, including junction outflow obstruction (EGJOO), jackhammer esophagus (JE), or esophagogastric distal esophageal spasm (DES). EGJOO is similar to achalasia, but with peristalsis and a mean integrated relaxation pressure (IRP) greater than 15 mm Hg. Both JE and DES are spastic esophageal disorders. Patients with JE exhibit extreme esophageal hypercontractility, whereas patients with DES have a normal mean IRP and at least 20% premature contractions.
“The role POEM plays in management of these disorders is not clear, mainly due to scarcity of studies on this topic,” the authors wrote in Endoscopy International Open. “A previous multicenter study investigated the role of POEM in 73 patients with spastic esophageal disorders. However, the vast majority of patients (n = 54) in that study had type III (spastic) achalasia.” Since therapies such as botulinum toxin injections and calcium channel blockers are ineffective for many patients with nonachalasia esophageal motility disorders, “POEM is potentially an ideal treatment.”
The international, multicenter study involved 11 treatment centers and 50 patients. Patients with JE (n = 18), EGJOO (n = 15), and DES (n = 17) were included, each diagnosed according to the Chicago classification of esophageal motility disorders. Patients with type III achalasia were excluded.
Outcomes included technical success (completion of myotomy) and clinical success (Eckardt score at least 3 and symptom improvement). Prior to the procedure, the mean Eckardt score was 6.9 and chest pain was reported by almost three-quarters of the patients (72%).
Technical success was achieved in all patients. Myotomy thickness varied between cases; approximately half had a selective inner circular myotomy (48%), slightly less had a full-thickness myotomy (44%), and several were undefined (8%). Mean esophageal myotomy length was 12.5 cm and mean gastric myotomy length was 2.5 cm. Mean procedure time was approximately 90 minutes. Median duration of hospital stay was 2 days.
Nine adverse events (AEs) occurred in 8 patients, including submucosal hematoma, aspiration pneumonia, inadvertent mucosotomy, postprocedure pain, esophageal leak, bleed, and symptomatic capno-thorax/peritoneum.
“Although AEs occurred in 18% of patients,” the authors noted, “55.6% were rated as mild and 44.4% as moderate with no severe events. Most AEs can be managed intraprocedurally.”
Median follow-up time was approximately 8 months, during which 42 patients (87.5%) achieved clinical success, with many dramatically improved; over half of the patients (52%) had Eckardt scores of 0 or 1. From the group of patients who had chest pain prior to the procedure, 87% had resolution of chest pain. Although reflux developed in almost a quarter of the patients (22.2%), this was successfully managed with proton pump inhibitors in all instances. Most patients (82.9%) who underwent postoperative manometry had resolution of preoperative abnormalities.
Subgroup analysis was also performed. Clinical success was achieved in 94.1% of patients with DES, 93.3% of patients with EGJOO, and 75.0% with JE. Collectively, the spastic disorders (DES/JE) had a lower numerical response than EGJOO. However, the authors noted that “the difference was not statistically significant (P = .41), likely a type II error due to the relatively small number of included patients.” In all subgroups, postprocedural mean Eckardt scores decreased to less than 2. Patients with EGJOO were most likely to achieve Eckardt scores of 0 or 1. AEs were similar between subgroups.
“Remarkably, chest pain improved in more than 85% of patients,” the authors wrote. “Chest pain is frequently the major presenting symptom in these disorders and is difficult to treat.”
“It is important to mention that a long esophageal myotomy is essential to ensure that proximal esophageal spasms are effectively covered and treated,” the authors wrote. “Mean length of esophageal myotomy in patients with DES and JE in the current study was about 14 cm, which is more than twice the length of a typical endoscopic or surgical myotomy performed in achalasia patients.”
Even with the need for an extended myotomy, “results from the current study along with published data suggest POEM as an effective technique” for nonachalasia esophageal motility disorders, the authors concluded.
Since retrospective studies are inherently limited by design, the authors encouraged randomized trials to clarify the primary role of POEM in the management of nonachalasia esophageal motility disorders.
The authors reported compensation from Olympus, Boston Scientific, and Cook Medical.
SOURCE: Khashab MA et al. Endosc Int Open. 2018 Aug 10. doi: 10.1055/a-0625-6288.
FROM ENDOSCOPY INTERNATIONAL OPEN
Key clinical point: Peroral endoscopic myotomy (POEM) is safe and effective for jackhammer esophagus (JE), esophagogastric junction outflow obstruction (EGJOO), and distal esophageal spasm (DES).
Major finding: POEM was clinically successful in approximately 90% of patients with nonachalasia esophageal motility disorders.
Study details: A retrospective, multicenter study involving 50 patients with nonachalasia esophageal motility disorders.
Disclosures: Authors reported compensation from Olympus, Boston Scientific, and Cook Medical.
