SAGES guidelines for the surgical treatment of hiatal hernias.

BACKGROUND: Hiatal hernia (HH) is a common condition. A multidisciplinary expert panel was convened to develop evidence-based recommendations to support clinicians, patients, and others in decisions regarding the treatment of HH. METHODS: Systematic reviews were conducted for four key questions regarding the treatment of HH in adults: surgical treatment of asymptomatic HH versus surveillance; use of mesh versus no mesh; performing a fundoplication versus no fundoplication; and Roux-en-Y gastric bypass (RYGB) versus redo fundoplication for recurrent HH. Evidence-based recommendations were formulated using the Grading of Recommendations, Assessment, Development, and Evaluations methodology by subject experts. When the evidence was insufficient to base recommendations on, expert opinion was utilized instead. Recommendations for future research were also proposed. RESULTS: The panel provided one conditional recommendation and two expert opinions for adults with HH. The panel suggested routinely performing a fundoplication in the repair of HH, though this was based on low certainty evidence. There was insufficient evidence to make evidence-based recommendations regarding surgical repair of asymptomatic HH or conversion to RYGB in recurrent HH, and therefore, only expert opinions were offered. The panel suggested that select asymptomatic patients may be offered surgical repair, with criteria outlined. Similarly, it suggested that conversion to RYGB for management of recurrent HH may be appropriate in certain patients and again described criteria. The evidence for the routine use of mesh in HH repair was equivocal and the panel deferred making a recommendation. CONCLUSIONS: These recommendations should provide guidance regarding surgical decision-making in the treatment of HH and highlight the importance of shared decision-making and consideration of patient values to optimize outcomes. Pursuing the identified research needs will improve the evidence base and may allow for stronger recommendations in future evidence-based guidelines for the treatment of HH.

Management of symptomatic, asymptomatic, and recurrent hiatal hernia: a systematic review and meta-analysis.

BACKGROUND: The surgical management of hiatal hernia remains controversial. We aimed to compare outcomes of mesh versus no mesh and fundoplication versus no fundoplication in symptomatic patients; surgery versus observation in asymptomatic patients; and redo hernia repair versus conversion to Roux-en-Y reconstruction in recurrent hiatal hernia. METHODS: We searched PubMed, Embase, CINAHL, Cochrane Library and the ClinicalTrials.gov databases between 2000 and 2022 for randomized controlled trials (RCTs), observational studies, and case series (asymptomatic and recurrent hernias). Screening was performed by two trained independent reviewers. Pooled analyses were performed on comparative data. Risk of bias was assessed using the Cochrane Risk of Bias tool and Newcastle Ottawa Scale for randomized and non-randomized studies, respectively. RESULTS: We included 45 studies from 5152 retrieved records. Only six RCTs had low risk of bias. Mesh was associated with a lower recurrence risk (RR = 0.50, 95%CI 0.28, 0.88; I2 = 57%) in observational studies but not RCTs (RR = 0.98, 95%CI 0.47, 2.02; I2 = 34%), and higher total early dysphagia based on five observational studies (RR = 1.44, 95%CI 1.10, 1.89; I2 = 40%) but was not statistically significant in RCTs (RR = 3.00, 95%CI 0.64, 14.16). There was no difference in complications, reintervention, heartburn, reflux, or quality of life. There were no appropriate studies comparing surgery to observation in asymptomatic patients. Fundoplication resulted in higher early dysphagia in both observational studies and RCTs ([RR = 2.08, 95%CI 1.16, 3.76] and [RR = 20.58, 95%CI 1.34, 316.69]) but lower reflux in RCTs (RR = 0.31, 95%CI 0.17, 0.56, I2 = 0%). Conversion to Roux-en-Y was associated with a lower reintervention risk after 30 days compared to redo surgery. CONCLUSIONS: The evidence for optimal management of symptomatic and recurrent hiatal hernia remains controversial, underpinned by studies with a high risk of bias. Shared decision making between surgeon and patient is essential for optimal outcomes.

Overcoming the Arduous Transition for Robotic Hepatopancreatobiliary Cases: A Multi-Procedure Learning Curve Study Utilizing CUSUM Analysis.

