A global analysis of implants and replacements of pacemakers and cardioverter-defibrillators before, during, and after the COVID-19 pandemic in Italy.

At the beginning of the COVID-19 emergency, non-urgent surgical procedures had to be deferred, but also emergencies were reduced. To assess the global trend of pacemaker (PM) and implantable cardiac-defibrillator (ICD) procedures performed in Italy before, during, and after the first COVID-19 emergency, all the Italian hospital discharge records related to PM/ICD procedures performed between 2012 and 2021, sent to the National Institute of Health, were reviewed. Compared to 2019, in 2020, there was a reduction of first PM implants (52,216 to 43,962, -16%; p < 0.01), but not replacements (16,591 to 17,331, + 4%; p = 0.16). In particular, in April 2020, there was a drop of first implants (- 53,4% vs the average value of April 2018 and April 2019; p < 0.01), while the reduction of replacements was less evident (-32.6%; p = NS). In 2021, PM procedures increased to values similar to the pre-pandemic period. A reduction of ICD procedures was observed in 2020 (22,355, -7% toward 2019), mainly in April 2020 (- 46% vs April 2018/April 2019; p = 0.03). In 2021, the rate of ICD procedures increased (+ 14% toward 2020). A non-significant reduction of "urgent" procedures (complete atrioventricular block for PM and ventricular fibrillation for ICD), even in April 2020, was observed. In 2020, there was a reduction of first PM implants and ICDs, offset by increased activity in 2021. No decrease in PM replacements was observed, and the drop in "urgent" PM and ICD procedures was not statistically significant.

National spine surgery registries' characteristics and aims: globally accepted standards have yet to be met. Results of a scoping review and a complementary survey.

BACKGROUND: Surgery involving implantable devices is widely used to solve several health issues. National registries are essential tools for implantable device surveillance and vigilance. In 2017, the European Union encouraged Member States to establish "registries and databanks for specific types of devices" to evaluate device safety and performance and ensure their traceability. Spine-implantable devices significantly impact patient safety and public health; spine registries might help improve surgical outcomes. This study aimed to map existing national spine surgery registries and highlight their features and organisational standards to provide an essential reference for establishing other national registries. METHODS: A scoping search was performed using the Embase, PubMed/Medline, Scopus, and Web of Science databases for the terms "registry", "register", "implantable", and all terms and synonyms related to spinal diseases and national registries in publications from January 2000 to December 2020. This search was later updated and finalised through a web search and an ad hoc survey to collect further detailed information. RESULTS: Sixty-two peer-reviewed articles were included, which were related to seven national spine registries, six of which were currently active. Three additional active national registries were found through the web search. The nine selected national registries were set up between 1998 and 2021. They collect data on the procedure and use patient-reported outcome measures (PROMs) for the follow-up. CONCLUSION: Our study identified nine currently active national spine surgery registries. However, globally accepted standards for developing a national registry of spine surgery are yet to be established. Therefore, an international effort to increase result comparability across registries is highly advisable. We hope the recent initiative from the Orthopaedic Data Evaluation Panel (ODEP) to establish an international collaboration will meet these needs.

Genetic Profiling of Cell-Free DNA in Liquid Biopsies: A Complementary Tool for the Diagnosis of B-Cell Lymphomas and the Surveillance of Measurable Residual Disease.

PURPOSE: To assess the potential value of LiqBio as a complementary tool for diagnosis and surveillance of BCL. METHODS: This prospective multi-center study included 78 patients (25 follicular lymphomas (FL) and 53 large B-cell lymphomas (LBCL)). We performed next-generation sequencing (NGS) of cfDNA LiqBio and paired gDNA tissue biopsies at diagnosis and compared the mutational statuses. Also, through NGS of LiqBio, we identified MRD biomarkers and compared this novel LiqBio-MRD method with PET/CT in detecting MRD at follow-up. RESULTS: We identified mutations in 71% of LiqBio and 95% of tissue biopsies, and found a correlation between variant allele frequency of somatic mutations. Additionally, we identified mutations in 73% of LiqBio from patients with no available tissue samples or no mutations in them. Regarding the utility of LiqBio-MRD as a dynamic monitoring tool, when compared with the PET/CT method, a lower sensitivity was observed for LiqBio-MRD at 92.3% (vs. 100% for PET/CT), but a higher specificity of 91.3% (vs. 86.9% for PET/CT). CONCLUSION: Genetic profiling of tumor cfDNA in plasma LiqBio is a complementary tool for BCL diagnosis and MRD surveillance.

Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review.

