Complete vs Culprit-Only Revascularization in Older Patients With Myocardial Infarction and High Bleeding Risk: A Randomized Clinical Trial.

Importance: Patients with high bleeding risk (HBR) have a poor prognosis, and it is not known if they may benefit from complete revascularization after myocardial infarction (MI). Objective: To investigate the benefit of physiology-guided complete revascularization vs a culprit-only strategy in patients with HBR, MI, and multivessel disease. Design, Setting, and Participants: This was a prespecified analysis of the Functional Assessment in Elderly MI Patients With Multivessel Disease (FIRE) randomized clinical trial data. FIRE was an investigator-initiated, open-label, multicenter trial. Patients 75 years or older with MI and multivessel disease were enrolled at 34 European centers from July 2019 through October 2021. Physiology treatment was performed either by angiography- or wire-based assessment. Patients were divided into HBR or non-HBR categories in accordance with the Academic Research Consortium HBR document. Interventions: Patients were randomized to either physiology-guided complete revascularization or culprit-only strategy. Main Outcomes and Measures: The primary outcome comprised a composite of death, MI, stroke, or revascularization at 1 year. Secondary outcomes included a composite of cardiovascular death or MI and Bleeding Academic Research Consortium (BARC) types 3 to 5. Results: Among 1445 patients (mean [SD] age, 81 [5] years; 917 male [63%]), 1025 (71%) met HBR criteria. Patients with HBR were at higher risk for the primary end point (hazard ratio [HR], 2.01; 95% CI, 1.47-2.76), cardiovascular death or MI (HR, 1.89; 95% CI, 1.26-2.83), and BARC types 3 to 5 (HR, 3.28; 95% CI, 1.40-7.64). The primary end point was significantly reduced with physiology-guided complete revascularization as compared with culprit-only strategy in patients with HBR (HR, 0.73; 95% CI, 0.55-0.96). No indication of interaction was noted between revascularization strategy and HBR status for primary and secondary end points. Conclusions and Relevance: HBR status is prevalent among older patients with MI, significantly increasing the likelihood of adverse events. Physiology-guided complete revascularization emerges as an effective strategy, in comparison with culprit-only revascularization, for mitigating ischemic adverse events, including cardiovascular death and MI. Trial Registration: ClinicalTrials.gov Identifier: NCT03772743.

Glucometrics and device satisfaction in children and adolescents with type 1 diabetes using different treatment modalities: A multicenter real-world observational study.

AIMS: To analyze metabolic outcomes, diabetes impact and device satisfaction in children and adolescents with type 1 diabetes in Italy who used different treatment modalities for diabetes care in a real-life context. METHODS: In this multicenter, nationwide, cross-sectional study, 1464 participants were enrolled at a routine visit. The following treatment modalities were considered MDI + SMBG; MDI + CGM; Sensor Augmented Pump Therapy; predictive management of low glucose; Hybrid Closed Loop (HCL); Advanced Hybrid Closed Loop (AHCL). Health related quality of life was evaluated by the Italian version of the Diabetes Impact and Device Satisfaction Scale (DIDS) questionnaire. RESULTS: Patients treated with AID systems were more likely to have HbA1c ≤ 6.5 %, higher percentage of time with glucose levels between 70 and 180 mg/dL, lower percentage of time with glucose levels above 180 mg/dL, higher device satisfaction, and reduced impact of diabetes. All the therapeutic modalities with respect to MDI + CGM, except for MDI + SMBG, contributed to increase the device satisfaction. HCL and AHCL respect to MDI + CGM were associated with lower diabetes impact. CONCLUSION: Real-life use of automated insulin delivery systems is associated with reduced type 1 diabetes impact, increased device satisfaction, and achievement of glycemic goals.

Ozone infiltration as an adjunctive treatment to piezoelectric surgery in the management of medication-related osteonecrosis of the jaws: case series of 29 patients.

