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ICD lead extraction complication rates warrant surgical backup
CHICAGO– Transvenous lead extraction was associated with a significant risk of urgent cardiac surgery and mortality in a real-world cohort of patients undergoing procedures across a wide spectrum of centers and operators.
Among the 11,304 extractions, the major complication rate was 2.3% and mortality rate 0.9%.
While the complication rate was in line with previously published single-center registry data, the mortality rate was more than twice that reported in recent single-center studies from high-volume centers (0.9% vs. 0.4%), Dr. Nitesh Sood reported at the American Heart Association annual scientific sessions.
Of the 98 perioperative deaths, 18 occurred during the lead extraction procedure.
Another 41 patients (16%) required urgent cardiac surgery, of whom 14 (34%) died during or in the immediate postoperative period after surgery.
“Thus, while overall rate of major complications remains low, there exists a significant risk of urgent cardiac surgery and mortality during transvenous lead extractions [TLE] performed in the ‘real world.’ Appropriate training of all personnel involved and optimal cardiothoracic surgical back-up at centers performing TLE is imperative,” Dr. Sood of the Southcoast Health System, Fall River, Mass., concluded.
The analysis is the largest real-world cohort of TLE involving 11,304 patients with an implantable cardioverter defibrillator (ICD) in the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR) ICD Registry with lead extraction data submitted between April 2010 and July 2012. Major complication was a combined endpoint of major operative complications, postoperative or in-hospital mortality, as defined by the NCDR ICD Registry.
The 258 complications included 62 cardiac arrests, 55 pericardial tamponades, 47 pneumothoraces, and 40 cardiac perforations.
In multivariate analysis, significant predictors of any complication were female sex (adjusted odds ratio, 1.46), heart failure admission vs. lead extraction admission (OR, 2.6), noncardiac admission vs. lead extraction admission (OR, 2.4), lead-only procedure vs. extraction during generator change/upgrade (OR, 1.76), age of lead (OR, 1.08), and clinical status requiring lead replacement (OR, 2.2). Dr. Sood reported.
Among lead characteristics, multivariate predictors of major perioperative complications included at least three concurrent leads extracted (OR, 2.13), longer implant duration (OR, 1.13), flat coil design vs. round (OR, 2.68), greater proximal coil surface area (OR, 1.04), and dislodgement of other leads during extraction (OR, 3.97), he noted.
CHICAGO– Transvenous lead extraction was associated with a significant risk of urgent cardiac surgery and mortality in a real-world cohort of patients undergoing procedures across a wide spectrum of centers and operators.
Among the 11,304 extractions, the major complication rate was 2.3% and mortality rate 0.9%.
While the complication rate was in line with previously published single-center registry data, the mortality rate was more than twice that reported in recent single-center studies from high-volume centers (0.9% vs. 0.4%), Dr. Nitesh Sood reported at the American Heart Association annual scientific sessions.
Of the 98 perioperative deaths, 18 occurred during the lead extraction procedure.
Another 41 patients (16%) required urgent cardiac surgery, of whom 14 (34%) died during or in the immediate postoperative period after surgery.
“Thus, while overall rate of major complications remains low, there exists a significant risk of urgent cardiac surgery and mortality during transvenous lead extractions [TLE] performed in the ‘real world.’ Appropriate training of all personnel involved and optimal cardiothoracic surgical back-up at centers performing TLE is imperative,” Dr. Sood of the Southcoast Health System, Fall River, Mass., concluded.
The analysis is the largest real-world cohort of TLE involving 11,304 patients with an implantable cardioverter defibrillator (ICD) in the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR) ICD Registry with lead extraction data submitted between April 2010 and July 2012. Major complication was a combined endpoint of major operative complications, postoperative or in-hospital mortality, as defined by the NCDR ICD Registry.
The 258 complications included 62 cardiac arrests, 55 pericardial tamponades, 47 pneumothoraces, and 40 cardiac perforations.
In multivariate analysis, significant predictors of any complication were female sex (adjusted odds ratio, 1.46), heart failure admission vs. lead extraction admission (OR, 2.6), noncardiac admission vs. lead extraction admission (OR, 2.4), lead-only procedure vs. extraction during generator change/upgrade (OR, 1.76), age of lead (OR, 1.08), and clinical status requiring lead replacement (OR, 2.2). Dr. Sood reported.
Among lead characteristics, multivariate predictors of major perioperative complications included at least three concurrent leads extracted (OR, 2.13), longer implant duration (OR, 1.13), flat coil design vs. round (OR, 2.68), greater proximal coil surface area (OR, 1.04), and dislodgement of other leads during extraction (OR, 3.97), he noted.
CHICAGO– Transvenous lead extraction was associated with a significant risk of urgent cardiac surgery and mortality in a real-world cohort of patients undergoing procedures across a wide spectrum of centers and operators.
Among the 11,304 extractions, the major complication rate was 2.3% and mortality rate 0.9%.
While the complication rate was in line with previously published single-center registry data, the mortality rate was more than twice that reported in recent single-center studies from high-volume centers (0.9% vs. 0.4%), Dr. Nitesh Sood reported at the American Heart Association annual scientific sessions.
Of the 98 perioperative deaths, 18 occurred during the lead extraction procedure.
Another 41 patients (16%) required urgent cardiac surgery, of whom 14 (34%) died during or in the immediate postoperative period after surgery.
“Thus, while overall rate of major complications remains low, there exists a significant risk of urgent cardiac surgery and mortality during transvenous lead extractions [TLE] performed in the ‘real world.’ Appropriate training of all personnel involved and optimal cardiothoracic surgical back-up at centers performing TLE is imperative,” Dr. Sood of the Southcoast Health System, Fall River, Mass., concluded.
The analysis is the largest real-world cohort of TLE involving 11,304 patients with an implantable cardioverter defibrillator (ICD) in the American College of Cardiology Foundation’s National Cardiovascular Data Registry (NCDR) ICD Registry with lead extraction data submitted between April 2010 and July 2012. Major complication was a combined endpoint of major operative complications, postoperative or in-hospital mortality, as defined by the NCDR ICD Registry.
The 258 complications included 62 cardiac arrests, 55 pericardial tamponades, 47 pneumothoraces, and 40 cardiac perforations.
In multivariate analysis, significant predictors of any complication were female sex (adjusted odds ratio, 1.46), heart failure admission vs. lead extraction admission (OR, 2.6), noncardiac admission vs. lead extraction admission (OR, 2.4), lead-only procedure vs. extraction during generator change/upgrade (OR, 1.76), age of lead (OR, 1.08), and clinical status requiring lead replacement (OR, 2.2). Dr. Sood reported.
Among lead characteristics, multivariate predictors of major perioperative complications included at least three concurrent leads extracted (OR, 2.13), longer implant duration (OR, 1.13), flat coil design vs. round (OR, 2.68), greater proximal coil surface area (OR, 1.04), and dislodgement of other leads during extraction (OR, 3.97), he noted.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point: Appropriate training and optimal cardiothoracic surgical backup is necessary at all centers performing lead extractions, because of a significant risk of urgent cardiac surgery and death.
Major finding: The major complication rate was 2.3% and mortality rate 0.9%.
Data source: Retrospective analysis of 11,304 patients with transvenous lead extraction in the NCDR ICD Registry.
Disclosures: The study was supported by the American College of Cardiology Foundation’s National Cardiovascular Data Registry. Dr. Sood reported having no financial disclosures. Three coauthors reported relationships with device makers.
CABG plus mitral repair put under spotlight
CHICAGO – Early results from a randomized trial cast doubt on the benefits of routinely repairing a leaky mitral valve during coronary artery bypass grafting in patients with moderate ischemic mitral regurgitation.
At 1 year, there was no significant difference between patients undergoing CABG alone or CABG plus mitral repair in the primary endpoint of left ventricular reverse modeling, as defined by changes in LV end-systolic volume index (LVESVI) at 1 year (z score 0.50).
Both groups achieved significant reductions in LVESVI, with a median reduction of about 6 mL/m2 from baseline, Dr. Robert Michler, chair of cardiovascular and thoracic surgery at Montefiore Medical Center, New York, reported at the American Heart Association scientific sessions.
At 1 year, patients who underwent CABG and mitral valve repair had significantly less residual moderate or severe mitral regurgitation (11% vs. 31%; P < .001).
On the other hand, the combination procedure was associated with significantly higher rates of any neurologic event (9.6% vs. 3.1%; P = .03), longer cross-clamp (117 vs. 74 minutes) and cardiopulmonary bypass times (163 vs. 106 minutes; P values both < .001), and longer ICU (4.8 vs. 4.0 days; P = .006) and hospital length of stay (11.3 vs. 9.4 days; P = .002), according to the results, also published online (N. Engl. J. Med. 2014 [doi: 10.1056/NEJMoa1410490]).
“The trial did not demonstrate a clinically meaningful advantage to the routine addition of mitral valve repair to CABG,” Dr. Michler said, on behalf of the Cardiothoracic Surgical Trials Network investigators.
The 2014 AHA/American College of Cardiology mitral valve guidelines give a weak class IIb recommendation for mitral valve repair for patients with chronic mitral regurgitation (MR) who are undergoing other cardiac surgery, he noted.
The study evenly randomized 301 patients with moderate ischemic mitral regurgitation to CABG alone or CABG plus valve repair with an undersized ring (average, 28.3 mm for men and 27.1 mm for women).
The mean LVESVI at baseline was 54.8 mL/m2 in the CABG-alone group and 59.6 mL/m2 in the combined procedure group.
At 12 months, mean LVESVIs were 46.1 mL/m2 and 49.6 mL/m2, respectively.
The trial lacked a clinical primary endpoint, and longer follow-up is ongoing to determine whether the lower incidence of moderate or severe MR at 1 year will translate into a net clinical benefit for patients undergoing CABG plus mitral repair, Dr. Michler said.
Designated discussant Dr. David Adams, director of Mount Sinai Hospital’s mitral valve repair reference center in New York, cautioned the audience on the length of the study and called for a full 5 years of follow-up rather than the 2 years as planned.
“Ischemic mitral regurgitation is a disease that hurts you over time. That’s in patients that have had MI, had previous CABG, had attempted mitral valve repair, and had PCI [percutaneous coronary intervention]. So we need much longer term follow-up of this very important data set to really understand its implications,” he said.
In light of roughly half of the patients being in heart failure at baseline, session cochair Dr. Robert Bonow, vice chair of medicine, Northwestern University, Chicago, questioned whether there were differences in outcomes related to changes in baseline ejection fraction (EF) or whether improvement in EF in patients with low EF correlated with reduction in mitral regurgitation with CABG alone.
What is known right now is that mean LVEF increased to the same degree after CABG in both groups, Dr. Michler responded. This was true despite this being a “sick population of patients,” with more than half having diabetes, 50% with heart failure, 20% with renal insufficiency, 10% with prior stroke, and a mean ejection fraction of 40% in both groups.
“What we have yet to identify and plan to explore is the correlation between reverse ventricular remodeling, ejection fraction, and outcome, meaning both the degree of mitral regurgitation and whether there is any signal with respect to repeat hospitalizations, heart failure, or possibly even mortality,” Dr. Michler said.
Both Dr. Michler and Dr. Adams remarked that surgery was extremely safe for the CABG alone and CABG plus MR groups, as reflected by the low mortality at 30 days (2.7% vs. 1.3%) and 1 year (7.3% vs. 6.7%).
The composite endpoint of major adverse cardiac or cerebrovascular events was also similar between groups.
The trial was funded by the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Michler reported grant support from NIH during the conduct of the study. Dr. Adams reported coinventing a mitral valve repair ring.
CHICAGO – Early results from a randomized trial cast doubt on the benefits of routinely repairing a leaky mitral valve during coronary artery bypass grafting in patients with moderate ischemic mitral regurgitation.
