Rate Of Postoperative Adverse Events Research Articles

12: The impact of surgeon volume on perioperative adverse events in women undergoing minimally invasive hysterectomy for large uteri

To evaluate the impact of surgeon volume on perioperative adverse events in women undergoing minimally invasive hysterectomy (MIH) for uteri >250 grams. This is a retrospective cohort study of all women who underwent vaginal (VH), laparoscopic (TLH), laparoscopic-assisted vaginal (LAVH), or robotic-assisted laparoscopic hysterectomy (RH) between January 2014 and July 2016 at a tertiary care referral center. Hysterectomy was performed for the following indications: fibroids, pelvic pain, abnormal uterine bleeding, and prolapse. Women were excluded if there was a preoperative diagnosis of malignancy. Patients were identified by Current Procedural Terminology codes and the system-wide electronic medical record was queried for demographic and perioperative data. Perioperative adverse events were defined a priori and classified using the Clavien-Dindo scale. Surgeon volume was defined as the mean number of MIH cases performed per month by each surgeon during the study period. Seven hundred sixty-three patients met inclusion criteria: 416 (54.5%) TLH, 196 (25.7%) RH, 90 (11.8%) TVH, and 61 (8%) LAVH. Mean (±SD) age was 47 ± 6 years, and body mass index (BMI) was 31.1 ± 7.4 kg/m2. Sixty-six surgeons performed MIH for uteri >250 grams during the study period. The mean monthly case volume was 16.4 ± 7.2 cases, and the median MIH volume was 23 cases (range: 1–147 cases). The mean uterine weight was 522.8 ± 322.7 grams. The rate of postoperative adverse events >Dindo grade 2 was 17.8% (95% CI = 15.2-20.7); 2.2% (95% CI = 1.4-3.6) were grade 3 and 0.5% (95% CI = 0.7-1.4) grade 4; there were no grade 5 adverse events. The overall rate of intraoperative adverse events was 4.2% (95% CI = 2.9-5.9). The rate of conversion to laparotomy was 5.5% (95% CI = 4.0-7.4). There was no difference in adverse event rates between the routes of MIH cases (25.6% vs. 17.5% vs. 18.0% vs. 14.8%, p = 0.2). Women who experienced any adverse event compared to those who did not were more likely to be of Hispanic, Asian or “other” ethnicity, had higher intraoperative blood loss (EBL) and longer operating case time. In a logistic regression model controlling for age, BMI, uterine weight, operating time, history of laparotomy and parity, higher monthly MIH volume remained significantly associated with adverse events (adjOR = 1.14, 95% CI = 1.0-1.3, p = 0.01), as did higher EBL (adjOR = 1.4, 95% CI = 1.1-1.8, p = 0.006). When controlling for the same variables, higher monthly MIH case volume remained significantly associated with intraoperative complications (adjOR = 1.30, 95% CI = 1.0-1.6, p = 0.02) as well as higher EBL (adjOR = 3.1, 95% CI = 2.0-4.9, p < 0.001). Conversion from a minimally invasive approach to laparotomy was not associated with monthly MIH case volume; however, conversion was associated with higher EBL (adjOR = 2.9, 95% CI = 1.8-4.9) and heavier uteri (adjOR = 9.7, 95% CI = 3.9-23). The overall rate of serious adverse events associated with MIH for uteri >250 grams was low. Higher EBL and longer operative times were associated with higher perioperative adverse event rates. Higher monthly MIH case volume was associated with a higher rate of intra- and postoperative adverse events but was not associated with conversion to laparotomy.

Inversed relationship between completeness of follow-up and coverage of postoperative complications in gallstone surgery and ERCP: a potential source of bias in patient registers

ObjectiveTo analyse the completeness in GallRiks of the follow-up frequency in relation to the intraoperative and postoperative outcome.DesignPopulation-based register study.SettingData from the national Swedish Registry for Gallstone Surgery and Endoscopic...

