A direct comparison of severe acute respiratory syndrome coronavirus 2 positive patients with a severe acute respiratory syndrome coronavirus 2 negative control group undergoing an operative intervention during the current pandemic is lacking, and a reliable estimate of the assumed difference in morbidity and mortality between both patient categories remains unknown. We included all consecutive patients with a confirmed pre- or postoperative severe acute respiratory syndrome coronavirus 2 positive status (operated in 27 hospitals) and negative control patients (operated in 4 hospitals) undergoing emergency or elective operations. A propensity score-matched comparison of clinical outcomes was performed between severe acute respiratory syndrome coronavirus 2 positive and negative tested patients (control group). Primary outcome was overall 30-day mortality rate between both groups. Main secondary outcomes were overall, pulmonary, and thromboembolic complications. In total, 161 severe acute respiratory syndrome coronavirus 2 positive and 342 control severe acute respiratory syndrome coronavirus 2 negative patients were included in this study. The 30-day overall postoperative mortality rate was greater in the severe acute respiratory syndrome coronavirus 2 positive cohort compared with the negative control group (16% vs 4% respectively; P = .007). After propensity score matching, the severe acute respiratory syndrome coronavirus 2 positive group consisted of 123 patients (median 70 years of age [interquartile range 59–77] and 55% male) were compared with 196 patients in the matched control group (median 69 years (interquartile range 58–75] and 53% male). The 30-day mortality rate and risk were greater in the severe acute respiratory syndrome coronavirus 2 positive group compared with the matched control group (12% vs 4%; P = .009 and odds ratio 3.4 [95% confidence interval 1.5–8.5]; P = .005, respectively). Overall, pulmonary and thromboembolic complications occurred more often in severe acute respiratory syndrome coronavirus 2 positive patients (P < .01). Patients diagnosed with perioperative severe acute respiratory syndrome coronavirus 2 have an increased risk of 30-day mortality, pulmonary complications, and thromboembolic events. These findings serve as an evidence-based argument to postpone elective surgery and selected emergency cases.

We envision this work to assist researchers and medical device developers (beside other stakeholders) to better understand biomaterial‐based medical device development and its approval process proposed by the new MDR and IVDR in the European Union, as more complex biomaterials emerge, with the MDR reflecting the progress in biomaterial discoveries. Additionally, insufficient international harmonization in regulatory laws and poor‐quality data reporting contribute to the problem. This review describes the possible reasons for a slowing biomaterials translational trend observed over the past decades, focusing on the European Market, and suggests a feasible approach for biomaterials‐based medical device translation into the clinic. Suitable solutions to upgrade biomaterial translation to the clinic have not yet been provided by the field: no additional hurdles should be imposed for researchers, clinicians, the medical device industry, and insurance companies, which all should collaborate on bringing innovative solutions to patients. The new MDR and IVDR represent a substantial advancement in ensuring patient safety and reflect a major step forward in healthcare. However, they should not constrain innovation in biomaterials‐based medical device development. Incorporating reverse engineering from patient safety and a ‘safe by design’ (SbD) strategy early into medical device development might lead to a smoother and successful approval process. A solid R&D phase, with an emphasis on device safety and performance assessment, is fundamental to ensure an effective transition into the clinic. We offer an overview of the recently implemented regulations on medical devices and in vitro diagnostics across the EU, describing a shifting paradigm in the field of biomaterials discovery. As more complex biomaterials emerge, suitable regulations will be necessary to keep bringing safe and well‐performing medical solutions to patients.

