Composite Complication Rate Research Articles

Evaluation of a Center of Excellence Program for Spine Surgery

The Centers for Medicare and Medicaid Services and many private health plans are encouraging patients to seek orthopedic care at hospitals designated as centers of excellence. No evaluations have been conducted to compare patient outcomes and costs at centers of excellence versus other hospitals. The objective of our study was to assess whether hospitals designated as spine surgery centers of excellence by a group of over 25 health plans provided higher quality care. Claims representing approximately 54 million commercially insured individuals were used to identify individuals aged 18-64 years with 1 of 3 types of spine surgery in 2007-2009: 1-level or 2-level cervical fusion (referred to as cervical simple fusion), 1-level or 2-level lumbar fusion (referred to as lumbar simple fusion), or lumbar discectomy and/or decompression without fusion. The primary outcomes were any complication (7 complications were captured) and 30-day readmission. The multivariate models controlled for differences in age, sex, and comorbidities between the 2 sets of hospitals. A total of 29,295 cervical simple fusions, 27,214 lumbar simple fusions, and 28,911 lumbar discectomy/decompressions were identified, of which 42%, 42%, and 47%, respectively, were performed at a hospital designated as a spine surgery center of excellence. Designated hospitals had a larger number of beds and were more likely to be an academic center. Across the 3 types of spine surgery (cervical fusions, lumbar fusions, or lumbar discectomies/decompressions), there was no difference in the composite complication rate [OR 0.90 (95% CI, 0.72-1.12); OR 0.98 (95% CI, 0.85-1.13); OR 0.95 (95% CI, 0.82-1.07), respectively] or readmission rate [OR 1.03 (95% CI, 0.87-1.21); OR 1.01 (95% CI, 0.89-1.13); OR 0.91 (95%, CI 0.79-1.04), respectively] at designated hospitals compared with other hospitals. On average, spine surgery centers of excellence had similar complication rates and readmission rates compared with other hospitals. These results highlight the importance of empirical evaluations of centers of excellence programs.

The association between hospital obstetrical volume and maternal postpartum complications

The purpose of this study was to examine the relationship between delivery volume and maternal complications. We used administrative data to identify women who had been admitted for childbirth in 2006. Hospitals were stratified into deciles that were based on delivery volume. We compared composite complication rates across deciles. We evaluated 1,683,754 childbirths in 1045 hospitals. Decile 1 and 2 hospitals had significantly higher rates of composite complications than decile 10 (11.8% and 10.1% vs 8.5%, respectively; P < .0001). Decile 9 and 10 hospitals had modestly higher composite complications as compared with decile 6 (8.8% and 8.5% vs 7.6%, respectively; P < .0001). Sixty percent of decile 1 and 2 hospitals were located within 25 miles of the nearest greater volume hospital. Women who deliver at very low-volume hospitals have higher complication rates, as do women who deliver at exceedingly high-volume hospitals. Most women who deliver in extremely low-volume hospitals have a higher volume hospital located within 25 miles.

Outcomes of minimally invasive valve surgery in patients with chronic obstructive pulmonary disease

We hypothesize that minimally invasive valve surgery in patients with chronic obstructive pulmonary disease (COPD) is superior to the conventional median sternotomy approach. We retrospectively reviewed 2846 consecutive surgery performed at our institution between January 2005 and September 2010, and identified 165 patients with COPD who underwent isolated valve surgery. In-hospital mortality, composite complication rates, intensive care unit and total hospital length of stay of those who had undergone a minimally invasive approach were compared with a cohort that underwent a standard median sternotomy approach. Of the 165 patients, 100 underwent a minimally invasive approach and 65 had a median sternotomy. Baseline characteristics did not differ between the two groups. The mean age was 71 ± 11 years for the minimally invasive group and 68 ± 12 years for the median sternotomy group, (P = 0.31). In-hospital mortality was 1 (1%) in the minimally invasive group and 3 (5%) in the median sternotomy group, P = 0.14. Composite postoperative complications were significantly reduced in the minimally invasive group (30 versus 54%, P = 0.002). The median intensive care unit length of stay was 47 h (IQR 40-70) versus 73 h (IQR 51-112), P < 0.001, and the median postoperative length of stay was 6 days (IQR 5-9) versus 9 days (IQR 7-13), P < 0.001, for the minimally invasive and the median sternotomy groups, respectively. Minimally invasive valve surgery in patients with COPD is associated with excellent short-term results, and thus should be considered an option in these patients.