BACKGROUND/OBJECTIVE: Quick optimization and mastery of a new technique is an important part of procedural medicine, especially in the field of minimally invasive surgery. Complex surgeries such as robotic pancreaticoduodenectomies (RPD) and robotic distal pancreatectomies (RDP) have a steep learning curve; therefore, findings that can help expedite the burdensome learning process are extremely beneficial. This single-surgeon study aims to report the learning curves of RDP, RPD, and robotic Heller myotomy (RHM) and to review the results' implications for the current state of robotic hepatopancreaticobiliary (HPB) surgery. STUDY DESIGN: This is a retrospective case series of a prospectively maintained database at a non-university tertiary care center. Total of 175 patients underwent either RDP, RPD, or RHM with the surgeon (DRJ) from January 2014 to January 2020. RESULTS: Statistical significance of operating room time (ORT) was noted after 47 cases for RDP (p < 0.05), 51 cases for RPD (p < 0.0001), and 18 cases for RHM (p < 0.05). Mean ORT after the statistical mastery of the procedure for RDP, RPD, and RHM was 124, 232, 93 min, respectively. No statistical significance was noted for estimated blood loss or length of stay. CONCLUSIONS: Robotic HPB procedures have significantly higher learning curves compared to non-HPB procedures, even for an experienced HPB surgeon with extensive laparoscopic experience. Our RPD curve, however, is quicker than the literature average. We suggest that this is because of the simultaneous implementation of HPB (RDP and RPD) and non-HPB robotic surgeries with a shorter learning curve-especially foregut procedures such as RHM-into an experienced surgeon's practice. This may accelerate the learning process without compromising patient safety and outcomes.

End-of-Life Decision-Making for Patients With Geriatric Trauma Cared for in a Trauma Intensive Care Unit.

BACKGROUND: The geriatric trauma population is growing and fraught with poor physiological response to injury and high mortality rates. Our primary hypothesis analyzed how prehospital and in-hospital characteristics affect decision-making regarding continued life support (CLS) versus withdrawal of care (WOC). Our secondary hypothesis analyzed adherence to end-of-life decisions regarding code status, living wills, and advanced directives. MATERIALS AND METHODS: We performed a retrospective review of patients with geriatric trauma at a level I and level II trauma center from January 1, 2007, to December 31, 2014. Two hundred seventy-four patients met inclusion criteria with 144 patients undergoing CLS and 130 WOC. RESULTS: A total of 13 269 patients with geriatric trauma were analyzed. Insurance type and injury severity score (ISS) were found to be significant predictors of WOC ( P = .013/.045). Withdrawal of care patients had shorter time to palliative consultation and those with geriatrics consultation were 16.1 times more likely to undergo CLS ( P = .026). Twenty-seven (33%) patients who underwent CLS and 31 (24%) patients who underwent WOC had a living will, advanced directive, or DNR order ( P = .93). CONCLUSIONS: Of the many hypothesized predictors of WOC, ISS was the only tangible independent predictor of WOC. We observed an apparent disconnect between the patient's wishes via living wills or advanced directives "in a terminal condition" and fulfillment during EOL decision-making that speaks to the complex nature of EOL decisions and further supports the need for a multidisciplinary approach.

Surveillance strategies in the follow-up of melanoma patients: too much or not enough?