Effectiveness and safety of anti-fibrinolytic therapy in on-pump CABG

Objective: To evaluate the effectiveness and safety of anti-fibrinolytic therapy in on-pump coronary artery bypass grafting (CABG). Methods: Two hundred and eleven patients receiving on-pump CABG in Fuwai Hospital were recruited and randomized into treatment group (group T) and control group (group C) between October 2014 and February 2017. Tranexamic acid was given with a 10 mg/kg loading dose and 10 mg·kg(-1)·h(-1) infusion dose to group T and equal volume of saline was given to group C throughout the surgery. Postoperative drainage, allogeneic transfusion, complications, adverse events and mortality were recorded. Results: Patients of group T had less postoperative drainage [860 (670, 1 190)ml vs 985 (783, 1 365)ml], decreased red blood cell [2 (0, 8)U vs 6 (2, 10)U] and fresh frozen plasma [1 (0, 3) U vs 2 (0, 3)U] transfusion volume, lower fresh frozen plasma transfusion rate (53.33% vs 70.75%) than patients of group C (all P<0.05). No statistically significant differences existed in the rate of postoperative complications, adverse events and death between the two groups (all P>0.05). Conclusion: Tranexamic acid has definite anti-fibrinolytic effect, which can significantly reduce postoperative bleeding and allogeneic transfusion while no severe side effects were observed.

Invited Commentary

Invited Commentary

General Health Adverse Events Within 30 Days Following Anterior Cervical Discectomy and Fusion in US Patients: A Comparison of Spine Surgeons' Perceptions and Reported Data for Rates and Risk Factors.

Study Design:Survey study and retrospective review of prospective data.Objectives:To contrast surgeons’ perceptions and reported national data regarding the rates of postoperative adverse events following anterior cervical discectomy and fusion (ACDF) and to assess the accuracy of surgeons in predicting the impact of patient factors on such outcomes.Methods:A survey investigating perceived rates of perioperative complications and the perceived effect of patient risk factors on the occurrence of complications following ACDF was distributed to spine surgeons at the Cervical Spine Research Society (CSRS) 2015 Annual Meeting. The equivalent reported rates of adverse events and impacts of patient risk factors on such complications were assessed in patients undergoing elective ACDF from the National Surgical Quality Improvement Program (NSQIP).Results:There were 110 completed surveys from attending physicians at CSRS (response rate = 44%). There were 18 019 patients who met inclusion criteria in NSQIP years 2011 to 2014. The rates of 11 out of 17 (65%) postoperative adverse events were mildly overestimated by surgeons responding to the CSRS questionnaire in comparison to reported NSQIP data (overestimates ranged from 0.24% to 1.50%). The rates of 2 out of 17 (12%) postoperative adverse events were mildly underestimated by surgeons (range = 0.08% to 1.2%). The impacts of 5 out of 10 (50%) patient factors were overestimated by surgeons (range relative risk = 0.56 to 1.48).Conclusions:Surgeon estimates of risk factors for and rates of adverse events following ACDF procedures were reasonably nearer to national data. Despite an overall tendency toward overestimation, surgeons’ assessments are roughly appropriate for surgical planning, expectation setting, and quality improvement initiatives.

Benefits of Thoracic Epidural Analgesia in Patients Undergoing an Open Posterior Component Separation for Abdominal Herniorrhaphy

ABSTRACTAn open posterior component separation (PCS) is a commonly utilized surgical approach for repair of complex abdominal wall defects and hernias. Although this approach may improve surgical outcomes, significant postoperative pain can be expected given the required laparotomy and extensive abdominal wall manipulation. Both systemic opioids and thoracic epidural analgesia (TEA) are viable postoperative analgesic options, and both are commonly utilized. Although the benefits of TEA have been investigated following a variety of surgeries, there is a paucity of literature related to its efficacy for this particular surgery. The aim of this study was to evaluate the benefits of TEA following open PCS under the hypothesis that the incorporation of TEA into the postoperative analgesic regimen would hasten bowel recovery. Patients who previously underwent an open PCS were identified through an electronic medical record query. A retrospective chart review was then performed, and patients who had TEA, either alone or combined with systemic opioids, were compared with patients who had only systemic opioids. The primary end point was a comparison of the postoperative day (POD) on which a full diet was started. Secondarily, time to liquid diet, postsurgical length of stay (LOS), intensive care unit (ICU) admission rate, ICU LOS, and the rates of several postoperative adverse events were compared. A post hoc analysis was also performed, using the same end points, to compare the subgroup of TEA patients who avoided systemic opioids with all patients who received systemic opioids, whether alone or combined with TEA. One hundred and one patients were ultimately included for analysis. Time to full diet was not significantly different between patients who had TEA, either with or without systemic opioids, and those who received only systemic opioids (TEA 2.6 ± 1.7 vs. systemic opioids 3.1 ± 2.1 [mean POD ± SD], P = .21). Additionally, no statistically significant differences were found for any secondary outcome. In the post hoc analysis, the subgroup of TEA patients who avoided systemic opioids had a significantly faster time to bowel recovery when compared with all patients who received systemic opioids (2.2 ± 1.0 vs. 3.2 ± 2.2, P = .0033). This subgroup also had a significantly shorter time to liquid diet and a decreased postoperative LOS. In conclusion, for patients undergoing an open PCS, the inclusion of TEA in the postoperative analgesic regimen did not by itself hasten the return of bowel function. However, when TEA was utilized and systemic opioids were avoided, bowel recovery occurred significantly sooner and resulted in a shortened hospital LOS.

