1-year Outcomes Research Articles

Comparison of Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents: 5-Year Outcomes From the BIONICS and NIREUS Trials.

The BIONICS (BioNIR Ridaforolimus-Eluting Coronary Stent System in Coronary Stenosis) and the NIREUS (BioNIR Ridaforolimus Eluting Coronary Stent System [BioNIR] European Angiography Study) randomized clinical trials showed noninferiority of the ridaforolimus-eluting stent (RES) compared with the zotarolimus-eluting stent (ZES) with respect to 1-year target-lesion failure and 6-month angiographic late lumen loss. We aimed to evaluate clinical outcomes between treatment groups over a 5-year follow-up. Patient-level data from the BIONICS (n=1919) and NIREUS (n=302) were pooled, comparing the outcomes of patients implanted with RES and ZES. The primary end point was the 5-year rate of target-lesion failure. A total of 2221 patients (63.2±10.3 years, 79.7% men) undergoing percutaneous coronary intervention with RES (n=1159) or ZES (n=1062) were included. Most clinical and angiographic characteristics were similar between groups. At 5 years, the primary end point of target-lesion failure was similar between treatment groups (12.2% RES versus 11.3% ZES, P=0.52). Rates of TLR (7.6% RES versus 6.8% ZES, P=0.42) target-vessel-related myocardial infarction (4.8% RES versus 4.9% ZES, P=0.95) and stent thrombosis (0.9% RES versus 0.9% ZES, P=0.87) also did not differ between groups. Target-vessel revascularization and cardiac death were higher among the RES group (12.3% versus 9.5% P=0.037, and 3.6% versus 2.2% P=0.042, respectively). However, after correction for baseline characteristics, there was no significant difference in cardiac death between groups. In a pooled analysis of 2 randomized trials, 5-year clinical outcomes were similar between patients undergoing percutaneous coronary intervention with RES and ZES. These results support the long-term safety and efficacy of RES for the treatment of patients with coronary artery disease.

Interwoven nitinol stent-assisted arteriovenous fistula maturation: 2 year-outcomes of a single center experience.

The aim of this study was to report 2-year outcomes of interwoven nitinol (SuperaTM) stent-assisted arteriovenous fistula (AVF) maturation in patients who presented with non-matured AVF. We reviewed the clinical data of 20 patients who presented with non-matured AVF (19 patients with brachiocephalic AVF and 1 patient with radiocephalic AVF) and underwent balloon angioplasty followed by SuperaTM stenting in the cephalic vein for long-term hemodialysis between January 2017 and January 2022. The outcomes were evaluated in these patients in terms of technical success, post-intervention complications, reintervention, and cumulative patency (6months, 1year, and 2years). The study included 20 patients who presented with non-matured AVF. The mean age of the patients was 65 years (range, 40-85). The SuperaTM stents of size 6.5mm were used in 15 patients (75%), and those of 7.5mm and 5.5mm were used in 4 (20%) and 1 (5%) patient, respectively. The average stent length was 99.5mm (range, 80-120). Technical success was achieved in all patients. Early use within 1 week by needling at the SuperaTM stent segment (cannulation zone) was successful in all patients without any complications. The mean follow-up time was 24.5 months. During the follow-up period, reinterventions to maintain the function of AVF were performed in 8 patients (40%) (7 patients with juxta-anastomotic stenosis, 1 patient with in-stent restenosis). The reintervention rate was 0.39 procedures per patient per year. The primary patency at 6 months, 1 year, and 2 years were 85.5%, 62.6%, and 54.2%, respectively. The assisted primary patency at 6 months, 1 year, and 2 years were 95%, 84.5%, and 78.8%, respectively. The use of the SuperaTM stent to improve the AVF maturation rate was associated with acceptable outcomes at 2 years. Its benefit over other strategies was the early use of the access for hemodialysis.

Tirzepatide for Obesity Treatment and Diabetes Prevention.

