AbsorbaSeal™ Vascular Closure Device: A Novel Device for Hemostasis Following Interventional Peripheral Vascular Procedures.

INTRODUCTION: Vascular closure devices (VCDs) are designed to achieve rapid hemostasis during percutaneous coronary and peripheral vascular procedures. Studies demonstrate that VCDs improve time to hemostasis (TTH) and time to ambulation (TTA) in comparison to standard manual compression. The available products, however, typically have 13-17 steps in their application, often require hemostatic collagen or other agents as part of the process, and can result in significant scarring at the puncture site that can impact future access. The aim of this study was to investigate the performance of a three-step, novel VCD for access site TTH, short-term and long-term histology, and a first-in-man clinical study. MATERIALS AND METHODS: This study evaluated AbsorbaSeal™ (CyndRx, LLC, Brentwood, Tennessee), a simple, three-step, VCD with bio-absorbable components. Following an institutional review board (IRB) approval, a 6-F sheath was placed directly into the porcine aorta, AbsorbaSeal™ was used to seal the puncture site, and a measure of total time of deployment (TTD) and TTH was performed, as well as histologic evaluation at 30, 60, and 180 days. A complement activation test was performed to determine the potential for activation of the complement system as a mediator of inflammation. The test was performed by directly incubating the VCDs AbsorbaSeal™ and Angio-Seal™ (Terumo Interventional Systems, Tokyo, Japan) in human serum. Serum samples were removed after 30, 60, and 90 minutes and tested for the presence and amount of complement protein SC5b-9. In the first in-man trial, the device was deployed in anticoagulated patients undergoing interventional vascular procedures. The TTH, estimated blood loss, patient pain scores, and procedural and follow-up complications were recorded. RESULTS: In the acute and chronic porcine studies, TTD averaged 25 seconds (17-29 seconds). Vascular control was immediate, yielding a TTH of effectively zero seconds. Histologic evaluation demonstrated complete endothelial coverage of the device by 30 days without evidence of bleeding, clotting, or inflammation. At 60 days, the significant mass of the device had dissolved and normal appearing collagen surrounded the devices with essentially no inflammatory response. By six months, all but one microscopic segment of one of the devices had been absorbed with normal appearing vascular endothelium, and no, or minimal, scarring appreciated. The complement test demonstrated that the AbsorbaSeal™ had similar, or lower, complement concentrations than the negative controls and significantly less than Angio-Seal™. This supported the histologic findings of minimal to no inflammation. The VCD was deployed in 20 patients undergoing interventional vascular procedures. The mean TTH was 2.3 ± 1.5 minutes. Estimated blood loss was 11.7 mL ± 3.5 mL, and no significant hematoma was noted. Post-procedure pain scores were low, with a mean of 1.4 ± 0.8 on a 0-10 pain rating scale. There were no perioperative complications and no adverse events at follow-up. CONCLUSIONS: The AbsorbaSeal™ is safe and simple to use for vascular closure after interventional vascular procedures with favorable outcomes including a short TTH, minimal procedural blood loss, low postoperative pain scores, and no perioperative complications or adverse effects. Histologic evaluation reveals rapid device absorption and little scar formation both short- and long-term. A direct study of complement activation supports that AbsorbaSeal™ evokes a minimal inflammatory response that is significantly less than Angioseal.

The effect of component separation technique on quality of life (QOL) and surgical outcomes in complex open ventral hernia repair (OVHR).

INTRODUCTION: Outcomes following OVHR may be affected by type of component separation. In this study, outcomes including QOL of patients undergoing OVHR were evaluated based on the utilization of transversus abdominis release (TAR), posterior rectus sheath release (PRSR) alone or in combination with external oblique release (EOR + PRSR). METHODS: A prospective, single-institution study following open ventral hernia repair involving component separation was performed from May 2005 to April 2015. Self-reported QOL outcomes were obtained preoperatively and at 1, 6 and 12 months postoperatively using the Carolinas Comfort Scale (CCS). A CCS of 2 (mild but bothersome discomfort) or greater was considered symptomatic. Comorbidities, complications, outcomes and CCS scores were reviewed. Univariate group comparisons were performed using Chi-square and Wilcoxon two-sample tests with statistical significance set at p < 0.05. RESULTS: During the study period, 292 OVHRs with CST met inclusion criteria. Single-sided, different releases on opposite sides, etc., were eliminated. Demographics included: average age-57.9 ± 11.9 years, BMI-34.0 ± 7.9 kgm2, 53.2% female, 69% at least one prior hernia repair and average defect size-291.2 ± 236.2 cm2. Preoperative discomfort (82 vs. 75 vs. 79%, p = 0.77) and movement limitation (94 vs. 70 vs. 78%, p = 0.1) in TAR, PRSR and EOR + PRSR were similar. Average follow-up was 16.4 months. At 1, 6 and 12 months postoperatively, there was no difference in reported CCS pain scores, movement limitation or mesh sensation among the groups (p > 0.05). Comparing OVHR patients outcomes by CST type, TAR was associated with decreased wound infections compared to others (3.2 vs. 16.1 vs. 20%, p = 0.07) while recurrence rates were increased in EOR + PRSR compared to TAR and PRSR alone(8.4 vs. 3 vs. 1.8%, p = 0.03). Eighty percent of recurrences had a biologic mesh secondary to contaminated field during hernia repair. The other two recurrences were one which occurred superior to the mesh at a suture site and one who developed a wound infection postoperatively. Mesh infection rates were low (0 vs. 1.5 vs. 2.6%, p > 0.05) even including contaminated cases (0 vs. 2 vs. 3.6%, p > 0.05) and were statistically equivalent among all three techniques. CONCLUSION: While QOL is not impacted by type of component separation on short- or long-term follow-up, the TAR may provide benefits such as decreased wound infection rates. Overall QOL had a significant improvement from preoperative regardless of type of component separation. When controlling for field contamination, there were no differences in recurrence or infection.

