How to avoid baseplate failure: the effect of compression and reverse shoulder arthroplasty baseplate design on implant stability.

BACKGROUND: Failure to achieve fixation of the glenoid baseplate will lead to clinical failure. The fixation of the baseplate to the scapula must be able to withstand sufficient shear forces to allow bony ingrowth. The importance of compression to neutralize the forces at the baseplate-bone interface has been assumed to be critical in limiting excessive micromotion. The purpose of this study is to determine the effect of compression on implant stability with different baseplate designs. METHODS: Various baseplate designs (1-piece monolithic central screw [1P], 2-piece locking central screw [2PL], and 2-piece nonlocking center screw [2PNL]) were investigated at 3 different compressive forces (high [810 N], medium [640 N], and low [530 N]). Synthetic bone cylinders were instrumented, and peripheral screws were used in all models. The combination of 1 locking and 3 nonlocking peripheral screw fixation was selected as worst-case scenario. Dynamic testing protocol followed the ASTM F2028-17 standard. The baseplate micromotion at high compression was compared to low compression. Additionally, the baseplate micromotion for each design was compared at baseline (first 50 cycles) and at 10,000 cycles for the 3 different compressive forces where motion above 150 µm was defined as failure. RESULTS: Baseplate micromotion was found to negatively correlate with compression (rpb = -0.83, P < .0001). At baseline, all baseplate designs were considered stable, regardless of compression. With high compression, average micromotion at the glenoid baseplate-bone interface remained below the 150-µm threshold for all baseplate designs at 10,000 cycles (1P: 50 ± 10 µm; 2PL: 78 ± 32 µm; 2PNL: 79 ± 8 µm; P = .060). With medium compression, average micromotion at 10,000 cycles for all 3 designs remained below the 150-µm threshold (1P: 88 ± 22 µm; 2PL: 132 ± 26 µm; 2PNL: 107 ± 39 µm). The 2PL design had the highest amount of micromotion (P = .013). With low compression, both 2-piece designs had an average micromotion above the 150-µm threshold whereas the 1-piece design did not (1P: 133 ± 35 µm; 2PL: 183 ± 21 µm; 2PNL: 166 ± 39 µm). The 2PL design had significantly higher micromotion when compared to 1P design (P = .041). DISCUSSION: The stability of a central screw baseplate correlates with the amount of compression obtained and is affected by implant design. For the same amount of compression, more micromotion is observed in a 2-piece design than a 1-piece design.

Do preoperative factors and implant design features influence humeral stem extraction efforts?

BACKGROUND: Variations in humeral component designs in hemiarthroplasty and anatomic total shoulder arthroplasty cases can impact the degree of difficulty during a revision surgery that necessitates the removal of the humeral stem. However, no metric exists to define stem extraction effort nor to identify associated factors that contribute to extraction difficulty. The purpose of this study is to describe a method to quantify stem extraction difficulty and to define features that will impact the effort during stem removal. METHODS: This was a retrospective review of 58 patients undergoing revision of hemiarthroplasty or anatomic total shoulder arthroplasty requiring stem extraction. Each included patient had existing preoperative radiographic examination, an intraoperative video of the stem removal process, and explants available for analysis by 3 surgeons. The following factors were assessed for the impact on extraction difficulty: (1) preoperative features such as cement use, fill of proximal humerus, and stem design features; (2) intraoperative data on extraction time and bone removal; and (3) postoperative findings related to extraction artifacts (EAs). A scoring system was established to distinguish easy (Easy group) and difficult (Difficult group) stem removal cases and further used to identify the features that may affect intraoperative difficulty of stem removal. RESULTS: The Difficult group accounted for 26% (15/58) of the study population with an 18-minute average stem extraction time, average EA count of 69, and 35 mm of bone removed. The Easy group accounted for 74% (43/58) of patients, with a 4-minute average extraction time, average EA count of 23, and 10 mm of bone removed. Logistic regression model was able to correctly classify 82% of the cases, explaining 26.7% of the variance in humeral stem removal with cement and proximal coating variables. The likelihood of cemented stem removal being difficult is 5 times greater compared to an uncemented stem, and having proximal coating doubles the likelihood of a difficult stem removal compared to cases with no coating. CONCLUSIONS: Quantifying stem extraction difficulty is possible with intraoperative video as well as explant analysis. Preoperative features of the fixation type and specific features of stem design such as proximal coating will impact difficulty of stem extraction.

