1-year Follow-up Research Articles

Evolving use and clinical outcomes of coronary intravascular lithotripsy: insights from an international, multicentre registry

BackgroundIntravascular lithotripsy (IVL) is increasingly used for treatment of coronary artery calcification. This study aimed to evaluate contemporary utilisation patterns, safety and efficacy of IVL in an unselected real-world patient cohort.MethodsWe included 454 patients undergoing IVL from May 2019 to February 2024 across seven centres in two European countries. Key endpoints included device success, technical success, procedural success, IVL-related complications and major adverse cardiovascular events (MACE) at 1-year follow-up.ResultsThe cohort (mean age 73±9 years, 75% male) had a mean SYNTAX Score of 22.0±13.6. Device, technical and procedural success were achieved in 98%, 91% and 89% of patients, respectively. IVL-related complications occurred in six patients (1%). At 1-year follow-up, MACE was observed in 37 patients (13%). Over time, IVL use increased in patients with acute coronary syndrome (p=0.004) and in combination with intracoronary imaging (p=0.002), while use of other calcium modification devices decreased (p=0.034).ConclusionIn this real-world registry, IVL demonstrated efficacy across diverse clinical and anatomical settings. High success rates, low complication rates and MACE rates were observed acutely and at 1-year follow-up. Utilisation patterns evolved over time, with increased adoption in acute scenarios and alongside intracoronary imaging.

MammaPrint Genomic Assay Providing Prognostic Information in Early Breast Cancer: 10-Year Follow-Up From a Retrospective German Breast Cancer Registry Analysis

Introduction: Gene expression assays, such as the MammaPrint® (Agendia, Amsterdam, the Netherlands) 70-gene signature, are increasingly used by oncologists to understand breast cancer biology and improve treatment planning. This study assesses the utility of MammaPrint genomic risk in predicting treatment outcomes for women with breast cancer in a retrospective German cohort with a 10-year follow-up, treated based on clinicopathological features alone. Methods: The sample set of 117 tumours from the ‘Patients Tumour Bank of Hope’ (PATH) biobank with 10-year follow-up were classified using MammaPrint into high or low risk of distant metastasis. Patients were previously treated according to St. Gallen and Adjuvant! Online high- or low-risk criteria. Statistical analyses compared overall survival (OS) and treatment outcomes between clinical and genomic risk groups. Results: Among the 78 patients with clinically high-risk tumours, 50% (39) were reclassified as MammaPrint low risk. In total, 57.3% (67/117) patients with MammaPrint low-risk tumours demonstrated a significantly higher 10-year OS of 93.4%, irrespective of nodal status, compared to patients with MammaPrint high-risk tumours (71.2%; p=0.001). Chemotherapy improved OS in patients with MammaPrint high-risk tumours by 29.4%, but not for patients with MammaPrint low-risk tumours (p=0.016). Discussion: The findings confirm the prognostic utility of MammaPrint for identifying genomically low-risk patients who may safely omit chemotherapy while suggesting genomically high-risk cases may benefit from chemotherapy. By providing a more precise assessment of cancer risk than traditional clinicopathological methods alone, MammaPrint may help reduce unnecessary treatments and improve long-term quality of life for patients diagnosed with early-stage breast cancer.

Cost-Effectiveness of Three Different New-Generation Drug-Eluting Stents in the Randomised BIO-RESORT Trial at 3 Years.

Evidence on health economic outcomes for percutaneous coronary intervention (PCI) comparing different contemporary drug-eluting stents (DES) with each other is scarce, as most previous randomised DES trials did not assess such aspects. This prespecified health economic evaluation of the Comparison of Biodegradable Polymer and Durable Polymer Drug-Eluting Stents in an All Comers Population (BIO-RESORT) trial aimed to compare at 3-year follow-up both health effects and costs of PCI with one of three new-generation drug-eluting stents (DES) in patients with obstructive coronary artery disease. The randomised BIO-RESORT trial assessed in 3514 patients the ultrathin-strut biodegradable polymer Orsiro sirolimus-eluting stent (SES) and very-thin-strut Synergy everolimus-eluting (EES) stent versus the thin-strut durable polymer Resolute Integrity zotarolimus-eluting stent (ZES). In the current analysis, we used the perspective of a health insurer in the Netherlands. The main endpoints were quality-adjusted life years (QALYs), and costs for each treatment strategy. Bootstrapping with 5000 resamples was performed to capture the uncertainty of results. Mean QALYs for each stent group were 2.566 for the SES, 2.551 for the EES, and 2.550 for the ZES. Mean costs per strategy were €14,670 for the SES, €14,946 for the EES, and €15,069 for the ZES. The SES had the highest probability of being cost-effective for every willingness-to-pay threshold up to €100,000 per QALY. Furthermore, in 79% of modelling scenarios, the SES was more effective and cheaper than ZES. At 3-year follow-up, PCI with the SES had the highest probability of being cost-effective due to greater effectiveness and lower costs compared with the ZES and EES. These findings suggest that, due to the overall high volume of coronary stenting in clinical practice, use of this SES could result in substantial cost savings, complemented by slight additional health benefits.

One-stage surgery by a halo-vest to treat simultaneous double spine fractures–dislocation in a patient with ankylosing spondylitis: case report and review of literature

Study DesignA case report.BackgroundIn this study, we report the outcome of one-stage surgery using a halo-vest to treat simultaneous double spine fractures–dislocation in a patient with ankylosing spondylitis (AS).Case presentationWe report a case of a 57-year-old male patient with AS who sustained simultaneous double spine fractures due to a traffic accident. We performed an open approach after successful closed reduction using a halo-vest. At the 1-year follow-up, we finally achieved bone union after postoperative. At the 3-year follow-up visit, he reported a significant resolution of both cervical and back pain and had returned to his routine daily activities.ConclusionThis is the first report of using a halo-vest to treat simultaneous double spine fractures–dislocation in a patient with AS. The authors included five research studies that situate this case study in the existing literature and highlight a gap in current knowledge. Based on our experience with this case and a review of the literature, one-stage surgery by a halo-vest is an effective option for the treatment of simultaneous double spine fractures–dislocation in patients with AS.