Obesity is chronic disease and causal precursor to myriad other conditions, including type 2 diabetes. In an earlier analysis of the SURMOUNT-1 trial, tirzepatide was shown to provide substantial and sustained reductions in body weight in persons with obesity over a 72-week period. Here, we report the 3-year safety outcomes with tirzepatide and its efficacy in reducing weight and delaying progression to type 2 diabetes in persons with both obesity and prediabetes. We performed a phase 3, double-blind, randomized, controlled trial in which 2539 participants with obesity, of whom 1032 also had prediabetes, were assigned in a 1:1:1:1 ratio to receive tirzepatide at a once-weekly dose of 5 mg, 10 mg, or 15 mg or placebo. The current analysis involved the participants with both obesity and prediabetes, who received their assigned dose of tirzepatide or placebo for a total of 176 weeks, followed by a 17-week off-treatment period. The three key secondary end points, which were controlled for type I error, were the percent change in body weight from baseline to week 176 and onset of type 2 diabetes during the 176-week and 193-week periods. At 176 weeks, the mean percent change in body weight among the participants who received tirzepatide was -12.3% with the 5-mg dose, -18.7% with the 10-mg dose, and -19.7% with the 15-mg dose, as compared with -1.3% among those who received placebo (P<0.001 for all comparisons with placebo). Fewer participants received a diagnosis of type 2 diabetes in the tirzepatide groups than in the placebo group (1.3% vs. 13.3%; hazard ratio, 0.07; 95% confidence interval [CI], 0.0 to 0.1; P<0.001). After 17 weeks off treatment or placebo, 2.4% of the participants who received tirzepatide and 13.7% of those who received placebo had type 2 diabetes (hazard ratio, 0.12; 95% CI, 0.1 to 0.2; P<0.001). Other than coronavirus disease 2019, the most common adverse events were gastrointestinal, most of which were mild to moderate in severity and occurred primarily during the dose-escalation period in the first 20 weeks of the trial. No new safety signals were identified. Three years of treatment with tirzepatide in persons with obesity and prediabetes resulted in substantial and sustained weight reduction and a markedly lower risk of progression to type 2 diabetes than that with placebo. (Funded by Eli Lilly; SURMOUNT-1 ClinicalTrials.gov number, NCT04184622.).

Abstract 4129533: Phenotypes and clinical outcome of heart failure with preserved ejection fraction (HFpEF) patients in China: Findings from the Chinese Cardiovascular Association Database-Heart Failure Center Registry

Background: Heart failure with preserved ejection fraction (HFpEF) is a heterogenous syndrome with 5 phenotypes. We aimed to evaluate the clinical outcome of HFpEF patients with various phenotypes in China. Methods and Results: Data from the Chinese Cardiovascular Association (CCA) Database-HF Center Registry between January 2017 and December 2021 were analyzed, 51,466 hospitalized HFpEF patients with 1-year follow-up results were included in this analysis. The patients were categorized into five phenotypes based on published phenotyping method. Clinical characteristics and 1-year outcome and related risk factors of HFpEF patients with various phenotypes were explored. Results demonstrated significant differences in baseline characteristics and clinical outcomes among the phenotypes, patients with phenotype-3 (right heart and pulmonary-related HFpEF), phenotype-4 (valvular- and rhythm-related HFpEF) and phenotype-5 (extracardiac disease-related HFpEF) exhibited high incidence of adverse outcomes. Phenotype-3 and -4 exhibited high risk of heart failure rehospitalization, whereas phenotype-5 showed high cardiovascular mortality. The independent prognostic risk factors varied across different phenotypes as well. Conclusion: One-year outcome differs among HFpEF patients with various phenotyping. Future studies are warranted to validate if personalized treatment strategies based on HFpEF phenotypes could improve the individual outcome of HFpEF patients, especially for phenotype-3, -4 and -5 HFpEF patients. Keywords: Heart failure with preserved ejection fraction, phenotype, prognosis, population study, risk factors.

Extracerebral Normalization of 18F-FDG PET Imaging Combined with Behavioral CRS-R Scores Predict Recovery from Disorders of Consciousness.

Identifying patients likely to regain consciousness early on is a challenge. The assessment of consciousness levels and the prediction of wakefulness probabilities are facilitated by 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET). This study aimed to develop a prognostic model for predicting 1-year postinjury outcomes in prolonged disorders of consciousness (DoC) using 18F-FDG PET alongside clinical behavioral scores. Eighty-seven patients with prolonged DoC newly diagnosed with behavioral Coma Recovery Scale-Revised (CRS-R) scores and 18F-FDG PET/computed tomography (18F-FDG PET/CT) scans were included. PET images were normalized by the cerebellum and extracerebral tissue, respectively. Images were divided into training and independent test sets at a ratio of 5:1. Image-based classification was conducted using the DenseNet121 network, whereas tabular-based deep learning was employed to train depth features extracted from imaging models and behavioral CRS-R scores. The performance of the models was assessed and compared using the McNemar test. Among the 87 patients with DoC who received routine treatments, 52 patients showed recovery of consciousness, whereas 35 did not. The classification of the standardized uptake value ratio by extracerebral tissue model demonstrated a higher specificity and lower sensitivity in predicting consciousness recovery than the classification of the standardized uptake value ratio by cerebellum model. With area under the curve values of 0.751 ± 0.093 and 0.412 ± 0.104 on the test sets, respectively, the difference is not statistically significant (P = 0.73). The combination of standardized uptake value ratio by extracerebral tissue and computed tomography depth features with behavioral CRS-R scores yielded the highest classification accuracy, with area under the curve values of 0.950 ± 0.027 and 0.933 ± 0.015 on the training and test sets, respectively, outperforming any individual mode. In this preliminary study, a multimodal prognostic model based on 18F-FDG PET extracerebral normalization and behavioral CRS-R scores facilitated the prediction of recovery in DoC.

Efficacy and safety of upadacitinib in patients with active ankylosing spondylitis refractory to biologic therapy: 2-year clinical and radiographic results from the open-label extension of the SELECT-AXIS 2 study.