Improved mechanical fixation of an all-polyethylene glenoid reduces postoperative radiolucent lines.

BACKGROUND: The rationale for advances in implant design is to improve performance in comparison to their predecessors. The purpose of this study was to compare a newer, self-pressurizing peripheral peg glenoid to a traditional polyethylene pegged glenoid through biomechanical evaluation and a retrospective radiographic and clinical review. METHODS: Three testing conditions (uncemented, partially cemented, and fully cemented) were chosen to assess the 2 component designs in a foam block model. The number of hammer hits to seat the component, amount of time to seat the component, and resistance-to-seat were collected. The implants were then cyclically loaded following ASTM F2028-17 testing standard. Clinically, postoperative radiographs of patients with a self-pressurized glenoid component (n = 225 patients) and traditional glenoid component (n = 206 patients) were evaluated for radiolucent lines and glenoid seating at various timepoints. Clinical outcomes (American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, Simple Shoulder Test, and visual analog scale pain scores) and complications were recorded. The presence of radiolucent lines at the bone-cement interface was evaluated using the Modified Franklin Grade and the Lazarus grade. RESULTS: The self-pressurizing glenoid design required significantly more hammer hits than traditional glenoid designs in all groups tested (P < .029). Moreover, the self-pressurizing design had significantly more resistance-to-seat than traditional components in both the uncemented and partially cemented group (P < .002). No difference in resistance-to-seat was found between designs in the fully cemented group. The uncemented and partially cemented groups did not survive the full 50,000 cycles; however the self-pressurizing design had significantly less motion than the traditional design (P < .001). No differences between component designs were found in the fully cemented group at 50,000 cycles. The self-pressurizing glenoid component had 0.005% radiographic radiolucent lines, and the traditional glenoid component had 45% radiographic radiolucent lines, with 38% of the radiolucencies in the traditional glenoid component group being defined as grade E. There were no progressive radiolucencies, differences in clinical outcomes, or complications at 2 years postoperatively. CONCLUSION: In the fully cemented condition, the 2 component designs had comparable performance; however, the differences in designs could be better observed in the uncemented group. The self-pressurizing all-polyethylene design studied has superior biomechanical stability. Clinically, the improved stability of the glenoid component correlated with a reduction of radiolucent lines and will likely lead to a reduction in glenoid component loosening.

"Ex-vivo" T-cell depletion in allogeneic hematopoietic stem cell transplantation: New clinical approaches for old challenges.

Allogeneic transplantation still remains as standard of care for patients with high-risk hematological malignancies at diagnosis or after relapse. However, GvHD remains yet as the most relevant clinical complication in the early post-transplant period. TCD allogeneic transplant is now considered a valid option to reduce severe GvHD and to provide a platform for cellular therapy to prevent relapse disease or to treat opportunistic infections.

Outcome of patients with Fanconi anemia developing myelodysplasia and acute leukemia who received allogeneic hematopoietic stem cell transplantation: A retrospective analysis on behalf of EBMT group.

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is curative for bone marrow failure in patients with Fanconi anemia (FA), but the presence of a malignant transformation is associated with a poor prognosis and the management of these patients is still challenging. We analyzed outcome of 74 FA patients with a diagnosis of myelodysplastic syndrome (n = 35), acute leukemia (n = 35) or with cytogenetic abnormalities (n = 4), who underwent allo-HSCT from 1999 to 2016 in EBMT network. Type of diagnosis, pre-HSCT cytoreductive therapies and related toxicities, disease status pre-HSCT, donor type, and conditioning regimen were considered as main variables potentially influencing outcome. The 5-year OS and EFS were 42% (30-53%) and 39% (27-51%), respectively. Patients transplanted in CR showed better OS compared with those transplanted in presence of an active malignant disease (OS:71%[48-95] vs 37% [24-50],P = .04), while none of the other variables considered had an impact. Twenty-two patients received pre-HSCT cytoreduction and 9/22 showed a grade 3-4 toxicity, without any lethal event or negative influence on survival after HSCT(OS:toxicity pre-HSCT 48% [20-75%] vs no-toxicity 51% [25-78%],P = .98). The cumulative incidence of day-100 grade II-IV a-GvHD and of 5-year c-GvHD were 38% (26-50%) and 40% (28-52%). Non-relapse-related mortality and incidence of relapse at 5-years were 40% (29-52%) and 21% (11-30%) respectively, without any significant impact of the tested variables. Causes of death were transplant-related events in most patients (34 out of the 42 deaths, 81%). This analysis confirms the poor outcome of transformed FA patients and identifies the importance of achieving CR pre-HSCT, suggesting that, in a newly diagnosed transformed FA patient, a cytoreductive approach pre-HSCT should be considered if a donor have been secured.