PURPOSE: Medication-related osteonecrosis of the jaws has been reported to be associated with bisphosphonate and RANKL inhibitor medications. This prospective clinical study aimed to assess the outcomes of pre-operative ozone infiltration therapy in patients with established MRONJ. METHODS: The treatment protocol for ozone applications were designed as 20 applications ozone infiltration therapy followed by surgical interventions of necrotic tissue debridement using piezoelectric surgery instruments. The evaluation of the results based on the clinical and radiologic specifications considering the necrotic lesion reduction and healing. The study included 31 lesions in 29 patients. The mean follow-up was 23.6 months. RESULTS: 25 lesions out of 31 healed totally without any remissions. The outcomes were not affected by any variables such as gender, age, type of pharmacological treatment, lesion location, and MRONJ staging. The statistically significant results were found among the clinical condition of the patients (p = 0.01) and administration route of medications (p = 0.004). Healing was significantly less in patients that received intra-vascular administrations. Clinical conditions of the patients were divided as osteoporosis, oncologic, and arthritis. Significantly better results were obtained in osteoporosis patients. 38% of the population experienced spontaneous sequestration with signs of improvements and the surgical interventions were canceled. According to the results, total healing of MRONJ lesions was seen in 79% patients (81% lesions). CONCLUSION: Ozone therapy and debridement with Piezoelectric surgery can be considered as a safe and beneficial adjunctive treatment alternative for osteonecrosis lesions in cases of established MRONJ.

Comparison of Mid-Term Prognosis in Intermediate-to-Low-Risk Contemporary Population with Guidelines-Oriented Age Cutoff.

BACKGROUND: Current European guidelines support transcatheter aortic valve implantation (TAVI) in intermediate-to-low-risk patients ≥75 years-old, but its prognostic relevance is unknown. METHODS: Intermediate-to-low-risk (The Society of Thoracic Surgeons score <8%) patients enrolled in the HORSE registry were included. We compared the populations aged under 75 with those over 75. The primary endpoint was all-cause mortality. RESULTS: A total of 2685 patients were included: 280 (8.6%) < 75 and 2405 ≥ 75 years. Through a mean follow-up of 437 ± 381 days, 198 (8.2%) and 23 (8.2%) patients died in the two arms without statistically significant differences (log-rank p = 0.925). At Cox regression analysis, age did not predict the occurrence of all-cause death, neither as a continuous variable (HR 1.01, 95% CI 0.99-1.04, p = 0.294) nor dichotomizing according to the prespecified cutoff of 75 years (HR 0.97, 95% CI 0.63-1.51, p = 0.924). Time-to-event ROC curves showed low accuracy of age to predict all-cause mortality (area under the curve of 0.54 for both 1-year and 2-year outcomes). CONCLUSIONS: TAVI has comparable benefits across age strata for intermediate-to-low-risk patients. The age cutoff suggested by the current guidelines is not predictive of the risk of adverse events during hospital stays or of all-cause mortality through a mid-term follow-up.

Impact of Caloric Restriction in Breast Cancer Patients Treated with Neoadjuvant Chemotherapy: A Prospective Case Control Study.

Background and aims: It is well established that caloric restriction (CR) may influence metabolic and hormonal factors involved in cancer development and progression. Recently, several studies have demonstrated that CR may have a favorable impact on the response to systemic therapy in breast cancer (BC) patients. However, there is a lack of data regarding the influence of CR during neoadjuvant chemotherapy (NACT). Our study's primary aim was to evaluate CR's impact on BC patients undergoing NACT. Secondly, we investigated the nutritional efficacy and safety of this intervention. Methods: We performed a prospective, case-control study in two breast units. A diet group consisting of 39 patients undergoing NACT and CR was enrolled in our study at the same time. CR consisted of a 30% reduction in caloric intake, which increased to 50% on the days before, during, and after the administration of chemotherapy. A control group of 60 patients that underwent the same treatment approach only followed the general dietary recommendations for BC according to WCRF guidelines. The diet group was monitored during the study for both dietary adequacy and weight trends. Results: CR combined with NACT showed a statistically significant therapeutic response in tumor size (OR 2.94, IC 1.07-8.01, p = 0.009) and lymph node status (OR 3.22, IC 1.22-8.56, p = 0.001) compared to NACT alone, even after the adjustment for all biological parameters. Our data also showed the efficacy and safety of this intervention in both anthropometric and biochemical analyses. Conclusions: Patients who adhered to CR showed a better response to NACT, both in the breast and in the axillary lymph nodes, compared to the patients in the control group. Furthermore, the CR diet combined with NACT showed good tolerance and safety.