The clinical effect of thoracoscopic segmentectomy in the treatment of lung malignancies less than 2CM in diameter

ObjectiveTo investigate the clinical effect of thoracoscopic segmentectomy in the treatment of lung malignancies less than 2CM in diameter.MethodsIn this retrospective study, a total of 103 patients with lung cancer who received outpatient or inpatient treatment from December 2020 to May 2022 were selected and divided into the lobectomy group (n = 48) and the segmentectomy group (n = 55) according to different surgical methods. The lobectomy group was treated with thoracoscopic lobectomy, while the segmentectomy group was treated with thoracoscopic segmentectomy. The prognostic effect, complications, blood gas level and respiratory function indexes of the two groups were observed and compared.ResultsThe general data of the two groups of patients, such as gender, age, course of disease, body mass index, lesion diameter, lesion site and pathological type, were analyzed by statistical software. There was no statistical significance in the operation time and the number of lymph node dissection between the two groups (P > 0.05), while the drainage volume and intraoperative blood loss in the segmentectomy group were lower than those in the lobectomy group, and the drainage time and hospital stay were shorter than those in the lobectomy group, with statistical significance (P < 0.05). Before treatment, there were no statistically significant differences in various lung function indexes between the two groups (P > 0.05). After treatment, the values of FVC, FEV1 and FEV1/FVC in each group had different amplitude changes, and the values of FVC, FEV1 and FEV1/FVC in the segmentectomy group were significantly higher than those in the lobectomy group, with statistical significance (P < 0.05). Thoracoscopic segmentectomy showed a lower incidence of respiratory complications (P = 0.042) and higher pulmonary air leak (P = 0.023) than thoracoscopic lobectomy. After propensity score-matched analysis, respiratory complications remained significantly higher in thoracoscopic segmentectomy (P = 0.017). However, the difference in the total complication rate between the two groups was not statistically significant (P > 0.05). There were no differences during the 2-year follow-up (median follow-up in months: 18.4; interquartile range, 14.8–21.3) in terms of overall survival (P = 0.49) and disease-free survival (P = 0.34) between groups (P > 0.05).ConclusionsFor patients with lung cancer less than 2 cm in diameter, thoracoscopic segmentectomy can achieve good short-term efficacy, with rapid postoperative recovery and little impact on lung function, which may be helpful to improve patients’ postoperative quality of life.

Outcomes Following Autologous Osteochondral Transplantation for Osteochondral Lesions of the Talus at 10-Year Follow-Up: A Retrospective Review.

The purpose of this study was to evaluate outcomes following autologous osteochondral transplantation (AOT) for the treatment of osteochondral lesions of the talus (OLT) at a minimum of 10-year follow-up. Retrospective chart review identified patients who underwent AOT for the treatment of OLT. Pre-operative magnetic resonance imaging (MRI) scans were obtained in all patients. Clinical outcomes assessed included: pre- and post-operative foot and ankle outcome score (FAOS), visual analog scale (VAS), patient satisfaction, complications, failures and secondary surgical procedures. Thirty-nine patients with a mean lesion size was 122.3 ± 64.1 mm2 and mean follow-up time of 138.9 ± 16.9 months were included. The mean FAOS scores improved from a preoperative score of 51.9 ± 16.0 to 75.3 ± 21.9 (P < 0.001). Increasing lesion size was variable associated with inferior FAOS scores (R2 = 0.2228). There was statistically significant higher mean T2 relaxation values at the superficial layer at the site of the AOT graft (42.9 ± 5.2 ms) compared to the superficial layer of the adjacent native cartilage (35.8 ± 3.8 ms) (P < 0.001). Seventeen complications (43.6%) were observed, the most common of which was anterior ankle impingement (25.6%). There were 2 failures (5.1%), both of which had a history of prior bone marrow stimulation via microfracture and post-operative cysts identified on MRI. This retrospective review found that AOT for the treatment of large OLTs produced a 94.9% survival rate at a minimum of 10-year follow-up. Increasing lesion size was associated with inferior clinical outcomes. The findings of this study indicates that AOT is a viable long-term surgical strategy for the treatment of large OLTs.

Ten-Year Follow-Up After Descemet Membrane Endothelial Keratoplasty.

To examine clinical results up to 10 years after Descemet Membrane Endothelial Keratoplasty (DMEK) and Triple-DMEK. Prospective study including 201 eyes, of which 54 eyes [38 DMEKs and 16 Triple-DMEKs; Fuchs endothelial dystrophy (n = 45), pseudophakic bullous keratopathy (n = 9)] reached the minimum follow-up of 5 years and were followed up for up to 10 years. We evaluated best-corrected visual acuity (BCVA, logarithm of the minimum angle of resolution [logMAR]), endothelial cell density (ECD, cells/mm2), minimal central corneal thickness (CCT, μm), central retinal thickness (μm), rebubbling, graft survival and re-DMEK rate, chamber angle alterations, and incidence of glaucoma. Fifty-four eyes had a 5-year and 37 eyes an 8- to 10-year follow-up. Mean follow-up was 94.4 ± 12.1 months. Best-corrected visual acuity increased from 0.6 ± 0.3 logMAR to 0.1 ± 0.2 logMAR at 6 months (P ≤ 0.001) and was 539 ± 54 μm at long term. Endothelial cell density decreased from 2488 ± 320.9 (donor) to 980.1 ± 437 cells/mm2 with an average ECD loss/year of 4% and did not correlate with BCVA. Central corneal thickness decreased from 596.9 ± 82.2 μm to 498.6 ± 24.3 μm at 12 months (P ≤ 0.001) and remained stable (P = 1.000). Mean rebubbling rate was 0.3 ± 0.5/eye and did not correlate with BCVA. Eight eyes (14.8%) received at least 1 rebubbling. Primary graft failure/rejection rate was 1.5%/0% within the first postoperative year, and secondary graft failure rate was 12.4% at 7 years. Eight eyes (preoperative n = 3, de novo n = 5) had open-angle glaucoma without chamber angle changes (14.8%, P ≤ 0.001). Although ECD decreases continuously in the long-term follow-up, excellent visual acuity can be preserved 10 years after DMEK and Triple-DMEK. The final outcome can be estimated 6 months after surgery.