At 1 year, there was no significant difference between patients undergoing CABG alone or CABG plus mitral repair in the primary endpoint of left ventricular reverse modeling, as defined by changes in LV end-systolic volume index (LVESVI) at 1 year (z score 0.50).
Both groups achieved significant reductions in LVESVI, with a median reduction of about 6 mL/m2 from baseline, Dr. Robert Michler, chair of cardiovascular and thoracic surgery at Montefiore Medical Center, New York, reported at the American Heart Association scientific sessions.
At 1 year, patients who underwent CABG and mitral valve repair had significantly less residual moderate or severe mitral regurgitation (11% vs. 31%; P < .001).
On the other hand, the combination procedure was associated with significantly higher rates of any neurologic event (9.6% vs. 3.1%; P = .03), longer cross-clamp (117 vs. 74 minutes) and cardiopulmonary bypass times (163 vs. 106 minutes; P values both < .001), and longer ICU (4.8 vs. 4.0 days; P = .006) and hospital length of stay (11.3 vs. 9.4 days; P = .002), according to the results, also published online (N. Engl. J. Med. 2014 [doi: 10.1056/NEJMoa1410490]).
“The trial did not demonstrate a clinically meaningful advantage to the routine addition of mitral valve repair to CABG,” Dr. Michler said, on behalf of the Cardiothoracic Surgical Trials Network investigators.
The 2014 AHA/American College of Cardiology mitral valve guidelines give a weak class IIb recommendation for mitral valve repair for patients with chronic mitral regurgitation (MR) who are undergoing other cardiac surgery, he noted.
The study evenly randomized 301 patients with moderate ischemic mitral regurgitation to CABG alone or CABG plus valve repair with an undersized ring (average, 28.3 mm for men and 27.1 mm for women).
The mean LVESVI at baseline was 54.8 mL/m2 in the CABG-alone group and 59.6 mL/m2 in the combined procedure group.
At 12 months, mean LVESVIs were 46.1 mL/m2 and 49.6 mL/m2, respectively.
The trial lacked a clinical primary endpoint, and longer follow-up is ongoing to determine whether the lower incidence of moderate or severe MR at 1 year will translate into a net clinical benefit for patients undergoing CABG plus mitral repair, Dr. Michler said.
Designated discussant Dr. David Adams, director of Mount Sinai Hospital’s mitral valve repair reference center in New York, cautioned the audience on the length of the study and called for a full 5 years of follow-up rather than the 2 years as planned.
“Ischemic mitral regurgitation is a disease that hurts you over time. That’s in patients that have had MI, had previous CABG, had attempted mitral valve repair, and had PCI [percutaneous coronary intervention]. So we need much longer term follow-up of this very important data set to really understand its implications,” he said.
In light of roughly half of the patients being in heart failure at baseline, session cochair Dr. Robert Bonow, vice chair of medicine, Northwestern University, Chicago, questioned whether there were differences in outcomes related to changes in baseline ejection fraction (EF) or whether improvement in EF in patients with low EF correlated with reduction in mitral regurgitation with CABG alone.
What is known right now is that mean LVEF increased to the same degree after CABG in both groups, Dr. Michler responded. This was true despite this being a “sick population of patients,” with more than half having diabetes, 50% with heart failure, 20% with renal insufficiency, 10% with prior stroke, and a mean ejection fraction of 40% in both groups.
“What we have yet to identify and plan to explore is the correlation between reverse ventricular remodeling, ejection fraction, and outcome, meaning both the degree of mitral regurgitation and whether there is any signal with respect to repeat hospitalizations, heart failure, or possibly even mortality,” Dr. Michler said.
Both Dr. Michler and Dr. Adams remarked that surgery was extremely safe for the CABG alone and CABG plus MR groups, as reflected by the low mortality at 30 days (2.7% vs. 1.3%) and 1 year (7.3% vs. 6.7%).
The composite endpoint of major adverse cardiac or cerebrovascular events was also similar between groups.
The trial was funded by the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Michler reported grant support from NIH during the conduct of the study. Dr. Adams reported coinventing a mitral valve repair ring.
CHICAGO – Early results from a randomized trial cast doubt on the benefits of routinely repairing a leaky mitral valve during coronary artery bypass grafting in patients with moderate ischemic mitral regurgitation.
At 1 year, there was no significant difference between patients undergoing CABG alone or CABG plus mitral repair in the primary endpoint of left ventricular reverse modeling, as defined by changes in LV end-systolic volume index (LVESVI) at 1 year (z score 0.50).
Both groups achieved significant reductions in LVESVI, with a median reduction of about 6 mL/m2 from baseline, Dr. Robert Michler, chair of cardiovascular and thoracic surgery at Montefiore Medical Center, New York, reported at the American Heart Association scientific sessions.
At 1 year, patients who underwent CABG and mitral valve repair had significantly less residual moderate or severe mitral regurgitation (11% vs. 31%; P < .001).
On the other hand, the combination procedure was associated with significantly higher rates of any neurologic event (9.6% vs. 3.1%; P = .03), longer cross-clamp (117 vs. 74 minutes) and cardiopulmonary bypass times (163 vs. 106 minutes; P values both < .001), and longer ICU (4.8 vs. 4.0 days; P = .006) and hospital length of stay (11.3 vs. 9.4 days; P = .002), according to the results, also published online (N. Engl. J. Med. 2014 [doi: 10.1056/NEJMoa1410490]).
“The trial did not demonstrate a clinically meaningful advantage to the routine addition of mitral valve repair to CABG,” Dr. Michler said, on behalf of the Cardiothoracic Surgical Trials Network investigators.
The 2014 AHA/American College of Cardiology mitral valve guidelines give a weak class IIb recommendation for mitral valve repair for patients with chronic mitral regurgitation (MR) who are undergoing other cardiac surgery, he noted.
The study evenly randomized 301 patients with moderate ischemic mitral regurgitation to CABG alone or CABG plus valve repair with an undersized ring (average, 28.3 mm for men and 27.1 mm for women).
The mean LVESVI at baseline was 54.8 mL/m2 in the CABG-alone group and 59.6 mL/m2 in the combined procedure group.
At 12 months, mean LVESVIs were 46.1 mL/m2 and 49.6 mL/m2, respectively.
The trial lacked a clinical primary endpoint, and longer follow-up is ongoing to determine whether the lower incidence of moderate or severe MR at 1 year will translate into a net clinical benefit for patients undergoing CABG plus mitral repair, Dr. Michler said.
Designated discussant Dr. David Adams, director of Mount Sinai Hospital’s mitral valve repair reference center in New York, cautioned the audience on the length of the study and called for a full 5 years of follow-up rather than the 2 years as planned.
“Ischemic mitral regurgitation is a disease that hurts you over time. That’s in patients that have had MI, had previous CABG, had attempted mitral valve repair, and had PCI [percutaneous coronary intervention]. So we need much longer term follow-up of this very important data set to really understand its implications,” he said.
In light of roughly half of the patients being in heart failure at baseline, session cochair Dr. Robert Bonow, vice chair of medicine, Northwestern University, Chicago, questioned whether there were differences in outcomes related to changes in baseline ejection fraction (EF) or whether improvement in EF in patients with low EF correlated with reduction in mitral regurgitation with CABG alone.
What is known right now is that mean LVEF increased to the same degree after CABG in both groups, Dr. Michler responded. This was true despite this being a “sick population of patients,” with more than half having diabetes, 50% with heart failure, 20% with renal insufficiency, 10% with prior stroke, and a mean ejection fraction of 40% in both groups.
“What we have yet to identify and plan to explore is the correlation between reverse ventricular remodeling, ejection fraction, and outcome, meaning both the degree of mitral regurgitation and whether there is any signal with respect to repeat hospitalizations, heart failure, or possibly even mortality,” Dr. Michler said.
Both Dr. Michler and Dr. Adams remarked that surgery was extremely safe for the CABG alone and CABG plus MR groups, as reflected by the low mortality at 30 days (2.7% vs. 1.3%) and 1 year (7.3% vs. 6.7%).
The composite endpoint of major adverse cardiac or cerebrovascular events was also similar between groups.
The trial was funded by the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Michler reported grant support from NIH during the conduct of the study. Dr. Adams reported coinventing a mitral valve repair ring.
AT THE AHA SCIENTIFIC SESSIONS 2014
Key clinical point: CABG plus mitral repair did not significantly improve left ventricular remodeling at 1 year, and was associated with some untoward events.
Major finding: At 12 months, mean LVESVI was 46.1 mL/m2 with CABG alone and 49.6 mL/m2 with CABG plus mitral repair.
Data source: A randomized trial in 301 patients with moderate mitral regurgitation.
Disclosures: The trial was funded by the National Institutes of Health and the Canadian Institutes for Health Research. Dr. Michler reported grant support from NIH during the conduct of the study. Dr. Adams reported coinventing a mitral valve repair ring.
Nonoperative management okay after draining diverticular-associated abscess
SAN FRANCISCO – Patients who did not undergo elective surgical resection after successful percutaneous drainage of a diverticular-associated abscess had low rates of recurrent diverticulitis in a retrospective study, a finding that suggests nonoperative management is a reasonable option in such patients, Dr. Tarek K. Jalouta said.
Percutaneous drainage of diverticular-associated abscess resolved symptoms in 118 of 165 (72%) patients who underwent the procedure at two teaching hospitals in 2001-2013. Sixty of the patients with successful drainage did not undergo elective surgical resection, and eight of these died within a year of the drainage procedure.
Among the remaining 52 patients who had nonoperative management, 72% remained free of diverticulitis after 5 years, Dr. Jalouta and his associates reported at the annual clinical congress of the American College of Surgeons.
“A significant number of patients successfully recover from complicated diverticulitis following percutaneous drainage,” Dr. Jalouta said. “Subsequent nonoperative management carries an acceptable risk for recurrent episodes and may be considered as a reasonable management option.”
All patients diagnosed with diverticular-associated abscess received IV antibiotics within 24-48 hours of diagnosis. The decision to perform percutaneous drainage was at the discretion of the consulting surgeon and the interventional radiologist.
Practice parameters issued by the American Society of Colon and Rectal Surgeons in 2014 suggest that elective colectomy “should typically be advised” following successful medical treatment of diverticular-associated abscess with or without percutaneous drainage, noted Dr. Jalouta of Spectrum Health System, Grand Rapids, Mich. Separate guidelines from the Association of Coloproctology of Great Britain and Ireland state that there is not sufficient evidence to make a formal recommendation on this topic, he added.
For the cohort of 165 patients, the abscesses averaged 6 cm in diameter and were pelvic in 73% of patients, abdominal in 22%, and in both locations in 5%. Multiple abscesses were present in 17%. Patients had a mean age of 61 years and a mean body mass index of 21 kg/m2, and 52% were female.
The patients who did not undergo surgery after successful percutaneous drainage were significantly older than those who had surgery – 62 years vs. 55 years. Those subgroups did not differ in other respects.
An estimated 130,000 U.S. hospitalizations each year are due to diverticulitis, with 10%-20% of cases complicated by an associated intra-abdominal abscess, he said. Most diverticular-associated abscesses smaller than 5 cm in diameter will respond to antibiotic therapy, but patients with larger abscesses or associated sepsis often get percutaneous drainage.
The results were slightly better than those seen in two previous studies. In one study of 511 patients admitted for acute diverticulitis in 1994-2003, 5 of 12 patients (42%) who did not undergo surgery after percutaneous drainage of abscesses averaging 7 cm in size had a recurrence of diverticulitis (Am. J. Gastroenterol. 2005;100:910-7), Dr. Jalouta said. A separate study of 32 patients managed without surgery after percutaneous drainage of diverticular-associated abscesses found a recurrence-free survival rate of 58% after 7 years (Dis. Colon Rectum 2013;56:622-6).