Patient satisfaction with remote monitoring of cardiac implantable electronic devices: the VALIOSA questionnaire.

BACKGROUND: Remote monitoring of cardiac implantable electronic devices (CIEDs) has demonstrated substantial benefits. Treatment guidelines have therefore endorsed its use and is being increasingly adopted in the clinical setting, but the level of satisfaction they convey remains still unknown. We developed and validated a questionnaire to measure patient satisfaction with remote monitoring using Medtronic CareLink® Network and assessed its internal reliability and dimensional validity. METHODS: After a thorough literature review, cognitive debriefing of 18 patients, and an expert panel discussion, a 30-item instrument was proposed and grouped into 5 dimensions (items): 1- Information on cardiac condition (3), 2- Device convenience (3), 3- Transmission process (6), 4- Satisfaction with medical monitoring (8), and 5- General opinions (10). Correlation with the visual analog scale (VAS), overall health related quality of life (HRQoL) measured by the EuroQoL-5D accompanied by the VAS as well as with the Medical Outcomes Study (MOS) SF-36 were assessed. Psychometric properties, exploratory factor analysis and a second order confirmatory factor analysis (a hierarchical CFA with a general common factor explaining the relations between the first order common factors, See Figure 1) were estimated. Models were assessed based on item loading size, sign and statistical significance, and goodness-of-fit statistics. RESULTS: A total of 186 patients (77% male) with a mean age of 66.03 (SD = 13.94) years were assessed. 48% had implantable cardioverter-defibrillators, 24% had pacemakers, and 29% had cardiac resynchronization therapy devices. An overall Cronbach's α = 0.893 was achieved, with acceptable reliabilities for isolated dimensions. Correlations with corresponding VAS scales were meaningful and significant (p < 0.01). The second order factor solution yielded good goodness-of-fit indexes (χ2/df = 1.44, CFI = 0.96, TLI = 0.95, RMSEA = 0.05). Satisfaction with remote monitoring was not related to HRQoL (r < 0.05), except for the correlation between the SF-36 mental component and the information on cardiac condition dimension (r = 0.263, p < 0.001). CONCLUSIONS: The 30-item questionnaire showed good reliability and validity to assess satisfaction with remote monitoring in patients with CIEDs.

Calcium Phosphate Bone Void Filler Increases Threaded Suture Anchor Pullout Strength: A Biomechanical Study.

PURPOSE: To compare the response to cyclical loading and ultimate pull-out strength of threaded suture anchor with and without calcium phosphate bone void filler augmentation in a polyurethane foam block model and in vitro proximal humerus cadaveric model. METHODS: This controlled biomechanical study consisted of 2 parts: (1) preliminary polyurethane foam block model, and (2) in vitro cadaveric humeri model. The preliminary foam block model intended to mimic osteoporotic bone using a 0.12 g/mL foam material. Half of the foam block models were first filled with injectable calcium phosphate bone substitute material (CP-BSM), whereas the other half were not augmented with CP-BSM. Each specimen was then instrumented with a threaded suture anchor. The same technique and process was performed in a matched cadaveric humeri model. Testing then consisted of a stepwise, increasing axial load protocol for a total of 40 cycles. If the anchor remained intact after cyclic loading, the repair was loaded to failure. The number of completed cycles, failure load, and failure modes were compared between groups. RESULTS: Average pull-out strength for suture anchor with CP-BSM in the osteoporotic foam block model was significantly higher at 332.68 N ± 47.61 compared with the average pull-out strength of suture anchor without CP-BSM at 144.38 N ± 14.58 (P = .005). In the matched cadaveric humeri model, average pull-out strength for suture anchor with CP-BSM was significantly higher at 274.07 N ± 102.07 compared with the average pull-out strength of suture anchor without CP-BSM at 138.53 N ± 109.87 (P = .029). CONCLUSIONS: In this time zero, biomechanical study, augmentation of osteoporotic foam block and cadaveric bone with calcium phosphate bone substitute material significantly increases pull-out strength of threaded suture anchors. CLINICAL RELEVANCE: Considering concerns about suture anchor pull-out from osteoporotic bone, augmentation with calcium phosphate bone substitute material increases load to failure resistance.