The cost of preventable comorbidities on wound complications in open ventral hernia repair.

BACKGROUND: Patients with complex ventral hernias may benefit from preoperative optimization. This study evaluates the financial impact of preventable comorbidities (PCM) in elective open ventral hernia repair. METHODS: In this single institution prospectively collected data from 2007-2011, hospital charges (included all hernia-related visits, interventions, or readmissions) and wound-related complications in patients with PCM-diabetes, tobacco use, and obesity-were compared to patients without such risks using standard statistical methods. RESULTS: Within the study period, there were 118 patients with no PCM; of those, 33 had complications, and 85 did not. In the 131 patients with two or more PCM, 81 had complications; 89 of 251 patients had complications in the group with only 1 PCM; groups with PCM were significantly more likely to have complications compared to the no PCM group (62% versus 35.4% versus 28%, P < 0.05). The majority of the patient population was female (57.2%) with a mean age of 57.8 y (range, 22-84 ys), and median defect size was 150 cm2 (interquartile range, 50-283 cm2). Body mass index was higher in PCM group with complications than in PCM without complications (40 versus 36 kg/m2, P < 0.05). For patients with complications, the average hospital charges were $80,660 in the PCM group compared to $55,444 in the no PCM group (P = 0.038). Hospital charges in those with PCM without complications compared to no PCM with complications were equivalent ($65,453 versus $55,444, P = 0.55). Even when no complications occurred, patients with PCM incurred higher charges than No PCM for inpatient ($61,269 versus $31,236, P < 0.02), outpatient ($4,185 versus $552, P < 0.04), and total hospital charges ($65,453 versus $31,788, P ≤ 0.001). Those patients without complications but with a single PCM incurred larger charges than those with no PCM during follow-up ($3578 versus $552, P = 0.04), but there was no difference in hospital or overall total charges (P > 0.05). Interestingly, patients without complications, both hospital ($38,333 versus $61,269, P = 0.02) and total charges ($41,911 versus $65,453, P = 0.01) were increased for patients with 2+ PCM compared to those with only a single PCM. If complications occurred, no difference between the single PCM group compared to the two or more PCM groups existed for hospital, follow-up, or overall charges (P > 0.05). CONCLUSIONS: Patients with PCM undergoing open ventral hernia repair are more likely to have complications than patients without comorbidities. Patients with PCM generate higher hospital charges than those without PCM even when no complications occur; furthermore, the more PCM, the patient has the more significant the impact. Interestingly, patients with multiple PCM and no complications had equivalent hospital costs compared to patients with no PCM and with complications. Aggressive risk reduction may translate into significant savings. Preoperative preparation of patients before elective surgery is indicated.

Quantification of the Effect of Diabetes Mellitus on Ventral Hernia Repair: Results from Two National Registries.

Two national databases were analyzed to determine the effect of varying severity of diabetes mellitus (DM) on ventral hernia repair (VHR) outcomes. The National Surgical Quality Improvement Program (NSQIP) and the National Inpatient Sample (NIS) were queried for patients with and without DM who underwent elective VHR between 2005 to 2012 and 1998 to 2011, respectively. In addition, patients with insulin dependent versus noninsulin-dependent DM were compared in NSQIP; complicated and uncomplicated diabetics were compared in NIS. Univariate and multivariate analyses were used. In NSQIP, 25,819 of 219,625 patients undergoing VHR were diabetic. In open VHR (OVHR), DM patients had an increased complication rate (P < 0.0001); DM patients requiring insulin had increased odds of wound, minor, and major complications (P < 0.0001). For laparoscopic VHR (LVHR), insulin dependence did not affect complication rates (P > 0.05). In NIS, 45,248 of 238,627 patients undergoing VHR were diabetic. In OVHR, patients with complicated diabetes had higher rates of minor complications (17.3% vs 12.7%, P < 0.0001) and had 58 per cent greater odds of major complications than patients with uncomplicated diabetes. LVHR had no difference in complications for complicated versus uncomplicated DM (P > 0.05). After multivariate analysis, insulin-dependent or complicated DM undergoing OVHR had significantly worse outcomes compared with noninsulin-dependent and uncomplicated diabetics. Preoperative optimization and LVHR should be considered in diabetic patients.