Preoperative Renal Insufficiency: Underreporting and Association With Readmission and Major Postoperative Morbidity in an Academic Medical Center.

Making a formal diagnosis of chronic kidney disease (CKD) in the preoperative setting may be challenging because of lack of longitudinal data. We explored the predictive value of a single reduced preoperative estimated glomerular filtration rate (eGFR) value on adverse patient outcomes in the first 30 days after elective surgery. We compared the rate of major postoperative adverse events, including 30-day readmission rate, hospital length of stay, infection, acute kidney injury (AKI), and myocardial infarction across patients with declining preoperative eGFR values. We hypothesized that there is an association between decreasing preoperative eGFR values and major postoperative morbidity including readmission within 30 days of discharge and that the reasons for unplanned readmissions may be associated with poor preoperative renal function. This was a retrospective analysis of the electronic health record of 39 989 adult patients who underwent elective surgery between June 2011 and July 2013 at our institution. Patients with reduced eGFR (<60 mL/min/1.73 m) were identified and categorized by the stages of CKD that correlated with the preoperative eGFR value. Odds of readmission to our hospital within 30 days, as well as new diagnosis of AKI, myocardial infarction, and infection, were determined with multivariate logistic regression. The subset of patients who were readmitted within 30 days also were subdivided further into patients who had an eGFR <60 mL/min/1.73 m and those with an eGFR ≥60 mL/min/1.73 m, as well as whether the readmission was planned or unplanned. Of the 4053 patients with eGFR <60 mL/min/1.73 m, 3290 (81.2%) did not carry a preoperative diagnosis of CKD. Adjusted odds ratios of being readmitted were 1.48 (99% confidence interval [CI], 1.18-1.87; P < .001) for eGFR 30 to 44 mL/min/1.73 m to 2.06 (99% CI, 1.32-3.23; P < .001) for eGFR <15 mL/min/1.73 m compared with patients with a preoperative eGFR value ≥60 mL/min/1.73 m. Patients with a lower eGFR also demonstrated increasing odds of AKI from 2.78 (99% CI, 1.86-4.17; P < .001) for eGFR 45 to 59 mL/min/1.73 m to 3.81 (99% CI, 1.68-8.16; P < .001) for eGFR <15 mL/min/1.73 m. This study highlights that preoperative renal insufficiency may be underreported and appears to be significantly associated with postoperative complications. It extends the association between a single low preoperative eGFR and postoperative morbidity to a broader range of surgical populations than previously described. Our results suggest that preoperative calculation of eGFR may be a relatively low-cost, readily available tool to identify patients who are at an increased risk of readmission within 30 days of surgery and postoperative morbidity in patients presenting for elective surgery.

A retrospective cohort study of hemostatic agent use during hysterectomy and risk of post-operative complications.