Kinetics and Risk Factors of Relapse after Allogeneic Stem Cell Transplantation in Children with Leukemia: A Long-Term Follow-Up Single-Center Study.

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an established treatment for high-risk hematological malignancies in the pediatric population, but relapse remains the leading cause of death. We analyzed risk factors associated with relapse. Data from 353 allo-HSCTs from 1989 to 2015 in our center were studied retrospectively. We performed a multivariate analysis of pre- and postransplantation variables and developed a predictive risk score for relapse using the significant factors in this training cohort. The results were confirmed in a validation cohort of 90 allo-HSCTs done in our institution from 2016 to the present. A total of 104 patients relapsed after allo-HSCT, with a relapse cumulative incidence of 31 ± 2%. In multivariate analysis, only 2 variables influenced relapse: disease phase (advanced versus early, HR, 2.84; 95% CI, 1.76 to 4.57; P = .001) and presence of chronic graft-versus-host disease (GVHD) (acute GVHD versus chronic GVHD [HR, 4.27; 95% CI, 1.99 to 9.15; P = .0001] and no GVHD versus chronic GVHD [HR, 6.86; 95% CI, 3.63 to 12.97] P = .0001]. Applying the personalized risk score (0 to 3), the relapse cumulative incidence was 70 ± 5% in patients with a score of 3 (without GVHD and in the advanced phase) compared with 6 ± 4% in patients with a score of 0 (with chronic GVHD and in an early phase). This score has been verified in the validation set. With a median follow-up of 54 months, the disease-free survival (DFS) and overall survival rate were 37 ± 3% and 45 ± 4%, respectively. The association of GVHD with the graft-versus-leukemia effect is clearly established in our study, and the form of GVHD associated with less relapse and the best DFS is the classical form of chronic GVHD according to the National Institutes of Health classification. The proposed relapse risk score was validated in an independent cohort and allows personalization of the prognosis.

Improving preoperative planning of revision surgery after previous anatomic total shoulder arthroplasty.

BACKGROUND: The purpose of this study was to compare preoperative radiographic evaluation with intraoperative video and explant analysis in patients undergoing revision of a previous anatomic total shoulder arthroplasty (TSA). METHODS: We evaluated the preoperative radiographs of 165 revisions of failed TSAs for component loosening and glenohumeral registry (ie, the spatial relationship of the glenoid component and the prosthetic humeral head). Seventy-nine intraoperative videos were evaluated for component stability, rotator cuff (RC) integrity, synovitis, and glenoid bone loss. Eighty-seven explants were reviewed to assess wear patterns and presence of backside cement. RESULTS: Of 79 glenoid components, 47 were radiographically loose, but only 30 of 79 were loose intraoperatively. Thirty-two were radiographically fixed, but only 26 of 32 were fixed intraoperatively. If radiographically loose, 53% had severe glenoid bone loss. If radiographically fixed, 77% had mild to moderate bone loss (P = .008). Synovitis was associated with glenoid fixation: mild with a loose glenoid (6%) and severe with a fixed glenoid (30%, P = .012). Superior registry comprised 46%. RC deficiency was associated with posterior and anterior registry (88% and 79%, respectively). Explant examination revealed an eccentric wear pattern was predominant. CONCLUSION: Radiographic evaluation of glenoid loosening in patients undergoing revision of TSAs will often differ from intraoperative findings (40% false-positive rate and 17% false-negative rate). Assessment of glenohumeral registry can help anticipate RC deficiency, with posterior and anterior registry associated with RC deficiency. Patients with a loose glenoid are more likely to have severe synovitis and more severe glenoid bone deficiencies. Failed TSAs are more likely to have asymmetrical wear of the glenoid component, suggesting altered pathomechanics that may have led to failure.

Do preoperative radiographs help predict intraoperative challenges in revision surgery after previous shoulder hemiarthroplasty?