Biologic mesh in ventral hernia repair: Outcomes, recurrence, and charge analysis.

BACKGROUND: Biologic mesh choice in ventral hernia repair is challenging due to lack of prospective data. This study examines long-term, single-center biologic mesh outcomes. METHODS: Prospective operative outcomes data was queried for open ventral hernia repair with biologic mesh. Univariate and multivariate analysis were used to compare mesh outcomes. RESULTS: In the study, 223 patients underwent open ventral hernia repair with biologic mesh, including 40 with Alloderm, 23 AlloMax, 70 FlexHD, 68 Strattice, and 22 Xenmatrix. Overall, 9.8% had an American Society of Anesthesiology classification of 4, 54.6% with a classification of 3, and 35.6% with a classification of 1 or 2. Operative time averaged 241 minutes with estimated blood loss of 202 mL. Hernia defects averaged 257 ± 245 cm2 with mesh size 384 cm2. Biologic mesh was used as a fascial bridge in 19.6%, component separation was performed in 47.5%, and 82% had concomitant procedure. Inpatient mortality was 1.4%. Hernia recurrence varied significantly by mesh type: 35% Alloderm, 34.5% AlloMax, 37.1% FlexHD, 14.7% Strattice, and 59.1% Xenmatrix (P = .001). The mean follow-up was 18.2 months. After multivariate analysis comparing to Strattice, AlloMax had a 3.4 higher odds ratio for recurrence, FlexHD a 2.9 odds ratio, and Xenmatrix a 7.8 odds ratio. The rate of mesh infections requiring explantation was <1%. Total hospital charges averaged $131,004 ± $143,320. Mean charges varied significantly between meshes; Xenmatrix was the most expensive and AlloMax was the least expensive (P < .05). CONCLUSION: In 223 ventral hernia repair performed with biologic mesh at a tertiary care institution, Strattice, a porcine acellular dermal mesh, had significantly lower odds of hernia recurrence compared with AlloMax, FlexHD, and Xenmatrix. Choice of biologic mesh affects long-term postoperative outcomes in ventral hernia repair.

Predictive modeling for chronic pain after ventral hernia repair.

BACKGROUND: Few studies predict which patients have dissolution of their postoperative discomfort or develop chronic pain after ventral hernia repair (VHR). This study develops a predictive model to determine which patients are at the greatest risk of chronic pain after VHR. METHODS: A prospective study of VHR patients was performed via the International Hernia Mesh Registry. Anonymous, self-reported, quality of life data using the Carolinas Comfort Scale (CCS) was recorded preoperatively, and 1,6, and 12 months postoperatively. Pain was identified as a score of 2 or more (mild but bothersome to severe) for any Carolinas Comfort Scale pain-specific questions. Logistic regression analyses were performed to determine statistically significant predictors of chronic pain. Univariate analysis selected potential predictors with a P value less than .15, and a subsequent multivariable model was built using backward elimination setting retention criterion at P < .15. Goodness-of-fit of the model was tested using Hosmer-Lemeshow test. A value of greater than 70% for the area under the curve (AUC) was considered most accurate diagnostically. The final model was then internally validated with bootstrap analysis. RESULTS: A total of 887 patients underwent VHR between 2007 and 2014. The patients had an average age of 57.2 ± 12.8 years, 52.4% were female, 17.0% were active smokers, and 13.2% used narcotics preoperatively. With 74% follow-up at 1 year, 26.0% of the patients reported chronic discomfort. After logistic regression model, independent predictors of pain at 6 months were preoperative pain score 2 or more (P < .0001), preoperative narcotic use (P = .06), and 1-month postoperative pain score 2 or more (P < .0001), AUC = .74. Baseline, 1-month, and 6-month predictors determined the final multivariate regression model for prediction of chronic pain at 1 year, AUC = .73. Older age was protective against chronic pain (odds ratio [OR] .98, 95%confidence interval [CI] = .96 to .998, P = .03), female sex increased risk with an OR of 1.7(CI = 1.1 to 2.7, P = .02); preoperative pain, and recurrent hernia repair nearly doubled the risk of developing chronic pain postoperatively (OR = 3.0, CI = 1.8 to 4.8, P < .0001 and 1.6, CI = .98 to 2.6, P = .06, respectively). Importantly, presence of pain at 1 month was a strong predictor of chronic pain at 1-year follow-up (OR = 2.6, CI = 1.7 to 4.2, P < .0001). CONCLUSIONS: Patients who have preoperative pain and at 1 month postoperatively are significantly more likely to have chronic pain. Both short- and long-term pain can be predicted from female sex, younger age, and repair of recurrent hernias. This predictive model may aid in preoperative counseling and when considering postoperative intervention for pain management in VHR patients.

