Clinical efficacy and safety of multipotent adult progenitor cells (invimestrocel) for acute respiratory distress syndrome (ARDS) caused by pneumonia: a randomized, open-label, standard therapy-controlled, phase 2 multicenter study (ONE-BRIDGE).

BACKGROUND: Acute respiratory distress syndrome (ARDS) is a life-threatening inflammatory lung injury with high mortality; no approved medication exists. Efficacy and safety of bone marrow-derived, allogeneic, multipotent adult progenitor cells (invimestrocel) plus standard treatment in patients with ARDS caused by pneumonia was evaluated. METHODS: A randomized, open-label, standard therapy-controlled, phase 2 study (January 2019-September 2021) conducted in 29 centers in Japan. Patients with ARDS caused by pneumonia, with extensive early fibroproliferation on high-resolution computed tomography and low risk of systemic organ failure identified by an Acute Physiology and Chronic Health Evaluation (APACHE II) score were included. Patients were randomized 2:1 to receive a single intravenous infusion of 9.0 × 108 cells of invimestrocel (administered at a rate of up to 10 mL/min over 30-60 min by free flow) plus standard treatment (N = 20) or standard treatment (N = 10) consistent with the clinical practice guidelines of the Japanese Respiratory Society for the management of ARDS. Primary endpoint was ventilator-free days (VFDs) through day 28 after study treatment. Analysis of covariance was performed with treatment group, age, partial pressure arterial oxygen/fraction of inspired oxygen ratio, and APACHE II score as covariates. RESULTS: Median (interquartile range) number of VFDs was numerically higher in the invimestrocel group versus standard group (20.0 [0.0-24.0] vs 11.0 [0.0-14.0]) but was not statistically significantly different (least square [LS] means [95% confidence interval (CI)]: invimestrocel group, 11.6 [6.9-16.3]; standard group, 6.2 [- 0.4 to 12.8]; LS mean difference [95% CI], 5.4 [- 1.9 to 12.8]; p = 0.1397). Ventilator weaning rate at day 28 was 65% (13/20) versus 30% (3/10), and mortality rate was 21% (4/19) versus 29% (2/7) at day 28 and 26% (5/19 patients) versus 43% (3/7 patients) at day 180, for the invimestrocel and standard groups, respectively. No allergic or serious adverse reactions were associated with invimestrocel. CONCLUSIONS: In Japanese patients with ARDS caused by pneumonia, invimestrocel plus standard treatment resulted in no significant difference in the number of VFDs but may result in improved survival compared with standard treatment. Invimestrocel was well tolerated. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT03807804; January 8, 2019; https://clinicaltrials.gov/ct2/show/NCT03807804 .

A systematic review of the 60 year literature: Effects of outreach programs in supporting historically marginalized and first-generation, low-income students in healthcare education.

We have reviewed over 60 years of studies on healthcare education outreach programs that are aimed to support first-generation, low-income, as well as underrepresented racial and ethnic minority groups (historically marginalized students) to pursue pre-health professions. As a systematic literature review, we present the challenges studies on healthcare education outreach programs had as three main categories: 1) Design, 2) Evaluation, and 3) Analysis. 1) Designs of studies on healthcare education outreach programs often lacked theoretical foundations whereby a) the interventions did not present theories underlying a causal mechanism of inequity in health professions; and/or 1b) the defined outcome measures were not clearly aligned with the problem the intervention tried to address. 2) Evaluations of studies on healthcare education outreach programs were not always conducted effectively whereby: 2a) controlled groups were commonly absent for comparison with the intervention group; and/or 2b) post measures were solely used without pre-measures. 3) Analyses of studies on healthcare education outreach programs were not adequate whereby: 3a) the response rates and effect size were commonly low; and/or 3b) qualitative results commonly did not supplement quantitative results. Overall, our findings reveal studies on healthcare education outreach programs have common challenges that hinder the reliability of their effects supporting historically marginalized students in pursuing pre-health professions. To address such challenges with studies on healthcare education outreach programs aimed at supporting historically marginalized students, we created a decision flow chart for researchers to ask themselves: 1) how is the design guided by theoretical goals; 2) how are measurements used to evaluate success; and 3) how does the analysis lead to reliable results?