The efficacy and safety of upadacitinib in patients with ankylosing spondylitis (AS) and inadequate response/intolerance to biologic disease-modifying antirheumatic drugs (bDMARD-IR) were evaluated through 1 year in the SELECT-AXIS 2 study. Here, we assess 2-year efficacy, safety, and imaging outcomes in SELECT-AXIS 2. Patients who received continuous upadacitinib, and those who switched from placebo to upadacitinib at week 14, could enter the open-label extension (OLE). Efficacy endpoints included Assessment of SpondyloArthritis international Society (ASAS) and Axial Spondyloarthritis Disease Activity Score (ASDAS) responses, and changes from baseline in measures of disease activity, back pain, function, and quality of life. Radiographic progression was evaluated using the modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS). As observed (AO) and AO with non-responder imputation (AO-NRI) analyses were used for binary endpoints; AO with mixed-effects model for repeated measures (AO-MMRM) for continuous endpoints; and AO-analysis of covariance for mSASSS. Treatment-emergent adverse events (TEAEs) in patients receiving ≥ 1 upadacitinib dose through week 104 are presented as events (E)/100 patient-years (PY). Subgroup analyses were performed by prior tumor necrosis factor/interleukin-17 inhibitor exposure and bDMARD lack of efficacy/intolerance. Of 420 patients who entered the bDMARD-IR AS study, 409 entered the OLE, and 331 (continuous upadacitinib, n = 163; placebo to upadacitinib, n = 168) completed week 104. Improvements in efficacy measures were sustained through the OLE, with similar response rates between the continuous upadacitinib and placebo to upadacitinib groups at week 104. At week 104, 64.9% and 61.7% of patients, respectively, had achieved ASAS 40% response (AO-NRI). Mean changes from baseline were similar between the two groups at week 104 across measures (ASDAS: -2.1 and -2.0; total back pain: -4.9 and -4.6, respectively; AO-MMRM). Over 93.0% of patients showed no radiographic progression (mSASSS mean change from baseline < 2) at week 104. The overall TEAE rate was 165.2 E/100 PY, with low rates of major adverse cardiovascular and venous thromboembolic events (0.3 E/100 PY each). Upadacitinib efficacy, including very low rates of radiographic progression, was demonstrated through 104 weeks in treatment-refractory patients with active AS. Treatment was well tolerated, with no newly identified safety signals. NCT04169373.

Abstract 4122710: Impact of cigarette smoking on long-term clinical outcomes in patients with coronary chronic total occlusion lesions

Cigarette smoking is a significant risk factor for coronary artery disease (CAD). However, evidence regarding on the long-term clinical effects of smoking in the Asian population with chronic total coronary occlusion (CTO) is insufficient. This study aimed to assess the effects of smoking on 5-year (median follow-up period 4.2 ± 1.5 years, interquartile range 4.06-5.0 years) clinical outcomes in patients with CTO lesions who had undergone percutaneous coronary intervention (PCI) or medical treatment (MT). We enrolled 681 consecutive patients with CTO who had undergone diagnostic coronary angiography and subsequent PCI or MT. Patients were categorized into smokers (n = 304) and non-smokers (n = 377). The primary endpoint encompassed major adverse cardiovascular events (MACE), including a composite of all-cause death, myocardial infarction (MI), and revascularization over a 5-year period. Propensity score matching (PSM) analysis was used to adjust for potential baseline confounders. After PSM analysis, two propensity-matched groups (200 pairs, n = 400) were generated, and the baseline characteristics of both groups were balanced. The smokers exhibited a higher cardiovascular risk of MACE (29.5% vs. 18.5%, p = 0.010) and non-target vessel revascularization (17.5 vs. 10.5%, p = 0.044) than those of the non-smokers(Table 1). In a landmark analysis using Kaplan-Meier (KM) curvesat the 1-year, the smokers had significantly higher rate of MACE in early period (up to 1-year) (18.8% and 9.2%, p=0.008) compared with non-smokers(Figure 1). Cox hazard regression analysis by propensity score-adjustedwith , revealed that smoking was independently associated with an increased risk of MACE. The findings indicate that smoking is a strong cardiovascular risk factor in patients with CTO, regardless of treatment strategies (PCI or MT) (Figure 2). In addition, in a subgroup analysis, the risk of MACE was most prominently elevated in the group of smokers who underwent PCI.