Reverse cardiac remodeling induced by endovascular treatment of coarctation of the aorta

Abstract Background Previously, we have showed the 3-year clinical safety and efficacy of balloon expandable versus self-expandable stents in native coarctation of the aorta (CoA) in a randomized clinical trial (RCT). Very few prospective studies have addressed the changes of echocardiographic parameters in mid to long-term follow up of CoA patients treated endovascularly. Purpose We aimed to demonstrate the improvement of echocardiographic parameters among patients undergoing coarctoplasty with stent based on core laboratory-confirmed baseline and 3-year follow up transthoracic echocardiographic (TTE) images. Methods In the index RCT, adult patients with de novo native CoA were randomized into two groups based on stent types. All randomized patients received the 3-year structural follow-up including aortic CT angiography and TTE. The current prospective cohort substudy, included all patients with available baseline and three-year core laboratory TTEs. Results Of 92 patients initially randomized, 71 participated in the 3-year structural follow up. No baseline core lab images were available in 39 patients, and thus, 32 patients (a median age of 32 (24.8 – 37.5) years, (14 women [43.8%]) were included in this subgroup study. One out of the 32 patients presented with recoarctation which was successfully treated before the 3-year evaluation. Peak systolic gradient and end-systolic velocity of the coarctation stenting site were 17.38 ± 6.55 mmHg and 0.93 ± 0.24 m/s respectively in the 3-year follow-up. Septal E’ and lateral E’ velocities were improved significantly (8.6 ± 1.73 cm/s to 9.35 ± 2 cm/s, P = 0.02 and 12.74 ± 2.96 cm/s to 13.92 ± 2.44 cm/s, P = 0.03, respectively). In addition, septal E/E’ ratio (10.84 ± 2.83 to 9.21 ± 3.17, P = 0.02) and lateral E/E’ ratio (7.39 ± 2.24 to 6.29 ± 1.97, P = 0.02) showed significant improvement. Significant reduction in LV mass [160 (130–203) g to 142 (IQR= 121–172) g, P = 0.001], and septal and posterior LV thicknesses were also demonstrated (0.9 (0.8–1.0) cm to 0.81 (0.77–0.93) cm, P = 0.004) and 0.92 ± 0.14 cm to 0.85 ±0.09 cm, P = 0.01, respectively). Twelve (37.5%) patients had baseline LVH which was normalized in 9 (75%). Lastly, 12 (41.3%) of our population had diastolic dysfunction at baseline study which significantly decreased to 4 (13.7%) in the three-year follow-up evaluation. Conclusion In the present core laboratory-based study, coarctoplasty with stent has favorable effects on diastolic function and LV hypertrophy during midterm follow-up in adult population with de novo native aortic coarctation treated with stent.

Contemporary LDL-cholesterol management in male and female patients at high-cardiovascular risk: results from the European observational SANTORINI study

Abstract Background Middle aged women have a faster increase in atherosclerotic cardiovascular disease (ASCVD) events than men over time. Undertreatment with guideline-recommended therapy in women may be one of the drivers for this burden. Purpose To compare high- or very high-risk male and female patients regarding contemporary 1-year low-density lipoprotein cholesterol (LDL-C) goal attainment, lipid-lowering therapy (LLT) intensity, and major adverse cardiovascular event (MACE) rate. Methods SANTORINI is an observational, prospective study that enrolled high- and very high-cardiovascular risk patients between March 2020 and Feb 2021, across 623 sites and 14 countries in Europe from primary &amp; secondary care settings, with a further 1-year prospective follow-up. We included all patients with an LDL-C measurement at baseline and 1-year follow up (1yFU) for the current analysis. LDL-C goal attainment was defined separately for high and very-high risk categories according to 2019 ESC/EAS guidelines. Results Overall, 5197 males with a mean age of 65 years, and 2013 females with a mean age 66 years were included. At baseline, male patients had higher prevalence of pre-existing ASCVD (81.6% vs. 63.5%), and a lower prevalence of familial hypercholesterolaemia (8.7% vs. 17.2%) than female patients (Table 1). The proportion of patients reaching LDL-C goal improved from baseline to 1yFU, but was greater in males (22.9% and 33.3%, respectively) than females (16.9% and 24.6%, respectively). Similarly, the proportion of patients receiving no LLT decreased from baseline to 1yFU for both sexes, however, more females than males received no LLT at 1yFU (male: 20.7% to 2.7%; female: 23.9% to 3.9%). High intensity statin use increased for both sexes but was higher for males (22.2% to 27.3%) than for females (15.5% to 19.5%) at 1yFU. By contrast, PCSK9i use at baseline and 1yFU was lower for males (6.6% to 9.3%) than for females (9.8% to 13.4%). Nevertheless, the use of combination LLT at 1yFU was lower among females than males (male: 27.8% to 42.2%; female: 26.7% to 40.2%). During follow-up, MACE-4 was higher in males (5.31/100 patient years [PY]; 95% confidence interval [CI]: 4.68–5.95) than in females (3.63/100PY; 95% CI: 2.79–4.47). Similar results were observed for MACE-3 (Table 2). Conclusions Despite similar guideline recommendations, use of combination LLT and high intensity statin therapy was lower in female patients at high or very high cardiovascular risk than in male patients over one year of follow-up. Accordingly, female patients had lower LDL-C goal attainment both at baseline and at one-year. Nevertheless, due to intrinsic risk factors, female patients had lower rates of MACE-4 and MACE-3 than male patients.