The OSSE: Development and validation of an "Objective Structured Supervision Evaluation".

Background: Trainee supervision and teaching are distinct skills that both require faculty physician competence to ensure patient safety. No standard approach exists to teach physician supervisory competence, resulting in variable trainee oversight and safety threats. The Objective Structured Teaching Evaluation (OSTE) does not adequately incorporate the specific skills required for effective supervision. To address this continuing medical education gap, the authors aimed to develop and identify validity evidence for an "Objective Structured Supervision Evaluation" (OSSE) for attending physicians, conceptually modeled on the historic OSTE. Methods: An expert panel used an iterative process to create an OSSE instrument, which was a checklist of key supervision items to be evaluated during a simulated endotracheal intubation scenario. Three trained "standardized residents" scored faculty participants' performance using the instrument. Validity testing modeled a contemporary approach using Kane's framework. Participants underwent simulation-based mastery learning (SBML) with deliberate practice until meeting a minimum passing standard (MPS). Results: The final instrument contained 19 items, including three global rating measures. Testing domains included supervision climate, participant control of patient care, trainee evaluation, instructional skills, case-specific measures, and overall supervisor rating. Reliability of the assessment tool was excellent (ICC range 0.84-0.89). The assessment tool had good internal consistency (Cronbach's α = 0.813). Out of 24 faculty participants, 17 (70.8%) met the MPS on initial assessment. All met the MPS after SBML and average score increased by 19.5% (95% CI of the difference 10.3%-28.8%, p = 0.002).

Magnification loupes influence on neck and trunk flexion of dental hygienists while scaling-A pilot study.

OBJECTIVE: Work-related musculoskeletal disorders (MSDs) are common in the dental hygiene profession. Awkward postures contribute to MSDs and magnification loupes have been suggested to reduce this risk factor and minimize MSDs. METHODS: After IRB approval, 24 hygienists were enrolled in the study: twelve hygienists wearing loupes with a standard manufacturer determined declination angle (control) and 12 hygienists wearing loupes with a custom measured declination angle (experimental). To measure changes in neck and trunk flexion, accelerometers were placed on the occipital region of head, cervical vertebrae C5, and thoracic vertebrae T5 and baseline posture was recorded. Typodonts with artificial calculus simulated the oral environment. Participants were randomly assigned to wear their designated loupes during the first or second trial of the experiment and scaled in each quadrant (UR, LR, UL, LL) of the mouth for two minutes. Participants completed the scaling task twice: in the loupes and no loupes condition in a counterbalanced order. Three-way mixed design ANOVA was used to determine posture differences in neck and trunk posture. RESULTS: Those wearing custom loupes (M = 16.52, SD = 6.40) had significantly less trunk flexion while scaling compared to hygienists wearing standard loupes (M = 22.27, SD = 6.40), F(1, 22) = 7.14, P = .01. Neck flexion was not significantly affected while scaling between loupes vs no loupes or loupes type condition, (P's > .05). CONCLUSION: Posture was partially impacted by loupes type. Custom loupes resulted in less trunk flexion. Neck flexion was not affected by either loupes type.

Optimizing genomic selection for blight resistance in American chestnut backcross populations: A trade-off with American chestnut ancestry implies resistance is polygenic.