BACKGROUND: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of device registries for this Regulation have not been reported. As part of the Coordinating Research and Evidence for Medical Devices (CORE-MD) project, we identified and reviewed European cardiovascular and orthopaedic registries to assess their structures, methods, and suitability as data sources for regulatory purposes. METHODS: Regional, national and multi-country European cardiovascular (coronary stents and valve repair/replacement) and orthopaedic (hip/knee prostheses) registries were identified using a systematic literature search. Annual reports, peer-reviewed publications, and websites were reviewed to extract publicly available information for 33 items related to structure and methodology in six domains and also for reported outcomes. RESULTS: Of the 20 cardiovascular and 26 orthopaedic registries fulfilling eligibility criteria, a median of 33% (IQR: 14%-71%) items for cardiovascular and 60% (IQR: 28%-100%) items for orthopaedic registries were reported, with large variation across domains. For instance, no cardiovascular and 16 (62%) orthopaedic registries reported patient/ procedure-level completeness. No cardiovascular and 5 (19%) orthopaedic registries reported outlier performances of devices, but each with a different outlier definition. There was large heterogeneity in reporting on items, outcomes, definitions of outcomes, and follow-up durations. CONCLUSION: European cardiovascular and orthopaedic device registries could improve their potential as data sources for regulatory purposes by reaching consensus on standardised reporting of structural and methodological characteristics to judge the quality of the evidence as well as outcomes.

A far-reaching Regulation for the Italian National Registry of Implantable Prostheses: a possible model for other health registries.

Medical device registries are major tools for public health, able to provide early warning systems for increasing the patient safety. We are now at the forefront of a final legal and procedural step to design the Regulation of the Italian Implantable Prostheses Registry (RIPI) and to make data collection mandatory. This can ensure prostheses traceability, recall of patients and fuel biomedical and epidemiological research. Data completeness will be greatly improved when the Regulation is issued. At that time, rules for accessing data and subjects/entities allowed to access the Registry will be clearly defined. Therefore, the Regulation content is crucial, with no chance to fail in its design. The thorough expertise gained at the Italian National Institute of Health (Istituto Superiore di Sanità) by the Italian Arthroplasty Registry in terms of scientific, technical and privacy management may represent a prototypical model for other registries. Our aim is to identify a few key issues to shape a far-reaching Regulation that might permit the flexible and dynamic functioning of RIPI providing suggestions for other registries at national and international level.

The rise of registry-based research: a bibliometric analysis.

Background and purpose - The main purpose of arthroplasty registries is to collect information on patients, techniques, and devices to monitor and improve the outcome of the specific procedure. This study analyses the role played by registries in the orthopedic research community and describes publication trends, characteristics, and patterns of this field of research.Patients and methods - A descriptive-bibliometric review was conducted. Scopus was the database used for the research. All articles published from 1991 to December 2020 containing keywords related to registries and arthroplasty were considered. In particular, the following dimensions were analyzed in detail: (i) papers/year; (ii) journals; (iii) countries; (iv) research growth rate; (v) collaboration among countries. VOSviewer software was used to perform the bibliometric analysis. Finally, the 50 most cited papers of the last 10 years were briefly analyzed.Results - 3,933 articles were identified. There has been growing interest in the topic since 2010. Acta Orthopaedica ranked first for the number of articles published. The country with the largest number of articles citing registries was the United States, followed by the United Kingdom and Sweden. The relative number of articles per 100,000 inhabitants is 0.60 for Europe and 0.38 for the United States. The literature in this research area has an average yearly growth rate of 28%.Interpretation - The publication rate in the field of arthroplasty registries is constantly growing with a noteworthy impact in the evolution of this research and clinical area. The growth rate is significantly higher than that of arthroplasty literature (28% vs. 10%) and the collaboration among countries is strong and increasing with time.

Seventeen-year trend (2001-2017) in pacemaker and implantable cardioverter-defibrillator utilization based on hospital discharge database data: An analysis by age groups.

