1-year Outcomes Research Articles

Management and outcomes of acute myocardial infarction in patients with Alzheimer's disease: a study of 2.7 million individuals with myocardial infarction, 2010 - 2020

Abstract Background As a consequence of population ageing, the prevalence of Alzheimer’s Disease (AD) is rising. Evidence-based clinical decision-making for those with AD that present with acute myocardial infarction (MI) is limited by difficulty in identifying which patients will benefit from guideline-directed invasive management versus a more conservative approach. Purpose This study aimed to assess the prevalence of AD in patients presenting with acute MI and characterise its association with patient factors, treatment utilisation and clinical outcomes. Methods A retrospective cohort study was conducted using the United States National Readmission Database (NRD), 2010–2020. International Classification of Disease (ICD; version 9 and 10, Clinical Modification) codes were used to identify patients with a principal diagnosis of MI, pre-existing AD and other comorbidities, in addition to invasive procedures (invasive coronary angiography ± percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery). Logistic and flexible parametric survival models (adjusted for age, sex, MI subtype, smoking status, comorbidities, and MI treatments) were used to evaluate the association between AD and in-hospital and 1-year clinical outcomes, respectively. Results Overall, 2,750,798 individuals were admitted with MI during the study period, of which 35,367 had Alzheimer’s disease; 1.3%; Figure 1). Patients with AD were older (median age 85 vs. 67), more likely to be female (57.6 vs. 37.9%), present with non-ST-elevation MI (77.7 vs. 69.5%), and had a greater burden of individual comorbidities (including chronic kidney disease and depression) and multimorbidity (≥2 long-term conditions; 77.4 vs. 71.0%). Patients with AD were less likely to undergo invasive management (coronary angiography ± PCI/CABG; 27.7 vs 77.6%; p < 0.001; adjusted odds ratio [aOR] 0.24, 95% confidence intervals [CI] 0.23–0.25). Patients with AD had greater mortality both in-hospital (11.9 vs. 5.2%; aOR 1.30 (95% CI: 1.26–1.35, p < 0.001) and 1-year (15.9 vs. 7.3%; adjusted hazard ratio [aHR] 1.21; 95% CI 1.18–1.25). AD was associated with a greater risk of major adverse cardiovascular events (MACE; myocardial infarction, stroke or all-cause mortality; 27.8 vs. 17.7%; aHR 1.10, 95% CI 1.08–1.12) at 1-year post-MI (figure 2). However, patients with AD that were selected to undergo invasive management experienced reduced MACE (aHR 0.74, 95% CI 0.70–0.77) and all-cause mortality (aHR 0.53, 95% CI 0.49–0.57) in comparison to those managed conservatively. Conclusions Patients with Alzheimer’s Disease presenting with acute MI face a poor prognosis marked by a high rate of MACE and all-cause mortality. Future research should seek to identify those who benefit most from invasive management. At present, individualised, shared and multidisciplinary decision-making is key to guide the management of patients with AD that present with acute MI.

A graded association between mobility limitation and prognosis in patients with heart failure

Abstract Background In the era of an aging population worldwide, geriatric conditions have become a high-priority clinical concern in treating heart failure (HF). Although mobility limitation is one of the most common geriatric conditions, no study has quantified the dose-response relationship between the level of mobility limitation and the risk of adverse clinical outcomes in patients with HF. Purpose This study aimed to characterize the association between the level of mobility limitation and prognosis in patients with HF. Methods This study was conducted as a patient-level pooled analysis of data from two prospective multicenter cohort studies. The analysis included consecutive patients hospitalized for HF without any exclusion criteria, with a total of 2103 participants. We categorized the patients into four groups based on their level of mobility limitation: Category I, independent outdoor walking; Category II, independent indoor walking; Category III, indoor walking with assistance; and Category IV, abasia. The primary endpoint was a 2-year composite outcome of re-hospitalization for HF or all-cause mortality after hospital discharge. Results During the 2820.7 person-year follow-up period, 998 patients experienced the composite outcome. The cumulative incidences of the composite outcome for Categories I to IV were 24.9, 47.0, 59.3, and 84.8 per 100 person-years, respectively (Figure). After adjusting for potential confounders, a 1-point increase in the mobility limitation category was associated with a 19% higher risk of the composite outcome (hazard ratio: 1.19; 95% CIs: 1.10–1.29; p<0.001). Conclusions A strong and graded association exists between the level of mobility limitation and prognosis in patients with HF. Even among patients with mobility limitations, the risk of adverse clinical outcomes varies in a dose-response manner depending on the magnitude of mobility limitation. Our findings contribute to a more individualized approach for managing older patients with HF.Figure

5-year valve academic research consortium-3 outcomes and predictors of mortality in a 10-year Asian transcatheter aortic valve implantation registry