American chestnut was once a foundation species of eastern North American forests, but was rendered functionally extinct in the early 20th century by an exotic fungal blight (Cryphonectria parasitica). Over the past 30 years, the American Chestnut Foundation (TACF) has pursued backcross breeding to generate hybrids that combine the timber-type form of American chestnut with the blight resistance of Chinese chestnut based on a hypothesis of major gene resistance. To accelerate selection within two backcross populations that descended from two Chinese chestnuts, we developed genomic prediction models for five presence/absence blight phenotypes of 1,230 BC3F2 selection candidates and average canker severity of their BC3F3 progeny. We also genotyped pure Chinese and American chestnut reference panels to estimate the proportion of BC3F2 genomes inherited from parent species. We found that genomic prediction from a method that assumes an infinitesimal model of inheritance (HBLUP) has similar accuracy to a method that tends to perform well for traits controlled by major genes (Bayes C). Furthermore, the proportion of BC3F2 trees' genomes inherited from American chestnut was negatively correlated with the blight resistance of these trees and their progeny. On average, selected BC3F2 trees inherited 83% of their genome from American chestnut and have blight resistance that is intermediate between F1 hybrids and American chestnut. Results suggest polygenic inheritance of blight resistance. The blight resistance of restoration populations will be enhanced through recurrent selection, by advancing additional sources of resistance through fewer backcross generations, and by potentially by breeding with transgenic blight-tolerant trees.

Recent innovations in perfusion and cardiopulmonary bypass for neonatal and infant cardiac surgery.

The development and refinement of cardiopulmonary bypass (CPB) has made the repair of complex congenital heart defects possible in neonates and infants. In the past, the primary goal for these procedures was patient survival. Now that substantial survival rates have been achieved for even the most complex of repairs in these patients, focus has been given to the reduction of morbidity. Although a necessity for these complex neonatal and infant heart defect repairs, CPB can also be an important source of perioperative complications. Recent innovations have been developed to mitigate these risks and is the topic of this review. Specifically, we will discuss improvements in minimizing blood transfusions, CPB circuit design, monitoring, perfusion techniques, temperature management, and myocardial protection, and then conclude with a brief discussion of how further systematic improvements can be made in these areas.

Novel use of the AngioVac® system to remove thrombus during simultaneous extracorporeal membrane oxygenation life support.

Extracorporeal membrane oxygenation (ECMO) was introduced to clinical medicine over 40 years ago. While initially used as a treatment for acute respiratory failure in infants, the use of ECMO has grown to include respiratory and circulatory failure in both children and adults, cardiogenic shock, pulmonary embolism, sepsis, trauma, malignancy, pulmonary hemorrhage and as a treatment for hypothermic drowning.(1) Recent technological improvements in ECMO circuitry make it possible to minimize anticoagulation of the ECMO patient, decreasing the incidence of bleeding. Thrombus deposition within the ECMO circuit can be a life-threating complication. ECMO circuit thrombus can be contained in the circuit, adherent to cannula and deposited within the patient. The ability to remove thrombus while the patient remains on ECMO support could be a life-saving measure for some patients. The present case report outlines use of the AngioVac(®) thrombus removal system in concert with ECMO to remove a large thrombus adherent to an ECMO cannula.

Clinical outcomes of atypical extra-esophageal reflux symptoms following laparoscopic antireflux surgery.

INTRODUCTION: While it is well established that antireflux surgery is effective in relieving typical gastroesophageal reflux disease (GERD) symptoms such as heartburn and regurgitation, it is currently unclear whether atypical symptoms (cough, hoarseness, wheeze) foreshadow a less satisfactory outcome following laparoscopic antireflux surgery (LARS). The purpose of this study is to critically analyze the clinical outcomes of atypical symptoms in patients undergoing LARS. METHODS: Patients scheduled for LARS for GERD were prospectively enrolled over a 7-year period; all subjects underwent preoperative high-resolution manometry (HRM) and had evidence of GERD on ambulatory pH study. Cough, wheeze, and hoarseness were considered atypical symptoms. During preoperative and postoperative examinations, patients completed detailed foregut symptomatology questionnaires, using both 5-point Likert and 10-point visual analog scales (VAS) to document typical as well as atypical symptoms. Atypical symptom burden was calculated as a sum of VAS for the three atypical symptoms, termed the atypical score (ATS). HRM patterns were grouped into normal, spastic, and hypomotile. Statistical significance (p < 0.05) was determined using paired t-test, and analysis of variance with post hoc least significant difference (LSD). RESULTS: One hundred thirteen patients (age 49 ± 1.26 years, range 20-84 years, M:F 47:66) with mean follow-up of 28 ± 2.31 months (range 1-92 months) fulfilled inclusion criteria, having mean modified DeMeester score of 45.5 ± 2.78. Heartburn was noted in 84.1%, while atypical symptoms of some degree were reported by 92.0% (104 patients). Heartburn improved from a preoperative score of 7.1 ± 0.54 to 0.9 ± 0.24 after LARS, and ATS improved from 8.9 ± 0.71 to 2.2 ± 0.42. Significant improvements were noted for all atypical symptoms analyzed (p < 0.0001 for each). Improvement in atypical symptoms was least in the presence of hypomotility features on HRM (21.7% improvement), compared with normal motility (72.4%) and spastic features (83.9%). Preoperative atypical score (p < 0.0001) and esophageal hypomotility (p = 0.04) demonstrated a linear relationship with postoperative atypical score. CONCLUSIONS: In an unselected cohort of patients undergoing LARS, atypical GERD symptoms improved as significantly as typical symptoms. Symptom improvement was significantly lower in the presence of esophageal hypomotility and with higher symptomatic state. Therefore, patients with severe atypical symptoms or hypomotile esophagus may not achieve the same clinical satisfaction from LARS.