Dr. Jalouta reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Patients who did not undergo elective surgical resection after successful percutaneous drainage of a diverticular-associated abscess had low rates of recurrent diverticulitis in a retrospective study, a finding that suggests nonoperative management is a reasonable option in such patients, Dr. Tarek K. Jalouta said.
Percutaneous drainage of diverticular-associated abscess resolved symptoms in 118 of 165 (72%) patients who underwent the procedure at two teaching hospitals in 2001-2013. Sixty of the patients with successful drainage did not undergo elective surgical resection, and eight of these died within a year of the drainage procedure.
Among the remaining 52 patients who had nonoperative management, 72% remained free of diverticulitis after 5 years, Dr. Jalouta and his associates reported at the annual clinical congress of the American College of Surgeons.
“A significant number of patients successfully recover from complicated diverticulitis following percutaneous drainage,” Dr. Jalouta said. “Subsequent nonoperative management carries an acceptable risk for recurrent episodes and may be considered as a reasonable management option.”
All patients diagnosed with diverticular-associated abscess received IV antibiotics within 24-48 hours of diagnosis. The decision to perform percutaneous drainage was at the discretion of the consulting surgeon and the interventional radiologist.
Practice parameters issued by the American Society of Colon and Rectal Surgeons in 2014 suggest that elective colectomy “should typically be advised” following successful medical treatment of diverticular-associated abscess with or without percutaneous drainage, noted Dr. Jalouta of Spectrum Health System, Grand Rapids, Mich. Separate guidelines from the Association of Coloproctology of Great Britain and Ireland state that there is not sufficient evidence to make a formal recommendation on this topic, he added.
For the cohort of 165 patients, the abscesses averaged 6 cm in diameter and were pelvic in 73% of patients, abdominal in 22%, and in both locations in 5%. Multiple abscesses were present in 17%. Patients had a mean age of 61 years and a mean body mass index of 21 kg/m2, and 52% were female.
The patients who did not undergo surgery after successful percutaneous drainage were significantly older than those who had surgery – 62 years vs. 55 years. Those subgroups did not differ in other respects.
An estimated 130,000 U.S. hospitalizations each year are due to diverticulitis, with 10%-20% of cases complicated by an associated intra-abdominal abscess, he said. Most diverticular-associated abscesses smaller than 5 cm in diameter will respond to antibiotic therapy, but patients with larger abscesses or associated sepsis often get percutaneous drainage.
The results were slightly better than those seen in two previous studies. In one study of 511 patients admitted for acute diverticulitis in 1994-2003, 5 of 12 patients (42%) who did not undergo surgery after percutaneous drainage of abscesses averaging 7 cm in size had a recurrence of diverticulitis (Am. J. Gastroenterol. 2005;100:910-7), Dr. Jalouta said. A separate study of 32 patients managed without surgery after percutaneous drainage of diverticular-associated abscesses found a recurrence-free survival rate of 58% after 7 years (Dis. Colon Rectum 2013;56:622-6).
Dr. Jalouta reported having no financial disclosures.
On Twitter @sherryboschert
SAN FRANCISCO – Patients who did not undergo elective surgical resection after successful percutaneous drainage of a diverticular-associated abscess had low rates of recurrent diverticulitis in a retrospective study, a finding that suggests nonoperative management is a reasonable option in such patients, Dr. Tarek K. Jalouta said.
Percutaneous drainage of diverticular-associated abscess resolved symptoms in 118 of 165 (72%) patients who underwent the procedure at two teaching hospitals in 2001-2013. Sixty of the patients with successful drainage did not undergo elective surgical resection, and eight of these died within a year of the drainage procedure.
Among the remaining 52 patients who had nonoperative management, 72% remained free of diverticulitis after 5 years, Dr. Jalouta and his associates reported at the annual clinical congress of the American College of Surgeons.
“A significant number of patients successfully recover from complicated diverticulitis following percutaneous drainage,” Dr. Jalouta said. “Subsequent nonoperative management carries an acceptable risk for recurrent episodes and may be considered as a reasonable management option.”
All patients diagnosed with diverticular-associated abscess received IV antibiotics within 24-48 hours of diagnosis. The decision to perform percutaneous drainage was at the discretion of the consulting surgeon and the interventional radiologist.
Practice parameters issued by the American Society of Colon and Rectal Surgeons in 2014 suggest that elective colectomy “should typically be advised” following successful medical treatment of diverticular-associated abscess with or without percutaneous drainage, noted Dr. Jalouta of Spectrum Health System, Grand Rapids, Mich. Separate guidelines from the Association of Coloproctology of Great Britain and Ireland state that there is not sufficient evidence to make a formal recommendation on this topic, he added.
For the cohort of 165 patients, the abscesses averaged 6 cm in diameter and were pelvic in 73% of patients, abdominal in 22%, and in both locations in 5%. Multiple abscesses were present in 17%. Patients had a mean age of 61 years and a mean body mass index of 21 kg/m2, and 52% were female.
The patients who did not undergo surgery after successful percutaneous drainage were significantly older than those who had surgery – 62 years vs. 55 years. Those subgroups did not differ in other respects.
An estimated 130,000 U.S. hospitalizations each year are due to diverticulitis, with 10%-20% of cases complicated by an associated intra-abdominal abscess, he said. Most diverticular-associated abscesses smaller than 5 cm in diameter will respond to antibiotic therapy, but patients with larger abscesses or associated sepsis often get percutaneous drainage.
The results were slightly better than those seen in two previous studies. In one study of 511 patients admitted for acute diverticulitis in 1994-2003, 5 of 12 patients (42%) who did not undergo surgery after percutaneous drainage of abscesses averaging 7 cm in size had a recurrence of diverticulitis (Am. J. Gastroenterol. 2005;100:910-7), Dr. Jalouta said. A separate study of 32 patients managed without surgery after percutaneous drainage of diverticular-associated abscesses found a recurrence-free survival rate of 58% after 7 years (Dis. Colon Rectum 2013;56:622-6).
Dr. Jalouta reported having no financial disclosures.
On Twitter @sherryboschert
AT THE ACS CLINICAL CONGRESS
Key clinical point: Patients can do well without elective surgical resection following successful percutaneous drainage of diverticular-associated abscess.
Major finding: No recurrent diverticulitis was seen at 5 years in 37 of 52 patients who did not have surgery.
Data source: A retrospective review of all 165 patients who underwent percutaneous drainage of diverticular-associated abscesses in 12 years at two hospitals.
Disclosures: Dr. Jalouta reported having no financial disclosures.
VIDEO: Mortality rate after elective colorectal surgery hits 2%
SAN FRANCISCO– Patients undergoing elective colorectal surgery had an overall mortality rate of 1.7% after 30 days, an analysis of data from 65,716 patients showed.
Patients with significant preoperative morbidity had a significantly higher risk of dying after the surgery, Dr. Alodia Gabre-Kidan and her associates reported at the annual clinical congress of the American College of Surgeons.
In a video interview, Dr. Gabre-Kidan discusses the results of the retrospective study, including the especially high risk for patients with preoperative renal failure or heart failure. The findings should help clinicians better counsel patients who are considering elective colorectal surgery, said Dr. Gabre-Kidan of Columbia University, New York.
Dr. Gabre-Kidan reporting having no financial disclosures.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO– Patients undergoing elective colorectal surgery had an overall mortality rate of 1.7% after 30 days, an analysis of data from 65,716 patients showed.
Patients with significant preoperative morbidity had a significantly higher risk of dying after the surgery, Dr. Alodia Gabre-Kidan and her associates reported at the annual clinical congress of the American College of Surgeons.
In a video interview, Dr. Gabre-Kidan discusses the results of the retrospective study, including the especially high risk for patients with preoperative renal failure or heart failure. The findings should help clinicians better counsel patients who are considering elective colorectal surgery, said Dr. Gabre-Kidan of Columbia University, New York.
Dr. Gabre-Kidan reporting having no financial disclosures.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO– Patients undergoing elective colorectal surgery had an overall mortality rate of 1.7% after 30 days, an analysis of data from 65,716 patients showed.
Patients with significant preoperative morbidity had a significantly higher risk of dying after the surgery, Dr. Alodia Gabre-Kidan and her associates reported at the annual clinical congress of the American College of Surgeons.
In a video interview, Dr. Gabre-Kidan discusses the results of the retrospective study, including the especially high risk for patients with preoperative renal failure or heart failure. The findings should help clinicians better counsel patients who are considering elective colorectal surgery, said Dr. Gabre-Kidan of Columbia University, New York.
Dr. Gabre-Kidan reporting having no financial disclosures.
On Twitter @sherryboschert
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE ACS CLINICAL CONGRESS
Perioperative fluid levels increase ileus risk
SAN FRANCISCO – Too much or too little IV fluid on the day of surgery was associated with a 10%-12% increased risk for postoperative ileus in a retrospective study of 84,722 patients undergoing colon surgery.
Patients who received more than 5 liters of IV fluid on the day of surgery had a 10% increased risk of postoperative ileus and patients who received no more than 1.7 L on the surgery had a 12% increased risk of postoperative ileus, compared with patients who received 1.71-5 L of fluid, Dr. Julie K. Marosky Thacker and her associates reported at the annual clinical congress of the American College of Surgeons.
“This is one of the first studies to show that in a U.S.-based review, we have a significant number of patients getting over 5 L of fluid on the day of colon operation,” and that both high and low fluids increase the risk of postoperative ileus, Dr. Thacker said. “Observed fluid use is not compliant with the recommendations that are widespread and described in the principles of Enhance Recovery After Surgery.”
Perhaps optimizing fluids could decrease postoperative ileus and improve outcomes, she added.
The observational study of data on adults undergoing colon surgery at 524 U.S. hospitals found a wide variation in the amount of IV fluids used on the day of surgery, ranging from none to more than 8 L, with a median of 3.1 L, Dr. Thacker of Duke University, Durham, N.C., said. The researchers defined excessive fluids as the highest quartile of fluid levels and low fluids as the lowest quartile.
Overall, 18% of patients developed postoperative ileus. The higher risk for ileus with low or high IV fluids on the day of surgery was seen in open and laparoscopic procedures.
Patients with ileus had significantly longer hospitalizations, higher costs, and increased likelihood of readmission, compared with patients without ileus. The hospital length of stay averaged 10 days with ileus and 6 days without ileus. Total costs averaged $20,734 per patient with ileus and $13,865 without ileus. Among patients with ileus, readmission rates were 14% within 30 days, 17% within 60 days, and 20% within 90 days. Among patients without ileus, readmission rates were 9%, 12%, and 14% at those time points, respectively.
Data for the study came from the Premier Data research database of a nationally representative sample of adult patients having colon surgery from January 1, 2008 through June 30, 2012. Procedures included laparoscopic partial excision of the large intestine, isolation of a segment of the large intestine, open and other partial excisions of the large intestine, total intra-abdominal colectomy, anastomosis of the small intestine to the rectal stump, and other small-to-large intestinal anastomoses.
Patients had a mean age of 62 years, 46% were male, and 73% were white. Forty-six percent of patients were covered by Medicare and 36% by managed care plans. Sixty-one percent of hospitals were nonteaching hospitals, and 89% were in an urban location.
The analysis adjusted for the influence of multiple other factors that may be associated with the risk of ileus, she said.
Deltex Medical, which markets fluid monitoring systems, funded the study. Dr. Thacker has been a consultant for Deltex and for Premier Data Inc., which acquired the data.
On Twitter @sherryboschert
SAN FRANCISCO – Too much or too little IV fluid on the day of surgery was associated with a 10%-12% increased risk for postoperative ileus in a retrospective study of 84,722 patients undergoing colon surgery.
Patients who received more than 5 liters of IV fluid on the day of surgery had a 10% increased risk of postoperative ileus and patients who received no more than 1.7 L on the surgery had a 12% increased risk of postoperative ileus, compared with patients who received 1.71-5 L of fluid, Dr. Julie K. Marosky Thacker and her associates reported at the annual clinical congress of the American College of Surgeons.