AIMS: To analyze temporal trends (2001 -2017) of Pacemakers (PM) and Implantable Cardioverter-Defibrillators (ICD) procedures in Italy, according to the national Hospital Discharge Database (HDD). METHODS: Frequency and implant rate (IR) in the Italian population were analyzed by age groups (<50, 50-79, ≥80 years). RESULTS: From 2001 (2009 for Cardiac Resynchronization Therapy-Defibrillator - CRT-D) to 2017, first PM implants (1stPM) increased from 36,823 (637/million inhabitants) to 49,716 (820/million), ICD implants from 3,141 (54/million) to 24,255 (400/million) and CRT-D from 2,915 (49/million, 16.5% of ICD) to 8,595 (142/million, 35.4% of ICD). ICD implants due to ventricular tachycardia or ventricular fibrillation decreased from 55.6% to 13.5% and from 15.9% to 4.5% respectively, while the proportion increased among patients with heart failure (from 22.9% to 46.8%), hypertension (from 11.1% to 15.0%), diabetes (from 6.5% to 10.9%), and renal insufficiency (from 4.4% to 7.6%). Both PM and ICD procedures markedly increased in patients ≥80 years old. However, while IR for ICDs increased from 82/million to 1,038/million inhabitants, IR of 1stPM only changed from 6,111/million to 6,212/million as the population in this age group nearly doubled in Italy. CONCLUSION: Since 2001, the increase of 1stPM in Italy was mainly due to the ultra-octogenarian population growth. No differences were observed for IR in each PM age group, while the absolute number and IR increased in all groups (especially ≥80 years old) for ICDs and CRT-Ds. An increase in comorbidities and a reduction in implants for secondary prevention were observed in the ICD population.

[Italian Arthroplasty Registry: learning curve and optimization of data entry procedures.] / Registro Italiano Artroprotesi: curva di apprendimentoe ottimizzazione delle procedure di immissione dei dati.

Arthroplasty registries represent a fundamental tool for the production of evidence in total joint replacement. Italy started in 2005 a national registry (Italian Arthroplasty Registry - RIAP) organised as federation of regional registries under the coordination of the Istituto Superiore di Sanità. However, data collection still appears to be hardened by the additional workload required from clinicians. The aim of the study was to evaluate the data entry times for an inexperienced operator and the relative learning curve. The analysis carried out shows that after 15 cases, a plateau of about two minutes is reached for the compilation of a single case of primary hip and knee arthroplasty, up to 4 minutes for the shoulder and for revision surgery. The work burden for the orthopedist does not seem to justify the reluctance in data collection observed in these years of RIAP experience.

New medical device regulations: the regulator's view.

Advances in medical device technology have been dramatic in recent years resulting in both an increased number of medical devices and an increase in the invasiveness and critical function which devices perform. Two new regulations entered into force in Europe in May 2017, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR). These regulations will replace the current directives over the coming years. These regulations, for the first time introduce requirements relating to registries.Medical device manufacturers are required to have systematic methods for examining their devices once available on the market, by systematically gathering, recording and analysing data on safety and performance.Registries can assist public health protection in very practical ways, for example, to help urgently identify patients or devices. Registries can also be powerful tools for collecting and appraising real-world clinical evidence concerning medical devices. Clinical investigations are limited in terms of the sample size and the duration of follow-up which can reasonably be expected. Registries may also be the only available tool to examine rare adverse effects, sub-populations or for time durations which it is not possible or feasible to study in a clinical investigation. By ensuring that a core dataset is collected which can be compared to other registries or trial data, it is possible to pool data to better examine outcomes. There are a range of excellent initiatives which have aimed at ensuring the appropriate regulatory application of registry data. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180061.

Producing knowledge by admitting ignorance: Enhancing data quality through an "I don't know" option in citizen science.

The "noisy labeler problem" in crowdsourced data has attracted great attention in recent years, with important ramifications in citizen science, where non-experts must produce high-quality data. Particularly relevant to citizen science is dynamic task allocation, in which the level of agreement among labelers can be progressively updated through the information-theoretic notion of entropy. Under dynamic task allocation, we hypothesized that providing volunteers with an "I don't know" option would contribute to enhancing data quality, by introducing further, useful information about the level of agreement among volunteers. We investigated the influence of an "I don't know" option on the data quality in a citizen science project that entailed classifying the image of a highly polluted canal into "threat" or "no threat" to the environment. Our results show that an "I don't know" option can enhance accuracy, compared to the case without the option; such an improvement mostly affects the true negative rather than the true positive rate. In an information-theoretic sense, these seemingly meaningless blank votes constitute a meaningful piece of information to help enhance accuracy of data in citizen science.

Total knee arthroplasty in Italy: reflections from the last fifteen years and projections for the next thirty.

PURPOSE: Annual rates of knee arthroplasty are increasing in all developed countries, imposing a significant economic and organizational burden; it is crucial to forecast the future need for knee arthroplasty, to assist stakeholders in planning strategies and investments, especially in a country like Italy, with the largest proportion of elderly citizens in Europe. Few epidemiological studies have been performed worldwide to estimate the demand for future knee replacement, and a variety of methods have been proposed. METHODS: We investigated the epidemiology of knee arthroplasty performed in Italy in the last 15 years and projected incidence rates up to the year 2050, utilizing, comparing, and adapting the available methodologies. RESULTS: From 2001 to 2016, 812,639 primary TKA were performed in Italy on patients over 40. The total number of surgeries increased by 262% with an average annual growth rate of 6.6%. CONCLUSIONS: Adopting the best fitting projection method, an increase of 45% in incidence rate is expected for 2050.