BACKGROUND: After appropriate initial therapy for patients with stage II-III melanoma, there is no consensus regarding surveillance. Thus, follow-up is highly variable among institutions and individual providers. The National Comprehensive Cancer Network recommends routine clinical examination and consideration of imaging for stage IIB-IIIC every 3-12 mo with no distinction between stages. Detection of recurrence is important as novel systemic therapies and surgical resection of recurrence may provide survival benefits. METHODS: We retrospectively reviewed 369 patients with stage II and III melanoma treated at Ohio State University from 2009-2015, who underwent surgery as primary therapy. Two hundred forty-seven patients who were followed for a minimum of 6 mo after surgical resection to achieve no evidence of disease status (NED) were included in this analysis. One hundred twenty-two were lost to follow-up after surgery and were excluded. RESULTS: The rate of recurrence for stage IIA/IIB patients was 11% (14/125). Eleven of the 14 (79%) recurrences were detected by clinical symptoms or physical examination. Thirty-nine percent (49/125) of stage IIA or IIB patients were followed by clinical examination only, whereas 61% (76/125) were followed with at least two serial chest x-rays. The median time to first chest x-ray after NED status was 4.7 mo (n = 76), median time to second chest x-ray after NED status was 12.7 mo (n = 76), and 66% (50/76) continued to have additional serial chest x-rays. At median follow-up of 35 mo for the 125 patients with stage IIA/IIB, there was no difference in survival between those followed clinically (95% [95% CI: 0.88-0.99]) versus those followed with at least two serial x-rays (96% [95% CI: 0.89-0.98]). For stage IIC/IIIA-C patients, recurrence was detected in 23% (28/122) at median follow-up 31.2 mo. Fifty percent of recurrences were detected by imaging in asymptomatic patients, whereas 50% (14/28) had recurrence detected on imaging associated clinical findings. Eighty-seven percent (106/122) of stage IIC/IIIA-C patients were followed with at least two serial whole body positron emission tomography/computed tomography (CT) scans or whole body CT scans plus brain magnetic resonance imaging; median time between NED status and second scan was 10.3 mo. Of stage IIC/IIIA-C patients with recurrence, 57% (16/28) went on to surgical resection of the recurrence, whereas 11 (39%) patients received B-RAF inhibitor therapy, immune blockade therapy, or combination therapy. CONCLUSIONS: For stage IIA and IIB melanoma, surveillance chest x-rays did not improve survival compared to physical examination alone. However, for stage IIC and IIIA-C melanoma, where the recurrence rates are higher, routine whole body imaging detected 50% of recurrences leading to additional surgery and/or treatment with novel systemic therapies for the majority of patients. Detection of melanoma recurrence is important and specific substage should be used to stratify risk and define appropriate follow-up.

A Case of a Bilateral Inflammatory Breast Cancer: A Case Report.

Cases of bilateral inflammatory breast cancer (IBC) are extremely rare. Our search criteria only found one other record of metachronous bilateral IBC (1). We present the case of a patient who was treated for IBC with neoadjuvant chemotherapy, modified radical mastectomy (MRM), and whole breast radiation. Less than 1 year later, the patient had a recurrence of IBC on the left chest wall with in the radiated field, as well as a new IBC on the contralateral side. Bilateral IBC is extremely rare. This entity can present challenges for the standard treatment of IBC with neoadjuvant chemotherapy, MRM, and whole breast radiation (2). Our case study shows the importance of scheduled routine imaging, screening with physical examination after IBC management, and good patient compliance in this aggressive disease (3).

Dissemination of CPR video self-instruction materials to secondary trainees: Results from a hospital-based CPR education trial.

BACKGROUND: Cardiopulmonary resuscitation (CPR) video self-instruction (VSI) materials have been promoted as a scalable approach to increase the prevalence of CPR skills among the lay public, in part due to the opportunity for secondary training (i.e., sharing of training materials). However, the motivations for, and barriers to, disseminating VSI materials to secondary trainees is poorly understood. METHODS: This work represents an ancillary investigation of a prospective hospital-based CPR education trial in which family members of cardiac patients were trained using VSI. Mixed-methods surveys were administered to primary trainees six months after initial enrollment. Surveys were designed to capture motivations for, and barriers to, sharing VSI materials, the number of secondary trainees with whom materials were shared, and the settings, timing, and recipients of trainings. RESULTS: Between 07/2012 and 05/2015, 653 study participants completed a six-month follow-up interview. Of those, 345 reported sharing VSI materials with 1455 secondary trainees. Materials were shared most commonly with family members. In a logistic regression analysis, participants in the oldest quartile (age >63 years) were less likely to share materials compared to those in the youngest quartile (age ≤ 44 years, OR 0.58, CI 0.37-0.90, p=0.02). Among the 308 participants who did not share their materials, time constraints was the most commonly cited barrier for not sharing. CONCLUSIONS: VSI materials represent a strategy for secondary dissemination of CPR training, yet older individuals have a lower likelihood of sharing relative to younger individuals. Further work is warranted to remedy perceived barriers to CPR dissemination among the lay public using VSI approaches.

Leukoreduced whole blood-derived platelets treated with antimicrobial peptides maintain in vitro properties during storage.