Transcatheter aortic valve replacement with the self-expanding ACURATE Neo2 in patients with horizontal aorta: Insights from the ITAL-neo registry.

BACKGROUND: Horizontal aorta (HA), defined by an aortic angulation (AA) ≥48°, is associated with worse outcomes particularly after self-expanding (SE) trans-catheter heart valve (THV) implantation. Although the SE ACURATE Neo THV demonstrated favorable procedural success rates in patients with HA, it remains associated with a non-negligible rate of moderate or greater paravalvular leak (PVL). OBJECTIVES: Aim of the study was to assess the performance of ACURATE Neo2 in the setting of HA. METHODS: We performed a multicenter cohort analysis on patients with severe aortic valve stenosis and HA undergoing transcatheter aortic valve replacement (TAVR) with the Neo or Neo2 THV enrolled in the ITAL-neo registry. The primary endpoint was a composite of early safety and clinical efficacy at 30 days according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included the occurrence of moderate or severe PVL and 90-day clinical outcomes. RESULTS: Among 900 patients included in the ITAL-neo registry, 407 exhibited HA; of these, 300 received a Neo THV and 107 a Neo2 THV. HA, irrespective of the THV implanted, emerged as an independent risk factor for developing ≥ moderate PVL. Technical and device success at 30-day follow-up was comparable between groups. However, Neo2 was associated with a significantly lower rate of ≥moderate PVL vs. Neo: (5% vs. 15%; p < 0.001), which was confirmed also at 90-day follow-up. Additionally, no correlation was found between ≥moderate PVL and AA in the Neo2 group, while PVL degree increased proportionally to the AA in the Neo cohort. CONCLUSION: In patients with HA, the new generation Acurate Neo2 THV was associated with a comparable device success rate and a significantly lower rate of ≥moderate PVL, when compared with its predecessor.

The Use of Zirconia for Implant-Supported Fixed Complete Dental Prostheses: A Narrative Review.

The success of implant-supported fixed complete dental prostheses (ISFCDPs) depends on multiple factors: some are related to the fixtures, such as fixture material, surface characteristics, positioning, and type of connection to prosthetic components; others are related to the prostheses, such as design and materials used. Zirconia is a material widely used in fixed prosthodontics, whether on natural teeth or on implants, with excellent results over time. Regarding the use of zirconia for ISFCDPs, the 2018 ITI Consensus Report stated that "implant-supported monolithic zirconia prostheses may be a future option with more supporting evidence". Since CAD/CAM technology and zirconia are being continuously innovated to achieve better results and performances over time, a narrative review of the literature seems necessary to focus research efforts towards effective and durable solutions for implant-supported, full-arch rehabilitations. The objective of the present narrative review was to search the literature for studies regarding the clinical performance of zirconia-based ISFCDPs. According to the results of this review, the use of zirconia for ISFCDPs showed good clinical outcomes, with high survival rates ranging from 88% to 100% and prosthetic complications that were restorable by the clinicians in most cases.

Accuracy of Zygomatic Implant Placement Using a Full Digital Planning and Custom-Made Bone-Supported Guide: A Retrospective Observational Cohort Study.