Prevalence and prognostic relevance of non-obstructive coronary atherosclerosis in MINOCA: a meta-analysis of 35 studies

Abstract Background Myocardial infarction with non-obstructive coronary arteries (MINOCA) can result from a variety of pathological mechanisms, not always associated with atherosclerosis. It has been suggested to distinguish between patients without obstructive coronary artery disease (NObs-CAD, stenosis diameter 1-49%), and patients with smooth coronary arteries (NCA), but differences in terms of prognosis or therapeutic approaches have not been clearly elucidated. Objectives The aim of this study is to evaluate the prevalence and prognostic impact of NObs-CAD as assessed by invasive coronary angiography (ICA) in MINOCA. Methods A meta-analysis was performed including studies reporting the prevalence of NObs-CAD versus NCA in MINOCA patients. Data on prognosis stratified by the presence of NObs-CAD were collected. Random-effects models were used to estimate the prevalence of NObs-CAD. Pooled risk ratios (RR) with 95% confidence intervals (CI) for all-cause death, myocardial infarction (MI), and the composite of both outcomes of patients with NObs-CAD compared to NCA were calculated at short-term (&amp;lt;1 month), 1-year and long-term follow-up (more than 1 year). Results Thirty-five studies were analysed. The pooled prevalence of NObs-CAD estimated by ICA was 53% [95% CI 47-60%]. Heterogeneity was high (I2=98.0%), but none of the clinical and instrumental characteristics tested in meta-regression analyses had a significant impact on the I2, except for age (residual I2=97.2%, p=0.014) and geographical context. Specifically, studies conducted outside Europe reported a higher prevalence of NObs-CAD with lower I2 values. Thirteen studies provided prognostic data. The presence of NObs-CAD was associated with an increased risk of death or MI compared to NCA, as well as the risk of MI at 1-year follow-up (RR = 1.49 [95% CI 1.17-1.90] and RR = 1.80 [95% CI 1.26-2.59], respectively), whereas the risk of death was comparable. Similar results were observed at long-term, but not at short-term follow-up. Out of 13 studies, 4 provided information regarded the medications at discharge stratified by the presence or absence of NObs-CAD. NObs-CAD patients received more often aspirin (89% vs 69%; p&amp;lt;0.01), P2Y12-inhibitors (52% vs 29%; p&amp;lt;0.01), angiotensin-converting enzyme inhibitors/angiotensin-receptor blockers (53% vs 40%; p&amp;lt;0.01), beta-blockers (70% vs 57%; p&amp;lt;0.01), and statins (86% vs 60%; p&amp;lt;0.01) compared to NCA. Conclusions Stratification of patients according to the degree of coronary stenosis has prognostic implications in the setting of MINOCA, since NObs-CAD patients present a higher risk of reinfarction. Further dedicated trials are needed to clarify whether these patients may benefit from a tailored approach in terms of secondary prevention strategies.Central illustration

Does the presence of severe pulmonary hypertension affect survival at 5 years follow-up in patients who underwent TAVI for severe aortic stenosis?

Abstract Background Pulmonary hypertension (PH) is common in patients with severe aortic stenosis (AS) and is associated with increased mortality after transcatheter aortic valve implantation (TAVI) as well as surgical aortic valve replacement (SAVR). Preprocedural systolic pulmonary artery pressure (sPAP) often improves after TAVI because the most common type of PH is postcapillary PH secondary to left-sided heart disease, which potentially improves after treatment for AS. However, there are limited data regarding the prognostic impact on outcomes after TAVI and their predictors. Purpose The aim of this study is to compare survival at 5 years between patients with severe PH against those who did not have severe PH who underwent TAVI. Methods Between January 2012 until December 2022, we carried out a retrospective study of all patients who underwent TAVI at our hospital. Severe PH was defined as the presence of sPAP &amp;gt;40mmHg on echocardiography. Patients with aortic regurgitation and mixed aortic valve disease were excluded. Co-morbid pulmonary disease was defined as the presence of any significant pulmonary disease including COPD and Asthma. Co-morbid neurological disease was defined as the presence of any significant neurological disease including CVA/ TIA. Diabetes mellitus was defined as per WHO and included patients who were diet, medication and insulin controlled. Survival status and date of death were ascertained from our electronic health records. Counts and incidence rates of clinical outcomes at 5-year follow-up were computed from Kaplan-Meier analysis (See Figure 1). A Cox proportional hazards model was used to compute HRs and 95% CIs for the study outcomes. Results Of the 274 patients available for analysis, 115 (14%) patients had severe PH. The mean age was 84 years in both cohorts whilst patients in the severe PH cohort were frailer by Katz Index Score. Death occurred in 67 patients out of 115 patients who had severe PH and in 87 out of 158 patients who did not have severe PH after a median follow-up time of 4.1 years (58% vs 55%; adjusted HR: 1.04; 95% CI: 0.71-1.51; P = 0.86). Conclusion Our data shows that presence of severe pulmonary hypertension in severe aortic disease patients who had undergone TAVI did not affect survival at 5 years follow up compared to patients without severe pulmonary hypertension undergoing TAVI. Determining predictors of mortality in this high-risk cohort is likely to be complex and multifactorial, owing to the severe multi-comorbidity precluding them from SAVR.