Source: Khashab MA et al. Endosc Int Open. 2018 Aug 10. doi: 10.1055/a-0625-6288
Study examines POEM learning curve
Technical failures or adverse events complicated 4% of peroral endoscopic myotomies (POEMs) in a large single-center retrospective study.
Individual predictors of this composite negative outcome included case number, full-thickness myotomy, and procedure time, Zuqiang Liu, PhD, and his associates at Fudan University, Shanghai, China, wrote in the September issue of Clinical Gastroenterology and Hepatology.
After controlling for these risk factors, the composite rate of adverse events and technical failures dropped gradually after an endoscopist had performed his or her first 100 cases, according to the researchers. “Technical proficiency, demonstrated by plateauing of the procedure time, could be achieved after 70 cases,” they wrote. “The volume of cases required to manage challenging situations and prevent adverse events was thus higher than that needed for simple technical proficiency.” The experience of the training surgeon helped trainees gain technical proficiency faster, they added.
Peroral endoscopic myotomy (POEM) is minimally invasive and effectively treats spastic esophageal motility disorders. However, it is also a challenging procedure, and little is known about its learning curve. For the study, the researchers retrospectively reviewed technical failures and adverse events among 1,346 POEMs performed for achalasia at a single hospital in China between August 2010 and July 2015. They also assessed procedure time and a secondary composite outcome consisting of technical failure, adverse events, and clinical failure (further symptoms) for the first 192 cases performed by the original training surgeon.
There were 10 technical failures and 44 adverse events affecting a total of 54 patients (4%). Case number (P = .010), full-thickness myotomy (P = .002), and procedure time (P = .001) independently predicted this primary composite outcome. Adjusted cumulative sum analysis showed that the rate of this composite outcome decreased gradually after a surgeon had performed his or her first 100 cases. “The procedure time was high during the first few cases and decreased after endoscopists performed 70 cases,” indicating technical proficiency, the investigators wrote. The rate of the secondary composite outcome also fell gradually after the primary surgeon had performed between 90 and 100 cases.
For the first 192 cases performed by the lead surgeon, postprocedural follow-up time was typically 59 months, with a range of 3-71 months. Clinical failures occurred in 20 cases (10%). Rates of clinical failure were 6% at 1 year, 8% at 2 years, and 10% at 3 years.
This is the first study and the largest POEM database so far to assess the learning curve for this procedure by evaluating adverse events and clinical and technical failure, said the researchers. Previous studies consisted of small cases, usually of less than 100 patients each, they added. Such studies would inherently be biased because the smaller the caseload, the longer it might take for the learning curves of surgeons to plateau, they added.
Funders included the National Natural Science Foundation of China, the Major Project of Shanghai Municipal Science and Technology Committee, the Chen Guang Program of Shanghai Municipal Education Commission, and the Outstanding Young Doctor Training Project of Shanghai Municipal Commission of Health and Family Planning. The investigators reported having no relevant conflicts of interest.
SOURCE: Zuqiang L et al. Clin Gastroenterol Hepatol. 2017 Dec 5. doi: 10.1016/j.cgh.2017.11.048.
Determining competency in endoscopic procedures has been a vexing challenge since the introduction of flexible endoscopy. Traditionally, procedure volume has been used as a surrogate for technical competence. However, each endoscopist has their own learning curve. Furthermore, that curve is influenced by both the endoscopist and the characteristics of each patient. Thus, relying on procedure volume or length of time are likely inadequate markers of the true learning process. It has become more important to rely on more sophisticated measurements of competence, as illustrated in this study by Liu et al.
By using a large database of patients undergoing POEM, the authors applied risk-adjusted cumulative sum and moving averages (CUSUM) analysis to develop individual learning curves of six training endoscopists. The primary outcomes used to develop the curve were technical failure and adverse effects (likely the two outcomes patients are most concerned about). The analysis was adjusted for case complexity as well, reflecting that not all training episodes are the same. The results reveal that, although trainee endoscopists were able to perform POEM “quickly” by 70 cases, they did not achieve the more important primary outcomes of technical success and low adverse events until at least 100 procedures. This is akin to the difference between getting to the cecum quickly and having a high adenoma detection rate in colonoscopy.
Moving forward, using sophisticated measurement of individual endoscopists’ learning curves will allow maximal effectiveness of routine procedures such as colonoscopy.
Kal Patel, MD, is associate professor of medicine, Baylor College of Medicine, Houston. He has no conflicts of interest.
Determining competency in endoscopic procedures has been a vexing challenge since the introduction of flexible endoscopy. Traditionally, procedure volume has been used as a surrogate for technical competence. However, each endoscopist has their own learning curve. Furthermore, that curve is influenced by both the endoscopist and the characteristics of each patient. Thus, relying on procedure volume or length of time are likely inadequate markers of the true learning process. It has become more important to rely on more sophisticated measurements of competence, as illustrated in this study by Liu et al.