Laparoscopic fixation of biologic mesh at the hiatus with fibrin or polyethylene glycol sealant in a porcine model.

BACKGROUND: The objective of this study was to determine the acute and chronic fixation strengths achieved by fibrin or polyethylene glycol (PEG) sealants to secure biologic mesh at the esophageal hiatus in a porcine model. METHODS: For this study, 32 female domestic pigs were divided into four groups of 8 each. The four groups respectively received acute fibrin sealant, acute PEG sealant, chronic fibrin sealant, and chronic PEG sealant. Laparoscopically, a 5.5 × 8.5-cm piece of Biodesign Surgisis Hiatal Hernia Graft (porcine small intestine submucosa) was oriented with the U-shaped cutout around the gastroesophageal junction and the short axis in the craniocaudal direction to simulate hiatal reinforcement with a biologic mesh. The mesh then was secured with 2 ml of either fibrin sealant or PEG sealant. The pigs in the acute groups were maintained alive for 2 h to allow for complete polymerization of the sealants, and the pigs in the chronic group were maintained alive for 14 days. After the pigs were euthanized, specimens of the mesh-tissue interface were subjected to lap shear testing to determine fixation strength, and hematoxylin and eosin (H&E) stained slides were evaluated for evidence of remodeling. RESULTS: No significant differences were observed between the acute and chronic fixation strengths or the remodeling characteristics of the two sealants. However, fixation strength increased significantly over time for both types of sealant. Evidence of remodeling also was significantly more pronounced in the chronic specimens than in the acute specimens. CONCLUSIONS: This study demonstrated the feasibility of using fibrin or PEG sealants to secure biologic mesh at the hiatus in a porcine model.

Biomechanical and histologic evaluation of fenestrated and nonfenestrated biologic mesh in a porcine model of ventral hernia repair.

BACKGROUND: The purpose of this study was to compare tissue incorporation and adhesion characteristics of a novel fenestrated versus nonfenestrated crosslinked porcine dermal matrix (CPDM) (Bard CollaMend) in a porcine model of ventral hernia repair. STUDY DESIGN: Bilateral abdominal wall defects were created in 24 Yucatan minipigs, resulting in 48 defects, which were allowed to mature for 21 days. Twelve defects were repaired with fenestrated CPDM using a preperitoneal technique, 12 with fenestrated CPDM using an intraperitoneal technique, 12 with nonfenestrated CPDM using a preperitoneal technique, and 12 with nonfenestrated CPDM using an intraperitoneal technique. Half of the animals in the intraperitoneal group were euthanized after 1 month, and the other half after 3 months. Similarly, half of the animals in the preperitoneal group were euthanized after 1 month, and the other half after 6 months. Biomechanical testing and histologic evaluation were performed. RESULTS: Intraperitoneal placement of the CPDM products resulted in significantly greater adhesed area compared with preperitoneal placement (p < 0.05). Tissue ingrowth into preperitoneal fenestrated and nonfenestrated CPDM resulted in significantly greater incorporation strengths after 6 months compared with 1 month (p = 0.03 and p < 0.0001). Histologic analysis showed significantly greater cellular infiltration, extracellular matrix deposition, and neovascularization, with less fibrous encapsulation through the center of the fenestrations compared with all other sites evaluated, including nonfenestrated grafts. CONCLUSIONS: Histologic findings revealed increased tissue incorporation at fenestration sites compared with nonfenestrated grafts regardless of implant location or time in vivo. However, preperitoneal placement resulted in greater incorporation strength, less adhesed area, and lower adhesion scores compared with intraperitoneal placement for both fenestrated and nonfenestrated CPDM.

