Long-term outcomes after hypothermic oxygenated machine perfusion and transplantation of 1,202 donor livers in a real-world setting (HOPE-REAL study).

BACKGROUND & AIMS: Despite strong evidence for improved preservation of donor livers by machine perfusion, longer post-transplant follow-up data are urgently needed in an unselected patient population. We aimed to assess long-term outcomes after transplantation of hypothermic oxygenated machine perfusion (HOPE)-treated donor livers based on real-world data (i.e., IDEAL-D stage 4). METHODS: In this international, multicentre, observational cohort study, we collected data from adult recipients of HOPE-treated livers transplanted between January 2012 and December 2021. Analyses were stratified by donation after brain death (DBD) and donation after circulatory death (DCD), sub-divided by their respective risk categories. The primary outcome was death-censored graft survival. Secondary outcomes included the incidence of primary non-function (PNF) and ischaemic cholangiopathy (IC). RESULTS: We report on 1,202 liver transplantations (64% DBD) performed at 22 European centres. For DBD, a total number of 99 benchmark (8%), 176 standard (15%), and 493 extended-criteria (41%) cases were included. For DCD, 117 transplants were classified as low risk (10%), 186 as high risk (16%), and 131 as futile (11%), with significant risk profile variations among centres. Actuarial 1-, 3-, and 5-year death-censored graft survival rates for DBD and DCD livers were 95%, 92%, and 91%, vs. 92%, 87%, and 81%, respectively (log-rank p = 0.003). Within DBD and DCD strata, death-censored graft survival was similar among risk groups (log-rank p = 0.26, p = 0.99). Graft loss due to PNF or IC was 2.3% and 0.4% (DBD), and 5% and 4.1% (DCD). CONCLUSIONS: This study shows excellent 5-year survival after transplantation of HOPE-treated DBD and DCD livers with low rates of graft loss due to PNF or IC, irrespective of their individual risk profile. HOPE treatment has now reached IDEAL-D stage 4, which further supports its implementation in routine clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05520320. IMPACT AND IMPLICATIONS: This study demonstrates the excellent long-term performance of hypothermic oxygenated machine perfusion (HOPE) treatment of donation after circulatory and donation after brain death liver grafts irrespective of their individual risk profile in a real-world setting, outside the evaluation of randomised-controlled trials. While previous studies have established safety, feasibility, and efficacy against the current standard, according to the IDEAL-D evaluation framework, HOPE treatment has now reached the final IDEAL-D stage 4, which further supports its implementation in routine clinical practice.

Global Overview of Response Rates in Patient and Health Care Professional Surveys in Surgery: A Systematic Review.

OBJECTIVE: Identify key demographic factors and modes of follow-up in surgical survey response. SUMMARY BACKGROUND DATA: Surveys are widely used in surgery to assess patient and procedural outcomes, but response rates vary widely which compromises study quality. Currently there is no consensus as to what the average response rate is and which factors are associated with higher response rates. METHODS: The National Library of Medicine (MEDLINE/PubMed) was systematically searched from Januray 1, 2007 until February 1, 2020 using the following strategy: (((questionnaire) OR survey) AND "response rate") AND (surgery OR surgical). Original survey studies from surgical(-related) fields reporting on response rate were included. Through one-way analysis of variance we present mean response rate per survey mode over time, number of additional contacts, country of origin, and type of interviewee. RESULTS: The average response is 70% over 811 studies in patients and 53% over 1746 doctor surveys. In-person surveys yield an average 76% response rate, followed by postal (65%) and online (46% web-based vs 51% email) surveys. Patients respond significantly more often than doctors to surveys by mail (P < 0.001), email (P = 0.003), web-based surveys (P < 0.001) and mixed mode surveys (P = 0.006). Additional contacts significantly improve response rate in email (P = 0.26) and web-based (P = 0.041) surveys in doctors. A wide variation in response rates was identified between countries. CONCLUSIONS: Every survey is unique, but the main commonality between studies is response rate. Response rates appear to be highly dependent on type of survey, follow-up, geography, and interviewee type.

The learning curve of laparoscopic, robot-assisted and transanal total mesorectal excisions: a systematic review.