The aim of the study was to evaluate the accuracy of zygomatic implant placement using customized bone-supported laser-sintered titanium templates. Pre-surgical computed tomography (CT) scans allowed to develop the ideal virtual planning for each patient. Direct metal laser-sintering was used to create the surgical guides for the implant placement. Post-operative CT scans were taken 6 months after surgery to assess any differences between the planned and placed zygomatic implants. Qualitative and quantitative three-dimensional analyses were performed with the software Slicer3D, recording linear and angular displacements after the surface registration of the planned and placed models of each implant. A total of 59 zygomatic implants were analyzed. Apical displacement showed a mean movement of 0.57 ± 0.49 mm on the X-axis, 1.1 ± 0.6 mm on the Y-axis, and 1.15 ± 0.69 mm on the Z-axis for the anterior implant, with a linear displacement of 0.51 ± 0.51 mm on the X-axis, 1.48 ± 0.9 mm on the Y-axis, and 1.34 ± 0.9 mm on the Z-axis for the posterior implant. The basal displacement showed a mean movement of 0.33 ± 0.25 mm on the X-axis, 0.66 ± 0.47 mm on the Y-axis, and 0.58 ± 0.4 mm on the Z-axis for the anterior implant, with a linear displacement of 0.39 ± 0.43 mm on the X-axis, 0.42 ± 0.35 mm on the Y-axis, and 0.66 ± 0.4 mm on the Z-axis for the posterior implant. The angular displacements recorded significative differences between the anterior implants (yaw: 0.56 ± 0.46°; pitch: 0.52 ± 0.45°; roll: 0.57 ± 0.44°) and posterior implants (yaw: 1.3 ± 0.8°; pitch: 1.3 ± 0.78°; roll: 1.28 ± 1.1°) (p < 0.05). Fully guided surgery showed good accuracy for zygomatic implant placement and it should be considered in the decision-making process.

Predictability of intraoral scanner error for full-arch implant-supported rehabilitation.

OBJECTIVES: The present study aimed to analyze the behaviors of three intraoral scanners (IOSs): evaluating the interdistance and axial inclination discrepancies in full-arch scans, predictable errors were searched. MATERIALS AND METHODS: Six edentulous sample models with variable numbers of dental implants were used; reference data were obtained with a coordinate-measuring machine (CMM). Each IOS (i.e., Primescan, CS3600, and Trios3) performed 10 scans per model (180 total scans). The origin of each scan body was used as a reference point to measure interdistance lengths and axial inclinations. Precision and trueness of interdistance measurements and axial inclinations were evaluated to address error predictability. Bland-Altman analysis, followed by linear regression analysis and Friedman's test (plus Dunn's post hoc correction), was performed to evaluate the precision and trueness. RESULTS: Regarding interdistance, Primescan showed the best precision (mean ± SD: 0.047 ± 0.020 mm), while Trios3 underestimated the reference value more than the others (p < 0.001) and had the worst performance (mean ± SD: -0.079 ± 0.048 mm). Concerning the inclination angle, Primescan and Trios3 tended to overestimate angle values, while CS3600 underestimated them. Primescan had fewer inclination angle outliers, but it tended to add 0.4-0.6° to the measurements. CONCLUSIONS: IOSs showed predictable errors: they tended to overestimate or underestimate linear measurements and axial inclinations of scan bodies, one added 0.4-0.6° to the angle inclination values. In particular, they showed heteroscedasticity, a behavior probably related to the software or the device itself. CLINICAL SIGNIFICANCE: IOSs showed predictable errors that could affect clinical success. When performing a scan or choosing a scanner, clinicians should clearly know their behaviors.

A sustainable approach to enhance heavy hydrocarbons removal in landfarming treatment.