BACKGROUND: This study compares preoperative radiographic evaluation with intraoperative video and explant data in patients undergoing revision of a hemiarthroplasty. METHODS: From 2004 to 2017, 182 shoulder hemiarthroplasties underwent revision to reverse shoulder arthroplasty for symptomatic failure. Preoperative radiographs were evaluated for stem fixation, stability, and glenohumeral registry. Intraoperative videos (n = 48) were evaluated for humeral component stability and bone loss after humeral stem extraction. All explants (n = 83) were reviewed for humeral head wear patterns and extraction artifacts (EAs). RESULTS: A well-fixed stem was reliably identified on radiographs as well fixed (true-negative rate, 95%). Of cemented implants, 94% (97 of 103) were radiographically stable and 90% (18 of 20) were stable on intraoperative video. Significant proximal humeral bone loss was identified after cemented stem extraction in 83% of cases, and severe EAs were noted in 28% (14 of 50). Of uncemented implants, 95% (75 of 79) were radiographically stable and 96% (24 of 25) were operatively stable. Significant proximal humeral bone loss was identified after extraction in 36% of cases (9 of 25) (P = .001). Severe EAs were seen in 13% of explanted stems (3 of 23). Eccentrically worn humeral head explants were associated with eccentric glenohumeral registry in 84% of cases (P = .0075). CONCLUSION: Preoperative radiographs for revision of a failed hemiarthroplasty help identify well-fixed stems and predict humeral bone loss during extraction. Cemented stems will have more EAs and result in greater bone loss than uncemented stems. Glenohumeral registry can help to predict humeral head wear. Eccentric registry leads to eccentric humeral head wear in 84% of cases.

Assessment of the antinociceptive and anti-inflammatory activities of the stem methanol extract of Diplotropis purpurea.

Context: Since there is still a great need to search for plant species with antinociceptive and anti-inflammatory activities, Diploptropis purpurea (Rich.) Amshoff (Fabaceae) is studied for the first time. Objective: This evaluates the analgesic and anti-inflammatory activities of the stem methanol extract of Diplotropis purpurea (MEDP). Material and methods: The anti-inflammatory and analgesic effects of MEDP of D. purpurea were evaluated in vivo. The antinociceptive activity was assessed in CD1 male mice were treated by oral gavage with 500 mg/kg of MEDP 30 min before submitting to acetic acid-induced abdominal writhing, hot-plate, and formalin tests. Paws oedema induced by carrageenan, histamine or serotonin were performed in male Sprague-Dawley rats to determinate the anti-inflammatory activity. Results: Oral administration of MEDP produced significant antinociceptive effects on the inflammatory phase in the formalin test [12.0 s versus 72.5 s in carboxymethyl cellulose (CMC) control group]. MEDP produced an analgesic effect in the hot-plate model, although the effect was modest compared to tramadol (40 and 60%, respectively). The oral administration of MEDP in a dose of 500 mg/kg showed maximum inhibition (75.1%) after 0.5 h in carrageenan-induced oedema, but it did not modify histamine or serotonin-induced oedemas. Discussion and conclusion: In the peripheral nociception model, acetic acid-induced abdominal writhing, the MEDP did not show a protective effect, but its analgesic effects were evident in the inflammatory phase of the formalin test and in the hot-plate model. These results show that the anti-inflammatory effect was accompanied by a reduction in the perception of painful stimuli.

Outcome of haematopoietic stem cell transplantation in dyskeratosis congenita.

Dyskeratosis congenita (DC) is a genetic multisystem disorder with frequent involvement of the bone marrow. Haematopoietic stem cell transplantation (HSCT) is the only definitive cure to restore haematopoiesis, even though it cannot correct other organ dysfunctions. We collected data on the outcome of HSCT in the largest cohort of DC (n = 94) patients ever studied. Overall survival (OS) and event-free survival (EFS) at 3 years after HSCT were 66% and 62%, respectively. Multivariate analysis showed better outcomes in patients aged less than 20 years and in patients transplanted from a matched, rather than a mismatched, donor. OS and EFS curves tended to decline over time. Early lethal events were infections, whereas organ damage and secondary malignancies appeared afterwards, even a decade after HSCT. A non-myeloablative conditioning regimen appeared to be most advisable. Organ impairment present before HSCT seemed to favour the development of chronic graft-versus-host disease and T-B immune deficiency appeared to enhance pulmonary fibrosis. According to the present data, HSCT in DC is indicated in cases of progressive marrow failure, whereas in patients with pre-existing organ damage, this should be carefully evaluated. Further efforts to investigate treatment alternatives to HSCT should be encouraged.