COMPARISON OF DEVICES UTILIZED FOR TRANSCATHETER CLOSURE OF PATENT FORAMEN OVALE: A META ANALYSIS

Results: A total of 121 studies were included for review. We observed that Amplatzer has been the most common device utilized for closure, followed by CardioSEAL, Intrasept, Starlex and Helex devices respectively. Of the most common devices utilized, Helex had the lowest RNE rate in the follow up period [0.10 events/ 100 PY], followed by Amplatzer [0.60 events/ 100 PY] and Starlex devices [0.60 events/ 100 PY]. Amplatzer, Premere and Helex devices were associated with the lowest composite complication rates. CardioSEAL and Starlex devices were associated with the highest rate of atrial arrhythmias and Premere and Helex devices were associated with the lowest risk of atrial arrhythmias. The risk of thrombus formation was highest with the Starlex devices and lowest with the Helex devices. It was observed that the Helex devices were most common devices to embolize.

Invited Commentary

Mihos and colleagues [1] have performed an important study comparing a right minithoracotomy with a repeat sternotomy approach in patients requiring isolated mitral valve (MV) repair after a cardiac operation. The authors found a trend toward a lower mortality rate in the minithoracotomy group (3% versus 14%), which failed to reach significance because of the small sample size (88 patients in total). Despite the limited sample size, the authors were able to demonstrate a significantly lower composite complication rate, as well as shorter intensive care and hospital stays, in patients who underwent minimally invasive procedures.

Academic Season Does Not Influence Cardiac Surgical Outcomes at US Academic Medical Centers

Previous studies have demonstrated the influence of academic season on outcomes in select surgical populations. However, the influence of academic season has not been evaluated nationwide in cardiac surgery. We hypothesized that cardiac surgical outcomes were not significantly influenced by time of year at both cardiothoracic teaching hospitals and non-cardiothoracic teaching hospitals nationwide. From 2003 to 2007, a weighted 1,614,394 cardiac operations were evaluated using the Nationwide Inpatient Sample database. Patients undergoing cardiac operations at cardiothoracic teaching and non-cardiothoracic teaching hospitals were identified using the Association of American Medical College's Graduate Medical Education Tracking System. Hierarchic multivariable logistic regression analyses were used to estimate the effect of academic quarter on risk-adjusted outcomes. Mean patient age was 65.9 ± 10.9 years. Women accounted for 32.8% of patients. Isolated coronary artery bypass grafting was the most common operation performed (64.7%), followed by isolated valve replacement (19.3%). The overall incidence of operative mortality and composite postoperative complication rate were 2.9% and 27.9%, respectively. After accounting for potentially confounding risk factors, timing of operation by academic quarter did not independently increase risk-adjusted mortality (p = 0.12) or morbidity (p = 0.24) at academic medical centers. Risk-adjusted mortality and morbidity for cardiac operations were not associated with time of year in the US at teaching and nonteaching hospitals. Patients should be reassured of the safety of performance of cardiac operations at academic medical centers throughout a given academic year.

Randomized controlled trial of wound complication rates of subcuticular suture vs staples for skin closure at cesarean delivery

The purpose of this study was to determine the wound complication rates and patient satisfaction for subcuticular suture vs staples for skin closure at cesarean delivery. This was a randomized prospective trial. Subjects who underwent cesarean delivery were assigned randomly to stainless steel staples or subcuticular 4.0 Monocryl sutures. The primary outcomes were composite wound complication rate and patient satisfaction. A total of 435 patients were assigned randomly. Staple closure was associated with a 4-fold increased risk of wound separation (adjusted odds ratio [aOR], 4.66; 95% confidence interval [CI], 2.07-10.52; P < .001). Having a wound complication was associated with a 5-fold decrease in patient satisfaction (aOR, 0.18; 95% CI, 0.09-0.37; P < .001). After confounders were controlled for, there was no difference in satisfaction between the treatment groups (aOR, 0.71; 95% CI, 0.34-1.50; P = .63). Use of staples for cesarean delivery closure is associated with an increased risk of wound complications. Occurrence of a wound complication is the most important factor that influenced patient satisfaction.