The present study aimed to evaluate the best strategy to enhance the degradation rate of heavy petroleum hydrocarbons (HPH) contaminated soil in a landfarming plant. Samples of real contaminated soil, further spiked with HPH, were treated in mesocosm reactors simulating the landfarming system. One reactor was operated without any modification compared to the real landfarming plant. The other three reactors were operated with different strategies to improve the removal rate: biostimulation (BS) through the addition of nitrogen and phosphorus; bioaugmentation (BA) with the inoculation of sludge produced in the treatment of the process water from the oil re-fining plant of the same industrial area; combination of biostimulation and bioaugmentation (BAS). The biostimulation (BS) was the most effective strategy, leading to a reduction of the remediation time by 35% as compared to the traditional treatment. Bioaugmentation (BA) also provided positive effects leading to a reduction of the remediation time by 24%; its performance improved further when the addition of sludge was combined with the increase of phosphorous (BAS). Therefore, the key tool was represented by the phosphorous availability, whereas the application of sludge was most useful to provide waste with a new possibility of reuse, thus fulfilling the principles of the circular economy. The final characterization showed that the treated soil was suitable for reuse in industrial areas according to the legislation in force.

Clinical outcomes of left atrial appendage occlusion in patients with previous intracranial or gastrointestinal bleeding: Insights from the LOGIC (Left atrial appendage Occlusion in patients with Gastrointestinal or IntraCranial bleeding) International Multicenter Registry.

AIMS: To compare outcomes of patients who underwent left atrial appendage occlusion (LAAO) for nonvalvular atrial fibrillation (NVAF) and contraindication to anticoagulants due to history of either gastrointestinal (GI) or intracranial (IC) bleeding. METHODS: Patients with NVAF that underwent LAAO for GI or IC bleeding from seven centers were included in this observational study. Baseline characteristics, procedural features, and follow-up data were collected, and compared between the two groups. The primary outcomes were incidence of ischemic and hemorrhagic events at 12-month. RESULTS: Six hundred twenty-eight patients were included, 57% with previous GI-bleeding, and 43% with previous IC-bleeding. Median CHA 2 DS 2-VASc score was 4 (interquartile range [IQRs]: 3-5) for both GI-bleeding and IC-bleeding patients, while GI-bleeding patients had a higher HAS-BLED score (4 [IQRs: 3-4] vs. 3 [IQRs]: 2-3]; p = 0.001). At 12-month follow-up, relative risk reduction for stroke was similar between the two groups. The GI-bleeding group had more hemorrhagic events compared to IC-bleeding group (any bleeding 8.4% vs. 3.2%; p = 0.012; major bleeding BARC 3-5: 4.3% vs. 1.8; p = 0.010). At multivariate analysis history of GI bleeding was an independent predictor of hemorrhagic events (adjusted HR: 2.39, 95% confidence interval: 1.02-5.63; p = 0.047). CONCLUSIONS: Outcomes after LAAO may be affected by the different indications for the procedure. In our study, GI-bleeding and IC-bleeding as indication to LAAO differ in their baseline characteristics. LAAO confirms its efficacy in ischemic risk reduction in both groups, while GI bleeding seems to be an independent predictor of bleeding recurrence at 12 months behind the antithrombotic regimen.

Long Stent Implantation on the Left Anterior Descending Coronary Artery at a Follow-Up of More Than Five Years.

BACKGROUND: Stent implantation represents the standard of care in coronary intervention. While a short stent implanted on a focal lesion located on the left anterior descending artery (LAD) seems a reasonable alternative to an internal mammary implant, the same for long stents is still debated. METHODS: We reported the long-term data of 531 consecutive patients who underwent Percutaneous Coronary Intervention (PCI) with long stents in two highly specialized centres. The main inclusion criteria were the implantation of stents longer than 30 mm on the LAD and a minimum follow-up (FU) of five years. The primary endpoint was mortality, and the secondary endpoints were any myocardial infarction (MI), target vessel and lesion revascularization (TVR and TLR, respectively), and stent thrombosis (ST) observed as definite, probable, or possible. RESULTS: In this selected population with characteristics of complex PCI (99.1%), the long-term follow-up (mean 92.18 ± 35.5 months) estimates of all-cause death, cardiovascular death, and any myocardial infarction were 18.3%, 10.5%, and 9.3%, respectively. Both all-cause and cardiovascular deaths are significantly associated with three-vessel disease (HR 6.8; confidence of interval (CI) 95% 3.844-11.934; p < 0.001, and HR 4.7; CI 95% 2.265-9.835; p < 0.001, respectively). Target lesion (TLR) and target vessel revascularization (TVR) are associated with the presence of three-lesion disease on the LAD (HR 3.4; CI 95% 1.984-5.781; p < 0.001; HR 3.9 CI 95% 2.323-6.442; p < 0.001, respectively). Re-PCI for any cause occurred in 31.5% of patients and shows an increased risk for three-lesion stenting (HR 4.3; CI 95% 2.873-6.376; p < 0.001) and the treatment of bifurcation with two stents (HR 1.6; 95% CI 1.051-2.414; p = 0.028). Stent thrombosis rate at the 5-year FU was 4.4% (1.3% definite; 0.9% probable; 2.1% possible), including a 1.7% rate of very-late thrombosis. The stent length superior to 40 mm was not associated with poor outcomes (all-cause death p = 0.349; cardiovascular death p = 0.855; MI p = 0.691; re-PCI p = 0.234; TLR p = 0.805; TVR p = 0.087; ST p = 0.189). CONCLUSION: At an FU of longer than five years, patients treated with stents longer than 30 mm in their LAD showed acceptable procedural results but poor outcomes.