By using a large database of patients undergoing POEM, the authors applied risk-adjusted cumulative sum and moving averages (CUSUM) analysis to develop individual learning curves of six training endoscopists. The primary outcomes used to develop the curve were technical failure and adverse effects (likely the two outcomes patients are most concerned about). The analysis was adjusted for case complexity as well, reflecting that not all training episodes are the same. The results reveal that, although trainee endoscopists were able to perform POEM “quickly” by 70 cases, they did not achieve the more important primary outcomes of technical success and low adverse events until at least 100 procedures. This is akin to the difference between getting to the cecum quickly and having a high adenoma detection rate in colonoscopy.
Moving forward, using sophisticated measurement of individual endoscopists’ learning curves will allow maximal effectiveness of routine procedures such as colonoscopy.
Kal Patel, MD, is associate professor of medicine, Baylor College of Medicine, Houston. He has no conflicts of interest.
Determining competency in endoscopic procedures has been a vexing challenge since the introduction of flexible endoscopy. Traditionally, procedure volume has been used as a surrogate for technical competence. However, each endoscopist has their own learning curve. Furthermore, that curve is influenced by both the endoscopist and the characteristics of each patient. Thus, relying on procedure volume or length of time are likely inadequate markers of the true learning process. It has become more important to rely on more sophisticated measurements of competence, as illustrated in this study by Liu et al.
By using a large database of patients undergoing POEM, the authors applied risk-adjusted cumulative sum and moving averages (CUSUM) analysis to develop individual learning curves of six training endoscopists. The primary outcomes used to develop the curve were technical failure and adverse effects (likely the two outcomes patients are most concerned about). The analysis was adjusted for case complexity as well, reflecting that not all training episodes are the same. The results reveal that, although trainee endoscopists were able to perform POEM “quickly” by 70 cases, they did not achieve the more important primary outcomes of technical success and low adverse events until at least 100 procedures. This is akin to the difference between getting to the cecum quickly and having a high adenoma detection rate in colonoscopy.
Moving forward, using sophisticated measurement of individual endoscopists’ learning curves will allow maximal effectiveness of routine procedures such as colonoscopy.
Kal Patel, MD, is associate professor of medicine, Baylor College of Medicine, Houston. He has no conflicts of interest.
Technical failures or adverse events complicated 4% of peroral endoscopic myotomies (POEMs) in a large single-center retrospective study.
Individual predictors of this composite negative outcome included case number, full-thickness myotomy, and procedure time, Zuqiang Liu, PhD, and his associates at Fudan University, Shanghai, China, wrote in the September issue of Clinical Gastroenterology and Hepatology.
After controlling for these risk factors, the composite rate of adverse events and technical failures dropped gradually after an endoscopist had performed his or her first 100 cases, according to the researchers. “Technical proficiency, demonstrated by plateauing of the procedure time, could be achieved after 70 cases,” they wrote. “The volume of cases required to manage challenging situations and prevent adverse events was thus higher than that needed for simple technical proficiency.” The experience of the training surgeon helped trainees gain technical proficiency faster, they added.
Peroral endoscopic myotomy (POEM) is minimally invasive and effectively treats spastic esophageal motility disorders. However, it is also a challenging procedure, and little is known about its learning curve. For the study, the researchers retrospectively reviewed technical failures and adverse events among 1,346 POEMs performed for achalasia at a single hospital in China between August 2010 and July 2015. They also assessed procedure time and a secondary composite outcome consisting of technical failure, adverse events, and clinical failure (further symptoms) for the first 192 cases performed by the original training surgeon.
There were 10 technical failures and 44 adverse events affecting a total of 54 patients (4%). Case number (P = .010), full-thickness myotomy (P = .002), and procedure time (P = .001) independently predicted this primary composite outcome. Adjusted cumulative sum analysis showed that the rate of this composite outcome decreased gradually after a surgeon had performed his or her first 100 cases. “The procedure time was high during the first few cases and decreased after endoscopists performed 70 cases,” indicating technical proficiency, the investigators wrote. The rate of the secondary composite outcome also fell gradually after the primary surgeon had performed between 90 and 100 cases.
For the first 192 cases performed by the lead surgeon, postprocedural follow-up time was typically 59 months, with a range of 3-71 months. Clinical failures occurred in 20 cases (10%). Rates of clinical failure were 6% at 1 year, 8% at 2 years, and 10% at 3 years.
This is the first study and the largest POEM database so far to assess the learning curve for this procedure by evaluating adverse events and clinical and technical failure, said the researchers. Previous studies consisted of small cases, usually of less than 100 patients each, they added. Such studies would inherently be biased because the smaller the caseload, the longer it might take for the learning curves of surgeons to plateau, they added.