The Centers for Medicare and Medicaid Services (CMS) two midnight rule: policy at odds with reality.

INTRODUCTION: To reduce costs, the Centers for Medicare and Medicaid Services (CMS) implemented new policies governing which patients are automatically admitted as inpatients (staying greater than "two midnights") and which require additional justification with physician documentation to be admitted. This study examines procedures missing from the Medicare Inpatient Only (MIO) list and uses national data to evaluate its appropriateness. METHODS: Non-MIO procedures were identified from the current MIO list. Utilizing relevant billing codes, procedures were queried in the National Surgery Quality Improvement Program database for length of stay (LOS), percentage requiring >2 day stay, and inpatient status from 2005 to 2012. In addition, a separate analysis was performed for patients 65 years old or older who would qualify for Medicare. RESULTS: A majority of patients stayed more than 2 days for several procedures not included on the MIO list (% staying >2 days, mean LOS), including component separation (79.1%, 5.9 ± 12.3 days), diagnostic laparoscopy (64.2%, 5.5 ± 11.9 days), laparoscopic splenectomy (60.0%, 9.0 ± 13.6 days), open recurrent ventral hernia repair (58.2%, 6.3 ± 9.0 days), laparoscopic esophageal surgery (46.4%, 5.3 ± 13.3 days), and laparoscopic ventral hernia repair (24.7%, 2.5 ± 8.8 days). In patients ≥65 years, the average LOS was longer than the general population; for example, 40.2% of laparoscopic appendectomies and 38.7% of laparoscopic cholecystectomies in this older group required more than two nights in the hospital. In 92.3% of procedures examined, patients ≥65 years required greater than two nights in the hospital with an average LOS of 2.5-10.7 days. CONCLUSION: Commonly encountered non-MIO surgical procedures have national precedents for inpatient status. Before enacting policy, CMS and other regulatory bodies should consider current data to ensure rules are evidence-based and applicable.

Laparoscopic versus open peritoneal dialysis catheter placement.

BACKGROUND: Laparoscopy revolutionized many General Surgery procedures by decreasing hospital stay, minimizing recovery time, and reducing wound infection rates. This study evaluates the potential benefits of laparoscopic approach to peritoneal dialysis catheter (PDC) placement. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was queried for laparoscopic and open PDC placement. We evaluated patient demographics, comorbidities, operative time, length of stay (LOS), and postoperative outcomes. Univariate comparison and multivariate logistic regression analysis (MVA) adjusting for confounding factors including age, body mass index (BMI), comorbidities, and preoperative conditions were performed. RESULTS: A total of 3134 patients undergoing PDC placement were recorded in the NSQIP database between 2005 and 2012, including 2412 laparoscopic cases (LPDC) (77%) and 722 open (OPDC). Overall, the majority of cases were performed by General Surgeons (81%) with most of the remainder completed by Vascular Surgeons (16.8%). Patients undergoing LPDC versus OPDC demonstrated no significant difference in gender (54 vs. 56% males, p = 0.4), smoking history (8.5 ± 18.3 vs. 7.2 ± 16.9 pack years, p = 0.06), diabetes (42 vs. 40%, p = 0.4), COPD (4.6 vs. 5%, p = 0.63), or preoperative dialysis requirement (72 vs. 73 %, p = 0.6), but they were younger (57.2 ± 14.8 vs. 60.5 ± 15.9 years, p = 0.05) and had a higher BMI (29.3 vs. 29 kg/m(2), p = 0.04). In univariate analysis of LPDC versus OPDC, overall wound complications (1.6 vs. 2.9 %, p = 0.02), deep surgical site infections (0.12 vs. 0.83%, p < 0.006), minor complications (3.8 vs. 6.5 %, p < 0.05), major complications (4.3 vs. 6.9%, p < 0.05), and LOS (1.8 ± 11.9 vs. 4.4 ± 10 days, p < 0.0001) favored the LPDC approach, but only operative time (57.6 ± 4.6 vs. 71.8 ± 5.3, p < 0.001) remained significant in MVA after controlling for confounding factors. Both LPDC and OPDC had equivalently low rates of catheter failure (0.21 vs. 0.14%, p = 0.7). CONCLUSION: Using univariate analysis, there appears to be a benefit from LPDC placement. However, after controlling for confounding variables, the techniques appear to have equal outcomes. Surgeons should perform a LPDC or OPDC according to the approach with which they are most familiar. However, continued adoption, dispersal, and refinement of the laparoscopic approach may further optimize patient outcomes.