Matching individual attributes with task types in collaborative citizen science.

In citizen science, participants' productivity is imperative to project success. We investigate the feasibility of a collaborative approach to citizen science, within which productivity is enhanced by capitalizing on the diversity of individual attributes among participants. Specifically, we explore the possibility of enhancing productivity by integrating multiple individual attributes to inform the choice of which task should be assigned to which individual. To that end, we collect data in an online citizen science project composed of two task types: (i) filtering images of interest from an image repository in a limited time, and (ii) allocating tags on the object in the filtered images over unlimited time. The first task is assigned to those who have more experience in playing action video games, and the second task to those who have higher intrinsic motivation to participate. While each attribute has weak predictive power on the task performance, we demonstrate a greater increase in productivity when assigning participants to the task based on a combination of these attributes. We acknowledge that such an increase is modest compared to the case where participants are randomly assigned to the tasks, which could offset the effort of implementing our attribute-based task assignment scheme. This study constitutes a first step toward understanding and capitalizing on individual differences in attributes toward enhancing productivity in collaborative citizen science.

Communicating through Touch: Macro Fiber Composites for Tactile Stimulation on the Abdomen.

Research into sensory substitution systems has expanded, as alternative senses are utilized in real-time to afford object recognition or spatial understanding. Tactile stimulation has long shown promise as a communicatory strategy when applied unobtrusively to the redundant surface areas of the skin. Here, a novel belt, integrating a matrix of macro fiber composites, is purposed to deliver tactile stimuli to the abdomen. The design and development of the belt is presented and a systematic experimental study is conducted to analyze the impact of frequency and duty cycle. The belt is a beta precursor to a soft haptic feedback device that will enable situational awareness and obstacle avoidance through the localization of tactile stimulation relative to a body-centric frame of reference in a local environment.

Cross-cultural adaptation and validation of the Italian version of the Hip disability and Osteoarthritis Outcome Score (HOOS).

OBJECTIVE: To create a translated version of the HOOS to fit the Italian population and to test its psychometric properties and validity in hip osteoarthritis (OA) patients undergoing total hip arthroplasty (THA). DESIGN: The HOOS Italian version was developed according to published international guidelines that include preparation, forward translation and reconciliation, backward translation, review and harmonization, and proof reading. The Italian HOOS was administered to 145 patients (mean age 65.7 ± 11.6 years, 34-89, 58.6% women) undergoing THA. The following psychometric properties were evaluated: internal consistency (Cronbach's alpha); test-retest reliability (Pearson's r and intra-class correlation coefficient, ICC); convergent validity (Spearman's rho between HOOS and SF-36); responsiveness (comparison of pre/post-THA scores, Wilcoxon signed rank test). Interpretability (floor and ceiling effects, skewness and kurtosis indexes) and acceptability (time to compiling, missing answers, and autonomy in compilation) were also evaluated. RESULTS: Translation and transcultural adaptation were conducted in accordance with the international recommendation. The translation was deemed understandable and appropriate as to the transcultural adaptation. None of the patients reported to have met any difficulties in reading and understanding the HOOS items. Internal consistency and test-retest reliability were good for each HOOS subscale (Cronbach's alpha ≥0.7, Pearson's r and ICC > 0.80). Convergent validity showed the highest correlations (Spearman's rho > 0.5) between HOOS and SF-36 subscales relating to similar dimensions. As to responsiveness, all HOOS subscales scores improved significantly after THA (p < 0.01). Interpretability was acceptable despite ceiling effect in post-THA assessment. Acceptability was good: HOOS resulted easy and quick to fill out (12 min on average). CONCLUSIONS: The HOOS was successfully cross-culturally adapted into Italian. The Italian HOOS showed good psychometric properties therefore it can be useful to assess outcomes in OA patients after THA. This study provided a basis for its use within the Italian Arthroplasty Registry and for future clinical trials.

Heart rate at admission is a predictor of in-hospital mortality in patients with acute coronary syndromes: Results from 58 European hospitals: The European Hospital Benchmarking by Outcomes in acute coronary syndrome Processes study.