Funders included the National Natural Science Foundation of China, the Major Project of Shanghai Municipal Science and Technology Committee, the Chen Guang Program of Shanghai Municipal Education Commission, and the Outstanding Young Doctor Training Project of Shanghai Municipal Commission of Health and Family Planning. The investigators reported having no relevant conflicts of interest.
SOURCE: Zuqiang L et al. Clin Gastroenterol Hepatol. 2017 Dec 5. doi: 10.1016/j.cgh.2017.11.048.
Technical failures or adverse events complicated 4% of peroral endoscopic myotomies (POEMs) in a large single-center retrospective study.
Individual predictors of this composite negative outcome included case number, full-thickness myotomy, and procedure time, Zuqiang Liu, PhD, and his associates at Fudan University, Shanghai, China, wrote in the September issue of Clinical Gastroenterology and Hepatology.
After controlling for these risk factors, the composite rate of adverse events and technical failures dropped gradually after an endoscopist had performed his or her first 100 cases, according to the researchers. “Technical proficiency, demonstrated by plateauing of the procedure time, could be achieved after 70 cases,” they wrote. “The volume of cases required to manage challenging situations and prevent adverse events was thus higher than that needed for simple technical proficiency.” The experience of the training surgeon helped trainees gain technical proficiency faster, they added.
Peroral endoscopic myotomy (POEM) is minimally invasive and effectively treats spastic esophageal motility disorders. However, it is also a challenging procedure, and little is known about its learning curve. For the study, the researchers retrospectively reviewed technical failures and adverse events among 1,346 POEMs performed for achalasia at a single hospital in China between August 2010 and July 2015. They also assessed procedure time and a secondary composite outcome consisting of technical failure, adverse events, and clinical failure (further symptoms) for the first 192 cases performed by the original training surgeon.
There were 10 technical failures and 44 adverse events affecting a total of 54 patients (4%). Case number (P = .010), full-thickness myotomy (P = .002), and procedure time (P = .001) independently predicted this primary composite outcome. Adjusted cumulative sum analysis showed that the rate of this composite outcome decreased gradually after a surgeon had performed his or her first 100 cases. “The procedure time was high during the first few cases and decreased after endoscopists performed 70 cases,” indicating technical proficiency, the investigators wrote. The rate of the secondary composite outcome also fell gradually after the primary surgeon had performed between 90 and 100 cases.
For the first 192 cases performed by the lead surgeon, postprocedural follow-up time was typically 59 months, with a range of 3-71 months. Clinical failures occurred in 20 cases (10%). Rates of clinical failure were 6% at 1 year, 8% at 2 years, and 10% at 3 years.
This is the first study and the largest POEM database so far to assess the learning curve for this procedure by evaluating adverse events and clinical and technical failure, said the researchers. Previous studies consisted of small cases, usually of less than 100 patients each, they added. Such studies would inherently be biased because the smaller the caseload, the longer it might take for the learning curves of surgeons to plateau, they added.
Funders included the National Natural Science Foundation of China, the Major Project of Shanghai Municipal Science and Technology Committee, the Chen Guang Program of Shanghai Municipal Education Commission, and the Outstanding Young Doctor Training Project of Shanghai Municipal Commission of Health and Family Planning. The investigators reported having no relevant conflicts of interest.
SOURCE: Zuqiang L et al. Clin Gastroenterol Hepatol. 2017 Dec 5. doi: 10.1016/j.cgh.2017.11.048.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Key clinical point: One hundred cases was the typical learning curve for peroral endoscopic myotomy (POEM).
Major finding: The composite rate of technical failure or adverse events was 4%. An adjusted analysis showed that the rate of this negative composite outcome fell gradually after an endoscopist had performed his or her first 100 cases.
Study details: Single-center retrospective study of 1,346 patients undergoing POEM.
Disclosures: Funders included the National Natural Science Foundation of China, the Major Project of Shanghai Municipal Science and Technology Committee, the Chen Guang Program of Shanghai Municipal Education Commission, and the Outstanding Young Doctor Training Project of Shanghai Municipal Commission of Health and Family Planning. The investigators reported having no relevant conflicts of interest..
Source: Zuqiang L et al. Clin Gastroenterol Hepatol. 2017 Dec 5. doi: 10.1016/j.cgh.2017.11.048.
MI risk prediction after noncardiac surgery simplified
ORLANDO – The risk of perioperative MI or death associated with noncardiac surgery is vanishingly low in patients free of diabetes, hypertension, and smoking, Tanya Wilcox, MD, reported at the annual meeting of the American College of Cardiology.
How small is the risk? A mere 1 in 1,000, according to her analysis of more than 3.8 million major noncardiac surgeries in the American College of Surgeons National Surgical Quality Improvement Program database for 2009-2015, according to Dr. Wilcox of New York University.