Nationwide variation in outcomes and cost of laparoscopic procedures.

INTRODUCTION: Healthcare systems and surgeons are under increasing pressure to provide high-quality care for the lowest possible cost . This study utilizes national data to examine the outcomes and costs of common laparoscopic procedures based on hospital type and location. METHODS: The National Inpatient Sample was queried from 2008 to 2011 for five laparoscopic procedures: colectomy (LC), inguinal hernia repair, ventral hernia repair (LVHR), Nissen fundoplication (NF), and cholecystectomy (LCh). Outcomes, including complication rate and inpatient mortality, were stratified by region and hospital type. Both univariate and multivariate regression analyses were performed using regression-based survey methods; risk-adjusted mean costs for hospital were calculated after adjusting for patient characteristics. RESULTS: In univariate analysis, the rates of minor complications varied significantly between geographic regions for LCh, LC, NF, and LVHR (p < 0.05). Though LCh and LVHR had statistical variation between regions for rates of major complications (p < 0.05), all regions were equivalent in rates of inpatient mortality for the procedures (p > 0.05). Rural and urban centers had similar rates of complications (p > 0.05), except for higher rates of major complications following IHR and LC in rural centers (p < 0.02) and following Nissen fundoplication in urban facilities(p < 0.0003). Though urban centers were more expensive for all procedures (p < 0.0001), mortality was similar between groups (p > 0.05). For hospital ownership, private investor-owned facilities were substantially more expensive (p < 0.0001), but had no significant differences in complications compared to other hospital types (p > 0.05). In multivariate analysis, while patient factors helped explain differences between outcome differences in different hospital types and locations, in general, the difference in cost remained statistically significant between hospitals. CONCLUSION: Though patient demographics and characteristics accounted for some differences in postoperative outcomes after common laparoscopic procedures, higher cost of care was not associated with better outcomes or more complex patients.

Acuity, outcomes, and trends in the transfer of surgical patients: a national study.

INTRODUCTION: With the regionalization of surgical care, reduction in the rural workforce, rising healthcare costs, and increasing focus on surgical outcomes, appropriate transfer of surgical patients is an increasingly important aspect of health care. This study examines patients transferred for surgical intervention through a national sample. METHODS: The American College of Surgeons National Surgical Quality Improvement Program database was queried from 2005 to 2012 for surgery patients who were transferred from an outside hospital or emergency department (ED) and compared patients undergoing surgery without transfer. Patients were divided into two time periods (TP): 2005-2008 (TP1) and 2008-2012 (TP2) for analysis; patient characteristics and top CPT codes for each TP were collected. Univariate analysis and matched cohorts were used to compare the groups. RESULTS: Overall, 61,204 patients were transferred and underwent surgery. The rate of transferred surgery patients increased from 3.2% in TP1 to 4.5% in TP2 (p < 0.0001). Compared to non-transferred patients, transferred patients had higher rates of diabetes (23.4 vs. 17.6%, p < 0.0001), tobacco use (27.9 vs. 20.3%, p < 0.0001), Charlson comorbidity index (mean score 1.5 vs. 0.8, p < 0.0001), preoperative sepsis (32.0 vs. 9.4%, p < 0.0001), and need for emergent surgery (41.3 vs. 14.4%, p < 0.0001). From TP1 to TP2, there was an increase in transferred patients who were obese (33.9-36.4%, p < 0.0001) and had emergent transfers (39.6-41.8%, p < 0.0001), with a decrease in diabetic patients (24.7-23.1%, p < 0.0001). From TP1 to TP2, transferred patients had more minor complications (17.7-31.0%, p < 0.0001), but fewer major complications (32.1-23.9%, p < 0.0001) and lower 30-day mortality (11.8-8.1%, p < 0.0001). CONCLUSIONS: Patients transferred for surgery represent a higher acuity population than non-transferred patients, and the number of transfers continues to rise. Even when matched by comorbidities, transferred patients have worse outcomes. Surgical sub-specialization and physician tiering may complicate future transfer practices. Efficient transfers, effective physician communication, and ready availability of medical records are critical in improving patient transfers.

Systematic Review of Randomized Controlled Trials Comparing Manual Compression to Vascular Closure Devices for Diagnostic and Therapeutic Arterial Procedures.