BACKGROUND: Bacterial sepsis is still a complication in patients transfused with stored platelets (PLTs). We have recently demonstrated that selected antimicrobial peptides (AMPs) have bactericidal activity in bacteria-spiked PLTs. In a subsequent preclinical study, we have also shown that these AMPs do not elicit antibody response in rabbits and treatment of PLTs before transfusion does not affect their in vivo recovery and survival in severe combined immunodeficient mice. Here we have selected two such AMPs, Arg-Trp (RW) repeats of tri- and tetra-peptides (RW3 and RW4) in combination (i.e., cocktail), and evaluated their effect on the in vitro properties of PLTs. STUDY DESIGN AND METHODS: Leukoreduced ABO- and D-identical whole blood-derived PLT concentrates were pooled and divided into two 60-mL aliquots in CLX storage bags. On Day 0, one bag received a peptide cocktail of RW3 plus RW4 at 0.01 mmol/L final concentration (test) and the other bag received only phosphate-buffered saline (PBS), the AMP solvent (control). The treated PLTs were stored for 7 days at 20 to 24°C. Samples were collected on Days 1, 5, and 7 to evaluate the in vitro properties of PLTs with standard assays. RESULTS: In vitro properties of the RW3 plus RW4 cocktail-treated PLTs were similar to those incubated with PBS only. There were no significant differences between the control and test PLTs during the 7-day storage. CONCLUSION: Leukoreduced whole blood-derived PLTs treated with a mixture of RW3 and RW4 peptides maintain their in vitro properties during 7 days of storage.

Effect of storage on levels of nitric oxide metabolites in platelet preparations.

BACKGROUND: Nitric oxide (NO), a potent signaling molecule, is known to inhibit platelet (PLT) function in vivo. We investigated how the levels of NO and its metabolites change during routine PLT storage. We also tested whether the material of PLT storage containers affects nitrite content since many plastic materials are known to contain and release nitrite. STUDY DESIGN AND METHODS: For nitrite and nitrate measurement, leukoreduced apheresis PLTs and concurrent plasma (CP) were collected from healthy donors using a cell separator. Sixty-milliliter aliquots of PLT or CP were stored in CLX or PL120 Teflon containers at 20 to 24°C with agitation and daily samples were processed to yield PLT pellet and supernatant. In a separate experiment, PLTs were stored in PL120 Teflon to measure NO generation using electron paramagnetic resonance (EPR). RESULTS: Nitrite level increased markedly in both PLT supernatant and CP stored in CLX containers at a rate of 58 and 31 nmol/L/day, respectively. However, there was a decrease in nitrite level in PLTs stored in PL120 Teflon containers. Nitrite was found to leach from CLX containers and this appears to compensate for nitrite consumption in these preparations. Nitrate level did not significantly change during storage. CONCLUSION: PLTs stored at 20 to 24°C maintain measurable levels of nitrite and nitrate. The nitrite decline in nonleachable Teflon containers in contrast to increases in CLX containers that leach nitrite suggests that it is consumed by PLTs, residual white blood cells, or red blood cells. These results suggest NO-related metabolic changes occur in PLT units during storage.

A rest period does not affect in vitro storage properties in apheresis platelets collected from the buffy coat layer.

BACKGROUND: A previous study demonstrated that several in vitro storage properties of apheresis platelets (PLTs) that are isolated by sedimentation against the collection container and subsequently resuspended can benefit from a rest period before continuous agitation. This study examines whether the in vitro storage properties of apheresis PLTs isolated by collection from the buffy coat layer benefit from a rest period before agitation. STUDY DESIGN AND METHODS: Freshly collected apheresis PLTs (Trima, GambroBCT) were divided into five 60-mL aliquots. One aliquot was immediately placed on a flat-bed agitator; the other aliquots were held on a laboratory bench for 1, 2, 4, and 6 hours before continuous agitation. Samples were obtained on Days 1, 5, and 7 for standard in vitro PLT assays. The experiment was repeated 12 times. RESULTS: For each sampling day, no significant differences were observed in aliquots held with or without a rest period for any of the following PLT properties: PLT content, mean PLT volume, pH, pCO2, bicarbonate, glucose, lactate, hypotonic shock response, extent of shape change, aggregation, morphology, CD62P, CD63, and CD42b. Although regression analysis identified several in vitro properties whose mean levels appeared to improve with increasing length of the rest period, maximum differences in mean levels were small (<6%). CONCLUSION: The in vitro storage properties of Trima apheresis PLTs isolated from the buffy coat layer do not benefit from a rest period.