Impact of dapagliflozin on supraventricular and ventricular arrhythmias, assessed by Holter ECG, in patients with heart failure with reduced ejection fraction

Abstract Background &amp; Introduction Dapagliflozin has significantly reduced morbidity &amp; mortality in patients with heart failure with reduced ejection fraction (HFrEF) (1). Some studies reported supraventricular &amp; ventricular arrhythmia suppression, but Holter ECG was underused, hindering precise assessment of arrhythmia burden. Purpose We aim to assess the impact of dapagliflozin on reduction of arrhythmia in HFrEF at 1 year follow-up (FU) by Holter ECG. Methods This is a single center, prospective study. We have screened 219 HFrEF patients, but only 156 patients were enrolled with LVEF &amp;lt;40% in sinus rhythm from December 2021 to July 2023. All patients had dapagliflozin 10 mg once/day tablet with the standard HF therapy. Clinical evaluation, NYHA evaluation, 6-minute walking test (6MWT), echocardiogram, 24-hours Holter ECG and laboratory work-up were done at baseline, and FU at 6 months and 12 months. Results Males constituted 61.5% of study population; mean± SD participants’ age was 56.8 ± 8.6 years. The most common comorbidities were: ischemic etiology (63.3%), dilated cardiomyopathy (28.1%), hypertension (27.3%), smokers (14.7%), and type II diabetes (31.4%). LVEF was ≤ 35% in 85.9% of patients. We have reported (7.69%) deaths during 1-year FU, and 4 patients (2.56%) didn't complete 1-year FU. Main clinical and echocardiographic findings (baseline vs. 1-year FU): NYHA FC III&amp; ambulant IV dropped from (42.9 to 32.9%), P value&amp;lt;0.05. Distance walked in 6MWT improved from 191.52 ± 75.37 to 219.35 ± 71.51 mean± SD meters, P value&amp;lt;0.05. E/e improved (9.4 to 8.3 cm/s, P value &amp;lt;0.01), LVEF improved (31.3 to 36.4%, P value&amp;lt;0.05). HF emergency: [HF visits dropped (23.7 to 19.2%) and HF hospitalization dropped (11.1 to 7.8%)], P value&amp;lt;0.05. Holter ECG (baseline vs. 1-year FU): Supraventricular Arrhythmia: [Paroxysmal AF reduced (56.2 to 47.6%), frequent PACs (≥ 10%) dropped (3.8 to 1.4%) &amp; Intermittent 1st degree heart block dropped (12.5 to 7.3%)] P value &amp;lt;0.01. Ventricular Arrhythmia: [PVCs &amp;gt;5%-&amp;lt;10% dropped (16% to 9.3%), Frequent PVCs &amp;gt;10% dropped (3.2 to 1.4%), and NSVT dropped (7.8 to 3.1%)], P value &amp;lt;0.01. Stepwise logistic regression multivariable model aiming to predict the occurrence of ventricular and supraventricular arrhythmias has indicated a direct linear correlation with male gender, smoking, body mass index, left atrial volume, and a history of myocardial infarction. Conversely, there is an inverse relationship with systolic blood pressure, 6MWT distance, LVEF, and the administration of dapagliflozin (OR 0.72 [0.61 - 1.07], P value &amp;lt;0.01) concerning the likelihood of supraventricular and ventricular arrhythmias. Conclusions Dapagliflozin has demonstrated significant improvement in functional and echocardiographic parameters in HFrEF patients. Furthermore, it has effectively decreased the incidence of supraventricular and ventricular arrhythmias, identified through 24-hour Holter ECG monitoring during 1-year follow-up.

The gut-microbiome derived phenylacetylglutamine predicts adverse events in patients with acute coronary syndromes

Abstract Background and Introduction The gut microbiota-derived metabolite phenylacetylglutamine (PAG) is associated with incident cardiovascular events(1). Acute coronary syndromes (ACS) present a major health challenge, especially as population ages(2). Data from our group show increased PAG levels during aging in humans. However, the predictive potential of PAG for mortality and major adverse cardiovascular events (MACE) in patients (pts) with ACS is unknown. Purpose Here, we investigated the potential of PAG to predict ischemic and fatal events in pts with acute coronary syndromes (ACS). We also compared the predictive potential of PAG to another relevant gut-microbiota derived metabolite involved in CVD, namely Trimethylaminoxyde, (TMAO), and we evaluated their cumulative risk potential. Methods A total of 1’848 patients were enrolled in Cohort I of the SPUM-ACS study – a multi-center prospective ACS cohort study from Switzerland. Overall survival and incident MACE after 1 year follow-up were analyzed using Kaplan-Meier (KM) estimates and compared by log-rank test after patient stratification into PAG tertiles. Uni- and multivariable Cox-regression models were fit to calculate the hazard ratios for 1-year MACE in a crude model and adjusted model (adjusted for established confounders). Healthy controls served as additional controls. PAG plasma levels were quantified using LC-HRMS. Results The median PAG plasma level in the healthy control group was 1.76µM, whereas for the whole ACS patient population it was 1.92µM (Table 1). Pts in the third PAG tertile had a two times higher MACE rate and a four times higher mortality rate compared to pts in the first PAG tertile (p&amp;lt;0.001). (Table 2). PAG levels were significantly higher in pts who presented with MACE (2.63µM) or died (3.1µM) within the 1-year follow-up compared to the healthy control subjects (p&amp;lt;0.0001) (Figure 1A). Spearman correlation analysis revealed that plasma PAG levels were positively associated with age (r=0.43, p&amp;lt;0.0001), while a negative association with eGFR was observed (r=-0.51, p&amp;lt;0.0001) (Figure 1B). KM estimates indicated that pts in the highest PAG tertile had significantly higher 1-year MACE risk relative to those with low levels (Figure 1C; p&amp;lt;0.001 log rank). Following multivariable adjustment, PAG remained an independent predictor for MACE at 1-year follow-up with a hazard ratio (HR) of 1.8 (95% CI, 1.1–3.2, p=0.048) (Figure 1D). KM estimates of both, high levels of PAG and high levels of TMAO together, indicate that the combination of these two detrimental metabolites leads to an even higher risk of 1-year MACE relative to lower levels (Figure 1E). Conclusion PAG is a novel and independent predictor of adverse outcomes in patients with ACS. This study indicates the role of the gut-microbiome and its metabolites in predicting ischemic and fatal outcomes of pts with established CVD.