Coronary access following ACURATE neo implantation for transcatheter aortic valve-in-valve implantation: Ex vivo analysis in patient-specific anatomies.

Background: Coronary access after transcatheter aortic valve implantation (TAVI) with supra-annular self-expandable valves may be challenging or un-feasible. There is little data concerning coronary access following transcatheter aortic valve-in-valve implantation (ViV-TAVI) for degenerated surgical bioprosthesis. Aims: To evaluate the feasibility and challenge of coronary access after ViV-TAVI with the supra-annular self-expandable ACURATE neo valve. Materials and methods: Sixteen patients underwent ViV-TAVI with the ACURATE neo valve. Post-procedural computed tomography (CT) was used to create 3D-printed life-sized patient-specific models for bench-testing of coronary cannulation. Primary endpoint was feasibility of diagnostic angiography and PCI. Secondary endpoints included incidence of challenging cannulation for both diagnostic catheters (DC) and guiding catheters (GC). The association between challenging cannulations with aortic and transcatheter/surgical valve geometry was evaluated using pre and post-procedural CT scans. Results: Diagnostic angiography and PCI were feasible for 97 and 95% of models respectively. All non-feasible procedures occurred in ostia that underwent prophylactic "chimney" stenting. DC cannulation was challenging in 17% of models and was associated with a narrower SoV width (30 vs. 35 mm, p < 0.01), STJ width (28 vs. 32 mm, p < 0.05) and shorter STJ height (15 vs. 17 mm, p < 0.05). GC cannulation was challenging in 23% of models and was associated with narrower STJ width (28 vs. 32 mm, p < 0.05), smaller transcatheter-to-coronary distance (5 vs. 9.2 mm, p < 0.05) and a worse coronary-commissural overlap angle (14.3° vs. 25.6 o , p < 0.01). Advanced techniques to achieve GC cannulation were required in 22/64 (34%) of cases. Conclusion: In this exploratory bench analysis, diagnostic angiography and PCI was feasible in almost all cases following ViV-TAVI with the ACURATE neo valve. Prophylactic coronary stenting, higher implantation, narrower aortic sinus dimensions and commissural misalignment were associated with an increased challenge of coronary cannulation.

Balloon-Assisted Crossing of a Severely Calcified Aortic Valve During Transcatheter Balloon-Expandable Bioprosthesis Implantation.

A 91-year-old man presented with syncope secondary to severe aortic stenosis. A transthoracic echocardiogram revealed a calcified stenotic trileaflet aortic valve (AV) with a mean gradient of 60 mm Hg and cardiac computed tomography demonstrated a heavily calcified trileaflet AV without commissural fusion. Following heart team discussion, transfemoral transcatheter AV replacement (TAVR) was the preferred option in view of the patient's age. Due to the severe aortic leaflet calcifications, a balloon-expandable 32-mm Myval transcatheter heart valve (Meril Life Sciences) implantation preceded by balloon predilation was planned. After numerous catheter and wire exchanges, the transcatheter heart valve was finally implanted with a good final result.