Histologic and biomechanical evaluation of crosslinked and non-crosslinked biologic meshes in a porcine model of ventral incisional hernia repair.

BACKGROUND: The objective of this study was to evaluate the biomechanical characteristics and histologic remodeling of crosslinked (Peri-Guard, Permacol) and non-crosslinked (AlloDerm, Veritas) biologic meshes over a 12 month period using a porcine model of incisional hernia repair. STUDY DESIGN: Bilateral incisional hernias were created in 48 Yucatan minipigs and repaired after 21 days using an underlay technique. Samples were harvested at 1, 6, and 12 months and analyzed for biomechanical and histologic properties. The same biomechanical tests were conducted with de novo (time 0) meshes as well as samples of native abdominal wall. Statistical significance (p < 0.05) was determined using 1-way analysis of variance with a Fisher's least significant difference post-test. RESULTS: All repair sites demonstrated similar tensile strengths at 1, 6, and 12 months and no significant differences were observed between mesh materials (p > 0.05 in all cases). The strength of the native porcine abdominal wall was not augmented by the presence of the mesh at any of the time points, regardless of de novo tensile strength of the mesh. Histologically, non-crosslinked materials showed earlier cell infiltration (p < 0.01), extracellular matrix deposition (p < 0.02), scaffold degradation (p < 0.05), and neovascularization (p < 0.02) compared with crosslinked materials. However, by 12 months, crosslinked materials showed similar results compared with the non-crosslinked materials for many of the features evaluated. CONCLUSIONS: The tensile strengths of sites repaired with biologic mesh were not impacted by very high de novo tensile strength/stiffness or mesh-specific variables such as crosslinking. Although crosslinking distinguishes biologic meshes in the short-term for histologic features, such as cellular infiltration and neovascularization, many differences diminish during longer periods of time. Characteristics other than crosslinking, such as tissue type and processing conditions, are likely responsible for these differences.

Collagen type I:III ratio of the gastroesophageal junction in patients with paraesophageal hernias.

BACKGROUND: The purpose of this study was to examine the biological environment of the esophageal hiatus through analysis of the collagen content within the gastrohepatic ligament (GHL), gastrophrenic ligament (GPL), and phrenoesophageal ligament (PEL) in patients with type I hiatal hernias (HH) and type III paraesophageal hernias (PEH). METHODS: A control group (N=10) and patients with type I HH (N=10) and type III PEH (N=10) were included in the analysis. Specimens of the GHL, PEL, and GPL were collected intraoperatively. Slides stained with sirius red/fast green were created and ten photos at 400×magnification were taken of each specimen. Axiovision 4.7 (Zeiss) photo analysis software was employed for quantification of collagen I (red) and III (green) by calculating color area (µm2). Statistical significance (p<0.05) was determined using a one-way ANOVA and Fisher's LSD post-test. RESULTS: Cross-polarization microscopy revealed that the collagen I content was similar in the three study groups for the GHL, greater in the type III PEH group and in the control group compared to the type I HH group for the PEL, and greater in the type III PEH group compared to control group for the GPL. Collagen III quantity was greater in the control group than in the type I HH group for each ligament, and greater in the GHL and PEL when compared to the type III PEH group. Type III PEH patients had greater collagen III quantity than did type I HH patients for each ligament. Collagen type I:III ratio of the GHL was greater in both hernia groups compared to the control group. Type III PEH patients contained a higher I:III ratio than both the control and type I HH groups with respect to the PEL. There was no difference in the ratio with evaluation of the GPL for the three groups. CONCLUSION: Evaluation of the esophageal hiatus revealed that patients with PEH have a different biological environment with regard to collagen content compared to control patients. The collagen I:III ratio of the study groups was equal to or greater than the control group. Collagen deficiency in the GE junction supporting ligaments does not appear to be an etiology of PEH formation.