PURPOSE: A multitude of vascular closure devices (VCDs) are currently on the market for femoral arteriotomy closure after diagnostic and interventional angiography. Randomized, controlled trials (RCTs) comparing these devices to manual compression (MC) and their effect on time to hemostasis, time to ambulation, time to discharge, and immediate as well as long term complications have been studied. A systematic and through review of these evaluations and outcomes has not previously been performed. MATERIALS AND METHODS: A systematic review was completed to include all available RCTs comparing vascular closure device use to manual compression. Devices meeting inclusion criteria were as follows: VasoSeal® (Datascope Corporation, Montvale, NJ), AngioSeal™ (Sherwood-Davis & Geck, St Louis, MO/St Jude Medical, St Paul, MN), ProGlide® (Abbott Vascular, Abbott Park, IL), ProStar® (Abbot Vascular, Menlo Park, CA), StarClose SE® (Abbott Vascular, Redwood City, CA), ExoSeal™ (Cordis, Warren, NJ), Boomerang™ Wire (Cardiva Medical, Mountainview, CA), FemoSeal™ (St Jude Medical Systems, Uppsala, Sweden), EVS™ (expanded vascular stapling, Angiolink Co, Taunton, MA), X-PRESS™ (X-Site Medical, Blue Bell, PA), Duett™ (Vascular Solutions, Minneapolis, MN), EpiClose-T® (CardioDex Ltd., Tirat Ha Carmel, Israel), and FISH™ (femoral introducer sheath and hemostasis, FISH Device, Bloomington, IN). Vascular closure devices were compared both to manual compression and across all devices used for the following outcomes: time to hemostasis, time to ambulation, time to discharge, and outcomes such as bleeding, hematoma, pseudoaneurysm, limb ischemia, and overall major and minor complications, as well as impact on quality of life, cost analysis, and trends over time. Both diagnostic and interventional procedures were included. RESULTS: PUBMED and MEDLINE searches were carried out for VCDs identifying 1,363 articles. Manuscripts that included manual compression in the study numbered 176. Of these, 34 randomized controlled trials were included. Studies that met inclusion criteria were published from 1992-2015 and described a total of 14,401 patients, 5,659 patients undergoing MC, and 8,742 patients undergoing VCD placement. Overall, the rate of procedural success for VCD patients was 95.7%. The highest rate of unsuccessful device deployment was seen in the ExoSeal™ subset, which averaged 37.9% failure. The overall median time to hemostasis for manual compression was 22.9 minutes compared to VCDs at 5.95 minutes; FemoSeal™ had the shortest median time to hemostasis of 0.75 minutes. When comparing the type of procedure and its median time to hemostasis, MC versus VCD was 17 minutes versus 3.7 minutes for diagnostic procedures and 29.1 minutes versus 7.6 minutes for interventional procedures with similar sheath sizes at 6 and 7 French, respectively. Similarly, median time to ambulation for MC was eight hours compared to 3.5 hours for patients who received a VCD. Median time to discharge was similar at 1.6 days. However, time to discharge has diminished over the last decade comparing MC to VCD, with a median time to discharge of 3.1 versus 2.2 days compared to current trends at 0.8 versus 0.5 days, respectively. The overall rates of complications were similar between MC at 13.1% versus VCDs at 12.2% but varied significantly according to the VCD that was selected. For patients randomized to the vascular closure device who had undergone prior angioplasty, 94.4% of these patients preferred the use of VCD if a further angioplasty were to be performed in the future. A 13% reduction in overall costs with VCD was demonstrated due to earlier discharge and less required time with physician and nursing staff. CONCLUSION: Overall, the review of 34 RCTs demonstrates the utility of VCDs has shortened time to hemostasis, ambulation, and discharge compared to patients receiving MC. Over the last decade, with emphasis on and implementation of same-day procedures, use of VCDs has resulted in a reduction in time to discharge to half a day and a significant decrease in cost. Overall complication rates are similar, but vary between different devices on the market. Better short-term quality of life has also been described with the use of VCDs compared to MC. Further clinical and financial improvements may be found as newer technological advances of VCDs become available.

Bone Anchor Fixation in Abdominal Wall Reconstruction: A Useful Adjunct in Suprapubic and Para-iliac Hernia Repair.

Suprapubic hernias, parailiac or flank hernias, and lumbar hernias are difficult to repair and are associated with high-recurrence rates owing to difficulty in obtaining substantive overlap and especially mesh fixation due to bone being a margin of the hernia. Orthopedic suture anchors used for ligament reconstruction have been used to attach prosthetic material to bony surfaces and can be used in the repair of these hernias where suture fixation was impossible. A prospective, single institution study of ventral hernia repairs involving bone anchor mesh fixation was performed. Demographics, operative details, and outcomes data were collected. Twenty patients were identified, with a mean age 53 (range: 35-70 years) and mean body mass index 28.4 kg/m(2) (range 21-38). Ten lumbar, seven suprapubic, and three parailiac hernias were studied. The majority were recurrent hernias (n = 13), with one to seven previously failed repairs. The mean hernia defect size was very large (270 cm(2); range: 56-832 cm(2)) with average mesh size of 1090 cm(2) (range 224-3640 cm(2)). Both Mitek GII (Depuy, Raynham, MA) and JuggerKnot 2.9-mm (Biomet, Biomedical Instruments, Warsaw, IN) anchors were used, with an average of four anchors/case (range: 1-16). Mean operative time was 218 minutes (120-495). There were three minor complications, no operative mortality, and no recurrences during an average follow-up of 24 months. Pelvic bone anchors permit mesh fixation in high-recurrence areas not amenable to traditional suture fixation. The ability to safely and effectively use bone anchor fixation is an essential tool in complex open ventral hernia repair.