BACKGROUND: The standard treatment of rectal carcinoma is surgical resection according to the total mesorectal excision principle, either by open, laparoscopic, robot-assisted or transanal technique. No clear consensus exists regarding the length of the learning curve for the minimal invasive techniques. This systematic review aims to provide an overview of the current literature regarding the learning curve of minimal invasive TME. METHODS: A systematic literature search was performed. PubMed, Embase and Cochrane Library were searched for studies with the primary or secondary aim to assess the learning curve of either laparoscopic, robot-assisted or transanal TME for rectal cancer. The primary outcome was length of the learning curve per minimal invasive technique. Descriptive statistics were used to present results and the MINORS tool was used to assess risk of bias. RESULTS: 45 studies, with 7562 patients, were included in this systematic review. Length of the learning curve based on intraoperative complications, postoperative complications, pathological outcomes, or a composite endpoint using a risk-adjusted CUSUM analysis was 50 procedures for the laparoscopic technique, 32-75 procedures for the robot-assisted technique and 36-54 procedures for the transanal technique. Due to the low quality of studies and a high level of heterogeneity a meta-analysis could not be performed. Heterogeneity was caused by patient-related factors, surgeon-related factors and differences in statistical methods. CONCLUSION: Current high-quality literature regarding length of the learning curve of minimal invasive TME techniques is scarce. Available literature suggests equal lengths of the learning curves of laparoscopic, robot-assisted and transanal TME. Well-designed studies, using adequate statistical methods are required to properly assess the learning curve, while taking into account patient-related and surgeon-related factors.

Evaluation of the learning curve of robot-assisted laparoscopic ventral mesh rectopexy.

BACKGROUND: The current standard treatment for external rectal prolapse and symptomatic high-grade internal rectal prolapse is surgical correction with minimally invasive ventral mesh rectopexy using either laparoscopy or robotic assistance. This study examines the number of procedures needed to complete the learning curve for robot-assisted ventral mesh rectopexy (RVMR) and reach adequate performance. METHODS: A retrospective analysis of all primary RVMR from 2011 to 2019 performed in a tertiary pelvic floor clinic by two colorectal surgeons (A and B) was performed. Both surgeons had previous experience with laparoscopic rectopexy, but no robotic experience. Skin-to-skin operating times (OT) were assessed using LC-CUSUM analyses. Intraoperative and postoperative complications were analyzed using CUSUM analyses. RESULTS: A total of 182 (surgeon A) and 91 (surgeon B) RVMRs were performed in total. There were no relevant differences in patient characteristics between the two surgeons. Median OT was 75 min (range 46-155; surgeon A) and 90 min (range 63-139; surgeon B). The learning curve regarding OT was completed after 36 procedures for surgeon A and 55 procedures for surgeon B. Both before and after completion of the learning curve, intraoperative and postoperative complication rates remained below a predefined acceptable level of performance. CONCLUSIONS: 36 to 55 procedures are required to complete the learning curve for RVMR. The implementation of robotic surgery does not inflict any additional risks on patients at the beginning of a surgeon's learning curve.

Randomized multicenter trial on percutaneous versus open access in endovascular aneurysm repair (PiERO).

BACKGROUND: In endovascular valve and aortic repair, vascular access through a percutaneous approach has become the competing technique to an open surgical approach. The effect on postoperative complications and surgical site infections (SSIs) has been investigated, but randomized evidence is lacking. The objective was to investigate whether percutaneous access of the common femoral artery (CFA) with a percutaneous closure device would decrease the number of SSIs compared with open surgical access of the CFA in endovascular aneurysm repair (EVAR). METHODS: Patients with an abdominal aortic aneurysm suitable for EVAR were randomized to open or percutaneous access of the main device (MD) through the CFA. Through the contralateral side, access was obtained with the other technique than the one for which the MD was randomized. The primary outcome was number of SSIs. Secondary outcomes were wound complications, visual analog scale for pain scores, and standardized wound assessment scores during follow-up. Preoperative screening culture and groin biopsy specimens were obtained from all patients. RESULTS: Both groups contained 137 groins. SSI rate was 1.5% in the open group vs 0% in the percutaneous group. For MDs only, SSI rate was 3.1% (odds ratio, 3.3; 95% confidence interval, 0.31-347; P = .34). Wound complications were comparable in both groups. Neither nasal nor groin Staphylococcus aureus carriage had a significant effect on SSIs, Southampton Wound Assessment score, or visual analog scale score. Adjusted pain score was 0.69 lower, in favor of percutaneous access. Wound assessment was better after 2 weeks (odds ratio, 3.57; 95% confidence interval, 1.02-12.44; P = .046), also in favor of percutaneous access. CONCLUSIONS: Percutaneous access of the CFA does not reduce the number of SSIs. It does, however, reduce pain and improve wound healing with less inflammation 1 day and 2 weeks after EVAR, respectively.

The effect of age on resilience of health-related quality of life among polytrauma patients: a cross-sectional multicenter study.