Evaluation of intraperitoneal placement of absorbable and nonabsorbable barrier coated mesh secured with fibrin sealant in a New Zealand white rabbit model.

BACKGROUND: This study aimed to evaluate the acute and chronic fixation strength of fibrin sealant (FS) as an alternative method of fixation for laparoscopic ventral hernia repair (LVHR). METHODS: Representative mesh types for LVHR included one nonabsorbable barrier mesh (Composix) and three absorbable barrier meshes (Sepramesh, Proceed, and Parietex composite). Macroporous polypropylene mesh (Prolite Ultra) served as the control mesh. Three methods of fixation were used, namely, 0-polypropylene suture+FS (ARTISS 4 IU), FS alone (ARTISS), and tacks alone, to secure 3×4-cm pieces of mesh (10 of each combination) to the peritoneal surface of New Zealand white rabbit abdominal wall. After 2 h of incubation at 37 °C, specimens underwent acute testing. Subsequently, a chronic phase was completed using the aforementioned fixation methods (10 of each combination), in which two 4×4-cm pieces of mesh were secured intraperitoneally in each of 75 New Zealand white rabbits, which survived 8 weeks until they were sacrificed. A transparent grid overlay was used to measure the mesh and adhesion area. Adhesion tenacity was characterized using the Garrard adhesion scale. In both the acute and chronic samples, a 3×3-cm area of mesh-tissue interface underwent lap shear testing at a rate of 0.42 mm/s using a tensiometer (Instron 5542). The maximum load sustained by the mesh-tissue construct was recorded as the acute fixation strength in newtons (N). Data are given as means±standard error of the mean. Statistical significance (p<0.05) was determined using a one-way analysis of variance (ANOVA) with Fisher's least significant difference (LSD) posttest or a nonparametric Kruskal-Wallis test (adhesion scores). RESULTS: The acute fixation strength was significantly greater for all the meshes secured with either suture+FS or tacks alone than for FS alone (p<0.001 for all comparisons). All the meshes except Proceed demonstrated greater acute fixation strength with suture+FS than with tacks alone (p≤0.016). Composix achieved greater acute fixation with suture+FS than all the other meshes (p≤0.022). Acute fixation with suture + FS was greater for Parietex Composite and ProLite Ultra than for Proceed (p≤0.015). When the animals were sacrificed, 48 of 50 meshes fixed with FS alone were insufficiently affixed to the abdominal wall, which may have resulted in hernia recurrence in a hernia model. The chronic fixation strength was greater for all the mesh types with either suture+FS or tacks only than with FS alone (p≤0.0005). The chronic fixation strength was greater with suture+FS than with tacks for Proceed and ProLite Ultra (p≤0.013). Neither mesh area nor adhesion tenacity differed significantly with any mesh/fixation method combination. CONCLUSIONS: In a chronic rabbit model of LVHR, fixation strength with FS alone was inadequate for selected nonabsorbable and absorbable barrier-coated meshes. The acute and chronic fixation strengths of suture+FS were equivalent or superior to the fixation strength of tacks alone. Using a combination of suture and FS for mesh fixation in LVHR may provide adequate fixation while decreasing postoperative pain due to spiral titanium tacks. In this preclinical series, mesh secured to the peritoneal surface by FS alone may have led to early recurrence.

Best resident poster award: evaluation of anastomotic techniques for laparoscopic resection of isolated small intestine pathology.