Abstract 4139177: Five-Year Clinical Outcomes of Balloon-Expandable versus Self-Expanding Transcatheter Aortic Valve Replacement in Patients with Small Aortic Annulus

Introduction: Self-expanding transcatheter aortic valves (SEV) have reportedly better hemodynamic outcomes, and similar clinical outcomes compared to balloon-expanding valves (BEV) at 1 year in patients with a small aortic annulus based on results from the SMART trial. Head-to-head comparison of long-term clinical outcomes, however, is lacking. Objectives: To compare the long-term (5 years) echocardiographic and cardiovascular outcomes in BEV versus SEV in patients with small aortic annulus undergoing transcatheter aortic valve replacement (TAVR). Methodology: The RESOLVE registry included consecutive patients who underwent TAVR and survived up to 30 days at Cedars-Sinai Medical Center with either BEV or SEV from 2015 to 2020, with clinical variables obtained from the STS/TVT registry. CT core lab analysis identified patients with a small aortic annulus (&lt;430 mm 2 ), who were systematically followed up with clinical exams and echocardiography until December 2023. The primary outcome was a composite of all-cause mortality, stroke or transient ischemic attack, or heart failure hospitalization at 5 years. Results: Out of 1392 patients, a total of 423 met criteria for small aortic annulus (345 BEV, 78 SEV), with a median follow-up of 5 years (4-6 years). There were no significant differences in baseline sociodemographic and clinical characteristics between the BEV and SEV groups. (Figure 1) The post-TAVR invasive aortic valve mean gradient were similar in both groups [Median (IQR): BEV:3(1-5.8), SEV: 3.4(0.4-6.6), p 0.58], while echocardiographic gradients were higher in BEV group [Median (IQR): BEV:12 (9-15), SEV:8(6-11), p&lt;0.001)].There was no significant difference in primary outcome at 5 years in Cox multivariable regression analysis (HR:1.21, 95% CI 0.81-1.82, p 0.33) (Figure 2). There were no significant differences in other clinical endpoints at 5 years, although patients with SEV had lower echocardiographic gradients and higher indexed effective orifice area. (Figure 2-3) Conclusion: Post-TAVR invasive aortic valve gradients were similar between BEV and SEV, despite higher echocardiographic transaortic gradients in BEV patients. We found no significant difference in 5-year clinical outcomes between patients who received TAVR with BEV or SEV.

Abstract 4136036: Five-year Outcomes of Heart-Kidney Transplant Recipients Bridged with Durable Mechanical Circulatory Support: Less AMR Better Survival?

Introduction: Despite the increased risk of sensitization in patients receiving pre-transplant durable mechanical circulatory support (D-MCS), it has been suggested that removing D-MCS at the time of transplant may lead to a drop in HLA-antibody levels. Whether this may reduce rejection rates and improve long-term outcomes in patients undergoing heart-kidney transplantation (HKTx) has not been widely investigated. Therefore, we aim to investigate the impact of pre-transplant D-MCS on 5-year clinical outcomes of patients undergoing HKTx. Methods: We included 98 patients undergoing HKTx between 2010 and 2018 at a single center. Recipient pre-transplant characteristics and clinical outcomes were compared between patients receiving D-MCS (n=24) versus non-D-MCS patients (n=74). The D-MCS cohort included those who received total artificial heart (n=13), left ventricular assist device (n=8), and biventricular assist devices (n=3). Endpoints included 1- and 5-year survival, 1-year-freedom from acute cellular rejection (defined as grade 2R or 3R), 1-year-freedom from antibody-mediated rejection (AMR, defined as pathologic AMR of grade ≥1), 5-year freedom from cardiac allograft vasculopathy (CAV, stenosis ≥30% by angiography), 5-year freedom from non-fatal major adverse cardiac events (NF-MACE including myocardial infarction, new congestive heart failure, percutaneous coronary intervention, implantable cardioverter defibrillator/pacemaker implant, stroke), and 5-year freedom from left ventricular dysfunction (LVEF ≤40). Results: At 1 year, freedom for AMR was numerically higher in the D-MCS group (100 vs. 90.2%, P=0.12). Additionally, the 5-year post-transplant survival rate was higher in the D-MCS group (95.8% vs. 80.8%), but it did not reach statistical significance (P=0.091). Comparable outcomes were noted for other outcomes, including 5-year freedom from CAV, NF-MACE, or LVD (Table 1 ). Conclusion: The current study hints at better 5-year survival in HTKx recipients receiving pre-transplant D-MCS, which could be attributed to lower rates of AMR in this population. Future larger studies are warranted to further validate these findings.

Ocular involvement of oak processionary caterpillar hairs: Clinical outcome up to one year.