Physicians are frequently asked by surgeons to clear patients for noncardiac surgery in terms of cardiovascular risk. Because current risk scores are complex, aren’t amenable to rapid bedside calculations, and may entail cardiac stress testing, Dr. Wilcox decided it was worth assessing the impact of three straightforward cardiovascular risk factors – current smoking and treatment for hypertension or diabetes – on 30-day postoperative MI-free survival. For this purpose she turned to the National Surgical Quality Improvement Program database, a validated, risk-adjusted, outcomes-based program to measure and improve the quality of surgical care utilizing data from 250 U.S. surgical centers.
Of the 3,817,113 patients who underwent major noncardiac surgery, 1,586,020 (42%) of them had none of the three cardiovascular risk factors of interest, 1,541,846 (40%) had one, 643,424 (17%) had two, and 45,823, or 1.2%, had all three. The patients’ mean age was 57, 75% were white, and 57% were women. About half of all patients underwent various operations within the realm of general surgery; next most frequent were orthopedic procedures, accounting for 18% of total noncardiac surgery. Of note, only 23% of patients with zero risk factors were American Society of Anesthesiologists Class 3-5, compared with 51% of those with one cardiovascular risk factor, 76% with two, and 71% with all three.
The incidence of acute MI or death within 30 days of noncardiac surgery climbed in stepwise fashion according to a patient’s risk factor burden. In a multivariate analysis adjusted for age, race, and gender, patients with any one of the cardiovascular risk factors had a 30-day risk of acute MI or death that was 1.52 times greater than those with no risk factors, patients with two risk factors were at 2.4-fold increased risk, and those with all three were at 3.63-fold greater risk than those with none. The degree of increased risk associated with any single risk factor ranged from 1.47-fold for hypertension to 1.94-fold for smoking.
“Further study is needed to determine whether aggressive risk factor modifications in the form of blood pressure control, glycemic control, and smoking cessation could reduce the incidence of postoperative MI,” Dr. Wilcox observed.
She reported having no financial conflicts regarding her study.
ORLANDO – The risk of perioperative MI or death associated with noncardiac surgery is vanishingly low in patients free of diabetes, hypertension, and smoking, Tanya Wilcox, MD, reported at the annual meeting of the American College of Cardiology.
How small is the risk? A mere 1 in 1,000, according to her analysis of more than 3.8 million major noncardiac surgeries in the American College of Surgeons National Surgical Quality Improvement Program database for 2009-2015, according to Dr. Wilcox of New York University.
Physicians are frequently asked by surgeons to clear patients for noncardiac surgery in terms of cardiovascular risk. Because current risk scores are complex, aren’t amenable to rapid bedside calculations, and may entail cardiac stress testing, Dr. Wilcox decided it was worth assessing the impact of three straightforward cardiovascular risk factors – current smoking and treatment for hypertension or diabetes – on 30-day postoperative MI-free survival. For this purpose she turned to the National Surgical Quality Improvement Program database, a validated, risk-adjusted, outcomes-based program to measure and improve the quality of surgical care utilizing data from 250 U.S. surgical centers.
Of the 3,817,113 patients who underwent major noncardiac surgery, 1,586,020 (42%) of them had none of the three cardiovascular risk factors of interest, 1,541,846 (40%) had one, 643,424 (17%) had two, and 45,823, or 1.2%, had all three. The patients’ mean age was 57, 75% were white, and 57% were women. About half of all patients underwent various operations within the realm of general surgery; next most frequent were orthopedic procedures, accounting for 18% of total noncardiac surgery. Of note, only 23% of patients with zero risk factors were American Society of Anesthesiologists Class 3-5, compared with 51% of those with one cardiovascular risk factor, 76% with two, and 71% with all three.
The incidence of acute MI or death within 30 days of noncardiac surgery climbed in stepwise fashion according to a patient’s risk factor burden. In a multivariate analysis adjusted for age, race, and gender, patients with any one of the cardiovascular risk factors had a 30-day risk of acute MI or death that was 1.52 times greater than those with no risk factors, patients with two risk factors were at 2.4-fold increased risk, and those with all three were at 3.63-fold greater risk than those with none. The degree of increased risk associated with any single risk factor ranged from 1.47-fold for hypertension to 1.94-fold for smoking.
“Further study is needed to determine whether aggressive risk factor modifications in the form of blood pressure control, glycemic control, and smoking cessation could reduce the incidence of postoperative MI,” Dr. Wilcox observed.
She reported having no financial conflicts regarding her study.
ORLANDO – The risk of perioperative MI or death associated with noncardiac surgery is vanishingly low in patients free of diabetes, hypertension, and smoking, Tanya Wilcox, MD, reported at the annual meeting of the American College of Cardiology.