AIMS: The purpose of this study was to investigate the relationship between heart rate at admission and in-hospital mortality in patients with ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation acute coronary syndrome (NSTE-ACS). METHODS: Consecutive ACS patients admitted in 2008-2010 across 58 hospitals in six participant countries of the European Hospital Benchmarking by Outcomes in ACS Processes (EURHOBOP) project (Finland, France, Germany, Greece, Portugal and Spain). Cardiogenic shock patients were excluded. Associations between heart rate at admission in categories of 10 beats per min (bpm) and in-hospital mortality were estimated by logistic regression in crude models and adjusting for age, sex, obesity, smoking, hypertension, diabetes, known heart failure, renal failure, previous stroke and ischaemic heart disease. In total 10,374 patients were included. RESULTS: In both STEMI and NSTE-ACS patients, a U-shaped relationship between admission heart rate and in-hospital mortality was found. The lowest risk was observed for heart rates between 70-79 bpm in STEMI and 60-69 bpm in NSTE-ACS; risk of mortality progressively increased with lower or higher heart rates. In multivariable models, the relationship persisted but was significant only for heart rates >80 bpm. A similar relationship was present in both patients with or without diabetes, above or below age 75 years, and irrespective of the presence of atrial fibrillation or use of beta-blockers. CONCLUSION: Heart rate at admission is significantly associated with in-hospital mortality in patients with both STEMI and NSTE-ACS. ACS patients with admission heart rate above 80 bpm are at highest risk of in-hospital mortality.

Monitoring Outcome of Joint Arthroplasty in Italy: Implementation of the National Registry.

Purpose Arthroplasty registries have an important role in improving outcomes in joint surgery. As the demand for joint arthroplasty continues to increase, growing attention is being paid to the establishment of national registries, which contribute to the enhancement of the quality of patients' care. Indeed, providing postmarketing surveillance data in terms of safety and effectiveness of medical devices, registries contribute to the best orthopaedic practice and support public health decision making. In this context, a project aimed at implementing a national arthroplasty registry in Italy has appeared to be essential, and the activities performed in the last years have consolidated data collection of hip and knee replacements. Methods Based on a close cooperation among public health institutions, clinicians, and involved stakeholders, the architecture of the registry is built on three pillars: (1) data collected using Hospital Discharge Records (HDRs) integrated by an additional dataset, (2) implants identified and characterized in a dedicated medical devices library, and (3) a federation of regional registries coordinated by a public health institution, the Italian National Institute of Health. Results Besides the organizational structure, statistical analyses on joint arthroplasty from national HDR database (2001-2014) and Italian registry data (2014) are presented. Currently, the institutions participating in the registry on a voluntary basis show 80% of completeness for hip and 58% for knee, and represent approximately 18% of the national volume. Conclusion To make data collection effective, participation should be mandatory and ruled by a national law. Level of Study Level III, observational analytic study.

Percutaneous coronary intervention reduces mortality in myocardial infarction patients with comorbidities: Implications for elderly patients with diabetes or kidney disease.

BACKGROUND: Percutaneous coronary intervention (PCI) reduces mortality in most myocardial infarction (MI) patients but the effect on elderly patients with comorbidities is unclear. Our aim was to analyse the effect of PCI on in-hospital mortality of MI patients, by age, sex, ST elevation on presentation, diabetes mellitus (DM) and chronic kidney disease (CKD). METHODS: Cohort study of 79,791 MI patients admitted at European hospitals during 2000-2014. The effect of PCI on in-hospital mortality was analysed by age group (18-74, ≥75years), sex, presence of ST elevation, DM and CKD, using propensity score matching. The number needed to treat (NNT) to prevent a fatal event was calculated. Sensitivity analyses were conducted. RESULTS: PCI was associated with lower in-hospital mortality in ST and non-ST elevation MI (STEMI and NSTEMI) patients. The effect was stronger in men [Odds ratio (95% confidence interval) 0.30 (0.25-0.35)] than in women [0.46 (0.39-0.54)] aged ≥75years, and in NSTEMI [0.22 (0.17-0.28)] than in STEMI patients [0.40 (0.31-0.5)] aged <75years. PCI reduced in-hospital mortality risk in patients with and without DM or CKD (54-72% and 52-73% reduction in DM and CKD patients, respectively). NNT was lower in patients with than without CKD [≥75years: STEMI=6(5-8) vs 9(8-10); NSTEMI=10(8-13) vs 16(14-20)]. Sensitivity analyses such as exclusion of hospital stays <2days yielded similar results. CONCLUSIONS: PCI decreased in-hospital mortality in MI patients regardless of age, sex, and presence of ST elevation, DM and CKD. This supports the recommendation for PCI in elderly patients with DM or CKD.