Background: Continuous telemonitoring of vital signs in a clinical or home setting may lead to improved knowledge of patients’ baseline vital signs and earlier detection of patient deterioration, and it may also facilitate the migration of care toward home. Little is known about the performance of available wearable sensors, especially during daily life activities, although accurate technology is critical for clinical decision-making. Objective: The aim of this study is to assess the data availability, accuracy, and concurrent validity of vital sign data measured with wearable sensors in volunteers during various daily life activities in a simulated free-living environment. Methods: Volunteers were equipped with 4 wearable sensors (Everion placed on the left and right arms, VitalPatch, and Fitbit Charge 3) and 2 reference devices (Oxycon Mobile and iButton) to obtain continuous measurements of heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and temperature. Participants performed standardized activities, including resting, walking, metronome breathing, chores, stationary cycling, and recovery afterward. Data availability was measured as the percentage of missing data. Accuracy was evaluated by the median absolute percentage error (MAPE) and concurrent validity using the Bland-Altman plot with mean difference and 95% limits of agreement (LoA). Results: A total of 20 volunteers (median age 64 years, range 20-74 years) were included. Data availability was high for all vital signs measured by VitalPatch and for HR and temperature measured by Everion. Data availability for HR was the lowest for Fitbit (4807/13,680, 35.14% missing data points). For SpO2 measured by Everion, median percentages of missing data of up to 100% were noted. The overall accuracy of HR was high for all wearable sensors, except during walking. For RR, an overall MAPE of 8.6% was noted for VitalPatch and that of 18.9% for Everion, with a higher MAPE noted during physical activity (up to 27.1%) for both sensors. The accuracy of temperature was high for VitalPatch (MAPE up to 1.7%), and it decreased for Everion (MAPE from 6.3% to 9%). Bland-Altman analyses showed small mean differences of VitalPatch for HR (0.1 beats/min [bpm]), RR (−0.1 breaths/min), and temperature (0.5 °C). Everion and Fitbit underestimated HR up to 5.3 (LoA of −39.0 to 28.3) bpm and 11.4 (LoA of −53.8 to 30.9) bpm, respectively. Everion had a small mean difference with large LoA (−10.8 to 10.4 breaths/min) for RR, underestimated SpO2 (>1%), and overestimated temperature up to 2.9 °C. Conclusions: Data availability, accuracy, and concurrent validity of the studied wearable sensors varied and differed according to activity. In this study, the accuracy of all sensors decreased with physical activity. Of the tested sensors, VitalPatch was found to be the most accurate and valid for vital signs monitoring.

Introduction: Peripheral arterial disease (PAD) may cause symptoms due to impaired tissue perfusion of the lower extremity. So far, assessment of PAD is mainly performed by determination of stenosis or occlusion in the large arteries and does not focus on microcirculation. Several diagnostic techniques have been recently introduced that may enable tissue perfusion measurements in the lower limb; however, most have not yet been implemented in clinical daily practice. This systematic review provides an overview of these diagnostic techniques and their ability to accurately detect PAD by peripheral tissue perfusion. Areas covered: A literature search was performed for articles that described a diagnostic technique to determine tissue perfusion in patients with known PAD compared with healthy controls. Expert opinion: So far, transcutaneous oxygen measurements are most often used to measure tissue oxygenation in PAD patients, but evidence seems too low to define this technique as a gold standard, and implementing this technique for home monitoring is difficult. New potentially suitable diagnostic tests should be non-invasive, contact-free, and quick. Further research is needed for all of these techniques before broad implementation in clinical use is justified, in hospital, and for home monitoring.

Background: Radiographic measurements of initial displacement of tibial plateau fractures and of postoperative reduction are used to determine treatment strategy and prognosis. We assessed the association between radiographic measurements and the risk of conversion to total knee arthroplasty (TKA) at the time of follow-up. Methods: A total of 862 patients surgically treated for tibial plateau fractures between 2003 and 2018 were eligible for this multicenter cross-sectional study. Patients were approached for follow-up, and 477 (55%) responded. The initial gap and step-off were measured on the preoperative computed tomography (CT) scans of the responders. Condylar widening, residual incongruity, and coronal and sagittal alignment were measured on postoperative radiographs. Critical cutoff values for gap and step-off were determined using receiver operating characteristic curves. Postoperative reduction measurements were categorized as adequate or inadequate on the basis of cutoff values in international guidelines. Multivariable analysis was performed to assess the association between each radiographic measurement and conversion to TKA. Results: Sixty-seven (14%) of the patients had conversion to TKA after a mean follow-up of 6.5 ± 4.1 years. Assessment of the preoperative CT scans revealed that a gap of >8.5 mm (hazard ratio [HR] = 2.6, p < 0.001) and step-off of >6.0 mm (HR = 3.0, p < 0.001) were independently associated with conversion to TKA. Assessment of the postoperative radiographs demonstrated that residual incongruity of 2 to 4 mm was not associated with increased risk of TKA compared with adequate fracture reduction of 4 mm resulted in increased risk of TKA. Coronal (HR = 1.6, p = 0.05) and sagittal malalignment (HR = 3.7 p < 0.001) of the tibia were strongly associated with conversion to TKA. Conclusions: Substantial preoperative fracture displacement was a strong predictor of conversion to TKA. Postoperative gaps or step-offs of >4 mm as well as inadequate alignment of the tibia were strongly associated with an increased risk of TKA. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

A vascular graft or endograft infection (VGEI) is a severe complication that can occur after vascular graft or endograft surgery and is associated with high morbidity and mortality rates. A multidisciplinary approach, consisting of a team of vascular surgeons, infectious diseases specialists, medical microbiologists, radiologists, nuclear medicine specialists, and hospital pharmacists, is needed to adequately diagnose and treat VGEI. A structured diagnostic, antibiotic, and surgical treatment algorithm helps clinical decision making and ultimately aims to improve the clinical outcome of patients with a VGEI.