“This is one of the first studies to show that in a U.S.-based review, we have a significant number of patients getting over 5 L of fluid on the day of colon operation,” and that both high and low fluids increase the risk of postoperative ileus, Dr. Thacker said. “Observed fluid use is not compliant with the recommendations that are widespread and described in the principles of Enhance Recovery After Surgery.”
Perhaps optimizing fluids could decrease postoperative ileus and improve outcomes, she added.
The observational study of data on adults undergoing colon surgery at 524 U.S. hospitals found a wide variation in the amount of IV fluids used on the day of surgery, ranging from none to more than 8 L, with a median of 3.1 L, Dr. Thacker of Duke University, Durham, N.C., said. The researchers defined excessive fluids as the highest quartile of fluid levels and low fluids as the lowest quartile.
Overall, 18% of patients developed postoperative ileus. The higher risk for ileus with low or high IV fluids on the day of surgery was seen in open and laparoscopic procedures.
Patients with ileus had significantly longer hospitalizations, higher costs, and increased likelihood of readmission, compared with patients without ileus. The hospital length of stay averaged 10 days with ileus and 6 days without ileus. Total costs averaged $20,734 per patient with ileus and $13,865 without ileus. Among patients with ileus, readmission rates were 14% within 30 days, 17% within 60 days, and 20% within 90 days. Among patients without ileus, readmission rates were 9%, 12%, and 14% at those time points, respectively.
Data for the study came from the Premier Data research database of a nationally representative sample of adult patients having colon surgery from January 1, 2008 through June 30, 2012. Procedures included laparoscopic partial excision of the large intestine, isolation of a segment of the large intestine, open and other partial excisions of the large intestine, total intra-abdominal colectomy, anastomosis of the small intestine to the rectal stump, and other small-to-large intestinal anastomoses.
Patients had a mean age of 62 years, 46% were male, and 73% were white. Forty-six percent of patients were covered by Medicare and 36% by managed care plans. Sixty-one percent of hospitals were nonteaching hospitals, and 89% were in an urban location.
The analysis adjusted for the influence of multiple other factors that may be associated with the risk of ileus, she said.
Deltex Medical, which markets fluid monitoring systems, funded the study. Dr. Thacker has been a consultant for Deltex and for Premier Data Inc., which acquired the data.
On Twitter @sherryboschert
SAN FRANCISCO – Too much or too little IV fluid on the day of surgery was associated with a 10%-12% increased risk for postoperative ileus in a retrospective study of 84,722 patients undergoing colon surgery.
Patients who received more than 5 liters of IV fluid on the day of surgery had a 10% increased risk of postoperative ileus and patients who received no more than 1.7 L on the surgery had a 12% increased risk of postoperative ileus, compared with patients who received 1.71-5 L of fluid, Dr. Julie K. Marosky Thacker and her associates reported at the annual clinical congress of the American College of Surgeons.
“This is one of the first studies to show that in a U.S.-based review, we have a significant number of patients getting over 5 L of fluid on the day of colon operation,” and that both high and low fluids increase the risk of postoperative ileus, Dr. Thacker said. “Observed fluid use is not compliant with the recommendations that are widespread and described in the principles of Enhance Recovery After Surgery.”
Perhaps optimizing fluids could decrease postoperative ileus and improve outcomes, she added.
The observational study of data on adults undergoing colon surgery at 524 U.S. hospitals found a wide variation in the amount of IV fluids used on the day of surgery, ranging from none to more than 8 L, with a median of 3.1 L, Dr. Thacker of Duke University, Durham, N.C., said. The researchers defined excessive fluids as the highest quartile of fluid levels and low fluids as the lowest quartile.
Overall, 18% of patients developed postoperative ileus. The higher risk for ileus with low or high IV fluids on the day of surgery was seen in open and laparoscopic procedures.
Patients with ileus had significantly longer hospitalizations, higher costs, and increased likelihood of readmission, compared with patients without ileus. The hospital length of stay averaged 10 days with ileus and 6 days without ileus. Total costs averaged $20,734 per patient with ileus and $13,865 without ileus. Among patients with ileus, readmission rates were 14% within 30 days, 17% within 60 days, and 20% within 90 days. Among patients without ileus, readmission rates were 9%, 12%, and 14% at those time points, respectively.
Data for the study came from the Premier Data research database of a nationally representative sample of adult patients having colon surgery from January 1, 2008 through June 30, 2012. Procedures included laparoscopic partial excision of the large intestine, isolation of a segment of the large intestine, open and other partial excisions of the large intestine, total intra-abdominal colectomy, anastomosis of the small intestine to the rectal stump, and other small-to-large intestinal anastomoses.
Patients had a mean age of 62 years, 46% were male, and 73% were white. Forty-six percent of patients were covered by Medicare and 36% by managed care plans. Sixty-one percent of hospitals were nonteaching hospitals, and 89% were in an urban location.
The analysis adjusted for the influence of multiple other factors that may be associated with the risk of ileus, she said.
Deltex Medical, which markets fluid monitoring systems, funded the study. Dr. Thacker has been a consultant for Deltex and for Premier Data Inc., which acquired the data.
On Twitter @sherryboschert
AT THE ACS CLINICAL CONGRESS
Key clinical point: Giving no more than 1.7 liters or more than 5 liters of IV fluids on the day of surgery increased the risk of ileus.
Major finding: The ileus risk was 10% higher with excessive IV fluids and 12% higher with low fluids.
Data source: A retrospective observational cohort study of data on 84,722 patients undergoing colon surgery.
Disclosures: Deltex Medical, which markets fluid monitoring systems, funded the study. Dr. Thacker has been a consultant for Deltex and for Premier Data Inc., which acquired the data.
VIDEO: Bioabsorbable polymer stents offer improved deliverability
CHICAGO – Two new types of drug-eluting, biodegradable polymer stents weren’t inferior to current drug-eluting stents, and they possibly may have caused fewer stent thrombosis episodes.
But do the new stents reduce the risk of long-term stent thrombosis? How will their ease of use affect choice of stents? And how should long-term coronary events that aren’t related to the stents themselves shape approaches to secondary prevention?
In an interview at the American Heart Association scientific sessions, Dr. Robert Harrington shared his perspectives on these questions and connected the stent studies’ results with new findings in prevention research.
The two studies of the new stents were not large enough, nor were patients followed long enough, to prove an advantage in stent thrombosis rates in a definitive way. But the lead investigator in the everolimus-eluting Synergy stent study described the stent as more flexible and deliverable than current coronary stents.
Those usability features may make that stent an attractive option for interventional cardiologists even if clinical outcomes are not significantly improved, Dr. Harrington noted.
“These technical features, such as improved deliverability, are things that will resonate with the interventional community,” he said. “It offers another option for complex cases, and that appeals greatly to interventional cardiologists who are looking for technical solutions,” said Dr. Harrington, professor and chairman of medicine at Stanford (Calif.) University.
Dr. Harrington said that he had no disclosures regarding the studied stents, but he has received grants from several drug companies that market drugs used during and after patients undergo percutaneous coronary interventions.
On Twitter @mitchelzoler
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO – Two new types of drug-eluting, biodegradable polymer stents weren’t inferior to current drug-eluting stents, and they possibly may have caused fewer stent thrombosis episodes.
But do the new stents reduce the risk of long-term stent thrombosis? How will their ease of use affect choice of stents? And how should long-term coronary events that aren’t related to the stents themselves shape approaches to secondary prevention?
In an interview at the American Heart Association scientific sessions, Dr. Robert Harrington shared his perspectives on these questions and connected the stent studies’ results with new findings in prevention research.
The two studies of the new stents were not large enough, nor were patients followed long enough, to prove an advantage in stent thrombosis rates in a definitive way. But the lead investigator in the everolimus-eluting Synergy stent study described the stent as more flexible and deliverable than current coronary stents.
Those usability features may make that stent an attractive option for interventional cardiologists even if clinical outcomes are not significantly improved, Dr. Harrington noted.
“These technical features, such as improved deliverability, are things that will resonate with the interventional community,” he said. “It offers another option for complex cases, and that appeals greatly to interventional cardiologists who are looking for technical solutions,” said Dr. Harrington, professor and chairman of medicine at Stanford (Calif.) University.
Dr. Harrington said that he had no disclosures regarding the studied stents, but he has received grants from several drug companies that market drugs used during and after patients undergo percutaneous coronary interventions.
On Twitter @mitchelzoler
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
CHICAGO – Two new types of drug-eluting, biodegradable polymer stents weren’t inferior to current drug-eluting stents, and they possibly may have caused fewer stent thrombosis episodes.
But do the new stents reduce the risk of long-term stent thrombosis? How will their ease of use affect choice of stents? And how should long-term coronary events that aren’t related to the stents themselves shape approaches to secondary prevention?
In an interview at the American Heart Association scientific sessions, Dr. Robert Harrington shared his perspectives on these questions and connected the stent studies’ results with new findings in prevention research.
The two studies of the new stents were not large enough, nor were patients followed long enough, to prove an advantage in stent thrombosis rates in a definitive way. But the lead investigator in the everolimus-eluting Synergy stent study described the stent as more flexible and deliverable than current coronary stents.
Those usability features may make that stent an attractive option for interventional cardiologists even if clinical outcomes are not significantly improved, Dr. Harrington noted.
“These technical features, such as improved deliverability, are things that will resonate with the interventional community,” he said. “It offers another option for complex cases, and that appeals greatly to interventional cardiologists who are looking for technical solutions,” said Dr. Harrington, professor and chairman of medicine at Stanford (Calif.) University.
Dr. Harrington said that he had no disclosures regarding the studied stents, but he has received grants from several drug companies that market drugs used during and after patients undergo percutaneous coronary interventions.
On Twitter @mitchelzoler
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
EXPERT ANALYSIS FROM THE AHA SCIENTIFIC SESSIONS
Levofloxacin didn’t prevent BK virus after kidney transplant, increased quinolone resistance
PHILADELPHIA – A 3-month course of levofloxacin after kidney transplant didn’t prevent BK virus from colonizing the urine, setting the stage for viremia in these immunosuppressed patients.
However, the antibiotic was associated with a significant 75% increase in the risk of developing a quinolone-resistant infection, compared with placebo, Dr. Greg A. Knoll and his colleagues reported in the Nov. 15 issue of JAMA (2014 [doi:10.1001/jama.2014.14721]).In a randomized trial of 154 kidney transplant patients, BK virus developed in 29% of those taking levofloxacin and in 33% of those taking placebo, a nonsignificant difference, coauthor Greg Knoll said at a late-breaking poster session during Kidney Week 2014, where the study was simultaneously presented.Levofloxacin, a quinolone antibiotic, has been shown to have some antiviral properties, especially against polyomaviruses – including BK virus, said Dr. Knoll of the University of Ottawa and the Ottawa Hospital.
Almost everyone harbors latent BK virus, Dr. Knoll said in an interview. It sometimes causes mild cold symptoms when first contracted, but often there’s no indication of illness at all. “If you’re otherwise healthy, it goes dormant and stays that way,” he noted.
But it can cause serious problems in immunocompromised patients, especially those with a kidney transplant. “BK virus tends to live in the bladder and urinary tract,” Dr. Knoll said, “So, when it reactivates, that’s the site where it does its damage.”
The virus will first appear in the urine, and then follow a logical progression through the ureters and into the kidney. If it remains unchecked, it causes very severe kidney inflammation. That inflammation “looks a lot like rejection,” Dr. Knoll said. “In fact, for years, we were very confused about this and ended up giving patients with BK viremia more immunosuppressants – when we actually should have been giving them less.”
It’s been tough to find the right balance of treatment to combat BK infections and immunosuppressants to maintain the allograft, he said.