To determine if the use of intraoperative hemostatic agents was a risk factor for post-operative adverse events within 30days of patients undergoing hysterectomy. A population-based retrospective cohort study included data from patients undergoing hysterectomy for any indication between January 1, 2013, and December 31, 2014, at 52 hospitals in Michigan, USA. Any individuals with missing covariate data were excluded, and multivariable logistic regression and propensity score-matching were used to estimate the rate of post-operative adverse events associated with intra-operative hemostatic agents independent of demographic and surgical factors. There were 17960 surgical procedures included in the analysis, with 4659 (25.9%) that included the use of hemostatic agents. Hemostatic agent use was associated with an increase in predicted hospital re-admissions (P=0.007). Among all hysterectomy approaches, and after adjusting for demographic and surgical factors, hemostatic agent use during robotic-assisted laparoscopic hysterectomy was associated with an increased predicted rate of blood transfusions (P=0.019), an increased predicted rate of pelvic abscess diagnoses (P=0.001), an increased predicted rate of hospital re-admission (P=0.001), and an increased predicted rate of re-operation (P=0.021). Hemostatic agents should be used carefully owing to associations with increased post-operative re-admissions and re-operations when used during hysterectomy.

The Incidence of Perioperative Adverse Events in the Very Elderly Undergoing Urogynecologic Surgery.

To determine the incidence of perioperative adverse events in very elderly women (age ≥ 80 years) undergoing urogynecologic procedures and to examine the effect of preoperative functional status/capacity on these outcomes. This is a retrospective analysis of all women aged 80 years or older who underwent a urogynecologic procedure at a tertiary care specialty practice between 2006 and 2014. Subjects were identified by their Current Procedural Terminology codes and the electronic medical record was queried for demographic and perioperative data. Functional status was recorded using data from the preoperative anesthesia assessment, and included the functional status score (range, 1-4) and a functional capacity evaluation (metabolic equivalents [METs, range, 1 to 8+]). One hundred sixty-four women aged 80 years or older underwent a urogynecologic procedure during the study period. Mean age was 83 years (±3; range, 80-95 years). The median functional status was 2 (1-4) and median functional capacity was 5.5 METs (1.75-8.0). The overall postoperative adverse event rate was 18.3%; the incidence of serious events was 7.8%. Most serious events were associated with preexisting medical conditions. Presence of 3 or more comorbid conditions was associated with a higher risk of postoperative readmission, need for transfusion and deep vein thrombosis/pulmonary embolism. Preoperative functional status and functional capacity were not associated with postoperative adverse events. Patients with METs scores of 4.5 or less were more likely to need home services or a skilled nursing facility (SNF) postoperatively compared with patients with higher scores (28.9% vs 6.7%, P < 0.0001; odds ratio, 4.3; 95% confidence interval, 1.6-11.9). Dementia was also associated with SNF admission (36.3% vs 10%; P = 0.01; odds ratio, 3.6; 95% confidence interval, 1.1-12.8). The incidence of serious postoperative adverse events is low in very elderly patients undergoing urogynecologic procedures. Dementia and poor functional capacity appear to be associated with a higher need for postoperative home services or SNF admission.

Outcomes After Nonobstetric Surgery in Pregnant Patients: A Nationwide Study

ObjectiveTo evaluate outcomes after nonobstetric surgical procedures in pregnant patients. MethodsWe conducted a retrospective cohort study of 5591 pregnant women who underwent nonobstetric surgical procedures using Taiwan's National Health Insurance Research Database 2008-2012 claims data. Using a propensity score matching procedure, 22,364 nonpregnant women were selected for comparison. Logistic regression was used to calculate the odds ratios (ORs) and 95% CIs of postoperative complications and in-hospital mortality associated with pregnancy. ResultsPregnant women had higher risks of postoperative septicemia (OR=1.75; 95% CI, 1.47-2.07), pneumonia (OR=1.47; 95% CI, 1.01-2.13), urinary tract infection (OR=1.29; 95% CI, 1.08-1.54), and in-hospital mortality (OR=3.94; 95% CI, 2.62-5.92) compared with nonpregnant women. Pregnant women also had longer hospital stays and higher medical expenditures after nonobstetric surgical procedures than controls. Higher rates of postoperative adverse events in pregnant women receiving nonobstetric surgery were noted in all age groups. ConclusionSurgical patients with pregnancy showed more adverse events, with a risk of in-hospital mortality approximately 4-fold higher after nonobstetric surgery compared with nonpregnant patients. These findings suggest the urgent need to revise the protocols for postoperative care for this population.