To evaluate a consecutive series of patients that presented with ocular findings after contact with the oak processionary caterpillar (OPC) during an epidemic reproduction of the OPC in Germany in 2019 and to assess the 1-year outcome of those eyes with persisting OPC hairs in the cornea. Retrospective analysis of 11 eyes (11 patients) that presented in June/July 2019 with acute ocular symptoms after outdoor activity or caterpillar nest removal. Evaluation of patients charts and slit-lamp images up to one year. Assessment of the incidence of patients with OPC-associated ocular complaints in the subsequent years (2020-2023). All patients had conjunctival injection, foreign body sensation, pain, itching and/or burning sensation. In 9/11 eyes, multiple caterpillar hairs could be detected in the superficial and deeper cornea. Hair removal was attempted in 8/9 eyes; in one eye hair removal was impossible due to its deep stromal location (lost-to-follow-up). Entire hair removal was successful in 2/9 eyes, hence, six eyes with persisting hairs within the cornea were followed. Stromal haze developed adjacent to the hairs in all eyes and individual hairs disappeared (n = 4) and/or showed migration within the cornea (n = 3). Until 2023, the number of patients with OPC-associated ocular complaints decreased continuously. Ophthalmologists should be aware of the possibility of caterpillar hairs in patients with acute eye symptoms after outdoor acitivities, especially in early summer; the incidence may fluctuate, though. Hair removal is recommended to avoid possible intraocular migration, still residing hairs did not cause any serious long-term complications in our cohort. What is known Within the late spring and early summer season, mass reproduction of the oak processionary carterpillar (OPC) can lead to an increased number of patients with OPC-related eye complaints (pain, itching and burning sensation) caused by OPC hairs within a very short period of time. Within that season, people should be (more) actively sensitized to avoid trees with OPC hairs, take precautions and avoid eye rubing when having complaints What is new Complete surgical removal of the hairs can be difficult and is often unsuccessful due to their tiny size and often stromal location most possibly resulting from eye rubbing In the longer-term, residing hairs have shown to develop haze adjacent to the hair, migrate within the cornea or disappear/resolve. Since this may go along with an inflammatory reaction, long-term follow-up and topical steroids may be useful.

Abstract 4118338: Predictors and 3-Year Outcomes of Compromised Left Circumflex Coronary Artery After Left Main Crossover Stenting

Background : Predictors of decreased fractional flow reserve at left circumflex coronary artery after left main (LM) crossover stenting are still lacking. The objectives of the present study were to provide the predictors for low FFR at LCx and the possible treatment strategies for the compromised LCx-together with their long term outcomes. Methods: Total of 563 included patients out of 1974 patients admitted to our hospital from February 2015 to November 2020 with significant distal LM-bifurcation lesion. The enrolled patients underwent single-stent cross-over PCI under IVUS-guidance with further LCx-intervention as indicated by measured FFR. Results: The included patients showed angiographic significant LCx ostial affection after LM-stenting, but only 116 (20.6%) patients had FFR &lt;0.8. The 3-year composite MACE rates were comparable between the high and low FFR groups (16.8% vs. 15.5%, respectively; P =0.744). In a multivariable analysis, a low FFR in the LCx was associated with post-stenting MLA of the LCx (OR: 0.032, P &lt;0.001), post-stenting LCx-plaque burden (OR: 1.166, P &lt;0.001), post-stenting LM-MLA (OR: 0.821, P =0.038) and and pre-stenting LCx-MLA (OR: 0.371, P =0.044). In patients with low FFR, management of compromised LCx with DEB had the lowest 3-year MACE rate (8.1%) as compared to either KBI (17.5%) or stenting group (20.5%), P =0.299. Conclusion: FFR-guided LCx intervention can avoid unnecessary LCx intervention. The post-stenting predictors of low FFR include post-stenting MLA and plaque burden of the LCx and MV stent length. The 3-year MACE rates were comparable between high FFR patients and patients who had low FFR and adequately managed.

Three-Year Clinical and Hemodynamic Evaluation of the Hydra Self-Expanding Transcatheter Aortic Valve in Patients With Severe Aortic Stenosis.

The Hydra CE study revealed 1-year favorable efficacy of TAVR, showing a large effective orifice area (EOA), low gradient, and acceptable complication rates. We evaluated the 3-year clinical and hemodynamic outcomes of Hydra self-expanding transcatheter aortic valve (manufactured by Vascular Innovations Co Ltd, Nonthaburi, Thailand; a subsidiary of Sahajanand Medical Technologies Limited, India) in patients with symptomatic severe aortic stenosis at high or extremely high surgical risk. The Hydra CE study was a prospective, multicenter, single-arm study. A total of 157 patients were enrolled in the study, out of whom 54 patients from two centers (Lithuania and Poland) had provided consent for long-term follow-up at recruitment, with a planned 5-year follow-up period. The primary endpoint was all-cause mortality, and patients were followed up for up to 3 years, with an assessment of clinical and echocardiographic outcomes. Among the 54 patients, the average age was 81.0 ± 4.1 years. The mean STS score was 3.2 ± 2.0%. At 3 years, all-cause mortality had occurred in 14.8% of patients, including 3.7% cardiovascular deaths and 1.9% device-related deaths. There was a progressive enhancement in EOA that is, 0.68 ± 0.15 cm2 at baseline to 1.97 ± 0.52 cm2 at 3 years (p < 0.001) as well as significant improvement in the mean aortic valve gradient that is, 53.4 ± 14.24 mmHg at baseline to 8.6 ± 2.80 mmHg at 3 years (p < 0.001). New permanent pacemaker implantation rates up to 3-year follow-up was 12.9%. The 3-year results of the Hydra CE study demonstrated consistent improvements in hemodynamics over time. The study also revealed favorable safety and efficacy trends, along with low occurrences of new permanent pacemaker implantations and paravalvular leaks.