Complications After Pancreatectomy for Neuroendocrine Tumors: A National Study

Although resection of pancreatic neuroendocrine tumors (PNETs) has a demonstrated survival advantage, further evaluation of the overall morbidity of these procedures is needed. Our objective was to examine a composite outcome of major postoperative complications, including in-hospital mortality. The Nationwide Inpatient Sample (NIS), 1998-2006, was used to identify all patients with a diagnosis of PNET who had undergone pancreatectomy. Candidate predictors consisted of patient and hospital characteristics. Univariate analyses included chi(2) tests. Multivariate analyses were performed with logistic regression to determine which predictors were independently associated with the composite outcome. A total of 463 (2274 nationally weighted) patients were identified. Overall composite postoperative complication rate was 29.6%. The majority of complications involved infections (11.1%), digestive complications (8.8%), or pulmonary compromise (7.3%). In-hospital mortality rate was 1.7%. High Charlson comorbidity score, procedure type of Whipple or total pancreatectomy, and urban hospital location were all associated with significantly increased complication rate. Logistic regression analysis demonstrated: Charlson score of > or =3 versus score of 0 (adjusted odds ratio (OR) 4.1, 95% confidence interval (CI) 2.1-8.3), surgery type of Whipple or total pancreatectomy versus partial pancreatectomy (adjusted OR 2.7, 95% CI 1.8-4.1), and hospital location of urban versus rural (adjusted OR 4.5, 95% CI 3.0-6.9). While in-hospital mortality rates are low for surgical resection of PNETs, there is a considerable overall postoperative complication rate associated with these procedures. Careful patient and surgery selection may be the key to a surgical treatment approach for PNETs that may optimize outcomes.

Is Faculty Presence during Emergent Tracheal Intubations Justified?

We read with interest the prospective trial by Schmidt et al .1and the accompanying editorial,2which suggest that faculty supervision during emergency endotracheal intubations decreases the rate of airway complications. However, as with any observational study, confounders must be considered.First, several variables suggest that the set of intubations supervised by faculty anesthesiologists may have been slightly less emergent than those accomplished without faculty supervision. The reasons for intubation in the supervised group were more commonly airway protection and “other.” The supervised group was more likely to use neuromuscular blockade to accomplish tracheal intubation. The supervised group performed a higher proportion of intubations in the intensive care unit, a setting in which decompensating patients are more likely to be recognized before complete physiologic deterioration. Moreover, unlike some floor settings, intensive care unit beds are uniformly equipped with functioning suction, oxygen, and devices to deliver positive pressure mask ventilation and staffed by support personnel who are more experienced in identifying, mobilizing and participating in emergent clinical scenarios. Regardless of location, urgent and semiemergent intubations are more likely to allow time to assemble a full complement of personnel and equipment, to optimize patient position, and to consider aspiration prophylaxis, all of which should minimize risk of various complications.Second, as the authors suggest, the presence of a second anesthesia provider, irrespective of the level of training or experience, may facilitate safer tracheal intubation. Based on a multivariate logistic regression analysis of data collected in a prospective multicenter study,3tracheal intubation managed by an anesthesia team (including a junior and a senior provider) as opposed to a single senior provider, was shown to protect against airway complications. Our institution's experience and data support the conclusion that a second anesthesia provider, as opposed to a faculty anesthesiologist, is the process characteristic responsible for improved outcomes. The emergency intubation team at our institution includes a junior (CA-1 or CA-2) and senior anesthesiology resident (CA-3 with at least 24 months of laryngoscopic experience). Typically, a faculty member is present when difficult intubation is anticipated. Preliminary analysis of the electronic medical records for 2,460 emergent intubations over a 4-yr period revealed a 2.3% composite complication rate, with no differences based on faculty presence. Operator-reported complications included aspiration (n = 37), dental injury (n = 4), and esophageal intubation (n = 15). Of note, 8.4% of tracheal intubations were accomplished with the aid of a bougie introducer. The availability of this adjunct or providers' experience in its use was not presented by Schmidt et al . This may be responsible for the rate of frequent esophageal intubation in their studied population.Finally, time of day has been shown to affect survival to discharge after cardiopulmonary arrest.4The data collection sheet used by Schmidt et al ., which was presented in previous work,5includes the date and time of intubation. An analysis to evaluate the effect of nighttime or weekend intubations would be helpful. If nighttime intubations, or weekend intubations, or both, result in more complications, the explanation may be decreased faculty presence, but may also be a result of decreased nursing vigilance delaying the recognition of a need for emergency intubation, increased time from code activation to presence of the anesthesiology team, or circadian biologic factors in both patients and staff attempting the intubation.Faculty presence is the standard of care for intubations in the operating room. Extending this standard to emergency intubations would be desirable if it were to improve patient safety. However, undesirable effects on perioperative patient safety and healthcare costs must also be considered. During nights, weekends, and other periods of limited staffing, emergency intubations may pull on-call faculty away from the operating room or intensive care unit. Dedicated faculty to cover emergent intubations will entail increased on-call commitments and economic costs in many centers. These concerns justify a prospective study in either the intensive care unit or the floor with systematic or even randomized allocation of faculty presence to clarify the contribution of faculty anesthesiologists, urgency, location, time of day, and other confounders on significant patient airway outcomes.*University of Michigan Health System, Ann Arbor, Michigan. jmmhyre@umich.edu

