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.

Arthroscopic repair of rotator cuff injury with bioabsorbable suture anchor vs. all-suture anchor: a non-inferiority study.

BACKGROUND: Compare all-suture anchors to traditional anchors through clinical and radiological evaluation at pre-established end-points. MATERIALS AND METHODS: We performed a two-arms non-inferiority study on all-suture anchor (2.3 iconix™, Stryker) device with respect to traditional anchor (5.5 healix Advance™ BR, Depuy/Mitek) device under unpaired samples with size equal to 30 patients per group, all suffering from supraspinatus tendon rupture. We administrated DASH (Disabilities of the Arm, Shoulder and Hand); constant; and SST (Simple Shoulder Test) questionnaires in pre-operative, 3 ± 1 months post-intervention and 8 ± 1 months post-intervention. Questionnaires scores were the primary outcome. We also evaluated RMI at 3 and at 8 months after surgery to assess the presence of oedema or any loosening of the implant. RESULTS: All-suture anchor approach has been proven to have non-inferior performances with respect to traditional anchor approach, according to questionnaires scores at the 3-month endpoint. We observed 26 patients with oedema by MRI (18 in control group, 6 in experimental group). In the 8-month endpoint we found persistent edema in 12 patients (all treated with healix), 2 had mobilitazions (healix), 10 had partial retears (8 healix, 2 iconix) and 1 implant failure (healix). CONCLUSIONS: All suture devices have clinical and functional results comparable to traditional devices, while they tend to give fewer complications in terms of bone edema, loosening and retear rate. The effectiveness of all-suture devices should be further investigated in rotator cuff suture arthroscopic revision surgery, given the advantages they offer.

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.

Telerehabilitation Is a Valid Option for Total Knee Arthroplasty Patients: A Retrospective Pilot Study Based on Our Experience during the COVID-19 Pandemic.

INTRODUCTION: Total knee arthroplasty is an effective operation. Post-surgery rehabilitation, based on early and intensive progressive exercise programs, plays a substantial role and telerehabilitation can be an effective safe option. This retrospective study aimed to compare traditional in-presence rehabilitation and telerehabilitation for total knee arthroplasty, based on our experience during the Italian COVID-19 lockdown. MATERIALS AND METHODS: We retrospectively analyzed 164 patients (94 females and 70 males) enrolled in 2020 within 2 weeks after total knee replacement to perform post-operative outpatient rehabilitation. The clinical results of 82 patients (mean age 66.8 ± 10.2 years) performing telerehabilitation with those obtained from a similar cohort of 82 patients (mean age 65.4 ± 11.8 years) performing traditional in-presence outpatient rehabilitation were compared. Clinical outcomes were examined by comparing the gait speed (Time Up and Go-TUG test), the range of motion, the pain intensity (VAS), the functional status (Oxford Knee Score-OKS and Knee injury and Osteoarthritis Outcome Score-KOOS) and the overall satisfaction (Self-administered patient satisfaction scale) 12 weeks after the beginning of the physiotherapeutic protocol. RESULTS: Telerehabilitation was non-inferior to traditional in-presence rehabilitation in all of the investigated areas and no statistical difference in terms of effectiveness was detected at 12 weeks, as confirmed by the respective patient-reported outcome scores such as TUG test (reduced from 20 ± 2 s to 12 ± 1.5 s for the telerehab cohort and from 18 ± 1.5 s to 13.1 ± 2 s for the in-presence rehabilitation one), pain VAS, OKS (improved from 22 ± 1.3 to 36 ± 2.7 for the telerehab cohort and from 23 ± 2.1 to 35.1 ± 4.2 for the in-presence group), KOOS (improved from 46.2 ± 10.2 to 67.4 ± 3.8 for the telerehabilitation cohort and from 48.4 ± 8.4 to 68.3 ± 6.6 for the other group), and the Self-administered patient satisfaction scale (more than two-thirds of patients globally satisfied with the results of their surgery in both groups). CONCLUSION: The telerehabilitation program was effective after total knee replacement and yielded clinical outcomes that were not inferior to conventional outpatient protocols.

Placenta Accreta Spectrum (PAS) Disorder: Ultrasound versus Magnetic Resonance Imaging.

OBJECTIVE: PAS is one of the most dangerous conditions associated with pregnancy and remains undiagnosed before delivery in from half to two-thirds of cases. Correct prenatal diagnosis is essential to reduce the burden of maternal and fetal morbidity. The purpose of our study is to evaluate the accuracy of US and MRI in the diagnosis of PAS. STUDY DESIGN: In this retrospective study, 104 patients with suspected placenta accreta were enrolled and had been investigated with US and MRI. They were divided into four groups: no PAS, accreta, increta, and percreta. RESULTS: Compared to MRI, US results were higher in the diagnosis and in the identification of PAS severity (85% US vs. 80% MRI). For both methods, in the case of posterior placenta, there is greater difficulty in identifying the presence/absence of the disease (67% in both methods) and the severity level (61% US vs. 55% MRI). CONCLUSION: US, properly implemented with the application of defined and standardized scores, can be superior to MRI and absolutely sufficient for the diagnosis of PAS, limiting the use of MRI to a few doubtful cases and to cases in which surgical planning is necessary.

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.

Ultrasonographic Diagnosis of Placenta Accreta Spectrum (PAS) Disorder: Ideation of an Ultrasonographic Score and Correlation with Surgical and Neonatal Outcomes.

The objective of this study was to evaluate a novel ultrasonographic scoring system for the diagnosis of PAS and the prediction of maternal and neonatal outcomes. In this retrospective study, 138 patients with at least one previous caesarean section (CS) and placenta previa were included. They were divided into four groups ranging from Group 0 (Non PAS) to Group 3 (Placenta Percreta) according to the histological or surgical confirmation. Their ultrasound examinations during pregnancy were reviewed according to the nine different ultrasound signs reported by the European Working Group on Abnormally Invasive Placenta. For each parameter, 0 to 2 points were assigned. The sum of the points reflects the severity of PAS with a maximum score of 20. The scoring system revealed good performances in evaluation metrics, with an overall accuracy of 94%. In addition to this, patients' characteristics and surgical and neonatal outcomes were analyzed with an evidence of higher incidence of complications in severe forms. Our study suggests that antenatal ultrasonographic diagnosis of PAS is feasible with sufficient level of accuracy. This will be important in identifying high-risk patients and implementing preventive strategy.