Local Anesthesia in Open Inguinal Hernia Repair Improves Postoperative Quality of Life Compared to General Anesthesia: A Prospective, International Study.

The choice of general (GA) versus local anesthesia (LA) in open inguinal hernia repair (OIHR) has a substantial financial impact and may influence clinical outcomes. Our study compares postoperative quality of life (QOL) in patients undergoing OIHR under LA versus GA. A cooperative prospective study from centers in 10 countries was performed through the International Hernia Mesh Registry from 2007 to 2012. QOL was compared at one, six, 12, and 24 months for LA versus GA with univariate and multivariate analysis controlling for known confounding variables. Of 1128 patients who underwent OIHR, 585(52%) used GA and 533(48%) used LA. Most were male (92%) with unilateral (94%), primary (91%) repairs with a mean age 57 ± 16 years. There was no difference (P > 0.05) in age, gender, operative time, mesh size, length of stay, infection, recurrence, reoperation, or death. Multivariate analysis demonstrated significant QOL differences between groups: GA had higher odds of discomfort at one and six months [odds ratio (OR) 3.3, 2.0], movement limitation at one and six months (OR 3.5, 2.8), and mesh sensation at one and 12 months (OR 2.9, 1.8). Overall, patients undergoing OIHR under LA had improved postoperative QOL in the short and long term compared with GA.

Moving the Needle: Simulation's Impact on Patient Outcomes.

This review investigates the available literature that addresses the impact simulator training has on patient outcomes. The authors conducted a comprehensive literature search of studies reporting outcomes of simulation training and categorized studies based on the Kirkpatrick model of training evaluation. Kirkpatrick level 4 studies reporting patient outcomes were identified and included in this review. Existing evidence is promising, demonstrating patient benefits as a result of simulation training for central line placement, obstetric emergencies, cataract surgery, laparoscopic inguinal hernia repair, and team training.

Validity evidence for the Simulated Colonoscopy Objective Performance Evaluation scoring system.

BACKGROUND: Low-cost, objective systems to assess and train endoscopy skills are needed. The aim of this study was to evaluate the ability of Simulated Colonoscopy Objective Performance Evaluation to assess the skills required to perform endoscopy. METHODS: Thirty-eight subjects were included in this study, all of whom performed 4 tasks. The scoring system measured performance by calculating precision and efficiency. Data analysis assessed the relationship between colonoscopy experience and performance on each task and the overall score. RESULTS: Endoscopic trainees' Simulated Colonoscopy Objective Performance Evaluation scores correlated significantly with total colonoscopy experience (r = .61, P = .003) and experience in the past 12 months (r = .63, P = .002). Significant differences were seen among practicing endoscopists, nonendoscopic surgeons, and trainees (P < .0001). When the 4 tasks were analyzed, each showed significant correlation with colonoscopy experience (scope manipulation, r = .44, P = .044; tool targeting, r = .45, P = .04; loop management, r = .47, P = .032; mucosal inspection, r = .65, P = .001) and significant differences in performance between the endoscopist groups, except for mucosal inspection (scope manipulation, P < .0001; tool targeting, P = .002; loop management, P = .0008; mucosal inspection, P = .27). CONCLUSIONS: Simulated Colonoscopy Objective Performance Evaluation objectively assesses the technical skills required to perform endoscopy and shows promise as a platform for proficiency-based skills training.

Stress management-augmented behavioral weight loss intervention for African American women: a pilot, randomized controlled trial.

The relationship between chronic stress and weight management efforts may be a concern for African American (AA) women, who have a high prevalence of obesity, high stress levels, and modest response to obesity treatment. This pilot study randomly assigned 44 overweight/obese AA women with moderate to high stress levels to either a 12-week adaptation of the Diabetes Prevention Program Lifestyle Balance intervention augmented with stress management strategies (Lifestyle + Stress) or Lifestyle Alone. A trend toward greater percentage of baseline weight loss at 3-month data collection was observed in Lifestyle + Stress (-2.7 ± 3.6%) compared with Lifestyle Alone (-1.4 ± 2.3%; p = .17) and a greater reduction in salivary cortisol (Lifestyle + Stress: -0.2461 ± 0.3985 ng/mL; Lifestyle Alone: -0.0002 ± 0.6275 ng/mL; p = .20). These promising results suggest that augmenting a behavioral weight control intervention with stress management components may be beneficial for overweight/obese AA women with moderate to high stress levels and merit further investigation with an adequately powered trial.