Some retrospective studies suggested that quinolone antibiotics – including levofloxacin – could help fight cytomegalovirus infections and viral pneumonia, and decrease inflammatory markers in the urine of kidney transplant patients. “This was the little bit of evidence we needed to launch this study,” Dr. Knoll said.
The study investigators examined the time to first occurrence of BK viruria within the first year of transplant. Secondary outcomes included BK viremia, peak viral load, rejection, and patient and allograft survival.
Patients’ mean age was 48 years. They had undergone kidney transplant for a variety of reasons, including glomerulonephritis, polycystic kidney disease, diabetes, and hypertension. Comorbidities were common and included diabetes, history of cancer, cardiovascular disease, and hepatitis C and B infections. Most had received a living donor transplant (60%); the rest had kidneys from deceased donors.
Treatment began soon after transplantation. Patients were randomized to a target dose of 500 mg/day levofloxacin for 3 months. The mean length of follow-up was 46 weeks.
The primary outcome of BK viruria occurred in 46 patients – 29% of those in the levofloxacin group and 33.3% of those in the placebo group. That translated to a nonsignificant increased viruria risk of about 4%.
The time to viruria was not significantly different between the groups, with nearly 25% of each group developing it by 25 weeks. Nor was there a between-group difference in the occurrence of sustained viruria.
The secondary endpoint of BK viremia occurred in 7.9% of the levofloxacin group and 11.5% of the placebo group, also a nonsignificant finding. Infections were similar in both group, occurring in 59% of those taking levofloxacin and 45% of those taking placebo. The types of infections were similar: urinary tract/pyelonephritis (37% active vs. 38% placebo); cytomegalovirus (35% vs. 33%); pneumonia (3.5% vs. 1.7%); cellulitis (2.7% vs. 0.8%); and line infections and bacteremias, which were less than 1% in each group. No patient developed a Clostridium difficile infection.
However, patients taking levofloxacin developed significantly more quinolone-resistant infections (46.7% vs. 32.6%). Among isolates that are usually sensitive to quinolones, those patients taking the study drug were 75% more likely than were placebo patients to have a resistant strain (58.3% vs. 33.3%).
Because quinolones are an important part of infection prophylaxis in kidney transplant patients, “This would have significant implications for the management of common infections after transplantation,” Dr. Knoll said. “Our results don’t support the use of levofloxacin for preventing infections in patients with kidney transplants.”
The researchers were disappointed in the outcomes, “but there were people doing this already, and now we have the evidence to tell them to stop,” Dr. Knoll explained. “Of course, we are back to square one, with no proven treatment.”
He added that the quinolones remain critical antibiotics for kidney transplant patients – and that the study in no way suggests that should change.
“We were using these daily for 3 months, and that’s where we got into the resistance trouble,” he said. “That’s not anything like a 7- to 10-day course for a urinary tract infection.”
Dr. Knoll reported receiving investigator-initiated research grants from Astellas Canada and Pfizer Canada. The other coauthors had a number of financial relationships with pharmaceutical companies.
On Twitter @alz_gal
PHILADELPHIA – A 3-month course of levofloxacin after kidney transplant didn’t prevent BK virus from colonizing the urine, setting the stage for viremia in these immunosuppressed patients.
However, the antibiotic was associated with a significant 75% increase in the risk of developing a quinolone-resistant infection, compared with placebo, Dr. Greg A. Knoll and his colleagues reported in the Nov. 15 issue of JAMA (2014 [doi:10.1001/jama.2014.14721]).In a randomized trial of 154 kidney transplant patients, BK virus developed in 29% of those taking levofloxacin and in 33% of those taking placebo, a nonsignificant difference, coauthor Greg Knoll said at a late-breaking poster session during Kidney Week 2014, where the study was simultaneously presented.Levofloxacin, a quinolone antibiotic, has been shown to have some antiviral properties, especially against polyomaviruses – including BK virus, said Dr. Knoll of the University of Ottawa and the Ottawa Hospital.
Almost everyone harbors latent BK virus, Dr. Knoll said in an interview. It sometimes causes mild cold symptoms when first contracted, but often there’s no indication of illness at all. “If you’re otherwise healthy, it goes dormant and stays that way,” he noted.
But it can cause serious problems in immunocompromised patients, especially those with a kidney transplant. “BK virus tends to live in the bladder and urinary tract,” Dr. Knoll said, “So, when it reactivates, that’s the site where it does its damage.”
The virus will first appear in the urine, and then follow a logical progression through the ureters and into the kidney. If it remains unchecked, it causes very severe kidney inflammation. That inflammation “looks a lot like rejection,” Dr. Knoll said. “In fact, for years, we were very confused about this and ended up giving patients with BK viremia more immunosuppressants – when we actually should have been giving them less.”
It’s been tough to find the right balance of treatment to combat BK infections and immunosuppressants to maintain the allograft, he said.
Some retrospective studies suggested that quinolone antibiotics – including levofloxacin – could help fight cytomegalovirus infections and viral pneumonia, and decrease inflammatory markers in the urine of kidney transplant patients. “This was the little bit of evidence we needed to launch this study,” Dr. Knoll said.
The study investigators examined the time to first occurrence of BK viruria within the first year of transplant. Secondary outcomes included BK viremia, peak viral load, rejection, and patient and allograft survival.
Patients’ mean age was 48 years. They had undergone kidney transplant for a variety of reasons, including glomerulonephritis, polycystic kidney disease, diabetes, and hypertension. Comorbidities were common and included diabetes, history of cancer, cardiovascular disease, and hepatitis C and B infections. Most had received a living donor transplant (60%); the rest had kidneys from deceased donors.
Treatment began soon after transplantation. Patients were randomized to a target dose of 500 mg/day levofloxacin for 3 months. The mean length of follow-up was 46 weeks.
The primary outcome of BK viruria occurred in 46 patients – 29% of those in the levofloxacin group and 33.3% of those in the placebo group. That translated to a nonsignificant increased viruria risk of about 4%.
The time to viruria was not significantly different between the groups, with nearly 25% of each group developing it by 25 weeks. Nor was there a between-group difference in the occurrence of sustained viruria.
The secondary endpoint of BK viremia occurred in 7.9% of the levofloxacin group and 11.5% of the placebo group, also a nonsignificant finding. Infections were similar in both group, occurring in 59% of those taking levofloxacin and 45% of those taking placebo. The types of infections were similar: urinary tract/pyelonephritis (37% active vs. 38% placebo); cytomegalovirus (35% vs. 33%); pneumonia (3.5% vs. 1.7%); cellulitis (2.7% vs. 0.8%); and line infections and bacteremias, which were less than 1% in each group. No patient developed a Clostridium difficile infection.
However, patients taking levofloxacin developed significantly more quinolone-resistant infections (46.7% vs. 32.6%). Among isolates that are usually sensitive to quinolones, those patients taking the study drug were 75% more likely than were placebo patients to have a resistant strain (58.3% vs. 33.3%).
Because quinolones are an important part of infection prophylaxis in kidney transplant patients, “This would have significant implications for the management of common infections after transplantation,” Dr. Knoll said. “Our results don’t support the use of levofloxacin for preventing infections in patients with kidney transplants.”
The researchers were disappointed in the outcomes, “but there were people doing this already, and now we have the evidence to tell them to stop,” Dr. Knoll explained. “Of course, we are back to square one, with no proven treatment.”
He added that the quinolones remain critical antibiotics for kidney transplant patients – and that the study in no way suggests that should change.
“We were using these daily for 3 months, and that’s where we got into the resistance trouble,” he said. “That’s not anything like a 7- to 10-day course for a urinary tract infection.”
Dr. Knoll reported receiving investigator-initiated research grants from Astellas Canada and Pfizer Canada. The other coauthors had a number of financial relationships with pharmaceutical companies.
On Twitter @alz_gal
PHILADELPHIA – A 3-month course of levofloxacin after kidney transplant didn’t prevent BK virus from colonizing the urine, setting the stage for viremia in these immunosuppressed patients.
However, the antibiotic was associated with a significant 75% increase in the risk of developing a quinolone-resistant infection, compared with placebo, Dr. Greg A. Knoll and his colleagues reported in the Nov. 15 issue of JAMA (2014 [doi:10.1001/jama.2014.14721]).In a randomized trial of 154 kidney transplant patients, BK virus developed in 29% of those taking levofloxacin and in 33% of those taking placebo, a nonsignificant difference, coauthor Greg Knoll said at a late-breaking poster session during Kidney Week 2014, where the study was simultaneously presented.Levofloxacin, a quinolone antibiotic, has been shown to have some antiviral properties, especially against polyomaviruses – including BK virus, said Dr. Knoll of the University of Ottawa and the Ottawa Hospital.
Almost everyone harbors latent BK virus, Dr. Knoll said in an interview. It sometimes causes mild cold symptoms when first contracted, but often there’s no indication of illness at all. “If you’re otherwise healthy, it goes dormant and stays that way,” he noted.
But it can cause serious problems in immunocompromised patients, especially those with a kidney transplant. “BK virus tends to live in the bladder and urinary tract,” Dr. Knoll said, “So, when it reactivates, that’s the site where it does its damage.”
The virus will first appear in the urine, and then follow a logical progression through the ureters and into the kidney. If it remains unchecked, it causes very severe kidney inflammation. That inflammation “looks a lot like rejection,” Dr. Knoll said. “In fact, for years, we were very confused about this and ended up giving patients with BK viremia more immunosuppressants – when we actually should have been giving them less.”
It’s been tough to find the right balance of treatment to combat BK infections and immunosuppressants to maintain the allograft, he said.
Some retrospective studies suggested that quinolone antibiotics – including levofloxacin – could help fight cytomegalovirus infections and viral pneumonia, and decrease inflammatory markers in the urine of kidney transplant patients. “This was the little bit of evidence we needed to launch this study,” Dr. Knoll said.
The study investigators examined the time to first occurrence of BK viruria within the first year of transplant. Secondary outcomes included BK viremia, peak viral load, rejection, and patient and allograft survival.
Patients’ mean age was 48 years. They had undergone kidney transplant for a variety of reasons, including glomerulonephritis, polycystic kidney disease, diabetes, and hypertension. Comorbidities were common and included diabetes, history of cancer, cardiovascular disease, and hepatitis C and B infections. Most had received a living donor transplant (60%); the rest had kidneys from deceased donors.
Treatment began soon after transplantation. Patients were randomized to a target dose of 500 mg/day levofloxacin for 3 months. The mean length of follow-up was 46 weeks.
The primary outcome of BK viruria occurred in 46 patients – 29% of those in the levofloxacin group and 33.3% of those in the placebo group. That translated to a nonsignificant increased viruria risk of about 4%.
The time to viruria was not significantly different between the groups, with nearly 25% of each group developing it by 25 weeks. Nor was there a between-group difference in the occurrence of sustained viruria.
The secondary endpoint of BK viremia occurred in 7.9% of the levofloxacin group and 11.5% of the placebo group, also a nonsignificant finding. Infections were similar in both group, occurring in 59% of those taking levofloxacin and 45% of those taking placebo. The types of infections were similar: urinary tract/pyelonephritis (37% active vs. 38% placebo); cytomegalovirus (35% vs. 33%); pneumonia (3.5% vs. 1.7%); cellulitis (2.7% vs. 0.8%); and line infections and bacteremias, which were less than 1% in each group. No patient developed a Clostridium difficile infection.
However, patients taking levofloxacin developed significantly more quinolone-resistant infections (46.7% vs. 32.6%). Among isolates that are usually sensitive to quinolones, those patients taking the study drug were 75% more likely than were placebo patients to have a resistant strain (58.3% vs. 33.3%).
Because quinolones are an important part of infection prophylaxis in kidney transplant patients, “This would have significant implications for the management of common infections after transplantation,” Dr. Knoll said. “Our results don’t support the use of levofloxacin for preventing infections in patients with kidney transplants.”