Long-Term Clinical and Radiographic Outcomes of Hydrophilic Implants: A 10-Year Study in a Specialist Private Practice.

To report the 10-year clinical and radiographic outcomes of implants placed in grafted (GBR) and non-grafted (no-GBR) sites in a Swiss specialist private practice using hydrophilic implants with a low surface roughness flange. Fifty consecutively enrolled patients received 159 hydrophilic implants with a low surface roughness flange. A first re-evaluation was performed 1 year after delivery of restoration (T1). An additional examination was performed at the 10-year follow-up (T2) including the assessment of clinical (i.e., periodontal/peri-implant pockets probing depths (PPD) (mm), full-mouth bleeding score (%), implant survival rate, mid-buccal keratinized mucosa (KM) width in mm, and peri-implant phenotype), and radiographic (i.e., marginal bone level change [ΔMBL]) outcomes. Biological, mechanical and technical complications were also recorded. Out of the initial cohort, 22 patients (9/40.9% male and 13/59% female) and 63 implants (47 with GBR, 16 without GBR), could be re-examined at T2. Overall, ΔMBL (T2-T1) was -0.56 ± 0.96 mm. In the GBR group, ΔMBL were significantly higher at the distal sites compared to the no-GBR group (-0.75 ± 1.17 mm vs. -0.12 ± 1.29 mm, p = 0.045), however, in the GBR group MBL started at a higher level at T1 but were similar with the no-GBR group at T2. Implant survival was 100% with only very few technical complications (6.3%). Mean PPD amounted to 3.84 ± 1.00 mm with significantly higher values in the GBR group (3.98 ± 1.08 mm vs. 3.45 ± 0.60 mm; p = 0.016). Nineteen implants (30.1%) were diagnosed with peri-implant health while 44 (69.9%) presented with peri-implant mucositis. Within the limitations of this study, favorable clinical and radiographic conditions were recorded around hydrophilic implants with a low surface roughness flange placed in pristine and augmented bone after 10 years in function.

The 5-year outcomes of a health-empowerment program on low-income children’s behaviors and quality of life

BackgroundThis study aims to evaluate the 5-year impact of a Health Empowerment Program (HEP) on mitigating problematic conducts and enhancing the health-related quality of life (HRQOL) among children living in poverty.MethodsA prospective cohort study (N = 239, Intervention group: n = 124, Comparison group: n = 115) was established with participants recruited between July 2013 and March 2016 and followed until November 2021. During the 5-year study period, children and their parents from the intervention group were invited to join a multi-dimensional HEP. At baseline and follow-up, both intervention and comparison groups were assessed using the Chinese Strengths and Difficulties Questionnaire (SDQ) and Chinese Child Health Questionnaire Parent Form 28 (CHQ-PF28). Multiple linear regressions were conducted to identify changes in outcome variables as the effect of the HEP.ResultsUpon completion of the 5-year follow-up, children in the intervention group showed a larger decline in conduct problems (B = − 0.66, p <.001), hyperactivity inattention (B = − 0.67, p =.005), and total difficulties score (B = − 1.89, p =.002) of SDQ, a greater increase in prosocial behavior of SDQ (B = 0.53, p =.040), and more substantial enhancement in CHQ-PF28’s psychosocial summary score (B = 2.75, p =.017) compared to the comparison group.ConclusionsHEP is effective in mitigating behavioral problems and improving psychosocial HRQOL of children of low-income families, as evident by this 5-year cohort study.Trial Registration: This study received approval (UW 12–517) from the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster.

Comparison of Outcomes Between ST-Segment Elevation and Non-ST-Segment Elevation Myocardial Infarctions Based on Left Ventricular Ejection Fraction

Background: This study was conducted to address the lack of reports comparing the clinical outcomes of non-ST-segment elevation myocardial infarction (NSTEMI) and STEMI based on left ventricular ejection fraction (LVEF). Methods: A total of 9854 patients from the Korea Acute Myocardial Infarction Registry-National Institute of Health dataset were classified into three LVEF categories: heart failure (HF) with reduced ejection fraction (EF) (HFrEF, n = 1250), HF with mildly reduced EF (HFmrEF, n = 2383), and HF with preserved EF (HFpEF, n = 6221). Each group was further divided into NSTEMI and STEMI groups. The primary clinical outcome was the incidence of patient-oriented composite outcomes, defined as all-cause death, recurrent myocardial infarction, any repeat coronary revascularization, hospitalization for HF, and stroke. Results: Following adjustment, in-hospital mortality rates were comparable between the NSTEMI and STEMI groups in the HFrEF and HFmrEF groups. However, 3-year mortality rates were higher in the NSTEMI group. In contrast, in the HFpEF group, the STEMI group had higher rates of in-hospital all-cause death (p = 0.001) and cardiac death (p &lt; 0.001) compared to the NSTEMI group, which was associated with increased 3-year all-cause death (p = 0.026) and cardiac death (p &lt; 0.001) in the STEMI group. When in-hospital mortality was excluded, no difference in 3-year mortality rates was observed between the NSTEMI and STEMI groups in the HFpEF group. Conclusions: In-hospital mortality and 3-year outcomes varied across LVEF groups. Therefore, comparing NSTEMI and STEMI based on LVEF provides valuable insights into the differences in patient outcomes.