Continuous local anaesthetic wound infusion for postoperative pain after midline laparotomy for colorectal resection in adults

Continuous local anaesthetic wound infusion for postoperative pain after midline laparotomy for colorectal resection in adults

Shoulder Arthroscopy in Adults 60 or Older: Risk Factors That Correlate With Postoperative Complications in the First 30 Days

To investigate the 30-day postoperative adverse event (AE) rates of adults 60years or older after shoulder arthroscopy and identify risk factors for complications in this patient population. Patients aged 60 or more who underwent shoulder arthroscopy were identified in the American College of Surgeons National Surgery Quality Improvement Program database from 2006 to 2013 using 12 Current Procedural Terminology codes related to shoulder arthroscopy. Complications were categorized as severe AEs, minor AEs, and infectious AEs for separate analyses. Pearson's χ2 tests were used to identify associations between patient characteristics and AE occurrence and binary logistic regression for multivariate analysis of independent risk factors. In total, 7,867 patients were included for analysis. Overall, 1.6% (n= 127) of the older adults experienced at least one AE with 1.1% (n= 90) severe AEs, 0.6% (n= 46) minor AEs, and 0.4% (n= 28) infectious complications. Multivariate analysis revealed that age 80 years or older (odds ratio [OR]= 2.2, 95% confidence interval [CI]= 1.2-2.7, P= .01), body mass index greater than 35 (OR= 1.8, 95% CI= 1.1-2.7, P= .01), functionally dependent status (OR= 2.9, 95% CI= 1.3-6.8, P= .01), American Society of Anesthesiologists class greater than 2 (OR= 1.5, 95% CI= 1.0-2.2, P= .04), congestive heart failure (OR= 6.1, 95% CI= 1.8-21.2, P= .03), disseminated cancer (OR= 7.9, 95% CI= 1.4-43.9, P= .02), and existence of an open wound at the time of surgery (OR= 4.0, 95% CI= 1.1-14.6, P= .03) were independently associated with the occurrence of an AE. Nineteen of the patients included in the study required readmission to the hospital within the 30-day period for an overall readmission rate of 0.2%. Patients 60years or older who underwent shoulder arthroscopy for a variety of indications have a low overall 30-day postoperative complication rate of 1.6%. Although low, this is a higher rate than previously reported for the overall shoulder arthroscopy population. Independent patient characteristics associated with increased risk of AE occurrence included age 80 years or older, body mass index greater than 35, functional dependent status, American Society of Anesthesiologists score of 3 or 4, congestive heart failure, disseminated cancer, and existence of an open wound. Level III, retrospective comparative study.

Using Surgical Video to Improve Technique and Skill.

Using Surgical Video to Improve Technique and Skill.

Perioperative adverse events associated with colpocleisis for uterovaginal and posthysterectomy vaginal vault prolapse

Colpocleisis, a vaginal obliterative procedure, offers women with symptomatic pelvic organ prolapse an effective, durable anatomic repair and is associated with high patient satisfaction rates. Historically, colpocleisis was reserved for the medically frail or elderly with the goal of limiting anesthetic exposure, decreasing operative time, and minimizing adverse events. Several colpocleisis and colpectomy procedures exist and limited evaluation has been performed comparing these differences in regards to perioperative adverse events. The primary objective was to describe the overall rate of perioperative adverse events in patients undergoing colpocleisis. The secondary objective was to compare rates of adverse events between different colpocleisis procedures. This is a retrospective chart review of patients who underwent colpocleisis at a tertiary care center from January 2003 through December 2013. Subjects were identified by their Current Procedural Terminology (CPT) codes and categorized into 3 groups: (1)partial or complete vaginectomy/colpectomy (CPT 57106, 57110); (2)vaginal hysterectomy with total or partial colpectomy (CPT 58275, 58280); and (3) Le Fort colpocleisis (CPT 57120). Baseline demographics, perioperative data, and postoperative data were collected. Analysis of variance was used to describe perioperative and postoperative adverse events in all subjects and to compare outcomes among the 3 groups. In all, 245 subjects underwent colpocleisis during the study period. Mean age and body mass index were 78 (±7) years and 27.7 (±5.8) kg/m(2), respectively; 59.1% (140/245) of subjects had stage-4 prolapse. The most common adverse event was urinary tract infection occurring in 34.7% of subjects. Major adverse events were uncommon. There were no differences in event rates among the groups except for the following: patients undergoing concurrent vaginal hysterectomy had longer mean operative time (144 vs 108 vs 111 minutes, P= .0001), had higher estimated blood loss (253 vs 135 vs 146 mL, P= .0001), and weremore likely to experience postoperative venous thromboembolism (4.6% vs 0% vs 0%, P= .01). After controlling for age, body mass index, medical comorbidities, estimated blood loss, and operative time, the risk of venous thromboembolism was no longer significant. The overall rate of major perioperative and postoperative adverse events in women undergoing colpocleisis is low; however, concomitant hysterectomy is associated with longer operative times and higher blood loss.