Prognostic value of IL-22 levels and the TH17 pathway in patients with acute myocardial infarction

Abstract Introduction Acute myocardial infarction (AMI) induces a surge in inflammatory cytokines and cells including T helper cells (TH). TH17 cells are activated by pro-inflammatory cytokines such as IL-1, IL-6, and IL-21; they secrete IL-17 and IL-22 to promote neutrophil chemotaxis and to induce pro-inflammatory cytokine secretion from macrophages. Purpose We aimed to explore the prognostic value of the TH17 pathway and its component cytokines in AMI patients. Methods Patients with AMI (STEMI and NSTEMI) were included from the SPUM-ACS cohort (total N=4,787) selecting a time window &amp;lt;24 h from symptom onset to blood sampling before PCI. Patients with malignancies or immunosuppressive therapies were excluded. 160 patients who experienced death (N=85) or recurrent AMI (N=75) within 1-year follow-up (AMI-case) were compared to 152 counterparts with favorable outcome matched for age, sex, AMI subtype, and onset time (AMI-control). 45 healthy blood donors (HD) without cardiovascular disease were added as a reference group. Cytokine levels were reported as median + IQR and were analyzed with multivariate linear regression. Group comparisons were made using the Mann-Whitney U test or Kruskal-Wallis test and multiple comparisons corrected with Dunn’s test. Kaplan-Meier curves were cut off at a median IL-22 level and tested with Log-rank test. Results Our measurement showed correlation among components in TH17 pathway. IL-22 was significantly associated with IL-1β (β=-3.027e-1, p=0.0164), IL-6 (β=5.413e-3, p&amp;lt;0.0001), and IL-21 (β=3.567e-2, p&amp;lt;0.0001), but not with IL-1α or IL-1RA. IL-22 was not correlated with IL-17. Age (median=71.45 vs 71.30 years, p&amp;gt;0.05), percentage of women (23.8% vs 19.7%, p&amp;gt;0.05), and percentage of STEMI (70.6% vs 69.7%, p&amp;gt;0.05) did not differ between AMI-case and AMI-control. AMI-case and AMI-control both showed higher plasma IL-22 levels than HD, whereas there was no difference between AMI groups (Figure 1A). AMI patients who died within 1-year follow-up had higher IL-22 levels than those with recurrent AMI (Figure 1B). Regarding TH17 activation, patients who died had higher IL-17 levels (Figure 1C). Median IL-22 (4.86 pg/mL) levels were tested for predicting outcome: Patients with higher IL-22 levels had more risk for death or recurrent AMI (p=0.0253, Figure 2A). The mortality of patients above median IL-22 levels was higher than those below (p=0.0126); The KM-curves diverged early in less than 1 month after the initial event (Figure 2B). Conclusions Upstream regulators (IL-1β, IL-6) correlated with downstream effectors (IL-22, IL-17) within the pathways involving TH17 cells. Both IL-22 and Il-17 were higher in AMI patients who died within one year than in similar patients who survived. Investigating TH-17- and IL-22-related pathways may be of interest for further investigation in patients with AMI.

Smoking cessation after acute myocardial infarction: a Swiss-wide cohort study

Abstract Background Smoking is a major cardiovascular risk factor and of great importance in terms of both primary and secondary prevention. The present study aims to identify patient characteristics associated with smoking cessation within 1 year after acute myocardial infarction (AMI) to inform physician-patient interactions, secondary prevention measures, and public health planning. Methods ST-elevation myocardial infarction (STEMI) and non-STEMI (NSTEMI) patients enrolled between 2012 and 2022 in the AMIS Plus registry who were active smokers at the time of the index event were included. At the 1-year follow-up, patients were questioned about their smoking behaviour via telephone interview and were further classified into those who had quit (stoppers) or continued (continuers) smoking. Patient characteristics were collected at the time of the index event and at follow-up and then compared using descriptive statistics. Results From a total of 4523 patients with AMI, 4242 (93.8%) provided information regarding their smoking status at a median follow-up of 395 days (interquartile range 370 to 469) after the index event. Of 1691 (39.9%) active smokers at the time of AMI, 861 (50.9%) reported quitting whereas 830 (49.1%) were still smoking at the 1-year follow-up. Stoppers were younger (57 vs. 58 years, p&amp;lt;0.001), more likely to be male (82.8% vs. 77.7%, p=0.008) and have presented with STEMI (77.0% vs. 71.0%, p=0.005), and less likely to have had a previous AMI (6.6% vs. 13.3%, p&amp;lt;0.001) than continuers. Smoking cessation was more common in patients with a more severe AMI characterised by a greater extent of myocardial injury (in-hospital median peak creatine kinase level 1291 IU/L vs. 1101 IU/L, p=0.012), at least one in-hospital complication (13.9% vs. 9.9%, p=0.01), and participation in a rehabilitation programme (83.7% vs. 68.8%, p&amp;lt;0.001). Stoppers more frequently implemented other favourable lifestyle changes, such as dietary changes (56.2% vs. 45.2%, p&amp;lt;0.001) and increased physical activity (54.6% vs. 37.7%, p&amp;lt;0.001) than continuers. Self-reported weight gain was more prevalent among those who quit smoking (44.0% vs. 19.7%, p&amp;lt;0.001). Conclusions In Switzerland, half of the patients with AMI who were active smokers at the time of AMI, reported to have stopped smoking 1 year after the index event. Smoking cessation was associated with participation in a rehabilitation programme and occurred more often in patients with larger AMI sizes, higher in-hospital complication rates and more frequent implementation of other favourable lifestyle changes after AMI. The significant weight gain after smoking cessation seems to represent a major issue that should specifically be addressed.