How small is the risk? A mere 1 in 1,000, according to her analysis of more than 3.8 million major noncardiac surgeries in the American College of Surgeons National Surgical Quality Improvement Program database for 2009-2015, according to Dr. Wilcox of New York University.
Physicians are frequently asked by surgeons to clear patients for noncardiac surgery in terms of cardiovascular risk. Because current risk scores are complex, aren’t amenable to rapid bedside calculations, and may entail cardiac stress testing, Dr. Wilcox decided it was worth assessing the impact of three straightforward cardiovascular risk factors – current smoking and treatment for hypertension or diabetes – on 30-day postoperative MI-free survival. For this purpose she turned to the National Surgical Quality Improvement Program database, a validated, risk-adjusted, outcomes-based program to measure and improve the quality of surgical care utilizing data from 250 U.S. surgical centers.
Of the 3,817,113 patients who underwent major noncardiac surgery, 1,586,020 (42%) of them had none of the three cardiovascular risk factors of interest, 1,541,846 (40%) had one, 643,424 (17%) had two, and 45,823, or 1.2%, had all three. The patients’ mean age was 57, 75% were white, and 57% were women. About half of all patients underwent various operations within the realm of general surgery; next most frequent were orthopedic procedures, accounting for 18% of total noncardiac surgery. Of note, only 23% of patients with zero risk factors were American Society of Anesthesiologists Class 3-5, compared with 51% of those with one cardiovascular risk factor, 76% with two, and 71% with all three.
The incidence of acute MI or death within 30 days of noncardiac surgery climbed in stepwise fashion according to a patient’s risk factor burden. In a multivariate analysis adjusted for age, race, and gender, patients with any one of the cardiovascular risk factors had a 30-day risk of acute MI or death that was 1.52 times greater than those with no risk factors, patients with two risk factors were at 2.4-fold increased risk, and those with all three were at 3.63-fold greater risk than those with none. The degree of increased risk associated with any single risk factor ranged from 1.47-fold for hypertension to 1.94-fold for smoking.
“Further study is needed to determine whether aggressive risk factor modifications in the form of blood pressure control, glycemic control, and smoking cessation could reduce the incidence of postoperative MI,” Dr. Wilcox observed.
She reported having no financial conflicts regarding her study.
REPORTING FROM ACC 2018
Key clinical point: Noncardiac surgery patients can breathe easier regarding perioperative cardiovascular risk provided they don’t smoke and aren’t hypertensive or diabetic.
Major finding: .
Study details: This was a retrospective analysis of more than 3.8 million noncardiac surgeries contained in the American College of Surgeons National Surgical Quality Improvement Program database for 2009-2015.
Disclosures: The study presenter reported having no financial conflicts.
Magnetic LES augmentation for Barrett’s regression debated
SEATTLE –
The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.
Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”
Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.
Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.
The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.
“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.
Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.
At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.
Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.
Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).
There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.
Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.
The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m2, but BMI ranged as high as 44.3.
Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.
Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).
About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.
Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.
The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
SOURCE: Alicuben E et al. WCE 2018, Abstract S095.
The enthusiasm and reservation surrounding the presented results supporting relatively high rates of regression of Barrett’s esophagus in patients undergoing LES magnetic sphincter augmentation are both well founded. Barrett’s regression, which has been observed to occur spontaneously as well as following antireflux interventions, is always a rich topic for debate. The reported rate of regression in this study being higher than that of complete fundoplication (Nissen fundoplication) is perplexing. The premise for the development of magnetic sphincter augmentation at a focal site was based on the theory that complete fundoplication is supraphysiologic, resulting in desired resolution of regurgitation with unwanted sequelae of dysphagia and bloat in a substantial number of patients. The development of magnetic sphincter augmentation was inspired by the concept that it would provide very reproducible control of regurgitation nearing that of complete fundoplication in a permanent fashion and do so at a focal point (< 1 cm) at the level of the lower esophageal sphincter, minimizing dysphagia and bloat. Since the design is one to replicate appropriate physiology without over treating the targeted reflux disease, theoretically any regression of Barrett’s esophagus should likewise approach but not exceed that of complete fundoplication.
I anticipate further studies will add to this rich debate. Any reservations about the results of this study should not overshadow the inherent advantages of magnetic sphincter augmentation. Its implantation is fairly straightforward to teach to surgeons who have a practice focused on antireflux surgery and due to the limited dissection/tissue mobilization required, most patients can return home a few hours after surgery and immediately resume a diet of solid foods.
Dr. Alicuban and colleagues discuss the small but real concern of erosion, however, another point of inherent concern is the binary function of the device. It is either implanted or not, there is no ability beyond endoscopic dilation to treat relative outflow obstruction and no means to convert the device to a “partial wrap.”