Peripheral Vascular Surgery Using Targeted Beta Blockade Reduces Perioperative Cardiac Event Rate

Recent studies suggest that preoperative cardiac stress testing is unnecessary in low to intermediate cardiac risk patients undergoing operations, and that targeted beta blockade is cardiac protective. A cohort study of patients undergoing vascular surgery or major amputation, with low to intermediate cardiac risk, but without cardiac stress testing, was performed. Targeted beta blockade was initiated preoperatively. The primary end point was a composite of adverse cardiac outcomes. A comparison was made with historical controls who received selective stress testing and selective nontargeted beta blockade. One hundred consecutive patients were prospectively enrolled, and 80 retrospective controls were identified. There were no differences between groups with respect to median revised cardiac index (RCI; 0 versus 1). In the retrospective group, 14% underwent preoperative cardiac stress testing versus none in the prospective group (p=0.0002). Nontargeted beta blockade was given in 61% of the retrospective group. The median heart rate for the prospective group was significantly lower (66 versus 77 beats/minute; p=0.0007). The composite cardiac complication rate was 2% in the prospective group versus 10% in the retrospective group (p=0.02). There were no deaths. On multivariate analysis, after adjusting for revised cardiac index score, there was a lower cardiac complication rate in the prospective group (odds ratio, 2.46; 95% CI, 1.3 to 4.5; p=0.003). In patients undergoing vascular surgery or major amputation, with low to intermediate cardiac risk, preoperative targeted beta blockade alone is more effective than selective cardiac stress testing and nontargeted beta blockade in preventing cardiac morbidity.

Editorial Comment on: Laparoscopic and Robotic Assisted Radical Cystectomy for Bladder Cancer: A Critical Analysis

ORC. 2. Comparison of ORC, LRC, and RARC: In a nonrandomized comparison, RARC and LRC took longer than ORC but were associated with less blood loss and quicker recovery. RARC had the lowest complication rate of 20%, compared to 50% for LRC and 60% for ORC [3]. This needs to be verified in an appropriately powered randomized controlled trial with composite complication rates as the primary outcome measure. 3. Oncological outcomes: Haber and Gill have published medium-term follow-up in 37 patients undergoing LRC, 24 of whom (65%) were alive with no evidence of disease and 11 of whom (30%) were dead, two (5%) from metastasis and nine (24%) from unrelated causes. The 5-yr actuarial overall, cancer-specific, and recurrence-free survival were 63%, 92%, and 92%, respectively [4]. With RARC, at a maximum follow-up of 3.5 yr, the actuarial overall and recurrence-free survival were 95% and 90%, respectively [3]. It thus appears that minimal invasion does not compromise outcomes when compared to ORC [5]. 4. Ergonomics: One of the advantages of RARC over ORC and LRC may be reduced surgical fatigue during a long procedure. The hypothesis is that a less tired surgeon makes fewer errors and therefore has lesser complications, although this concept needs further scientific evaluation.