PURPOSE: The aim of this study was to determine the impact of age on patient-reported health-related quality of life (HRQoL) and the capacity to show resilience-i.e., the ability to adapt to stressful adverse events-after sustaining a polytrauma. METHODS: A cross-sectional multicenter cohort was conducted between 2013 and 2016 that included surviving polytrauma patients (ISS ≥ 16). HRQoL was obtained by the Short Musculoskeletal Function assessment and EuroQol (SMFA and EQ-5D-5L). The effect of age on HRQoL was tested with linear regression analysis. Next, the individual scores were compared with age- and sex-matched normative data to determine whether they showed resilience. Multivariate binary logistic regression was used to assess the effect of age on reaching the normative threshold of the surveys, correcting for several confounders. RESULTS: A total of 363 patients responded (57%). Overall, patients had a mean EQ-5D-5L score of 0.73. With higher age, scores on the SMFA subscales "upper extremity dysfunction," "lower extremity dysfunction" and "daily activities" significantly dropped. Only 42% of patients were classified as being resilient, based on the EQ-5D-5L score. Patients aged 60-69 showed the highest resilience (56%), and those aged 80 + showed the lowest resilience (0%). CONCLUSION: Sustaining a polytrauma leads to a serious decline in HRQoL. Aging is associated with a decline in the physical components of HRQoL. No clear relationship with age was seen on the non-physical components of quality of life. Octogenarians, and to a lesser extent septuagenarians and tricenarians, showed to be very vulnerable groups, with low rates of resilience after surviving a polytrauma.

A clinical decision aid for patients with suspected midfacial and mandibular fractures (the REDUCTION-I study): a prospective multicentre cohort study.

PURPOSE: To assess physical examination findings related to maxillofacial trauma to identify patients at risk of midfacial and mandibular fractures and then to construct a clinical decision aid to rule out the presence of midfacial and mandibular fractures in emergency department patients. METHODS: We performed a prospective multicentre cohort study in four hospitals in the Netherlands, including consecutive patients with maxillofacial trauma. Each patient received a standardized physical examination consisting of 15 and 14 findings for midfacial and mandibular traumas, respectively. Consequently, clinical decision aids were constructed with the focus being on ruling out the presence of midfacial and mandibular fractures, and diagnostic accuracy was calculated. RESULTS: A total of 993 consecutive patients were identified of whom 766 and 280 patients were suspected of midfacial and mandibular fractures, respectively. Midfacial fractures were diagnosed in 339 patients (44.3%), whereas mandibular fractures were observed in 66 patients (23.6%). The decision aid for midfacial trauma consisting of peri-orbital hematoma, epistaxis, ocular movement limitation, infra-orbital nerve paresthesia, palpable step-off and tooth mobility or avulsion, produced a sensitivity of 89.7 (86.0-92.5), a specificity of 42.6 (38.0-47.4), and a negative predictive value of 83.9% (78.4-88.2). The decision aid for mandibular trauma consisting of the angular compression test, axial chin pressure test, objective malocclusion, tooth mobility or avulsion and the tongue blade bite test resulted in a sensitivity of 98.5 (91.9-99.7), a specificity of 34.6 (28.5-41.2), and a negative predictive value of 98.7% (92.8-99.8). CONCLUSION: The constructed clinical decision aids for maxillofacial trauma may aid in stratifying patients suspected for midfacial and mandibular fractures to reduce unnecessary diagnostic imaging. CLINICAL TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov with the identifier NCT03314480.

Structural Validity of the Short Musculoskeletal Function Assessment in Patients With Injuries.

Background: The Short Musculoskeletal Function Assessment (SMFA) is a widely used patient-reported outcome measure, originally having 2 elements of outcome: the function index and the bother index. In multiple studies, it has been argued that the SMFA should be scored using 3, 4, or 6 subscales instead. Therefore, there is inconsistency with the number of underlying dimensions of the SMFA. Objective: The aim of this study was to evaluate the structural validity of the various proposed subscale configurations of the SMFA in a broad range of Dutch patients with injuries. Design: This study used a prospective cohort design. Methods: Participants with injuries were asked to complete the Dutch SMFA (SMFA-NL) at 5 to 8 weeks postinjury. The structural validity of the 6 different factor structures that have been proposed in other studies was evaluated using confirmatory factor analyses. Internal consistency was analyzed using Cronbach alpha. Results: A total of 491 patients participated (response rate = 74%). A 4-factor structure showed an acceptable fit (root-mean-square error of approximation [RMSEA] = 0.070, comparative fit index = 0.973, Tucker-Lewis index = 0.971). Other models, including the original 2-index structure, showed insufficient structural validity in Dutch patients with injuries. The 4-factor structure showed sufficient discriminant validity and good internal consistency (Cronbach alpha ≥ 0.83). Limitations: It is unclear whether conclusions are generalizable across different countries, people who are elderly, and people without injuries. Conclusion: In a broad range of patients with injuries, the SMFA-NL may be best scored and interpreted using a 4-factor structure. Other factor structures showed insufficient structural validity.