Radiofrequency balloon ablation: 1-year outcomes of the AURORA study.

A novel irrigated radiofrequency balloon (RFB) for pulmonary vein isolation (PVI) integrated into a 3D mapping platform was recently launched. Patients undergoing a first atrial fibrillation (AF) ablation at two German high-volume EP centers were included into the prospective AURORA registry. All patients underwent clinical follow-up (FU) at 90, 180, and 360days following ablation including 48-h Holter ECGs. A total of 99 patients were enrolled (43/99 (43.4%) women, median age 67years (interquartile range [IQR] 59-74), 43/99 (43.4%) persistent AF (Pers-AF), median left ventricular ejection fraction (LVEF) 60% (IQR 62-55)). Eighty-eight patients completed the follow-up. Acute PVI was achieved in 383/383 (100%) PV. Single-shot PVI was achieved in 211/383 (55.1%) PVs. Primary adverse events occurred in 3% of patients (1 postprocedural pharyngeal bleeding, 1 myocardial infarction, 1 non-cardiovascular death); no pericardial effusion, stroke, or phrenic nerve paralysis was observed. Median ablation and procedure times were 23 (IQR 18-32) and 67 (IQR 57-85) min, respectively. Median dose area product was 761 (IQR 509-1534) mGycm2. AF-free survival after a median FU of 361 (IQR 261-375) days was 78.4% for paroxysmal AF (PAF) and 75.4% for Pers-AF (p value = 0.828). Early recurrence of atrial tachyarrhythmia at the 90-day visit was the only independent predictor for AF recurrence at 1year upon multiple regression analysis (hazard ratio [HR] 3.198; 95% confidence interval [95% CI] 1.036-10.32, p value = 0.0433). RFB-based PVI is acutely successful, appears safe, and has comparable rhythm outcomes to other single-shot AF ablation tools. A recurrence of AF at 90days predicts later AF recurrence.

Impact of a Chronic Total Occlusion on Outcomes After FFR-Guided PCI or Coronary Bypass Surgery: A FAME 3 Substudy.

The clinical impact of a chronic total occlusion (CTO) in patients with 3-vessel coronary artery disease undergoing fractional flow reserve-guided percutaneous coronary intervention (PCI) with current-generation drug-eluting stents or coronary artery bypass grafting (CABG) is unclear. The FAME 3 trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 3) compared fractional flow reserve-guided PCI with CABG in patients with 3-vessel coronary artery disease. The primary end point was major adverse cardiac and cerebrovascular events, a composite of death, myocardial infarction, stroke, or repeat revascularization at 1 year. In this substudy, the 3-year outcomes were analyzed in patients with or without a CTO. Of the patients randomized to PCI or CABG in the FAME 3 trial, 305 (21%) had a CTO. In the PCI arm, revascularization of the CTO was attempted in 61% with a procedural success rate of 88%. The incidence of major adverse cardiac and cerebrovascular events at 3 years was not significantly different between those with or without a CTO in both the PCI (15.2% versus 20.1%; adjusted hazard ratio, 0.62 [95% CI, 0.38-1.03]; P=0.07) and the CABG (13.0% versus 12.9%; adjusted hazard ratio, 0.96 [95% CI, 0.55-1.66]; P=0.88) arms. In those without a CTO, PCI was associated with a significantly higher risk of major adverse cardiac and cerebrovascular events compared with CABG (adjusted hazard ratio, 1.61 [95% CI, 1.20-2.17]; P<0.01) but not in those with a CTO (adjusted hazard ratio, 1.21 [95% CI, 0.64-2.28]; P=0.56; Pinteraction=0.31). The presence of a CTO did not significantly impact the treatment effect of PCI versus CABG at 3 years in patients with 3-vessel coronary artery disease. URL: https://www.clinicaltrials.gov; Unique identifier: NCT02100722.

Early Improvement in Postoperative Clinical Outcomes without Patellar Resurfacing in Patella-Friendly Design of Medial Pivot TKA.