Impact of the opening of a specialized cardiac surgery recovery unit on postoperative outcomes in an academic health sciences centre

It is controversial as to whether cardiac surgery patients are optimally managed in a mixed medical-surgical intensive care unit (ICU) or in a specialized postoperative unit. We conducted a prospective cohort study in an academic health sciences centre to compare outcomes before and following the opening of a specialized cardiac surgery recovery unit (CSRU) in April 2005. The study cohort included 2,599 consecutive patients undergoing coronary artery bypass grafting (CABG), valve and combined CABG-valve procedures from April 2004 to March 2006. From April 2004 to March 2005 (year 1) all patients received postoperative care in mixed medical-surgical ICUs at two different sites staffed by critical care consultants, fellows and residents. From April 2005 until March 2006 (year 2) patients were cared for in a newly-established CSRU on one site staffed by cardiac anesthesiology fellows, a nurse practitioner and consultants in critical care, cardiac anesthesiology and cardiac surgery. The effect of this change on in-hospital mortality, the incidence of ten major postoperative complications, postoperative ventilation hours, readmission rates and case cancellations due to a lack of capacity was assessed using Chi-square or Wilcoxon tests, where appropriate. Coronary artery bypass grafting, valve and combined CABG-valve mortality rates were similar in years 1 and 2. There was a significant reduction in the composite major complication rate (16.3% to 13.0%, P=0.02) and in median postoperative ventilation hours (8.8 vs 8.0 hr, P=0.005) from year 1 to 2. On multivariable logistic regression analysis, the pre-merger interval (year 1) was a significant independent predictor of the occurrence of death or major complications. A specialized CSRU with a multi-disciplinary consultant model was associated with stable or improved outcomes postoperatively, when compared to a mixed medical- surgical ICU model of cardiac surgical care.

Vaginal birth after caesarean delivery: does maternal age affect safety and success?

To estimate maternal age effects on the rates of vaginal birth after caesarean delivery (VBAC), the related maternal complications and patient election to attempt VBAC, we conducted a secondary analysis of a retrospective cohort study of women who were offered VBAC from 1996 to 2000 in 17 community and university hospitals. We used bivariable and multivariable analyses to assess the association between maternal age and the study outcomes. A total of 25 005 patients were included, of whom 13 706 (54.81%) elected to attempt VBAC. After controlling for several confounding variables, using ages 21-34 years as the referent group, women aged 15-20 years were 27% less likely to have a failed VBAC attempt (OR = 0.73 [0.62, 0.87], P < 0.001). Analysing maternal age as a dichotomous variable, women who were of advanced maternal age (>or=35 years) were more likely to experience an unsuccessful trial of labour (OR = 1.14 [1.03, 1.25], P = 0.009). In addition, women >or=35 years of age had 39% more risk of experiencing one of the VBAC-related operative complications (OR = 1.39 [1.02, 1.89], P = 0.039). As women increase in age, they are less likely to attempt VBAC and more likely to have an unsuccessful labour trial. While teenage patients do not appear to be at increased risk for VBAC-related complications, patients of advanced maternal age do show an increase in composite VBAC-related operative complication rates.