European Group for Blood and Marrow Transplantation Centers with FACT-JACIE Accreditation Have Significantly Better Compliance with Related Donor Care Standards.

Previous studies have identified healthcare practices that may place undue pressure on related donors (RDs) of hematopoietic cell products and an increase in serious adverse events associated with morbidities in this population. As a result, specific requirements to safeguard RD health have been introduced to Foundation for the Accreditation of Cellular Therapy/The Joint Accreditation Committee ISCT and EBMT (FACT-JACIE) Standards, but the impact of accreditation on RD care has not previously been evaluated. A survey of transplant program directors of European Group for Blood and Marrow Transplantation member centers was conducted by the Donor Health and Safety Working Committee of the Center for International Blood and Marrow Transplant Research to test the hypothesis that RD care in FACT-JACIE accredited centers is more closely aligned with international consensus donor care recommendations than RD care delivered in centers without accreditation. Responses were received from 39% of 304 centers. Our results show that practice in accredited centers was much closer to recommended standards as compared with nonaccredited centers. Specifically, a higher percentage of accredited centers use eligibility criteria to assess RDs (93% versus 78%; P = .02), and a lower percentage have a single physician simultaneously responsible for an RD and their recipient (14% versus 35%; P = .008). In contrast, where regulatory standards do not exist, both accredited and nonaccredited centers fell short of accepted best practice. These results raise concerns that despite improvements in care, current practice can place undue pressure on donors and may increase the risk of donation-associated adverse events. We recommend measures to address these issues through enhancement of regulatory standards as well as national initiatives to standardize RD care.

Significant Improvements in the Practice Patterns of Adult Related Donor Care in US Transplantation Centers.

Recent investigations have found a higher incidence of adverse events associated with hematopoietic cell donation in related donors (RDs) who have morbidities that if present in an unrelated donor (UD) would preclude donation. In the UD setting, regulatory standards ensure independent assessment of donors, one of several crucial measures to safeguard donor health and safety. A survey conducted by the Center for International Blood and Marrow Transplant Research (CIBMTR) Donor Health and Safety Working Committee in 2007 reported a potential conflict of interest in >70% of US centers, where physicians had simultaneous responsibility for RDs and their recipients. Consequently, several international organizations have endeavored to improve practice through regulations and consensus recommendations. We hypothesized that the changes in the 2012 Foundation for the Accreditation of Cellular Therapy and the Joint Accreditation Committee-International Society for Cellular Therapy and European Society for Blood and Marrow Transplantation standards resulting from the CIBMTR study would have significantly impacted practice. Accordingly, we conducted a follow-up survey of US transplantation centers to assess practice changes since 2007, and to investigate additional areas where RD care was predicted to differ from UD care. A total of 73 centers (53%), performing 79% of RD transplantations in the United States, responded. Significant improvements were observed since the earlier survey; 62% centers now ensure separation of RD and recipient care (P < .0001). This study identifies several areas where RD management does not meet international donor care standards, however. Particular concerns include counseling and assessment of donors before HLA typing, with 61% centers first disclosing donor HLA results to an individual other than the donor, the use of unlicensed mobilization agents, and the absence of long-term donor follow-up. Recommendations for improvement are made.

Analysis of the Effect of Race, Socioeconomic Status, and Center Size on Unrelated National Marrow Donor Program Donor Outcomes: Donor Toxicities Are More Common at Low-Volume Bone Marrow Collection Centers.