Comparative in vitro evaluation of apheresis platelets stored with 100% plasma or 65% platelet additive solution III/35% plasma and including periods without agitation under simulated shipping conditions.

BACKGROUND: A comparative study evaluated the retention of apheresis platelet (A-PLT) in vitro properties prepared with PLT additive solution (PAS)-III or 100% plasma and stored with continuous agitation (CA) and without continuous agitation (WCA). STUDY DESIGN AND METHODS: PLTs collected with the Amicus cell separator (Fenwal, Inc.) were utilized to prepare two matched components, each with approximately 4 × 10(11) PLTs. In the primary study, one component contained 65% PAS-III/35% plasma and the other 100% plasma. Four storage scenarios were used, one with CA and three with periods without agitation under simulated shipping conditions. In vitro assays were used early and after 5 days of storage. RESULTS: pH levels after 5 days with CA were less with PAS-III components than 100% plasma components, with levels always above 6.6 in any component. With CA, a number of other variables were reduced even early during storage with PAS-III including morphology, extent of shape change, hypotonic stress response, adhesion, and aggregation. Storage WCA resulted in only a limited increase in the magnitude of the assay differences between PAS-III and 100% plasma components. Periods WCA did not reduce the pH below 6.6. The thromboelastograph variable associated with the strengthening of clots by PLTs was essentially comparable with PAS-III and plasma components throughout storage with CA or WCA. CONCLUSION: The data indicate that a 100% plasma medium provides for better retention of specific in vitro PLT properties, with CA and WCA, although the clinical significance of these in vitro decrements due to PAS-III is unknown.

Comparison of the in vitro storage properties of Amicus apheresis platelets collected using single- and double-needle procedures from the same donors.

BACKGROUND: Amicus apheresis platelets (PLTs) can be collected using either a single- (SN) or a double-needle (DN) procedure. To investigate whether the method of PLT collection using the same instrument influences PLT quality, the in vitro storage properties of Amicus PLTs were evaluated in the same donors collected by SN and DN procedures. STUDY DESIGN AND METHODS: Single apheresis PLT collections with concurrent plasma were performed on donors using the Amicus with a target yield of 4 × 10(11). A PLT unit was collected from a donor assigned to either a SN or a DN procedure; a subsequent donation from the same individual was collected by the other procedure (n = 10). Units were stored at 20 to 24°C with continuous agitation, assayed for 19 PLT storage variables, and analyzed by paired t test, with differences between values obtained with SN and DN collections considered significant with p values of less than 0.001. RESULTS: PLT units collected by SN procedure had contents and concentrations similar to those collected by DN procedures (4.1 × 10(11) ± 0.3 × 10(11) vs. 4.0 × 10(11) ± 0.3 × 10(11) and 1396 × 10(9) ± 131 × 10(9) vs. 1367 × 10(9) ± 110 × 10(9) PLTs/L). On Day 7, SN and DN PLTs had comparable pH values (7.07 ± 0.09 vs. 6.99 ± 0.17), morphology (52.4 ± 18.7% vs. 56.0 ± 13.3% discoid), aggregation (87.1 ± 11.5% vs. 91.3 ± 5.4%), and activation (45. ± 11.9% vs. 48.2 ± 8.7% CD62P), as well as all other variables (p > 0.05; Day 7 CO(2) , p = 0.0304). CONCLUSION: The in vitro storage properties of apheresis PLTs collected from the same donors using a SN and DN procedure with the Amicus instrument were maintained through 7 days of storage and yielded comparable results.

Characterizing the variation in pH measurements with apheresis platelets.