Cardiorespiratory Fitness and Short-term Complications After Bariatric Surgery

Morbid obesity is associated with reduced functional capacity, multiple comorbidities, and higher overall mortality. The relationship between complications after bariatric surgery and preoperative cardiorespiratory fitness has not been previously studied. We evaluated cardiorespiratory fitness in 109 patients with morbid obesity prior to laparoscopic Roux-en-Y gastric bypass surgery. Charts were abstracted using a case report form by reviewers blinded to the cardiorespiratory evaluation results. The mean age (+/- SD) was 46.0 +/- 10.4 years, and 82 patients (75.2%) were female. The mean body mass index (BMI) was 48.7 +/- 7.2 (range, 36.0 to 90.0 kg/m(2)). The composite complication rate, defined as death, unstable angina, myocardial infarction, venous thromboembolism, renal failure, or stroke, occurred in 6 of 37 patients (16.6%) and 2 of 72 patients (2.8%) with peak oxygen consumption (Vo(2)) levels < 15.8 mL/kg/min or > 15.8 mL/kg/min (lowest tertile), respectively (p = 0.02). Hospital lengths of stay and 30-day readmission rates were highest in the lowest tertile of peak Vo(2) (p = 0.005). There were no complications in those with BMI < 45 kg/m(2) or peak Vo(2) > or= 15.8 mL/kg/min. Multivariate analysis adjusting for age and gender found peak Vo(2) was a significant predictor of complications: odds ratio, 1.61 (per unit decrease); 95% confidence interval, 1.19 to 2.18 (p = 0.002). Reduced cardiorespiratory fitness levels were associated with increased, short-term complications after bariatric surgery. Cardiorespiratory fitness should be optimized prior to bariatric surgery to potentially reduce postoperative complications.

Chorionic villus sampling increases the alpha-fetoprotein level but not the number of fetal erythrocytes in maternal blood

NOT THE NUMBER OF FETAL ERYTHROCYTES IN MATERNAL BLOOD DENISE PELIKAN, SICCO SCHERJON, WILMA MESKER, GODELIEVE GROOT SWINGS, HANS TANKE, HUMPHREY KANHAI, Leiden University, Obstetrics, Leiden, Netherlands, Netherlands, Leiden University, Molecular Cell Biology, Leiden, Netherlands, Netherlands OBJECTIVE: To investigate the relation between alpha-fetoprotein (AFP) levels and the number of fetal erythrocytes in maternal blood before and after chorionic villus sampling (CVS). STUDY DESIGN: Blood samples of 53 women between 11 and 13 gestational weeks undergoing CVS, were collected 15 minutes before and after CVS. All pregnancies were cytogenetically normal. A biopsy forceps (n = 47) and a canula (n = 3) were used for transcervical CVS. An aspiration needle (n = 3) was used for transabdominal sampling. The AFP measurements were performed in a single run using the Chemiluminescent Microparticle Immunoassay. Supervised automated microscopy of Kleihauer-Betke stained slides was applied to quantify fetal erythrocytes. Per sample G 2.0x106 cells were evaluated. RESULTS: AFP measurements before and after CVS were obtained in 48 patients, whereas paired slides were complete in 50 patients. The mean AFP level before CVS was 13.9 mg/L (range 6.4-36.4, median 11.7, SD 7.3, SEM 1.1, 95% CI 11.8-16.0) and after CVS 37.2 mg/L (range 8.2-241.7, median 18.4, SD 46.4, SEM 6.7, 95% CI 23.7-50.7), indicating a significant increase of the AFP level in maternal plasma after CVS (Wilcoxon signed ranks test, P ! .0001). The mean number of fetal erythrocytes before CVS was 1.5 (range 0–24, median 0, SD 3.8, SEM 0.5, 95% CI 0.4–2.6) and after CVS 2.0 (range 0 – 23, median 1.0, SD 4.4, SEM 0.6, 95% CI 0.7–3.2). There was no significant increase in the fetal erythrocyte count before versus after CVS (Wilcoxon signed ranks test, P = .327). Consequently, the correlation between the fetal erythrocyte difference before and after CVS and the AFP level difference was not significant (r = 0.13, P = .39). CONCLUSION: Although an increase was found in AFP levels after CVS, no increase in fetal erythrocytes could be detected. This suggests that the CVS procedure results in a leakage of proteins due to placental tissue damage, rather than increased trafficking of fetal cells through the placental barrier. 229 RANDOMIZED COMPARISON OF SUBCUTANEOUS TISSUE REAPPROXIMATION ALONE AND IN COMBINATION WITH SUBCUTANEOUS DRAIN IN OBESE WOMEN UNDERGOING CESAREAN DELIVERY PATRICK RAMSEY, ANNA WHITE, DEBRA GUINN, GEORGE LU, LINDA FONSECA, ASHLEY CASE, DWIGHT ROUSE, University of Alabama at Birmingham, Obstetrics/Gynecology, Birmingham, Alabama, Northwest Perinatal Center and Women’s Healthcare Associates, Obstetrics/Gynecology, Portland, Oregon, Obstetrix Medical Group of Kansas & Missouri, Kansas City, Missouri, University of Texas Health Science Center at Houston, Obstetrics, Gynecology and Reproductive Sciences, Houston, Texas OBJECTIVE: To compare the efficacy of subcutaneous (SQ) suture reapproximation alone to suture plus SQ drain for the prevention of wound complications in obese women undergoing cesarean delivery. STUDY DESIGN: We conducted a prospective multicenter randomized trial of obese women undergoing cesarean delivery. Women preoperatively consented and only those with R4 cm of SQ thickness documented at fascial closure were randomized to either SQ suture closure alone (N = 148) or suture plus SQ drain (N = 132). Women receiving the drain had it placed to bulb suction and was removed at 72 hrs or earlier if output !30 mL/24 hour. The primary study outcome was a composite wound complication rate (defined by any of the following noted at the wound assessment: wound dehiscence, seroma, hematoma, or abscess). RESULTS: From 04/01-07/04 a total of 280 women were enrolled. Ninety-four percent of women (264/280) had a follow-up wound assessment. Both groups were similar with respect to age, parity, weight, cesarean indication, diabetes, steroid/antibiotic use, chorioamnionitis, and SQ thickness. The overall composite wound complication rate was 16.9% (24/142) in the suture group and 23.0% (28/122) in the suture + drain group (RR 1.4: 95% CI 0.8-2.2, P = .22). Individual wound complication rates are shown in the Table. CONCLUSION: The additional use of a SQ drain to a standard SQ suture reapproximation technique is not effective for the prevention of wound complications in obese women undergoing cesarean delivery.