Previous studies have shown that risks of collection-related pain and symptoms are associated with sex, body mass index, and age in unrelated donors undergoing collection at National Marrow Donor Program centers. We hypothesized that other important factors (race, socioeconomic status [SES], and number of procedures at the collection center) might affect symptoms in donors. We assessed outcomes in 2726 bone marrow (BM) and 6768 peripheral blood stem cell (PBSC) donors collected between 2004 and 2009. Pain/symptoms are reported as maximum levels over mobilization and collection (PBSC) or within 2 days of collection (BM) and at 1 week after collection. For PBSC donors, race and center volumes were not associated with differences in pain/symptoms at any time. PBSC donors with high SES levels reported higher maximum symptom levels 1 week after donation (P = .017). For BM donors, black males reported significantly higher levels of pain (OR, 1.90; CI, 1.14 to 3.19; P = .015). No differences were noted by SES group. BM donors from low-volume centers reported more toxicity (OR, 2.09; CI, 1.26 to 3.46; P = .006). In conclusion, race and SES have a minimal effect on donation-associated symptoms. However, donors from centers performing ≤ 1 BM collection every 2 months have more symptoms after BM donation. Approaches should be developed by registries and low-volume centers to address this issue.

Intensive Care Unit Admissions Among Children After Hematopoietic Stem Cell Transplantation: Incidence, Outcome, and Prognostic Factors.

We retrospectively analyzed posttransplantation events in 299 children who underwent hematopoietic stem cell transplantation between 2005 and 2011 in order to ascertain the incidence of life-threatening complications requiring pediatric intensive care unit (PICU) admission, the contributing risk factors, and the patient's long-term survival. Sixty-eight patients (23%) were admitted to the PICU. Risks factors associated with higher cumulative incidence of PICU admission on univariate analysis were nonmalignant disease, status at transplantation, type of transplant, source of stem cell, engraftment syndrome (ES), veno-occlusive disease, acute graft versus host disease (GvHD), chronic GvHD, thrombotic microangiopathy, bronchiolitis obliterans, hemorrhagic cystitis, and posterior reversible encephalopathy syndrome (PRES). On multivariate analysis, only ES, acute GvHD, transplant-associated thrombotic microangiopathy (TA-TMA), and PRES were statistically significant. The variables that had a negative impact on survival, on univariate analysis, were allogeneic transplant, age, male sex, a high O-PRISM score, a high O-PRISM3 score, engraftment failure, acute GvHD, TA-TMA, hemorrhagic cystitis, and PRES. On multivariate analysis, only age, allogeneic transplant, engraftment failure, acute GvHD, TA-TMA, and hemorrhagic cystitis had a negative impact on survival. In conclusion, our report provides new findings regarding life-threatening complications after hematopoietic transplantation for PICU admission and survival after that in a pediatric population.

Whip-Lock Stitch Is Biomechanically Superior to Whipstitch for Semitendinosus Tendons.

Purpose: To assess the biomechanical performance of different stitching methods using a suturing device by comparing the elongation, stiffness, failure load, and time to stitch completion in cadaveric semitendinosus tendons (STs) and quadriceps tendons (QTs). Methods: A total of 24 STs and 16 QTs were harvested from cadaveric knee specimens (N = 40). Samples were randomly divided into 2 groups: whipstitch (WS) and whip-lock (WL) stitch. Both tendon ends were clamped to a graft preparation stand, and a 2-part needle was used to place 5 stitches, each 0.5 cm apart. Stitching time was recorded. Samples were preconditioned and then underwent cyclic loading from 50 to 200 N at 1 Hz for 500 cycles, followed by load-to-failure testing at 20 mm/min. Stiffness (in newtons per millimeter), ultimate failure load (in newtons), peak-to-peak displacement (in millimeters), elongation (in millimeters), and failure displacement (in millimeters) were recorded. Results: Completion of the WS was significantly faster than the WL stitch in the ST (P < .001) and QT (P = .004). For the ST, the WL stitch exhibited higher ultimate failure loads and construct stiffness than the WS. Regarding the QT, the WL stitch showed higher stiffness and displacement than the WS; however, the ultimate failure load was higher for the WS in the QT. The ultimate failure load in the QT was higher than that in the ST for both stitches. In the ST, only 25% of WSs and 100% of WL stitches failed due to suture breakage. In the QT, suture breakage led to the failure of 100% of both the WL stitches and WSs. Conclusions: In the ST, the WL stitch resulted in improved biomechanical performance through higher ultimate load and fewer failures from tissue damage compared with the WS. In the QT, both the WS and the WL stitch showed similar biomechanical performance with ultimate failure loads above established clinical failure thresholds. Clinical Relevance: Various types of ligament and tendon injuries require suturing to enable repair or reconstruction. The success of ligament or tendon surgery often relies on soft-tissue quality. It is important to investigate the biomechanical properties of stitching techniques that help preserve soft-tissue quality as a step to determining their clinical suitability.