BACKGROUND: pH measurements of platelet (PLT) components remain a key parameter when assessing how storage and shipping conditions influence the retention of PLT properties. Studies were conducted to characterize variations in pH measured with two pH meters and a blood gas analyzer. STUDY DESIGN AND METHODS: Samples were obtained from apheresis PLT units that were stored with or without continuous agitation to measure a range of pH values. pH values were determined with pH meters at room temperature (20-24°C) upon placing of samples in 5-mL sterile polypropylene tubes and with the blood gas analyzer at 37°C upon injection of identical samples, with conversion to 22°C. RESULTS: The calculated coefficient of variation (%CV) of pH measurements using pH meters (n = 10) was 0.43% or less. The %CV values were comparable with different samples having pH values ranging from 6.0 to 7.4. The %CV levels with the blood gas analyzer were comparable to those observed with the pH meters. The difference in the mean pH values for the two pH meters was no greater than 0.10 units, with 9 of 10 samples having differences in values of 0.05 or less; however, greater differences of values (0.1 to 0.2) were observed between pH measured using the blood gas analyzer and pH meters. CONCLUSION: Our data show good precision and comparability of pH measurements with two pH meters. Differences in pH values were greater on comparison of the blood gas analyzer with the pH meters.

Storing apheresis platelets without agitation with simulated shipping conditions during two separate periods: immediately after collection and subsequently between Day 2 and Day 3.

BACKGROUND: Apheresis platelet (PLT) units are not routinely agitated during transit. Our study compared the in vitro properties of apheresis PLT units that were stored with continuous agitation (CA) and without continuous agitation (WCA) during two separate periods, immediately after collection and between Day 2 and Day 3 of storage. STUDY DESIGN AND METHODS: Two identical apheresis PLTs units were prepared from collections with Amicus (n = 11, Fenwal, Inc.) and Trima (n = 10, CaridianBCT) cell separators. One apheresis PLT unit was continuously agitated, starting routinely within 30 minutes of collection, and an identical apheresis PLT unit was held without agitation initially for 7 to 8 hours and subsequently for 24 hours between Day 2 and Day 3 of storage. The apheresis PLT units were maintained WCA at 20 to 24 °C in a shipping box. In vitro PLT properties were evaluated on Day 1 (day after collection), after 5 and 7 days of storage. RESULTS: With both Amicus and Trima apheresis PLT units, the mean PLT content and concentration of CA and WCA were comparable and essentially constant throughout storage. Mean pH levels (± 1 SD) after 5 days for Amicus apheresis PLT units were 6.97 ± 0.20 (WCA) and 7.13 ± 0.16 (p < 0.001, CA) and for Trima apheresis PLT units 6.97 ± 0.21 (WCA) and 7.22 ± 0.17 (p < 0.001, CA). In vitro variables, including percentage of disc PLTs, extent of shape change, and hypotonic stress levels, after 5 days of storage, showed mean differences between WCA and CA that were less than 15%. CONCLUSION: The in vitro results show that apheresis PLT units can be stored without agitation for 7 to 8 hours immediately after collection and also subsequently during storage for 24 hours with minimal influence on in vitro PLT properties compared to continuously agitated PLTs.

Influence of apheresis container size on the maintenance of platelet in vitro storage properties after a 30-h interruption of agitation.

We have previously conducted studies investigating maintenance of apheresis platelet in vitro quality measures during storage under simulated shipping conditions in which agitation was interrupted. This study examines the effect of increasing bag surface area on the preservation of in vitro platelet properties during storage with continuous agitation and with a 30 h interruption of agitation. Apheresis platelets were collected in 100% plasma with the Amicus separator to provide two identical platelet products, each with approximately 4-5 x 10(11) platelets. After collection, the volume was divided equally between 1.0 and 1.3 L PL2410 containers. In an initial study, both products were continuously agitated. In a second study, both products were subjected to a single 30-h period of interrupted agitation between Days 2 and 3 of storage by placement in a standard shipping box at room temperature. In each study, units were assayed during storage for standard in vitro platelet quality measures. Platelets stored in the 1.3 L container maintained slightly greater mean pH during 7 day storage with either continuous agitation (n=6) or with a 30-h interruption of agitation (n=12) than those of similarly treated identical platelets stored in the 1.0 L container. Most noteworthy, in experiments with products stored in the 1.0 L container in which there was a large decrease in pH to levels <6.7 or <6.3 on days 5 or 7, respectively, the pH in the matched product stored in the 1.3 L container was substantially greater (0.17+/-06 and 0.37+/-0.09 pH units greater, n=4, respectively). Other measures showed either small differences or comparability of platelet in vitro parameters with storage in the two containers after an interruption of agitation.