The researchers were disappointed in the outcomes, “but there were people doing this already, and now we have the evidence to tell them to stop,” Dr. Knoll explained. “Of course, we are back to square one, with no proven treatment.”
He added that the quinolones remain critical antibiotics for kidney transplant patients – and that the study in no way suggests that should change.
“We were using these daily for 3 months, and that’s where we got into the resistance trouble,” he said. “That’s not anything like a 7- to 10-day course for a urinary tract infection.”
Dr. Knoll reported receiving investigator-initiated research grants from Astellas Canada and Pfizer Canada. The other coauthors had a number of financial relationships with pharmaceutical companies.
On Twitter @alz_gal
FROM KIDNEY WEEK 2014
Key clinical point: Levofloxacin prophylaxis isn’t recommended after kidney transplant, because it failed to prevent BK viruria and was associated with an increase in quinolone-resistant bacterial isolates.
Major finding: Levofloxacin 500 mg daily for 3 months did not reduce the risk of BK viruria in patients who had a kidney transplant.
Data source: The randomized trial comprised 154 patients.
Disclosures: Dr. Knoll reported receiving investigator-initiated research grants from Astellas Canada and Pfizer Canada. The other coauthors had a number of financial relationships with pharmaceutical companies
Antibiotic bowel prep significantly reduces colon surgery infections
SAN FRANCISCO – Oral antibiotics with mechanical bowel preparation significantly reduce surgical site infections, length of hospital stay, and readmissions in both open and laparoscopic elective colorectal surgery, according to a review of 8,415 cases in the National Surgery Quality Improvement Program.
It “should be adopted for elective colorectal surgery,” concluded the investigators, led by colorectal surgeon Melanie Morris of the University of Alabama at Birmingham.
A quarter of the patients had no bowel prep, 45% had mechanical prep alone – GoLytely or another laxative, and 30% received both oral antibiotics and mechanical prep. Partial colectomy and sigmoid resections were the most common procedures, generally for neoplasms or diverticulitis.
Overall, 15% of the no-prep group, 12% of the mechanical prep group, and 6.5% of the oral antibiotic plus mechanical prep group developed subsequent surgical site infections (SSIs), a statistically significant difference. Results were similar when broken down into superficial, deep wound, and organ space infections (J. Am. Coll. Surg. 2014:219;S18-19).
On multivariate analysis and after adjusting for diabetes, smoking, age, and other potential confounders, the antibiotic group was 54% less likely than the no-prep group to develop an SSI (odds ratio 0.46), 26% less likely to be readmitted (OR 0.74), and more likely to leave the hospital earlier, at about 4 days instead of 5 (OR 0.90). SSIs and readmissions were only slightly less likely in the mechanical prep–only group, compared with the no-prep group, and there was no difference in length of stay.
There were fewer anastomotic leaks, fewer cases of sepsis, less significant bleeding, and other benefits for oral antibiotics with mechanical preparation. In addition, there was a protective effect against 30-day mortality in open procedures.
“Even in the minimally invasive group,” about two-thirds of patients, “oral antibiotic prep … was protective for surgical site infections,” Dr. Morris said at the annual clinical congress of the American College of Surgeons.
Still, bowel prep remains “a very controversial topic.” Nationwide some surgeons prep, some don’t. “People have very strong beliefs that may or may not be rooted in the data,” she said.
There are concerns about fluid and electrolyte disturbances, Clostridium difficile overgrowth, and other potential problems. Plus, mechanical preparation hasn’t worked any better than placebo in recent studies, but many of those studies didn’t include oral antibiotics. Effective bowel prep includes both, Dr. Morris said.
It’s possible that confounders might have been at work in the Alabama study. Perhaps surgeons shied away from bowel prep in older, sicker patients, but the rate of acute renal injury was the same in all three study groups at about 0.9%, suggesting similar background comorbidities.
“I don’t think confounding issues” explain the findings. Previously, “we’ve shown the benefit of oral antibiotic bowel prep in a [Veterans Affairs] cohort, and now we’ve shown it in this national cohort,” Dr. Morris said (Dis. Colon. Rectum 2012;55:1160-6).
After a marked reduction in surgical site infections in the VA study, “we changed our practices. We now do mechanical and oral antibiotic preps and have seen a 50% reduction in our SSI rate. We don’t feel like we are doing anything else differently,” she said.
Dr. Morris has no disclosures.
SAN FRANCISCO – Oral antibiotics with mechanical bowel preparation significantly reduce surgical site infections, length of hospital stay, and readmissions in both open and laparoscopic elective colorectal surgery, according to a review of 8,415 cases in the National Surgery Quality Improvement Program.
It “should be adopted for elective colorectal surgery,” concluded the investigators, led by colorectal surgeon Melanie Morris of the University of Alabama at Birmingham.
A quarter of the patients had no bowel prep, 45% had mechanical prep alone – GoLytely or another laxative, and 30% received both oral antibiotics and mechanical prep. Partial colectomy and sigmoid resections were the most common procedures, generally for neoplasms or diverticulitis.
Overall, 15% of the no-prep group, 12% of the mechanical prep group, and 6.5% of the oral antibiotic plus mechanical prep group developed subsequent surgical site infections (SSIs), a statistically significant difference. Results were similar when broken down into superficial, deep wound, and organ space infections (J. Am. Coll. Surg. 2014:219;S18-19).
On multivariate analysis and after adjusting for diabetes, smoking, age, and other potential confounders, the antibiotic group was 54% less likely than the no-prep group to develop an SSI (odds ratio 0.46), 26% less likely to be readmitted (OR 0.74), and more likely to leave the hospital earlier, at about 4 days instead of 5 (OR 0.90). SSIs and readmissions were only slightly less likely in the mechanical prep–only group, compared with the no-prep group, and there was no difference in length of stay.
There were fewer anastomotic leaks, fewer cases of sepsis, less significant bleeding, and other benefits for oral antibiotics with mechanical preparation. In addition, there was a protective effect against 30-day mortality in open procedures.
“Even in the minimally invasive group,” about two-thirds of patients, “oral antibiotic prep … was protective for surgical site infections,” Dr. Morris said at the annual clinical congress of the American College of Surgeons.
Still, bowel prep remains “a very controversial topic.” Nationwide some surgeons prep, some don’t. “People have very strong beliefs that may or may not be rooted in the data,” she said.
There are concerns about fluid and electrolyte disturbances, Clostridium difficile overgrowth, and other potential problems. Plus, mechanical preparation hasn’t worked any better than placebo in recent studies, but many of those studies didn’t include oral antibiotics. Effective bowel prep includes both, Dr. Morris said.
It’s possible that confounders might have been at work in the Alabama study. Perhaps surgeons shied away from bowel prep in older, sicker patients, but the rate of acute renal injury was the same in all three study groups at about 0.9%, suggesting similar background comorbidities.
“I don’t think confounding issues” explain the findings. Previously, “we’ve shown the benefit of oral antibiotic bowel prep in a [Veterans Affairs] cohort, and now we’ve shown it in this national cohort,” Dr. Morris said (Dis. Colon. Rectum 2012;55:1160-6).
After a marked reduction in surgical site infections in the VA study, “we changed our practices. We now do mechanical and oral antibiotic preps and have seen a 50% reduction in our SSI rate. We don’t feel like we are doing anything else differently,” she said.
Dr. Morris has no disclosures.
SAN FRANCISCO – Oral antibiotics with mechanical bowel preparation significantly reduce surgical site infections, length of hospital stay, and readmissions in both open and laparoscopic elective colorectal surgery, according to a review of 8,415 cases in the National Surgery Quality Improvement Program.
It “should be adopted for elective colorectal surgery,” concluded the investigators, led by colorectal surgeon Melanie Morris of the University of Alabama at Birmingham.
A quarter of the patients had no bowel prep, 45% had mechanical prep alone – GoLytely or another laxative, and 30% received both oral antibiotics and mechanical prep. Partial colectomy and sigmoid resections were the most common procedures, generally for neoplasms or diverticulitis.
Overall, 15% of the no-prep group, 12% of the mechanical prep group, and 6.5% of the oral antibiotic plus mechanical prep group developed subsequent surgical site infections (SSIs), a statistically significant difference. Results were similar when broken down into superficial, deep wound, and organ space infections (J. Am. Coll. Surg. 2014:219;S18-19).
On multivariate analysis and after adjusting for diabetes, smoking, age, and other potential confounders, the antibiotic group was 54% less likely than the no-prep group to develop an SSI (odds ratio 0.46), 26% less likely to be readmitted (OR 0.74), and more likely to leave the hospital earlier, at about 4 days instead of 5 (OR 0.90). SSIs and readmissions were only slightly less likely in the mechanical prep–only group, compared with the no-prep group, and there was no difference in length of stay.
There were fewer anastomotic leaks, fewer cases of sepsis, less significant bleeding, and other benefits for oral antibiotics with mechanical preparation. In addition, there was a protective effect against 30-day mortality in open procedures.
“Even in the minimally invasive group,” about two-thirds of patients, “oral antibiotic prep … was protective for surgical site infections,” Dr. Morris said at the annual clinical congress of the American College of Surgeons.
Still, bowel prep remains “a very controversial topic.” Nationwide some surgeons prep, some don’t. “People have very strong beliefs that may or may not be rooted in the data,” she said.
There are concerns about fluid and electrolyte disturbances, Clostridium difficile overgrowth, and other potential problems. Plus, mechanical preparation hasn’t worked any better than placebo in recent studies, but many of those studies didn’t include oral antibiotics. Effective bowel prep includes both, Dr. Morris said.
It’s possible that confounders might have been at work in the Alabama study. Perhaps surgeons shied away from bowel prep in older, sicker patients, but the rate of acute renal injury was the same in all three study groups at about 0.9%, suggesting similar background comorbidities.
“I don’t think confounding issues” explain the findings. Previously, “we’ve shown the benefit of oral antibiotic bowel prep in a [Veterans Affairs] cohort, and now we’ve shown it in this national cohort,” Dr. Morris said (Dis. Colon. Rectum 2012;55:1160-6).
After a marked reduction in surgical site infections in the VA study, “we changed our practices. We now do mechanical and oral antibiotic preps and have seen a 50% reduction in our SSI rate. We don’t feel like we are doing anything else differently,” she said.
Dr. Morris has no disclosures.
AT THE ACS CLINICAL CONGRESS
Key clinical point: Effective bowel prep must include oral antibiotics as well as laxatives.
Major finding: Prepping colorectal surgery patients with both oral antibiotics and laxatives halves the risk of surgery site infections (OR 0.46, 95% CI 0.36-0.59, P < .001),
Data source: Review of 8,415 cases in the National Surgery Quality Improvement Program
Disclosures: Dr. Morris has no relevant financial disclosures.
Neither aspirin nor clonidine reduced postoperative acute kidney injury
PHILADELPHIA- Neither perioperative aspirin nor clonidine reduced the risk of an acute kidney injury in patients who underwent major noncardiac surgery, a large randomized trial has determined.
The risk of an acute kidney injury (AKI) associated with aspirin was 10% more than placebo, and the risk with clonidine, 3% more, but those differences were not statistically significant, Dr. Amit X. Garg and associates wrote online in JAMA (JAMA 2015; doi:10.1001/jama.2014.15284).
Both drugs increased the risk of postoperative conditions that are associated with AKI, Dr. Garg of the London Health Sciences Centre and Western University, London, Ontario, and his co-authors noted. The study was simultaneously presented at Kidney Week 2014, which was sponsored by the American Society of Nephrology.
In fact, there was some suggestion that the drugs increased the risk of severe AKI, he said at the meeting. “But these were secondary measures and need to be interpreted cautiosuly, because the absolute number of severe AKIs was quite small.”