There is continued debate about the efficacy and indications for patellar resurfacing in total knee arthroplasty (TKA), especially with the emergence of patella-friendly designs. This study aimed to compare the postoperative outcomes in patients undergoing TKA with or without patellar resurfacing using the same implant design. This is a retrospective cohort study of patients who underwent TKA including those with patellar resurfacing (PR group) and those without (NPR group). Demographic data included age, gender, side of surgery, operative time, and body mass index (BMI). Outcomes included preoperative, 2-week, 6-week, and 1-year postoperative Knee Injury and Osteoarthritis Outcome Score and Joint Replacement (KOOS, JR) values along with knee range of motion (ROM). Postoperative complications were recorded. The power analysis with a large effect size indicated that a minimum sample size of 54 was required for Student's t-test and 34 for the paired t-test. A total of 90 medial pivot (MP) TKA were included in this study. There were 30 knees in the PR group and 60 in the NPR group. There was no significant difference between the groups for all demographic data, preoperative and postoperative ROM, and KOOS, JR values at all time points (p > 0.05 for all variables). The KOOS, JR significantly improved in the NPR groups at 2 weeks, 6 weeks, and 1 year postoperatively when compared with the preoperative score and at 6 weeks and 1 year postoperatively in the PR group (p < 0.01). No revisions related to the patellofemoral joint were observed in patients initially undergoing patellar resurfacing. One patient in the NPR group required secondary patellar resurfacing. The patella-friendly MP TKA yielded favorable postoperative outcomes, with or without patellar resurfacing. Improvements in KOOS, JR were observed earlier in the NPR group when compared with the PR group, suggesting that patellar resurfacing may not always be necessary for modern TKA designs. LEVEL OF EVIDENCE: Retrospective cohort study, Level III.

Development of a Dual-Plane MRI-Based Deep Learning Model to Assess the 1-Year Postoperative Outcomes in Lumbar Disc Herniation After Tubular Microdiscectomy.

Tubular microdiscectomy (TMD) is a treatment for lumbar disc herniation (LDH). Although the combination of MRI and deep learning (DL) has shown promise, its application in evaluating postoperative outcomes in TMD has not been fully explored. To evaluate whether integrating preoperative dual-plane MRI-based DL features with clinical features can assess 1-year outcomes in TMD for LDH. Retrospective. The study involved 548 patients who underwent TMD between January 2016 and January 2021. Training set (N = 305, mean age 51.85 ± 13.84 years, 56.4% male). Internal validation set (N = 131, mean age 51.85 ± 13.84 years, 54.2% male). External validation set (N = 112, mean age 51.54 ± 14.43 years, 50.9% male). 3 T MRI with sagittal and transverse T2-weighted sequences (Fast Spin Echo). Ground truth labels were based on improvement rate in 1-year Japanese Orthopaedic Association (JOA) scores. Information on 42 preoperative clinical features was collected. The largest protrusions were identified from T2 MRI by three clinicians and were used to train deep learning models (ResNet50, ResNet101, and ResNet152) to extract DL features. After feature selection, three models were built, namely, clinical, DL, and combined models. Chi-square or Fisher's exact tests was used for group comparisons. Quantitative differences were analyzed using the t-test or Mann-Whitney U test. P-values <0.05 were considered significant. Models were validated on internal and external datasets using metrics such as the area under the curve (AUC). The AUCs of the clinical models achieved 0.806 (internal) and 0.779 (external). ResNet152 performed best in three DL models, with AUCs of 0.858 (internal) and 0.834 (external). The combined model achieved AUCs of 0.889 (internal) and 0.857 (external). A model combining preoperative dual-plane MRI DL features and clinical features can assess 1-year outcomes of TMD for LDH. 4 TECHNICAL EFFICACY: Stage 2.

Bilobed lateral artery perforator-based flap for partial breast reconstruction – Technique description and results from a ten-year cohort

IntroductionWe present a new technique, the bilobed lateral artery perforator-based flap, for breast-conserving surgery of large central tumors or nearby, combining Zymany's bilobed flap and a Lateral Intercostal Perforator (LICAP) flap, and its 10-year outcomes. Materials and methodsWe studied 37 patients with malignant breast tumors near or involving the central skin, without ptosis or desire to correct it, who avoided mastectomy with this modified bilobed flap from 2013 to 2022. The same surgeon operated on them in different institutions. This research project was approved by our ethical committee (n. 2.322.212). ResultsThe mean age was 57.17 (±12.60) years. The mean specimen weight was 74.32 (±25.84)g, and the mean tumor size was 40.35 (±15.81) mm. Fourteen (37.84 %) tumors were larger than 5 cm and one was multicentric. Thirty-two (86.49 %) patients had invasive ductal carcinomas. Nipple areola complex was removed in 19 (51.35 %) cases due to clinical involvement, and immediately reconstructed in two cases with contralateral free grafting. Twenty-one (56.76 %) patients received neoadjuvant chemotherapy. Three (8.11 %) patients had immediate contralateral mastopexy. Radiotherapy was indicated in all cases. There were 3 (8.11 %) minor complications, one positive margin, and no surgical revisions. In a mean follow-up of 39.97 (±29.43) months, there were no local recurrences, 2 metastasis, and one death. Satisfaction and aesthetic results were good or excellent in most cases. ConclusionsThe new technique enabled breast conservation, with high rates of free margins, high levels of satisfaction, few complications in women with large central tumors on small breasts with limited ptosis.