Peripheral vascular complications in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I)

In-hospital peripheral vascular complications of balloon angioplasty were compared with those of directional atherectomy in the Coronary Angioplasty Versus Excisional Atherectomy Trial (CAVEAT-I) to identify patients at risk and evaluate costs and outcomes. The incidence, costs and outcomes of peripheral vascular complications after coronary intervention have not been fully characterized as a function of randomly assigned therapy. At 35 sites in the United States and Europe, 1,012 patients were randomized. Peripheral vascular complications were defined as the composite of pulse loss, pseudoaneurysm, hematoma > 4 cm in diameter or groin hemorrhage necessitating blood transfusion. Logistic models were derived to 1) predict these complications from baseline and procedural characteristics, 2) test the relevance of randomization assignment, and 3) assess their impact on hospital costs and long-term outcomes. Sixty-seven patients (6.6%) developed peripheral vascular complications, of whom 15 (22.4%) required a blood transfusion, 14 (20.9%) underwent vascular surgery, and 2 (3.0%) died. Both in-hospital deaths occurred in patients with peripheral vascular complications. There was no difference in composite peripheral vascular complication rates among patients randomized to angioplasty or atherectomy. Greater age, female gender, postprocedural heparin and intraaortic balloon counterpulsation were predictive of increased risk. In a representative 60% subset, mean hospital costs increased from $9,583 in patients without to $18,350 in those with peripheral vascular complications (p = 0.0001). The unadjusted mortality rate at 1 year was 7.5% for patients with peripheral vascular complications compared with 1.1% for all others (p = 0.0001). These complications identified patients at greater risk of death, myocardial infarction or repeat revascularization at 30 days and 1 year. The atherectomy group had a trend toward more frequent deaths and myocardial infarction. Directional atherectomy and balloon angioplasty had similar in-hospital peripheral vascular complication rates. Female gender, greater age, postprocedural heparin and intraaortic balloon counterpulsation were predictive of higher risk. The twofold increase in cost and sevenfold increase in long-term deaths highlight the need to prevent these periprocedural events and monitor patients closely.