Corrigendum: The silent epidemic of diabetic ketoacidosis at diagnosis of type 1 diabetes in children and adolescents in italy during the covid-19 pandemic in 2020.

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The Silent Epidemic of Diabetic Ketoacidosis at Diagnosis of Type 1 Diabetes in Children and Adolescents in Italy During the COVID-19 Pandemic in 2020.

Aim/Hypothesis: To compare the frequency of diabetic ketoacidosis (DKA) at diagnosis of type 1 diabetes in Italy during the COVID-19 pandemic in 2020 with the frequency of DKA during 2017-2019. Methods: Forty-seven pediatric diabetes centers caring for >90% of young people with diabetes in Italy recruited 4,237 newly diagnosed children with type 1 diabetes between 2017 and 2020 in a longitudinal study. Four subperiods in 2020 were defined based on government-imposed containment measures for COVID-19, and the frequencies of DKA and severe DKA compared with the same periods in 2017-2019. Results: Overall, the frequency of DKA increased from 35.7% (95%CI, 33.5-36.9) in 2017-2019 to 39.6% (95%CI, 36.7-42.4) in 2020 (p=0.008), while the frequency of severe DKA increased from 10.4% in 2017-2019 (95%CI, 9.4-11.5) to 14.2% in 2020 (95%CI, 12.3-16.4, p<0.001). DKA and severe DKA increased during the early pandemic period by 10.4% (p=0.004) and 8% (p=0.002), respectively, and the increase continued throughout 2020. Immigrant background increased and high household income decreased the probability of presenting with DKA (OR: 1.55; 95%CI, 1.24-1.94; p<0.001 and OR: 0.60; 95 CI, 0.41-0.88; p=0.010, respectively). Conclusions/Interpretation: There was an increase in the frequency of DKA and severe DKA in children newly diagnosed with type 1 diabetes during the COVID-19 pandemic in 2020, with no apparent association with the severity of COVID-19 infection severity or containment measures. There has been a silent outbreak of DKA in children during the pandemic, and preventive action is required to prevent this phenomenon in the event of further generalized lockdowns or future outbreaks.

Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry.

OBJECTIVES: The aim of this study was to evaluate outcomes of real-world patients with aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR) with the 34 mm Evolut R (Medtronic, Minneapolis, Minnesota). BACKGROUND: Larger aortic annulus has been associated with increased incidence of paravalvular leaks (PVLs) after TAVR. However, little is known, so far, about the performance of the 34 mm Evolut R in this setting. METHODS: From the multicenter, international, retrospective Horizontal Aorta in Transcatheter Self-expanding Valves (HORSE) registry, including patients who underwent TAVR for native severe AS, we selected patients treated with the 34 mm Evolut R evaluating procedural characteristics and VARC-2 defined device success. We also compared 34 mm Evolut R with other Evolut R sizes. RESULTS: Among the 4434 patients included in the registry, 572 (13%) received the 34 mm Evolut R valve. Mean age was 80.8 ± 6.5 years and the median STS PROM score was 4 [interquartile range 2-6]. Device success was achieved in 87.4% with 7.7% of PVLs; moreover, the rate of permanent pacemaker implantation (PPMI) was 22.4%. Patients who underwent 34 mm Evolut R implantation experienced more in-hospital permanent pacemaker implantation (22.4% vs. 15%; p < 0.001). At multivariate analysis, 34 mm Evolut R did not affect device success (OR: 0.81 [0.60-1.09]; p = 0.151). Device success was consistent with other THVs sizes (87.4% vs. 89.6%; p = 0.157). CONCLUSIONS: THV replacement in patients requiring 34 mm Evolut R has an acceptable performance. Compared to other Medtronic sizes it demonstrated to be comparable in terms of device success, despite an increased rate of pacemaker implantation.