As we forge ahead with increasingly creative ways to address reflux disease the lessons we learn will contribute to the development of better medical, endoscopic and minimally invasive surgical technologies and the robust, civil debate seen here is something we can all enthusiastically anticipate.
Kevin M. Reavis, MD, FACS, is with the Division of Gastrointestinal and Minimally Invasive Surgery The Oregon Clinic; associate professor, Oregon Health & Science University, Portland, and President, Oregon Medical Society.
The enthusiasm and reservation surrounding the presented results supporting relatively high rates of regression of Barrett’s esophagus in patients undergoing LES magnetic sphincter augmentation are both well founded. Barrett’s regression, which has been observed to occur spontaneously as well as following antireflux interventions, is always a rich topic for debate. The reported rate of regression in this study being higher than that of complete fundoplication (Nissen fundoplication) is perplexing. The premise for the development of magnetic sphincter augmentation at a focal site was based on the theory that complete fundoplication is supraphysiologic, resulting in desired resolution of regurgitation with unwanted sequelae of dysphagia and bloat in a substantial number of patients. The development of magnetic sphincter augmentation was inspired by the concept that it would provide very reproducible control of regurgitation nearing that of complete fundoplication in a permanent fashion and do so at a focal point (< 1 cm) at the level of the lower esophageal sphincter, minimizing dysphagia and bloat. Since the design is one to replicate appropriate physiology without over treating the targeted reflux disease, theoretically any regression of Barrett’s esophagus should likewise approach but not exceed that of complete fundoplication.
I anticipate further studies will add to this rich debate. Any reservations about the results of this study should not overshadow the inherent advantages of magnetic sphincter augmentation. Its implantation is fairly straightforward to teach to surgeons who have a practice focused on antireflux surgery and due to the limited dissection/tissue mobilization required, most patients can return home a few hours after surgery and immediately resume a diet of solid foods.
Dr. Alicuban and colleagues discuss the small but real concern of erosion, however, another point of inherent concern is the binary function of the device. It is either implanted or not, there is no ability beyond endoscopic dilation to treat relative outflow obstruction and no means to convert the device to a “partial wrap.”
As we forge ahead with increasingly creative ways to address reflux disease the lessons we learn will contribute to the development of better medical, endoscopic and minimally invasive surgical technologies and the robust, civil debate seen here is something we can all enthusiastically anticipate.
Kevin M. Reavis, MD, FACS, is with the Division of Gastrointestinal and Minimally Invasive Surgery The Oregon Clinic; associate professor, Oregon Health & Science University, Portland, and President, Oregon Medical Society.
The enthusiasm and reservation surrounding the presented results supporting relatively high rates of regression of Barrett’s esophagus in patients undergoing LES magnetic sphincter augmentation are both well founded. Barrett’s regression, which has been observed to occur spontaneously as well as following antireflux interventions, is always a rich topic for debate. The reported rate of regression in this study being higher than that of complete fundoplication (Nissen fundoplication) is perplexing. The premise for the development of magnetic sphincter augmentation at a focal site was based on the theory that complete fundoplication is supraphysiologic, resulting in desired resolution of regurgitation with unwanted sequelae of dysphagia and bloat in a substantial number of patients. The development of magnetic sphincter augmentation was inspired by the concept that it would provide very reproducible control of regurgitation nearing that of complete fundoplication in a permanent fashion and do so at a focal point (< 1 cm) at the level of the lower esophageal sphincter, minimizing dysphagia and bloat. Since the design is one to replicate appropriate physiology without over treating the targeted reflux disease, theoretically any regression of Barrett’s esophagus should likewise approach but not exceed that of complete fundoplication.
I anticipate further studies will add to this rich debate. Any reservations about the results of this study should not overshadow the inherent advantages of magnetic sphincter augmentation. Its implantation is fairly straightforward to teach to surgeons who have a practice focused on antireflux surgery and due to the limited dissection/tissue mobilization required, most patients can return home a few hours after surgery and immediately resume a diet of solid foods.
Dr. Alicuban and colleagues discuss the small but real concern of erosion, however, another point of inherent concern is the binary function of the device. It is either implanted or not, there is no ability beyond endoscopic dilation to treat relative outflow obstruction and no means to convert the device to a “partial wrap.”
As we forge ahead with increasingly creative ways to address reflux disease the lessons we learn will contribute to the development of better medical, endoscopic and minimally invasive surgical technologies and the robust, civil debate seen here is something we can all enthusiastically anticipate.
Kevin M. Reavis, MD, FACS, is with the Division of Gastrointestinal and Minimally Invasive Surgery The Oregon Clinic; associate professor, Oregon Health & Science University, Portland, and President, Oregon Medical Society.
SEATTLE –
The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.
Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”
Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.
Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.
The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.
“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.
Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.
At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.
Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.
Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).
There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.
Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.