A population-based review of bone morphogenetic protein: associated complication and reoperation rates after lumbar spinal fusion.

OBJECT The authors compared the rates of postoperative adverse events and reoperation of patients who underwent lumbar spinal fusion with bone morphogenetic protein (BMP) to those of patients who underwent lumbar spinal fusion without BMP. METHODS The authors retrospectively analyzed the PearlDiver Technologies, Inc., database, which contains the Medicare Standard Analytical Files, the Medicare Carrier Files, the PearlDiver Private Payer Database (UnitedHealthcare), and select state all-payer data sets, from 2005 to 2010. They identified patients who underwent lumbar spinal fusion with and without BMP. The ICD-9-CM code 84.52 was used to identify patients who underwent spinal fusion with BMP. ICD-9-CM diagnosis codes identified complications that occurred during the initial hospital stay. ICD-9-CM procedural codes were used to identify reoperations within 90 days of the index procedure. The relative risks (and 95% CIs) of BMP use compared with no BMP use (control) were calculated for the association of any complication with BMP use compared with the control. RESULTS Between 2005 and 2010, 460,773 patients who underwent lumbar spinal fusion were identified. BMP was used in 30.7% of these patients. The overall complication rate in the BMP group was 18.2% compared with 18.7% in the control group. The relative risk of BMP use compared with no BMP use was 0.976 (95% CI 0.963-0.989), which indicates a significantly lower overall complication rate in the BMP group (p < 0.001). In both treatment groups, patients older than 65 years had a statistically significant higher rate of postoperative complications than younger patients (p < 0.001). CONCLUSIONS In this large-scale institutionalized database study, BMP use did not seem to increase the overall risk of developing a postoperative complication after lumbar spinal fusion surgery.

Using Surgeon-Specific Outcome Reports and Positive Deviance for Continuous Quality Improvement

Using the thoracic morbidity and mortality classification to document all postoperative adverse events between October 2012 and February 2014, we created surgeon-specific outcome reports (SSORs) to promote self-assessment and to implement a divisional continuous quality improvement (CQI) program, on the construct of positive deviance, to improve individual surgeon's clinical performance. Mixed-methods study within a division of six thoracic surgeons, involving (1) development of real-time, Web-based, risk-adjusted SSORs; (2) implementation of CQI seminars (n= 6; September 2013 to June 2014) for evaluation of results, collegial discussion on quality improvement based on identification of positive outliers, and selection of quality indicators for future discussion; and (3) in-person interviews to identify facilitators and barriers to using SSORs and CQI. Interview transcripts were analyzed using thematic analysis. Interviews revealed enthusiastic support for SSORs as a means to improve patient care through awareness of personal outcomes with blinded divisional comparison for similar operations and diseases, and apply the learning objectives to continuous professional development and maintenance of certification. Perceived limitations of SSORs included difficulty measuring surgeon expertise, limited understanding of risk adjustment, resistance to change, and belief that knowledge of sensitive data could lead to punitive actions. All surgeons believed CQI seminars led to collegial discussions, whereas perceived limitations included quorum participation and failing to circle back on actionable items. Real-time performance feedback using SSORs can motivate surgeons to improve their practice, and CQI seminars offer the opportunity to review and interpret results and address issues in a supportive environment. Whether SSORs and CQI can lead to improvements in rates of postoperative adverse events is a matter of ongoing research.