The AKI investigation was a substudy of the Perioperative Ischemia Evaluation-2, (POISE-2) trial, which evaluated the risk of 30-day mortality or nonfatal myocardial infarction among 6,905 surgical patients with a moderate to high risk of a perioperative cardiac event. The aspirin regimen called for 200 mg before surgery and then 100 mg daily for up to 30 days after surgery. The clonidine regimen was 0.2 mg orally 2-4 hours before surgery, followed by a 0.3 mg/day transdermal patch worn for 72 hours after surgery. Both groups also had a placebo arm.
The patients were a mean of 69 years old. Cardiovascular disease was present in about 30%; these included coronary artery disease, stroke, and peripheral vascular disease. About a quarter smoked; 36% had diabetes; 86% had hypertension; 2% had atrial fibrillation. Medications included COX-2 inhibitors; statins; ACE, ARB or direct renin inhibitors; and antihypertensives.
At baseline about 24% had an estimated glomerular filtration rate of 60 ml/min or lower per 1.73 m2.
Surgical procedures were urgent or emergent, major vascular, major thoracic, major urological or gynecologic, and other unspecified procedures.
Aspirin did not reduce the risk of an AKI compared to placebo. AKI occurred in 462 patients taking aspirin and 426 taking placebo (13.4% vs. 12.3% respectively; adjusted risk ratio 1.10). Nor did clonidine reduce the risk of AKI compared to placebo. AKI occurred in 449 taking aspirin and 439 taking placebo (13% and 12.7% respectively; adjusted risk ratio 1.03). Neither of these findings was statistically significant.
AKI-related dialysis within 30 days occurred in 0.6% those taking aspirin and 0.3% of the matched placebo patients - a nonsignificant difference. Serum creatinine increased a mean of 11% with aspirin vs. 11% with placebo.
Dialysis was necessary in 0.5% of those taking clonidine and 0.3% of the matched placebo patients - another nonsignificant finding. A history of preoperative chronic kidney disease did not alter either of these findings.
A post hoc analysis determined that both drugs increased the incidence of conditions known to boost the risk of kidney injury. Aspirin increased the risk of major bleeding, which was associated with a greater risk of AKI (23.3% when bleeding occurred vs 12.3% when it did not; adjusted risk ratio 2.20).
Because of this doubling of risk, Dr. Garg suggested moderating pre-operative aspirin exposure in these patients.
“Among patients taking aspirin as part of a long-term regimen, these results support holding it for at least 3 days before surgery and then restarting it a week after surgery,” he recommended.
Clonidine increased the risk of clinically important hypotension, which was also related in turn to AKI (14.3% when hypotension was present vs. 11.8% when it was not; adjusted risk ratio for AKI 1.34).
Dr. Garg had no financial disclosures. A number of the POISE-2 investigators reported financial relationships with pharmaceutical companies.
PHILADELPHIA- Neither perioperative aspirin nor clonidine reduced the risk of an acute kidney injury in patients who underwent major noncardiac surgery, a large randomized trial has determined.
The risk of an acute kidney injury (AKI) associated with aspirin was 10% more than placebo, and the risk with clonidine, 3% more, but those differences were not statistically significant, Dr. Amit X. Garg and associates wrote online in JAMA (JAMA 2015; doi:10.1001/jama.2014.15284).
Both drugs increased the risk of postoperative conditions that are associated with AKI, Dr. Garg of the London Health Sciences Centre and Western University, London, Ontario, and his co-authors noted. The study was simultaneously presented at Kidney Week 2014, which was sponsored by the American Society of Nephrology.
In fact, there was some suggestion that the drugs increased the risk of severe AKI, he said at the meeting. “But these were secondary measures and need to be interpreted cautiosuly, because the absolute number of severe AKIs was quite small.”
The AKI investigation was a substudy of the Perioperative Ischemia Evaluation-2, (POISE-2) trial, which evaluated the risk of 30-day mortality or nonfatal myocardial infarction among 6,905 surgical patients with a moderate to high risk of a perioperative cardiac event. The aspirin regimen called for 200 mg before surgery and then 100 mg daily for up to 30 days after surgery. The clonidine regimen was 0.2 mg orally 2-4 hours before surgery, followed by a 0.3 mg/day transdermal patch worn for 72 hours after surgery. Both groups also had a placebo arm.
The patients were a mean of 69 years old. Cardiovascular disease was present in about 30%; these included coronary artery disease, stroke, and peripheral vascular disease. About a quarter smoked; 36% had diabetes; 86% had hypertension; 2% had atrial fibrillation. Medications included COX-2 inhibitors; statins; ACE, ARB or direct renin inhibitors; and antihypertensives.
At baseline about 24% had an estimated glomerular filtration rate of 60 ml/min or lower per 1.73 m2.
Surgical procedures were urgent or emergent, major vascular, major thoracic, major urological or gynecologic, and other unspecified procedures.
Aspirin did not reduce the risk of an AKI compared to placebo. AKI occurred in 462 patients taking aspirin and 426 taking placebo (13.4% vs. 12.3% respectively; adjusted risk ratio 1.10). Nor did clonidine reduce the risk of AKI compared to placebo. AKI occurred in 449 taking aspirin and 439 taking placebo (13% and 12.7% respectively; adjusted risk ratio 1.03). Neither of these findings was statistically significant.
AKI-related dialysis within 30 days occurred in 0.6% those taking aspirin and 0.3% of the matched placebo patients - a nonsignificant difference. Serum creatinine increased a mean of 11% with aspirin vs. 11% with placebo.
Dialysis was necessary in 0.5% of those taking clonidine and 0.3% of the matched placebo patients - another nonsignificant finding. A history of preoperative chronic kidney disease did not alter either of these findings.
A post hoc analysis determined that both drugs increased the incidence of conditions known to boost the risk of kidney injury. Aspirin increased the risk of major bleeding, which was associated with a greater risk of AKI (23.3% when bleeding occurred vs 12.3% when it did not; adjusted risk ratio 2.20).
Because of this doubling of risk, Dr. Garg suggested moderating pre-operative aspirin exposure in these patients.
“Among patients taking aspirin as part of a long-term regimen, these results support holding it for at least 3 days before surgery and then restarting it a week after surgery,” he recommended.
Clonidine increased the risk of clinically important hypotension, which was also related in turn to AKI (14.3% when hypotension was present vs. 11.8% when it was not; adjusted risk ratio for AKI 1.34).
Dr. Garg had no financial disclosures. A number of the POISE-2 investigators reported financial relationships with pharmaceutical companies.
PHILADELPHIA- Neither perioperative aspirin nor clonidine reduced the risk of an acute kidney injury in patients who underwent major noncardiac surgery, a large randomized trial has determined.
The risk of an acute kidney injury (AKI) associated with aspirin was 10% more than placebo, and the risk with clonidine, 3% more, but those differences were not statistically significant, Dr. Amit X. Garg and associates wrote online in JAMA (JAMA 2015; doi:10.1001/jama.2014.15284).
Both drugs increased the risk of postoperative conditions that are associated with AKI, Dr. Garg of the London Health Sciences Centre and Western University, London, Ontario, and his co-authors noted. The study was simultaneously presented at Kidney Week 2014, which was sponsored by the American Society of Nephrology.
In fact, there was some suggestion that the drugs increased the risk of severe AKI, he said at the meeting. “But these were secondary measures and need to be interpreted cautiosuly, because the absolute number of severe AKIs was quite small.”
The AKI investigation was a substudy of the Perioperative Ischemia Evaluation-2, (POISE-2) trial, which evaluated the risk of 30-day mortality or nonfatal myocardial infarction among 6,905 surgical patients with a moderate to high risk of a perioperative cardiac event. The aspirin regimen called for 200 mg before surgery and then 100 mg daily for up to 30 days after surgery. The clonidine regimen was 0.2 mg orally 2-4 hours before surgery, followed by a 0.3 mg/day transdermal patch worn for 72 hours after surgery. Both groups also had a placebo arm.
The patients were a mean of 69 years old. Cardiovascular disease was present in about 30%; these included coronary artery disease, stroke, and peripheral vascular disease. About a quarter smoked; 36% had diabetes; 86% had hypertension; 2% had atrial fibrillation. Medications included COX-2 inhibitors; statins; ACE, ARB or direct renin inhibitors; and antihypertensives.
At baseline about 24% had an estimated glomerular filtration rate of 60 ml/min or lower per 1.73 m2.
Surgical procedures were urgent or emergent, major vascular, major thoracic, major urological or gynecologic, and other unspecified procedures.
Aspirin did not reduce the risk of an AKI compared to placebo. AKI occurred in 462 patients taking aspirin and 426 taking placebo (13.4% vs. 12.3% respectively; adjusted risk ratio 1.10). Nor did clonidine reduce the risk of AKI compared to placebo. AKI occurred in 449 taking aspirin and 439 taking placebo (13% and 12.7% respectively; adjusted risk ratio 1.03). Neither of these findings was statistically significant.
AKI-related dialysis within 30 days occurred in 0.6% those taking aspirin and 0.3% of the matched placebo patients - a nonsignificant difference. Serum creatinine increased a mean of 11% with aspirin vs. 11% with placebo.
Dialysis was necessary in 0.5% of those taking clonidine and 0.3% of the matched placebo patients - another nonsignificant finding. A history of preoperative chronic kidney disease did not alter either of these findings.
A post hoc analysis determined that both drugs increased the incidence of conditions known to boost the risk of kidney injury. Aspirin increased the risk of major bleeding, which was associated with a greater risk of AKI (23.3% when bleeding occurred vs 12.3% when it did not; adjusted risk ratio 2.20).
Because of this doubling of risk, Dr. Garg suggested moderating pre-operative aspirin exposure in these patients.
“Among patients taking aspirin as part of a long-term regimen, these results support holding it for at least 3 days before surgery and then restarting it a week after surgery,” he recommended.
Clonidine increased the risk of clinically important hypotension, which was also related in turn to AKI (14.3% when hypotension was present vs. 11.8% when it was not; adjusted risk ratio for AKI 1.34).
Dr. Garg had no financial disclosures. A number of the POISE-2 investigators reported financial relationships with pharmaceutical companies.
AT KIDNEY WEEK 2014
Key clinical point: Perioperative treatment with either aspirin or clonidine did not lead to improvements in the risk of postoperative acute kidney injury.
Major finding: Compared to palcebo, the relative risk of acute kidney injury with aspirin was 1.10; it was 1.03 with clonidine.
Data source: The POISE-2 substudy comprised 6,905 patients who were randomized to aspirin, clonidine, or placebo.
Disclosures: Dr. Garg had no financial disclosures. Anumber of the POISE-2 investigators declared financial relationships with pharmaceutical companies.
Fellow involvement is linked to better outcomes of colorectal surgery
SAN FRANCISCO – Patients undergoing colorectal surgery have lower rates of complications and are 20% less likely to die if a fellow is involved in the surgery as compared with a senior resident, new data show.
“Advanced trainee level was associated with improved outcomes in colorectal surgery,” first author Dr. Lilian Chen concluded at the annual clinical congress of the American College of Surgeons, where she presented the data.
“Future studies should attempt to delineate the relative contributions of trainees on intraoperative and postoperative patient care and effects on outcome, and perhaps emphasis on appropriate case selection and resident involvement to optimize patient outcomes,” she recommended.
Using data from the National Surgical Quality Improvement Program (NSQIP), the investigators analyzed outcomes of 68,327 common open and laparoscopic abdominal colorectal operations done during 2005-2012 in which trainees participated.
Outcomes were compared for junior residents in postgraduate years 1 through 3 (involved in 23% of surgeries), senior residents in postgraduate years 4 and 5 (61%), and fellows in postgraduate years beyond year 5 (16%).
The prevalence of many surgical risk factors differed significantly across the three groups of trainees, but most differences were not considered clinically important, according to Dr. Chen, who is a fellow at the Lahey Hospital and Medical Center in Burlington, Mass. “The exceptions were systemic sepsis and emergency cases, where it appears that the fellows are doing proportionately less of these cases,” she noted.
