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.

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.

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.

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.

The EUROCARE-5 study on cancer survival in Europe 1999-2007: Database, quality checks and statistical analysis methods.

BACKGROUND: Since 25years the EUROCARE study monitors the survival of cancer patients in Europe through centralised collection, quality check and statistical analysis of population-based cancer registries (CRs) data. The European population covered by the study increased remarkably in the latest round. The study design and statistical methods were also changed to improve timeliness and comparability of survival estimates. To interpret the EUROCARE-5 results on adult cancer patients better here we assess the impact of these changes on data quality and on survival comparisons. METHODS: In EUROCARE-5 the survival differences by area were studied applying the complete cohort approach to data on nearly nine million cancer patients diagnosed in 2000-2007 and followed up to 2008. Survival time trends were analysed applying the period approach to data on about 10 million cancer cases diagnosed from 1995 to 2007 and followed up to 2008. Differently from EUROCARE-4, multiple primary cancers were included and relative survival was estimated with the Ederer II method. RESULTS: EUROCARE-5 covered a population of 232 million resident persons, corresponding to 50% of the 29 participating countries. The population coverage increased particularly in Eastern Europe. Cases identified from death certificate only (DCO) were on average 2.9%, range 0-12%. Microscopically confirmed cases amounted to over 85% in most CRs. Compared to previous methods, including multiple cancers and using the Ederer II estimator reduced survival estimates by 0.4 and 0.3 absolute percentage points, on average. CONCLUSIONS: The increased population size and registration coverage of the EUROCARE-5 study ensures more robust and comparable estimates across European countries. This enlargement did not impact on data quality, which was generally satisfactory. Estimates may be slightly inflated in countries with high or null DCO proportions, especially for poor prognosis cancers. The updated methods improved the comparability of survival estimates between recently and long-term established registries and reduced biases due to informative censoring.

A restricted spectrum of mutations in the SMAD4 tumor-suppressor gene underlies Myhre syndrome.

Myhre syndrome is a developmental disorder characterized by reduced growth, generalized muscular hypertrophy, facial dysmorphism, deafness, cognitive deficits, joint stiffness, and skeletal anomalies. Here, by performing exome sequencing of a single affected individual and coupling the results to a hypothesis-driven filtering strategy, we establish that heterozygous mutations in SMAD4, which encodes for a transducer mediating transforming growth factor ß and bone morphogenetic protein signaling branches, underlie this rare Mendelian trait. Two recurrent de novo SMAD4 mutations were identified in eight unrelated subjects. Both mutations were missense changes altering Ile500 within the evolutionary conserved MAD homology 2 domain, a well known mutational hot spot in malignancies. Structural analyses suggest that the substituted residues are likely to perturb the binding properties of the mutant protein to signaling partners. Although SMAD4 has been established as a tumor suppressor gene somatically mutated in pancreatic, gastrointestinal, and skin cancers, and germline loss-of-function lesions and deletions of this gene have been documented to cause disorders that predispose individuals to gastrointestinal cancer and vascular dysplasias, the present report identifies a previously unrecognized class of mutations in the gene with profound impact on development and growth.

Multiple tumours in survival estimates.

In international comparisons of cancer registry based survival it is common practice to restrict the analysis to first primary tumours and exclude multiple cancers. The probability of correctly detecting subsequent cancers depends on the registry's running time, which results in different proportions of excluded patients and may lead to biased comparisons. We evaluated the impact on the age-standardised relative survival estimates of also including multiple primary tumours. Data from 2,919,023 malignant cancers from 69 European cancer registries participating in the EUROCARE-4 collaborative study were used. A total of 183,683 multiple primary tumours were found, with an overall proportion of 6.3% over all the considered cancers, ranging from 0.4% (Naples, Italy) to 12.9% (Iceland). The proportion of multiple tumours varied greatly by type of tumour, being higher for those with high incidence and long survival (breast, prostate and colon-rectum). Five-year relative survival was lower when including patients with multiple cancers. For all cancers combined the average difference was -0.4 percentage points in women and -0.7 percentage points in men, and was greater for older registries. Inclusion of multiple tumours led to lower survival in 44 out of 45 cancer sites analysed, with the greatest differences found for larynx (-1.9%), oropharynx (-1.5%), and penis (-1.3%). Including multiple primary tumours in survival estimates for international comparison is advisable because it reduces the bias due to different observation periods, age, registration quality and completeness of registration. The general effect of inclusion is to reduce survival estimates by a variable amount depending on the proportion of multiple primaries and cancer site.

A wide difference in cancer survival between middle aged and elderly patients in Europe.

Nowadays the burden of cancer in elderly people has reached an alarming extent. The purpose of this study is comparing cumulative and conditional relative survival in elderly patients between 65 and 84 years and younger adults aged from 55 to 64. Fifty-three cancer registries of 22 European countries, participating in the EUROCARE-3 programme, collected information on the cases diagnosed over the period 1990-1994. We computed cumulative and conditional relative survival for 16 cancer sites. Middle aged patients experienced a better prognosis than the elderly for all cancer sites, in both sexes and the differences were more marked at 1 than 5 years since diagnosis. The very large differences noted in the first period after cancer detection declined in the subsequent years and, when 5-years conditional survival was considered, for several cancers the elderly and younger adults had the same probabilities of surviving. The death relative excess risks (RERs) in the elderly with respect younger individuals were really very high and markedly larger at 1 than 5 years, and in women than men. Genitourinary and gynaecological cancers showed the highest RERs, around 2.0 and between 1.5 and 2.5 respectively. This very high early mortality could be due not only to clinical aspects: the barriers to health care access and a consequent late diagnosis might represent for elderly patients the main determinant of this very large prognostic disadvantage. In conclusion, clinical management of cancer in the elderly remains a major issue to be faced with complex social and health care policies.