Cultural perceptions of weight in African American and Caucasian women.

OBJECTIVE: To determine if African American (AA) and Caucasian women grouped variables related to race and weight into discrete clusters and if there were discernable response patterns with unique subgroup characteristics. METHODS: Women (N=277, 48% AA) completed a card sorting task, ranking 28 variables. We used multidimensional scaling to determine perceived similarities and differences between variables, and latent class analysis to identify subgroups responding similarly. RESULTS: We identified 5 clusters of variables and 4 response patterns, which were demographically and anthropometrically distinct. CONCLUSIONS: These results can be used for empirical cultural tailoring of behavioral weight loss interventions.

Examining the Association Between Body Mass Index and Weight Related Quality of Life in Black and White Women.

Obesity not only increases risk for morbidity/mortality, but also impacts the quality of life of obese individuals. In the United States, black women have the highest prevalence of obesity of any other group with approximately 80% of black women over age 20 having a body mass index (BMI) ≥25 kg/m2. We aimed to examine the association between BMI and quality of life in this high risk population compared to this association in white women, using the Impact of Weight on Quality of Life (IWQOL)-Lite questionnaire. Data from 172 black women (mean BMI= 35.7; age=40.5) and 171 white women (mean BMI= 35.5; age=40.4) were collected between 2000 and 2010 analyzed in 2010. The mean IWQOL-Lite total score was 81.6 for black women compared to 66.9 for white women, a statistically significant difference. Hierarchical linear regression models revealed a significant BMI-by-race interaction indicating that the relationship between BMI and IWQOL-Lite score was moderated by race. Our findings suggest notable differences in weight-related quality of life in black and white women. At similar BMIs, black women consistently reported better quality of life than white women on all IWQOL-Lite subscales. The greatest difference in IWQOL-Lite scores between black and white women was seen in the self-esteem subscale. Additional research is needed to understand how to incorporate the weight perspectives of black women into weight management messages and interventions.

Body image as a mediator of the relationship between body mass index and weight-related quality of life in black women.

BACKGROUND: Body image (BI) may be important in understanding weight-related attitudes and behaviors in black women. Specifically, body dissatisfaction may mediate the relationship between body mass index (BMI) and weight-related quality of life (QOL) in black women. We examined the relationship between BMI and weight-related QOL in black women and tested for mediation by body dissatisfaction. METHODS: The sample included 149 black women recruited from Birmingham, Alabama, for a one-time clinic visit. BIs were self-reported using the Pulvers figure rating scale. Body discrepancy (BD), a surrogate measure of body dissatisfaction, was calculated as perceived current image minus ideal image. QOL was self-reported using the Impact of Weight on Quality of Life-Lite (IWQOL-Lite). Baron and Kenny's test for mediation was conducted where BMI was the predictor, IWQOL-Lite score was the outcome, and BD was the mediator under investigation. RESULTS: Mean age was 40.5 years, and mean BMI was 36.1 kg/m(2). The mean IWQOL-Lite score was 81.1±15.8 out of 100. Participants had a BD score of 2.3, indicating a desire to be two figure sizes smaller than their current perceived body size. Tests for mediation revealed that BD partially mediated the relationship between BMI and IWQOL-Lite scores in this sample. CONCLUSIONS: BD was in the pathway of the association between BMI and IWQOL-Lite scores. BI dissatisfaction may contribute to explaining more about black women's weight-related QOL beyond actual BMI alone. Additional research is needed to better understand black women's perception of weight and subsequent weight-related behaviors.

Attitudes and beliefs associated with leisure-time physical activity among African American adults.

OBJECTIVE: More than 60% of African American adults do not meet recommendations for moderate physical activity. We sought to discover the extent to which health attitudes and beliefs are associated with leisure-time physical activity in this population. DESIGN: Cross-sectional study. SETTING: African American adults were asked about their health attitudes and beliefs during a national survey. PARTICIPANTS: Participants were 807 African American men and women aged 18 years and older. Random-digit dialing was employed, sampling telephone numbers by geographical region, area code, and population size. MAIN OUTCOME MEASURES: Participants were asked six health belief questions on the importance of exercise and body weight in health. Logistic regression was used to determine which of these factors were associated with physical activity participation. RESULTS: The percent of respondents participating in some form of physical activity during the past month was 87.1% in men and 82.9% in women. Factors associated with previous month physical activity in men were perceived personal importance of exercise (P < .001) and necessity of exercise for health (P = .018). In women, perceived personal importance of exercise (P < .001), necessity of exercise for health (P = .006), and having enough activity space (P = .017) were associated with physical activity participation. CONCLUSION: Though the direction of causation is unknown, having the attitude that it is important to exercise or be physically active for health predicts physical activity participation in both African American men and women. Creating a sense of importance of physical activity to relieve stress and foster good health may stimulate physical activity participation in African American adults.