One-year outcomes of transcatheter mitral valve replacement in patients with severe mitral regurgitation

Abstract Background Mitral valve regurgitation (MR) is a prevalent valvular heart disease, and a subset of patients face challenges in undergoing surgical treatment. Transcatheter mitral valve replacement (TMVR) has emerged as a viable option for selected patients with severe MR deemed unsuitable for traditional valve surgery. Purpose This study aims to evaluate the feasibility, safety, durability, and clinical outcomes of a novel transapical mitral valve system (MitraFix valve) in treating moderate to severe MR patients. Methods The early feasibility study of the MitraFix TMVR transapical system is a multicenter, prospective, nonrandomized study. All patients underwent evaluation by a multidisciplinary heart team and were deemed suitable for mitral valve intervention. Clinical events were adjudicated by an independent clinical events committee. Results From June 2021 to July 2022, 10 patients (mean age: 71.2 ± 7.4 years, 40% male) were enrolled. The mean Society of Thoracic Surgeons(STS) predicted risk of mortality was 7.5 ± 2.7%. All implants were successful, with a mean operational time of 45.2 ± 25.9 min. One patient was converted to open cardiac surgery after successfully implanting the valve due to persistent apical bleeding. At 1-year follow-up, all-cause mortality was 20%, with a cardiovascular mortality at 10.0%. Among survival patients, 87.5% of surviving patients had MR ≤1+ and 75% patients were in NYHA functional class I or II at 1 year. The overall KCCQ score significantly increased from 55.8 (42.9, 72.9) points at baseline to 77.5 (73.7, 88.6) points at 1-year follow up (P = 0.012). Left ventricular ejection fraction showed no significant change from basline (51.5%) to 1 year (50.0%) (P=0.799). No evidence of mitral stenosis or left ventricular outflow tract (LVOT) obstruction was observed. Conclusions The MitraFix TMVR transapical system demonstrated excellent valve function, low mortality, sustained MR elimination and clinical improvement up to one year in this study. Further studies, encompassing a larger cohort of patients and an extended follow-up duration, are needed to confirm these findings.Change in MR and NYHA functional classChange in Quality-of-Life Assessment

Drug-coated balloon versus drug-eluting stent revascularization in the treatment of de novo acute myocardial infarction

Abstract Objective To assess the efficacy and safety of a drug-coated balloon (DCB) revascularization on percutaneous coronary intervention (PCI) in patients with de novo acute myocardial infarction (AMI). Background Data on DCB-only treatment in the context of AMI are limited. Methods A total of 96 patients with de novo AMI successfully treated with DCB alone were retrospectively enrolled. Visual residual stenosis ≤ 30% without flow-limiting dissection was considered a satisfactory pre-balloon angioplasty and followed by DCB treatment. We compared it with 96 propensity-matched patients treated with second-generation drug-eluting stent (DES) from the PTRG-DES registry (n = 13,160 patients). Major adverse cardiovascular events (MACE) comprised cardiac death, myocardial infarction, stroke, stent or target lesion thrombosis, target vessel revascularization, and major bleeding (Bleeding Academic Research Consortium bleeding type 3 or greater) at 1 year. Results Baseline clinical characteristics were comparable between the groups. The mean device diameter was larger in DES group (2.7 ± 0.3 mm vs. 3.1 ± 0.4 mm, P &amp;lt; 0.001). No abrupt vessel closure requiring treatment occurred after treatment with DCB. The MACE was comparable in both groups (6.2% in DCB group vs. 7.3% in DES group, P = 0.790) at 1-year follow-up. Conclusions In de novo AMI patients, DCB-only treatment approach had comparable clinical outcomes at 1-year follow-up. DCB-only treatment may be a safe and effective alternative to DES in carefully selected patients who had satisfactory pre-dilation results.

Posterior Fossa Arachnoid cysts (PFACs) in pediatric patients: a single-center retrospective study and proposal of a treatment flow-chart.

To investigate how different presentations of posterior fossa arachnoid cysts (PFACs) influence surgical indication and strategies and their impact on clinical and radiological outcome in children, proposing a treatment flow-chart. In this retrospective study, children < 14 years old with PFAC diagnosed at IRCCS Giannina Gaslini Hospital from 2008 to 2023 were identified Patients showing a mega cisterna magna (MCM), Dandy-Walker syndrome (DWS), Blake's pouch cyst (BPC), neuroenteric cysts or multiple cysts were excluded. Data regarding type of treatment, age at surgery, surgical complications were collected and analyzed. Clinical and radiological outcomes were considered at 1-, 3- and 5-years follow-up. A "wait and see" strategy in asymptomatic showed better clinical outcomes at 1-year follow-up (p = 0.047). No significant difference in clinical outcome or risk of re-surgery were observed between microsurgical fenestration, endoscopical fenestration or shunting were reported, while location of the cyst influenced surgical strategy (p = 0.015). Age < 12 months at surgery (p = 0.008), hydrocephalus (p = 0.001), especially when associated with macrocephaly (p = 0.004), and the placement of a shunt (p = 0.006) resulted as risk factors of re-surgery. An association between radiological and clinical outcomes was observed at 1-year follow-up. Treatment decision should be based on clinical presentation rather than radiological presentation. While a "wait and see" strategy is suggested in asymptomatic patients, when surgery is indicated, several factors should be considered, such as presence of hydrocephalus, location of the cyst and age of the patient, to improve clinical outcomes, reducing complications.

Clinical outcomes of edoxaban treatment in atrial fibrillation patients with high bleeding risk: insights from the ETNA-AF-China 1-year follow-up