The role of antibiotic prophylaxis in routine endoscopic retrograde cholangiopancreatography investigations as assessed prospectively in a nationwide study cohort

Objective. Risk factors for complications after endoscopic retrograde cholangiopancreatography (ERCP) with emphasis on the potential advantage of the use of prophylactic antibiotics were studied in a national population-based study cohort. Materials and methods. All ERCP procedures registered in the Swedish Registry of Gallstone Surgery and ERCP (GallRiks) between May 2005 and June 2013 were analyzed. Patients with ongoing antibiotic treatment, incomplete registration or those who had not undergone an index ERCP were excluded. Risk factors for adverse events were analyzed. Results. Data from 47,950 ERCPs were collected, but after applying the exclusion criteria, 31,188 examinations were analyzed. In the group receiving prophylactic antibiotics, the postoperative adverse event rate was 11.6% compared with 14.2% in the group without antibiotics. The odds ratio (OR) for the risk of postoperative adverse events in patients receiving prophylactic antibiotics was 0.74 (95% confidence interval [CI]: 0.69–0.79). When analyzing a subgroup of 21,893 ERCPs for the three most common indications (common bile duct stones, malignancy, and obstructive jaundice), the beneficial effect of prophylactic antibiotics on adverse events remained (OR = 0.76; 95% CI: 0.70–0.82). Further, in the subgroup of patients with obstructive jaundice, the administration of prophylactic antibiotics had a beneficial effect on septic complications (OR = 0.76; 95% CI: 0.58–0.97). Conclusion. The risk of adverse events after ERCP is reduced 26% if antibiotics are given prophylactically during ERCP investigations, as suggested by data gained from this national population-based study. However, in absolute terms, the reduction in adverse events by prophylactic antibiotics is modest (2.6%).

Cost-effectiveness of three treatment strategies for lumbar spinal stenosis: Conservative care, laminectomy, and the Superion interspinous spacer.

Lumbar spinal stenosis is a painful and debilitating condition resulting in healthcare costs totaling tens of billions of dollars annually. Initial treatment consists of conservative care modalities such as physical therapy, NSAIDs, opioids, and steroid injections. Patients refractory to these therapies can undergo decompressive surgery, which has good long-term efficacy but is more traumatic and can be associated with high post-operative adverse event (AE) rates. Interspinous spacers have been developed to offer a less-invasive alternative. The objective of this study was to compare the costs and quality adjusted life years (QALYs) gained of conservative care (CC) and decompressive surgery (DS) to a new minimally-invasive interspinous spacer. A Markov model was developed evaluating 3 strategies of care for lumbar spinal stenosis. If initial therapies failed, the model moved patients to more invasive therapies. Data from the Superion FDA clinical trial, a prospective spinal registry, and the literature were used to populate the model. Direct medical care costs were modeled from 2014 Medicare reimbursements for healthcare services. QALYs came from the SF-12 PCS and MCS components. The analysis used a 2-year time horizon with a 3% discount rate. CC had the lowest cost at $10,540, while Spacers and DS were nearly identical at about $13,950. CC also had the lowest QALY increase (0.06), while Spacers and DS were again nearly identical (.28). The incremental cost-effectiveness ratios (ICER) for Spacers compared to CC was $16,300 and for DS was $15,200. Both the Spacer and DS strategies are far below the commonly cited $50,000/QALY threshold and produced several times the QALY increase versus CC, suggesting that surgical care provides superior value (cost / effectiveness) versus sustained conservative care in the treatment of lumbar spinal stenosis.