Rates of several 30-day outcomes – septic shock, stroke, unplanned intubation, postoperative pneumonia, wound disruption, acute renal failure, deep incisional surgical site infection, and return to the operating room – differed significantly across groups, being less common for fellows than for either resident group.
The rate of mortality also differed significantly, at 2% for fellows but 4% each for junior and senior residents. In multivariate analysis, patients were significantly less likely to die if a fellow was involved in their surgery as compared with a senior resident (odds ratio, 0.80), but there was no significant difference between junior and senior residents.
“Our limitations include the retrospective analysis, and our inability to adjust for the type of hospital and training program, attending surgeon experience, the presence of subspecialty training in those programs, and the actual level of involvement of the trainee in intraoperative as well as postoperative care of patients,” acknowledged Dr. Chen, who disclosed that she had no relevant conflicts of interest.
Indeed, several session attendees took issue with potential confounders. Dr. Mary T. Hawn, chief of Gastrointestinal Surgery at the University of Alabama at Birmingham, commented, “I think you have to be really careful about understanding the data that you are working with. The first thing is that you can’t adjust for hospital characteristics, so you don’t know that a patient didn’t get transferred to a higher level of care, where there are residents available. ...
“So, I would say you should exclude all emergency cases, you should exclude all patients who are transferred, and things like that, and really try to do propensity adjustment or [seek] some reason that might explain what level of trainee is involved,” she recommended, noting that adjustment does not rule out a role for that factor. “I think this is really concerning because it’s harmful to our community programs to publish data like these, where we don’t really understand the true involvement or the mechanisms of why having the trainee there might be associated with higher mortality.”
Another attendee agreed, saying, “If I’m doing a case with a fellow, I’m going to let the fellow do it, and perhaps assisting, sometimes watching, while I let the fellow do it with the junior resident. If I’m in there with the junior resident, I’m doing the case while the junior resident is assisting me. So I think you need to take things like that into account when you think about what your data actually mean.”
Residents are commonly involved in nighttime emergency cases because the fellow is not at the hospital, a third attendee noted. Additionally, “the fellows will tend to cherry-pick the cases they want to do. The fellow is going to be involved in the cases that are more likely to be quality elective cases. So the diabetic on oxygen who’s coming in for the right colon is potentially going to get handed over to someone else to pick it up. So I would agree, I think that just publishing this and having that as your statement can be very harmful. You really need to be very objective and truthful about owning up to these confounding factors that you can’t really measure.”
“I have to completely agree with that, there are certainly things that we can’t prove. All we can say is that fellows are associated with this reduction in mortality, but we can’t say why ... ” Dr. Chen concurred. “I can’t say the fellow is the reason. There are too many variables involved, one of those being that if you have a colorectal fellow, you are probably at a specialty center with a colorectal fellowship or oncology fellowship and that could be the reason why you have lower mortality, better outcomes. It is just because of the staff and the facility that’s equipped to take those complex cases. So it could have nothing to do with the fellows at all.”
SAN FRANCISCO – Patients undergoing colorectal surgery have lower rates of complications and are 20% less likely to die if a fellow is involved in the surgery as compared with a senior resident, new data show.
“Advanced trainee level was associated with improved outcomes in colorectal surgery,” first author Dr. Lilian Chen concluded at the annual clinical congress of the American College of Surgeons, where she presented the data.
“Future studies should attempt to delineate the relative contributions of trainees on intraoperative and postoperative patient care and effects on outcome, and perhaps emphasis on appropriate case selection and resident involvement to optimize patient outcomes,” she recommended.
Using data from the National Surgical Quality Improvement Program (NSQIP), the investigators analyzed outcomes of 68,327 common open and laparoscopic abdominal colorectal operations done during 2005-2012 in which trainees participated.
Outcomes were compared for junior residents in postgraduate years 1 through 3 (involved in 23% of surgeries), senior residents in postgraduate years 4 and 5 (61%), and fellows in postgraduate years beyond year 5 (16%).
The prevalence of many surgical risk factors differed significantly across the three groups of trainees, but most differences were not considered clinically important, according to Dr. Chen, who is a fellow at the Lahey Hospital and Medical Center in Burlington, Mass. “The exceptions were systemic sepsis and emergency cases, where it appears that the fellows are doing proportionately less of these cases,” she noted.
Rates of several 30-day outcomes – septic shock, stroke, unplanned intubation, postoperative pneumonia, wound disruption, acute renal failure, deep incisional surgical site infection, and return to the operating room – differed significantly across groups, being less common for fellows than for either resident group.
The rate of mortality also differed significantly, at 2% for fellows but 4% each for junior and senior residents. In multivariate analysis, patients were significantly less likely to die if a fellow was involved in their surgery as compared with a senior resident (odds ratio, 0.80), but there was no significant difference between junior and senior residents.
“Our limitations include the retrospective analysis, and our inability to adjust for the type of hospital and training program, attending surgeon experience, the presence of subspecialty training in those programs, and the actual level of involvement of the trainee in intraoperative as well as postoperative care of patients,” acknowledged Dr. Chen, who disclosed that she had no relevant conflicts of interest.
Indeed, several session attendees took issue with potential confounders. Dr. Mary T. Hawn, chief of Gastrointestinal Surgery at the University of Alabama at Birmingham, commented, “I think you have to be really careful about understanding the data that you are working with. The first thing is that you can’t adjust for hospital characteristics, so you don’t know that a patient didn’t get transferred to a higher level of care, where there are residents available. ...
“So, I would say you should exclude all emergency cases, you should exclude all patients who are transferred, and things like that, and really try to do propensity adjustment or [seek] some reason that might explain what level of trainee is involved,” she recommended, noting that adjustment does not rule out a role for that factor. “I think this is really concerning because it’s harmful to our community programs to publish data like these, where we don’t really understand the true involvement or the mechanisms of why having the trainee there might be associated with higher mortality.”
Another attendee agreed, saying, “If I’m doing a case with a fellow, I’m going to let the fellow do it, and perhaps assisting, sometimes watching, while I let the fellow do it with the junior resident. If I’m in there with the junior resident, I’m doing the case while the junior resident is assisting me. So I think you need to take things like that into account when you think about what your data actually mean.”
Residents are commonly involved in nighttime emergency cases because the fellow is not at the hospital, a third attendee noted. Additionally, “the fellows will tend to cherry-pick the cases they want to do. The fellow is going to be involved in the cases that are more likely to be quality elective cases. So the diabetic on oxygen who’s coming in for the right colon is potentially going to get handed over to someone else to pick it up. So I would agree, I think that just publishing this and having that as your statement can be very harmful. You really need to be very objective and truthful about owning up to these confounding factors that you can’t really measure.”
“I have to completely agree with that, there are certainly things that we can’t prove. All we can say is that fellows are associated with this reduction in mortality, but we can’t say why ... ” Dr. Chen concurred. “I can’t say the fellow is the reason. There are too many variables involved, one of those being that if you have a colorectal fellow, you are probably at a specialty center with a colorectal fellowship or oncology fellowship and that could be the reason why you have lower mortality, better outcomes. It is just because of the staff and the facility that’s equipped to take those complex cases. So it could have nothing to do with the fellows at all.”
SAN FRANCISCO – Patients undergoing colorectal surgery have lower rates of complications and are 20% less likely to die if a fellow is involved in the surgery as compared with a senior resident, new data show.
“Advanced trainee level was associated with improved outcomes in colorectal surgery,” first author Dr. Lilian Chen concluded at the annual clinical congress of the American College of Surgeons, where she presented the data.
“Future studies should attempt to delineate the relative contributions of trainees on intraoperative and postoperative patient care and effects on outcome, and perhaps emphasis on appropriate case selection and resident involvement to optimize patient outcomes,” she recommended.
Using data from the National Surgical Quality Improvement Program (NSQIP), the investigators analyzed outcomes of 68,327 common open and laparoscopic abdominal colorectal operations done during 2005-2012 in which trainees participated.
Outcomes were compared for junior residents in postgraduate years 1 through 3 (involved in 23% of surgeries), senior residents in postgraduate years 4 and 5 (61%), and fellows in postgraduate years beyond year 5 (16%).
The prevalence of many surgical risk factors differed significantly across the three groups of trainees, but most differences were not considered clinically important, according to Dr. Chen, who is a fellow at the Lahey Hospital and Medical Center in Burlington, Mass. “The exceptions were systemic sepsis and emergency cases, where it appears that the fellows are doing proportionately less of these cases,” she noted.
Rates of several 30-day outcomes – septic shock, stroke, unplanned intubation, postoperative pneumonia, wound disruption, acute renal failure, deep incisional surgical site infection, and return to the operating room – differed significantly across groups, being less common for fellows than for either resident group.
The rate of mortality also differed significantly, at 2% for fellows but 4% each for junior and senior residents. In multivariate analysis, patients were significantly less likely to die if a fellow was involved in their surgery as compared with a senior resident (odds ratio, 0.80), but there was no significant difference between junior and senior residents.
“Our limitations include the retrospective analysis, and our inability to adjust for the type of hospital and training program, attending surgeon experience, the presence of subspecialty training in those programs, and the actual level of involvement of the trainee in intraoperative as well as postoperative care of patients,” acknowledged Dr. Chen, who disclosed that she had no relevant conflicts of interest.
Indeed, several session attendees took issue with potential confounders. Dr. Mary T. Hawn, chief of Gastrointestinal Surgery at the University of Alabama at Birmingham, commented, “I think you have to be really careful about understanding the data that you are working with. The first thing is that you can’t adjust for hospital characteristics, so you don’t know that a patient didn’t get transferred to a higher level of care, where there are residents available. ...
“So, I would say you should exclude all emergency cases, you should exclude all patients who are transferred, and things like that, and really try to do propensity adjustment or [seek] some reason that might explain what level of trainee is involved,” she recommended, noting that adjustment does not rule out a role for that factor. “I think this is really concerning because it’s harmful to our community programs to publish data like these, where we don’t really understand the true involvement or the mechanisms of why having the trainee there might be associated with higher mortality.”
Another attendee agreed, saying, “If I’m doing a case with a fellow, I’m going to let the fellow do it, and perhaps assisting, sometimes watching, while I let the fellow do it with the junior resident. If I’m in there with the junior resident, I’m doing the case while the junior resident is assisting me. So I think you need to take things like that into account when you think about what your data actually mean.”
Residents are commonly involved in nighttime emergency cases because the fellow is not at the hospital, a third attendee noted. Additionally, “the fellows will tend to cherry-pick the cases they want to do. The fellow is going to be involved in the cases that are more likely to be quality elective cases. So the diabetic on oxygen who’s coming in for the right colon is potentially going to get handed over to someone else to pick it up. So I would agree, I think that just publishing this and having that as your statement can be very harmful. You really need to be very objective and truthful about owning up to these confounding factors that you can’t really measure.”
“I have to completely agree with that, there are certainly things that we can’t prove. All we can say is that fellows are associated with this reduction in mortality, but we can’t say why ... ” Dr. Chen concurred. “I can’t say the fellow is the reason. There are too many variables involved, one of those being that if you have a colorectal fellow, you are probably at a specialty center with a colorectal fellowship or oncology fellowship and that could be the reason why you have lower mortality, better outcomes. It is just because of the staff and the facility that’s equipped to take those complex cases. So it could have nothing to do with the fellows at all.”
AT THE ACS CLINICAL CONGRESS
Key clinical point: Morbidity and mortality were lower with fellows involved than with residents involved.
Major finding: Patients were less likely to have complications and 20% less likely to die when a fellow was involved with the surgery as compared with a senior resident.
Data source: A retrospective cohort study of 68,327 colorectal surgeries from the NSQIP database.
Disclosures: Dr. Chen disclosed that she had no relevant conflicts of interest.