The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m2, but BMI ranged as high as 44.3.
Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.
Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).
About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.
Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.
The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
SOURCE: Alicuben E et al. WCE 2018, Abstract S095.
SEATTLE –
The study caught the attention of audience members – and raised a few eyebrows – at the 2018 World Congress of Endoscopic Surgery, where its results were presented, because the regression rate with the current standard operation for medically refractory gastroesophageal reflux – Nissen fundoplication – is only about 40%.
Lead investigator Evan Alicuben, MD, a general surgery resident at the university, cautioned that “longer-term follow-up is required to make a meaningful comparison with results following fundoplication.”
Fundoplication has been studied for decades, whereas the new study is likely the very first to look at the rates of Barrett’s regression after magnetic augmentation, and the 70% regression rate was based on postop endoscopies a median of 1.2 years after the procedure, not after the 5, 10, or even more years typically seen in fundoplication studies.
Magnetic sphincter augmentation (LINX Reflux Management System) was approved by the Food and Drug Administration in 2012 for reflux that persists despite maximum drug therapy. Patients have a band of magnetic titanium beads surgically placed around their LES; the band opens to let food pass, but tightens again to bolster the LES and prevent reflux.
The approach is gaining popularity. “We now know that it’s effective at controlling reflux symptoms, taking patients off proton pump inhibitors, and curing esophagitis,” at least in the short term. “One of the issues with [fundoplication] is that it may not last forever; the wrap comes undone or it slips. This device may give longer lasting” protection, Dr. Alicuben said.
“The main criticism is that it’s relatively new; people are still questioning it. The optimist in me wants to say that this is the answer we’ve been looking for; the pessimist [says] we need to wait to see what longer-term data show,” he said.
Barrett’s esophagus was confirmed by endoscopy in all 67 subjects before the magnets were placed, and each had at least one postop endoscopy.
At baseline, 29 had ultrashort-segment disease, which means there was no visible Barrett’s, but did have columnar epithelium with goblet cells on pathology. Thirty patients had short-segment disease, with up to 3 cm of visible involvement confirmed by pathology, while eight had long-segment disease, with involvement extending 3 cm or more.
Of the 67 patients, 48 had no evidence of Barrett’s after the procedure, for an overall regression rate of 71.6%. The regression rate was 82.8% in the ultrashort group (24/29); 73.3% in the short segment group (22/30); and 25% in the long segment group (2/8). Long-segment disease is notorious for persisting despite treatment; both patients had 3-cm lesions.
Among the 34 patients with two or more postop endoscopies, the regression rate was 73.5% (25).
There’s a lot of debate about whether ultrashort-segment disease is truly Barrett’s and whether it carries the same risk of malignant transformation, as one surgeon in the audience noted pointedly, worrying that including ultrashort patients oversold the results.
Dr. Alicuben countered that the regression rate remained strong even when ultrashort patients were excluded: 63% (24/38). “This is every bit as good if not better than the results of fundoplication,” another surgeon in the audience said.
The subjects were aged about 60 years, on average, with more men than women. Most had hiatal hernias, often measuring 3 cm or more. The mean body mass index was 27.3 kg/m2, but BMI ranged as high as 44.3.
Mean operative time was 66 minutes, and there were no major complications. None of the patients progressed to dysplasia or carcinoma. Median DeMeester scores fell from 35.3 to 9.2 after the operation in the 47 patients who had postop pH testing.
Surgeons have worried about esophageal erosion with the LINX system. A recent paper by Dr. Alicuben and his colleagues found 29 cases among almost 10,000 patients, which makes for an erosion rate of 0.3% at a median of about 2 years (J Gastrointest Surg. 2018 Apr 17. doi: 10.1007/s11605-018-3775-0).
About 500 LINX systems have been placed at the University of Southern California. Procedures in the study were performed between 2012 and late 2017.
Dr. Alicuben had no disclosures. Two investigators, including senior author John Lipham, MD, are paid consultants for Torax Medical, the maker of the LINX system, and Johnson & Johnson, which owns Torax through a subsidiary. There was no company funding for the review.
The World Congress of Endoscopic Surgery is hosted by the Society of American Gastrointestinal and Endoscopic Surgeons and the Canadian Association of General Surgeons
SOURCE: Alicuben E et al. WCE 2018, Abstract S095.
REPORTING FROM WCE 2018
Key clinical point: Magnetic lower esophageal sphincter augmentation might offer an easier and more effective fix for gastroesophageal reflux than the current standard, Nissen fundoplication.
Major finding: The overall regression rate of Barrett’s esophagus topped 70%.
Study details: Review of 67 patients
Disclosures: There was no industry funding, and the presenter had no disclosures. Two authors are consultants for Torax Medical, the company that makes the device.
Source: Alicuben E et al. WCE 2018, Abstract S095