Latin American consensus on diagnosis of gastroesophageal reflux disease.

BACKGROUND: Diagnosing gastroesophageal reflux disease (GERD) can be challenging given varying symptom presentations, and complex multifactorial pathophysiology. The gold standard for GERD diagnosis is esophageal acid exposure time (AET) measured by pH-metry. A variety of additional diagnostic tools are available. The goal of this consensus was to assess the individual merits of GERD diagnostic tools based on current evidence, and provide consensus recommendations following discussion and voting by experts. METHODS: This consensus was developed by 15 experts from nine countries, based on a systematic search of the literature, using GRADE (grading of recommendations, assessment, development and evaluation) methodology to assess the quality and strength of the evidence, and provide recommendations regarding the diagnostic utility of different GERD diagnosis tools, using AET as the reference standard. KEY RESULTS: A proton pump inhibitor (PPI) trial is appropriate for patients with heartburn and no alarm symptoms, but nor for patients with regurgitation, chest pain, or extraesophageal presentations. Severe erosive esophagitis and abnormal reflux monitoring off PPI are clearly indicative of GERD. Esophagram, esophageal biopsies, laryngoscopy, and pharyngeal pH monitoring are not recommended to diagnose GERD. Patients with PPI-refractory symptoms and normal endoscopy require reflux monitoring by pH or pH-impedance to confirm or exclude GERD, and identify treatment failure mechanisms. GERD confounders need to be considered in some patients, pH-impedance can identify supragrastric belching, impedance-manometry can diagnose rumination. CONCLUSIONS: Erosive esophagitis on endoscopy and abnormal pH or pH-impedance monitoring are the most appropriate methods to establish a diagnosis of GERD. Other tools may add useful complementary information.

Severity of Chronic Graft-versus-Host Disease and Late Effects Following Allogeneic Hematopoietic Cell Transplantation for Adults with Hematologic Malignancy.

The study aimed to determine the association of chronic graft-versus-host disease (cGVHD) diagnosis and severity with the development of subsequent neoplasms (SN) and nonmalignant late effects (NM-LE) in 2-year disease-free adult survivors following hematopoietic cell transplantation (HCT) for a hematologic malignancy. To do so, we conducted a retrospective analysis of 3884 survivors of HCT for hematologic malignancy in the Center of International Blood and Marrow Transplant Research database. We conducted a landmark analysis at the 2-year post-transplantation date, comparing first SN and NM-LE in survivors with and without cGVHD. The cumulative incidence (CuI) of SN and NM-LE were estimated through 10 years post-HCT in both groups, with death or disease relapse as a competing risk. Cox proportional hazards models were used to evaluate the associations of cGVHD and its related characteristics with the development of SN and NM-LE. The estimated 10-year CuI of SN in patients with GVHD (n = 2669) and patients without cGVHD (n = 1215) was 15% (95% confidence interval [CI], 14% to 17%) versus 9% (7.2% to 11%) (P < .001). cGVHD by 2 years post-HCT was independently associated with SN (hazard ratio [HR], 1.94; 95% CI, 1.53 to 2.46; P < .0001) with a standardized incidence ratio of 3.2 (95% CI, 2.9 to 3.5; P < .0001). Increasing severity of cGVHD was associated with an increased risk of SN. The estimated 10-year CuI of first NM-LE in patients with and without cGVHD was 28 (95% CI, 26% to 30%) versus 13% (95% CI, 11% to 15%) (P < .001). cGVHD by 2 years post-HCT was independently associated with NM-LE (HR, 2.23; 95% CI, 1.81 to 2.76; P < .0001). Multivariate analysis of cGVHD-related factors showed that increasing severity of cGVHD, extensive grade, having both mucocutaneous and visceral involvement, and receiving cGVHD treatment for >12 months were associated with the greatest magnitude of risk for NM-LE. cGVHD was closely associated with both SN and NM-LE in adult survivors of HCT for hematologic malignancy. Patients identified as having more severe involvement and both mucocutaneous and visceral organ involvement may warrant enhanced monitoring and screening for SNs and NM-LEs. However, caution is warranted when interpreting these results, as patients with cGVHD may have more vigilant post-transplantation health care and surveillance for late effects.