BACKGROUND: The purpose of this study was to compare perioperative outcomes for intracorporeal versus extracorporeal anastomotic techniques for isolated laparoscopic small-intestine resection. METHODS: A retrospective database was created for all adult patients who underwent a laparoscopic segmental small-intestine resection. Patients with inflammatory bowel disease or requiring an ileocolectomy were excluded. RESULTS: Laparoscopic resection was performed in 52 patients (ratio of men:women, 30:22) with a mean age of 47 ± 21 years. A laparoscopic intracorporeal anastomosis was performed in 30 patients (58%), and an extracorporeal anastomosis was performed in 22 patients (42%). There was no difference in mean operating room time, estimated blood loss, perioperative complication rate, or length of stay between the 2 groups. Ten patients had a complication, and 5 patients experienced a Clavien grade II or greater complication. CONCLUSIONS: Laparoscopic segmental small-bowel resection using either intracorporeal or extracorporeal anastomotic techniques is equally efficacious for pathology isolated to the small bowel.

Evaluation of acute fixation strength for mechanical tacking devices and fibrin sealant versus polypropylene suture for laparoscopic ventral hernia repair.

BACKGROUND: The purpose of this comparative study is to evaluate the acute fixation strength of mechanical tacking devices and fibrin sealant against polypropylene suture for laparoscopic ventral hernia repair. METHODS: Three metallic mechanical tacking devices (ProTack, Salute, EndoANCHOR), 4 absorbable tacking devices (AbsorbaTack, PermaSorb, I-Clip, and SorbaFix), and 2 types of fibrin sealant (Tisseel, Artiss) were compared with 0-polypropylene suture. Three constructs from each device or an amount of sealant sufficient to cover a 3 × 3 cm(2) area were used to affix a 4 × 3 cm piece of absorbable barrier-coated mesh (Proceed, Ethicon, Inc) to the peritoneal surface of porcine abdominal wall. Ten samples were completed for each fixation modality. Acute fixation strength was measured via a lap shear test on an Instron tensiometer. RESULTS: Acute fixation strength was significantly greater for suture (59.7 7.2 N) compared with all laparoscopic tacking devices and to fibrin sealant (P < .001 for all comparisons). Protack (29.5 ± 2.8 N) was stronger than Absorbatack (13.2 ± 3.7 N; P = .029). Protack, Permasorb, SorbaFix, and I-clip were stronger than fibrin sealant (P < .05 for all comparisons). CONCLUSIONS: The acute fixation strengths of metallic or absorbable tacks as well as fibrin sealant are all significantly less than that achieved with polypropylene suture. These factors should be considered in selecting the type of mechanical fixation for patients undergoing laparoscopic ventral hernia repair.

Abiomed Impella(®) 2.5 patient transport: lessons learned.

The Abiomed Impella(®) 2.5 is a micro-axial flow, catheter-based left ventricular assist system (LVAS). Designed for percutaneous insertion into the femoral artery and positioned across the aortic valve, the Impella(®) is capable of pumping 2.5 liters of blood per minute from the patient's left ventricle into the ascending aorta. Since United States Federal Food and Drug Administration clearance in June of 2008, use of the Impella(®) 2.5 has grown rapidly. We operate at the center of a "hub-and-spoke" regional referral network that facilitates the transfer of patients in cardiogenic shock to our facility for definitive care. Based on our recent experience of transporting patients supported on the Impella(®) 2.5 system, we review system operation, pump position, monitoring, and recommendations for providing safe and efficient transport.

Prospective evaluation of adhesion characteristics to intraperitoneal mesh and adhesiolysis-related complications during laparoscopic re-exploration after prior ventral hernia repair.