Abstract Background In China and many other countries, anticoagulated atrial fibrillation (AF) patients with high bleeding risk often raises clinical concern; the optimal dose of direct oral anticoagulants (DOACs) preventing stroke/systemic embolic events (SEE) in those population remains unclear. Purpose To assess the effectiveness and safety of edoxaban treatment in Chinese AF patients with high bleeding risk, and to compare 60 mg vs 30 mg dose in this real-world registry. Methods ETNA-AF-China is a prospective, observational study conducted in 89 centres across Chinese Mainland enrolling AF patients receiving edoxaban. This subgroup analysis was based on 1-year follow-up data. Patients were categorized to high bleeding risk group who had a DOAC score ≥6 (age, creatinine clearance, underweight, history of stroke/TIA/SEE, diabetes, hypertension, antiplatelet use, NSAIDs use, history of major/critical bleeding, liver disease) at baseline, or moderate-to-low bleeding risk group meeting criteria of DOAC score &amp;lt;6. The safety, effectiveness, and composite outcomes were reported by comparison between patient subgroups using Cox proportional hazards models. Results Of 4883 patients with 1-year follow-up, 1534 (31.4%, 60 mg: n=518, 30 mg: n=1016) were identified as high bleeding risk and 3349 (68.6%) as moderate-to-low bleeding risk. As expected, patients with high bleeding risk were more often elderly (48.2% ≥80 years), had lower body weight, worse renal function, higher CHA2DS2-VASc score than those with moderate-to-low risk (Figure 1). In both high risk and moderate-to-low risk subgroups, patients receiving 60 mg edoxaban were younger, with better renal function, lower CHA2DS2-VASc score compared with 30 mg. Annualised event rates of major bleeding (HR 2.95, 95%CI 1.62–5.36), all cause death (3.42, 2.29–5.09), CV death (3.27, 1.52–7.04), major adverse cardiac events (MACE, 2.61, 1.69–4.02) and all NCOs were significant higher in patients with high bleeding risk compared with moderate-to-low risk (Figure 2). After multivariable adjustment, edoxaban dose of 60 mg other than 30 mg were associated with significantly lower rates of all cause death (adjusted HR 0.41, 0.18–0.90) and lower trend of NCO3 (0.51, 0.28–0.92) and NCO4 (0.51, 0.30–0.88) by composite of stroke/SEE, major bleeding and death events in high risk subgroup; no significant difference between edoxaban doses and stroke or bleeding outcomes with cumulative low event rates were observed. Conclusion In routine clinical care, AF patients at high bleeding risk faces worse outcomes of death events, MACE, as well as the composite outcomes over moderate-to-low risk patients. Among patients with high bleeding risk, edoxaban use showed effectiveness and safety with overall low incidence, and potential better survival, composite endpoint benefit could be associated with 60mg. Further investigation is ongoing.

Low rates of haemorrhagic stroke, not increased by age, renal/hepatic impairment, concomitant anti-platelet use and high CHA2DS2-VASc scores, in the 4-year follow-up of ETNA-AF-Europe

Abstract Background Balancing the risks of stroke and bleeding is necessary to optimise oral anticoagulation use in clinical practice. Concerns remain over the increased bleeding risk in patients receiving NOACs, and long-term safety data in this population are limited. Purpose To report annualised rates of haemorrhagic stroke in various sub-populations of patients with atrial fibrillation (AF) treated with edoxaban during the 4-year follow-up of ETNA-AF-Europe. Methods ETNA-AF-Europe, a post-authorisation, observational study conducted across 776 sites from 10 European countries, assessed the risks and benefits of edoxaban use in patients with AF. Here, we present the annualised event rates of haemorrhagic stroke during the 4-year follow-up, that occurred overall (on-/off-edoxaban) and on-edoxaban, including sub-populations stratified by age, renal impairment, hepatic impairment, chronic concomitant antiplatelet use and CHA2DS2-VASc score. Patient characteristics were collected at baseline and annualised event rates were reported for outcomes. Results A total of 13,164 patients were included in the full analysis set. Baseline characteristics are reported in Table 1. The overall and on-edoxaban annualised haemorrhagic stroke rates were low (number of events, % [95% confidence interval]: 36, 0.1 [0.05;0.11] and 31, 0.1 [0.05;0.10] respectively). The overall haemorrhagic stroke rates remained low in subgroups stratified by age (&amp;lt;65 years: 4, 0.1 [0.00;0.11]; ≥65–75 years: 13, 0.1 [0.04;0.13]; ≥75 years: 19, 0.1 [0.05;0.12]), renal impairment (yes: 23, 0.1 [0.05;0.13]; no: 12, 0.1 [0.03;0.11]), hepatic impairment (yes: 0, 0.0 [0.00;0.00]; no: 35, 0.1 [0.06;0.11]), concomitant antiplatelet use (yes: 2, 0.1 [0.00;0.16]; no: 34, 0.1 [0.05;0.11]) and CHA2DS2-VASc score (low [0–1]: 0, 0.0 [0.00;0.00]; moderate [2–4]: 28, 0.1 [0.06;0.12]; high [&amp;gt;4]: 7, 0.1 [0.03;0.18]) (Figure). Likewise, on-edoxaban haemorrhagic stroke rates were low irrespective of age (&amp;lt;65 years: 3, &amp;lt;0.1 [0.00;0.010; ≥65–75 years: 12, 0.1 [0.04;0.13]; ≥75 years: 16, 0.1 [0.04;0.12]); renal impairment (yes: 20, 0.1 [0.05;0.12]; no: 10, 0.1 [0.02;0.10]); hepatic impairment (yes: 0, 0.0 [0.00;0.00]; no: 30, 0.1 [0.05;0.11]); chronic concomitant antiplatelet use (yes: 2, 0.1 [0.00;0.18; no: 29, 0.1[0.05;0.10]) or CHA2DS2-VASc score (low [0–1]: 0, 0.0 [0.00;0.00]; moderate [2–4]: 25, 0.1 [0.05;0.12]; High [&amp;gt;4]: 6, 0.1 [0.02;0.17]) (Figure). Conclusions The overall and on-edoxaban annualised rates of haemorrhagic stroke were low and were not increased by non-modifiable risk factors such as age, renal/hepatic impairment, concomitant antiplatelet use and high CHA2DS2-VASc scores during the 4-year follow-up. The overall annualised rates on-edoxaban in ETNA-AF-Europe registry are quite comparable with incidence rates reported in the literature in age-stratified populations (incidence/100 person-years: 55-64 years: 0.06 [0.04-0.07]; 65-74 years: 0.1 [0.09-0.1]; 75-84 years 0.2 [0.1-0.2]).Baseline Characteristics