EFFECT OF AMIODARONE ON RATES OF POST-OPERATIVE ATRIAL FIBRILLATION IN PATIENTS UNDERGOING CARDIAC SURGERY

Despite advancements in medical therapy, post-operative atrial fibrillation (POAF) remains a common complication following cardiac surgery and is associated with increased morbidity and mortality. The purpose of this study was to determine whether routine administration of amiodarone reduced the incidence of POAF in patients undergoing cardiac surgery. All patients undergoing non-emergent, on-pump isolated coronary artery bypass grafting (CABG), isolated valve, or concomitant CABG/valve surgery performed by a single surgeon from January 2010 through September 2013 were identified. Patients with pre-existing atrial fibrillation were excluded. Of the 558 patients who formed the final study population, 321 patients (57.5%) received the standard of care in terms of anti-arrhythmic and heart rate-controlling therapies. The remaining 237 (42.4%) received, in addition to the standard of care, routine amiodarone therapy which included a 300 mg intravenous bolus of amiodarone immediately upon return from the operating room followed by 400 mg orally three times daily for a total of 5 days or up until the date of discharge depending on which came first. Baseline characteristics, intra-operative variables and rates of in-hospital post-operative adverse events were compared between the two groups. Multiple logistic regression modeling was used to determine the risk-adjusted effect of amiodarone use on rates of POAF. Patients who received amiodarone were more likely to have a body mass index ≥ 30 kg/m2 (p = 0.02), to have NYHA IV symptoms (p = 0.01), and to leave the operating room on inotropic support (p = 0.04). While rates of in-hospital post-operative adverse events were generally similar between the two groups, amiodarone therapy was associated with lower rates of atrial fibrillation (Table 1). Following adjustment for potential confounding variables, amiodarone emerged as an independent predictor of reduced rates of POAF (OR 0.59, 95% CI 0.40-0.87, p < 0.01). Patients who received amiodarone therapy possessed an increased burden of co-morbid disease upon presentation for surgery and a higher rate of inotropic support immediately following surgery. Despite this, amiodarone was found to be associated with significantly reduced rates of POAF. The results of this study support the routine use of amiodarone in patients undergoing cardiac surgery.

SUBOPTIMAL ADHERENCE TO EVIDENCE BASED CORONARY ARTERY DISEASE (CAD) THERAPY: IMPACT OF GENDER, ETHNICITY, PRESCRIBING PHYSICIAN AND DRUG INTOLERANCE

BACKGROUND: Previous studies have examined the effect of a patient’s geographic place of residence on their access to cardiac care services, in particular as it applies to rates of procedure utilization and wait times. Less is known, however, about the effect of one’s geographic place of residence on clinical outcomes following these procedures. The purpose of this study was to examine 30-day rates of adverse events following cardiac surgery and to determine the effect of a patient’s geographic place of residence on these outcomes. METHODS: All patients undergoing non-emergent cardiac surgery at the sole, tertiary cardiac care center for the province of New Brunswick between April 2004 and March 2011 were identified. A patient’s geographic place of residence was defined as the driving distance from the patient’s home to the cardiac surgery center. Distance was divided into the following categories: 0-50km, 50-100km, 100-150km, 150-200km, 200-250km and >250km. Comparisons between distance categories were made on the basis of baseline clinical characteristics, intra-operative variables and rates of post-operative in-hospital and 30-day adverse events. Multivariable logistic regression was used to determine the risk-adjusted impact of increased distance on in-hospital and 30-day outcomes. The in-hospital adverse outcome of interest was a composite of reoperation, prolonged ventilation >24 hours, wound infection, stroke, renal failure, atrial fibrillation, and/or mortality, while the 30-day adverse outcome of interest was a composite of any complication (infectious, neurological, pulmonary, renal, valvular, vascular or other) and/or readmission from the time of discharge up until 30 days following surgery. RESULTS: 4493 patients were identified of whom 3897 (86.7%) had 30-day follow-up (0-50km: n1⁄4813; 50-100km: n1⁄4278; 100-150km: n1⁄41028; 150-200km: n1⁄4863; 200250km: n1⁄4405; and >250km: n1⁄41106). No differences were noted across distance categories in baseline clinical characteristics, intra-operative variables and rates of in-hospital adverse events. However, significant differences in 30-day rates of adverse events were noted (Table 1). Following risk adjustment, increased distance from the cardiac surgery center was independently associated with a greater likelihood of experiencing an adverse event at 30 days [0-50km: 1.00 (referent); 50-100km: OR 1.16 (95% CI 0.83-1.62); 100150km: 1.32 (1.05-1.65), 150-200km, 1.68 (1.33-2.11), 200-250km, 1.41 (1.06-1.88), and >250 km, 1.30 (1.041.63)]. CONCLUSION: Increased distance from the patient’s home to the cardiac surgery center was associated with worse 30-day outcomes following cardiac surgery. Further study is required to better understand why patients living farther are more likely to experience surgical complications and/or readmission to hospital during this study period.