BACKGROUND: The purpose of this study was to characterize the adhesion characteristics of absorbable- and nonabsorbable-barrier-coated meshes and to report adhesiolysis-related complications during laparoscopic re-exploration after prior ventral hernia repair. METHODS: Under an IRB-approved protocol, patients undergoing laparoscopic re-exploration after prior intraperitoneal mesh placement were prospectively graded intraoperatively for adhesion tenacity (0-4), adhesion surface area (0 = 0%, 10 = 100%), and ratio of adhesiolysis time to mesh surface area (min/cm(2)). Adhesiolysis-related complications were also recorded. Data are given as mean ± SD. Statistical significance (P < 0.05) was determined using the t test and Fisher's exact test. RESULTS: From March 2006 to March 2009, 69 patients underwent laparoscopic surgery after prior intraperitoneal mesh placement for ventral hernia repair. Previous meshes were absorbable-barrier-coated mesh (n = 18), permanent-barrier composite mesh [Composix® (n = 17)], permanent-barrier noncomposite mesh [DualMesh® (n = 14)], uncoated polypropylene mesh (n = 12), and biologic mesh (n = 8). Indications for laparoscopic re-exploration were recurrent ventral hernia (n = 58), chronic pain (n = 3), cholecystectomy (n = 3), parastomal hernia (n = 2), small bowel obstruction (n = 1), nephrectomy (n = 1), and Nissen fundoplication (n = 1). Adhesions to DualMesh were less tenacious (P < 0.05) compared to all other meshes. Surface area of adhesions to DualMesh were less (P < 0.05) than to Composix and to uncoated polypropylene mesh, but not to absorbable-barrier-coated and biologic meshes. Adhesiolysis time:mesh surface area was less (P < 0.05) for DualMesh compared to Composix, uncoated polypropylene, and biologic mesh, but not to absorbable-barrier-coated mesh. Adhesiolysis-related complications occurred in two (16.7%) (P = ns) patients with uncoated polypropylene mesh, one cystotomy and one enterotomy; both were repaired laparoscopically. There were two (16.7%) (P = ns) conversions to an open procedure: one converted patient had Composix (6.7%) and one had absorbable-barrier-coated mesh (5.9%). There were no adhesiolysis-related complications with these meshes. There were no adhesiolysis-related complications or conversions to open in the DualMesh or biologic mesh groups. CONCLUSIONS: Adhesion characteristics of mesh placed intraperitoneally and adhesiolysis-related complications during laparoscopic re-exploration after ventral hernia repair are associated with unique properties of the mesh and/or barrier.

Informed consent: cultural and religious issues associated with the use of allogeneic and xenogeneic mesh products.

BACKGROUND: Our aim was to investigate the views of major religions and cultural groups regarding the use of allogeneic and xenogeneic mesh for soft tissue repair. STUDY DESIGN: We contacted representatives from Judaism, Islam, Buddhism, Hinduism, Scientology, and Christianity (Baptists, Methodists, Seventh-Day Adventists, Catholics, Lutherans, Church of Jesus Christ of Latter-Day Saints, Evangelical, and Jehovah's Witnesses). We also contacted American Vegan and People for the Ethical Treatment of Animals (PETA). Standardized questionnaires were distributed to the religious and cultural authorities. Questions solicited views on the consumption of beef and pork products and the acceptability of human-, bovine-, or porcine-derived acellular grafts. RESULTS: Dietary restrictions among Jews and Muslims do not translate to tissue implantation restriction. Approximately 50% of Seventh-day Adventists and 40% of Buddhists practice vegetarianism, which may translate into a refusal of the use of xenogeneic tissue. Some Hindus categorically prohibit the use of human tissue and animal products; others allow the donation and receipt of human organs and tissues. PETA is opposed to all uses of animals, but not to human acellular grafts or organ transplantation. Some vegans prefer allogeneic to xenogeneic tissue. Allogeneic and xenogeneic acellular grafts are acceptable among Scientologists, Baptists, Lutherans, Evangelicals, and Catholics. Methodists, Jehovah's Witnesses, and The Church of Jesus Christ of Latter-Day Saints leave the decision up to the individual. CONCLUSIONS: Knowledge of religious and cultural preferences regarding biologic mesh assists the surgeon in obtaining a culturally sensitive informed consent for procedures involving acellular allogeneic or xenogeneic grafts.