Abstract Background Transaortic valvular implantation (TAVI) has revolutionised the management of aortic stenosis (AS). Uptake in Asia has caught up in recent years, after an initial lag due to expensive cost, limited subsidies, and scarce accessibility. Hence, longitudinal outcomes of TAVI remain largely unknown in Asian patients. Purpose This study aims to present the 5-year mortality endpoints in an Asian cohort followed up over a decade. Methods 253 patients with symptomatic severe aortic stenosis status post TAVI were retrospectively enrolled at a tertiary academic hospital from 2010-2021. The main outcomes were defined as short-term (30-day), mid-term (1-year) and long-term (5-year) all-cause mortality. Baseline demographics, procedural findings and clinical outcomes were analysed. Kaplan-Meier curves and multiple Cox regression analyses were constructed. Results The mean age was 75.2 + 10.2 years. 120 (47.4%) patients were female and 167 (66%) were Chinese. 168 patients (66.7%) received balloon-expandable valves, 80 patients (31.7%) underwent self-expandable valves, and 4 patients (1.6%) had mechanical-expandable valves. Malignancy was associated with worse short-term mortality at 30-days (HR 3.65, p = 0.054), while pulmonary disease and previous stroke were associated with worse long-term mortality at 5-years (HR 2.27, p = 0.012 and HR 2.02, p = 0.064). Worse all-cause mortality at 30-days, 1-year and 5-years were associated with high NT-Pro BNP levels (HR 1.04, p = 0.046; HR 1.05, p = 0.002 and HR 1.04, p < 0.001), the presence of peripheral arterial disease (PAD) (HR 4.32, p = 0.056; HR 4.48, p = 0.006 and HR 2.43, p = 0.023) and chronic kidney disease (CKD) (HR 6.19, p = 0.006; HR 6.77, p < 0.001 and HR 2.09, p = 0.008). Society of Thoracic Surgery (STS) score (HR 1.11, p = 0.001; HR 1.13, p < 0.001 and HR 1.12, p < 0.001) and Valve Academic Research Consortium (VARC) III endpoints of acute kidney injury (AKI) (HR 6.68, p = 0.047, HR 10.8, p < 0.001 and HR 6.99, p < 0.001), cardiogenic shock (HR 26.3, p < 0.001, HR 12.0, p < 0.001 and HR 4.29, p = 0.011) and structural complications (HR 40.3, p < 0.001, HR 18.1, p < 0.001 and HR 5.18, p = 0.008) were associated with worse all –cause mortality at time-points of 30-days, 1-year and 5-years respectively. On multivariate analyses adjusted for comorbidities and outcomes, STS score and structural complications were independent predictors of 30-day, 1-year, and 5-year all-cause mortality (HR 1.16; p = 0.003, HR 1.09, p = 0.003 and HR 1.10, p < 0.001) and (HR 62.7, p < 0.007; HR 18.9, p < 0.001 and HR 10.6, p = 0.001) respectively. Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) use was protective of survival within 1-year (HR 0.37, p = 0.022). Conclusions STS score and VARC III endpoints of structural complications were reliable predictors of all-cause mortality in Asian patients with TAVI. ACE inhibitor and ARB use was protective against mortality at 1-year.Cox regression analysesKaplan-Meier curves

Effects of Concurrent Administration of Spironolactone in Veterans with Metastatic Prostate Cancer Receiving Abiraterone: A Real-World Retrospective Study.

Prostate cancer is the most common cancer in men in the United States with low survival rates once metastasized. Abiraterone is approved for use in castrate-sensitive and castrate-resistant prostate cancer and is used extensively in the Veterans Affairs (VA) healthcare system. Spironolactone, a diuretic used to treat heart failure, edema, ascites, and hypertension, may increase androgen levels and reduce effectiveness of abiraterone when used concurrently to treat prostate cancer patients. While previous case studies support this, no large epidemiology studies have been conducted. The current study utilizes the large, VA prostate cancer data core and evaluates the effect of concomitant spironolactone on efficacy of abiraterone treatment in metastatic prostate cancer patients. The study selected 18,943 veterans with metastatic prostate cancer on abiraterone treatment. Of these, 581 patients (3.1%) were also on concomitant spironolactone. The concomitant treatment group, abiraterone + spironolactone, significantly differed from the abiraterone-only group in body mass index, prevalence rates of heart failure and liver disease, and being previously treated with docetaxel. A 1:1 propensity score matching method was used to balance sample sizes and baseline traits between the two treatment groups, abiraterone versus abiraterone + spironolactone. Kaplan-Meier curves and Cox proportional hazard model were used to compare 5-year overall survival and all-cause mortality outcomes, respectively, between the two groups. After propensity score matched, the abiraterone + spironolactone group was treated with abiraterone significantly longer than the abiraterone-only group (mean ± standard deviation days 549.0 ± 552.3 vs. 435.5 ± 474.1; p = 0.0002) and had a higher 5-year overall survival rate (44% vs. 37%; p = 0.0116). Veterans with metastatic prostate cancer treated with abiraterone + spironolactone also had a lower 5-year all-cause mortality compared to those only on abiraterone (hazard ratio 0.80, 95% confidence intervals 0.61-0.96; p = 0.012). This large VA observational study suggests that concomitant use of spironolactone does not compromise cancer control or survival of metastatic prostate cancer patients treated with abiraterone.

AMIC achieves sustained clinical improvement in isolated patellar cartilage defects over 5 years, correlating with MRI.

To evaluate 5-year postoperative clinical outcomes of autologous matrix-induced chondrogenesis (AMIC) for isolated ICRS grade 3-4 patellar cartilage defects and correlate outcomes with magnetic resonance imaging (MRI). The hypothesis was that AMIC would improve clinical symptoms and induce neocartilage formation, visible on MRI, making it a safe and effective option for repairing focal patellar cartilage defects. The cohort comprised 13 focal patellar lesions in 12 patients. Pain visual analogue scale (VAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), Kujala score, EuroQol-5D Health Survey questionnaire and MRI data were assessed preoperatively and at 2 and 5 years postoperatively. All MRI scans were evaluated using the Magnetic Resonance Observation of Cartilage Repair Tissue System. Descriptive statistics were calculated on all data. Inferential analysis comparing outcome scores before and after surgery employed the nonparametric Wilcoxon signed-rank test, with the nonparametric Friedman test used to detect differences across multiple test attempts. p < 0.05 was considered statistically significant. Twelve patients (23-52 years old) with patellofemoral chondral full-thickness defects (2-4 cm2) were treated. At a 5-year follow-up, eleven knees showed MRI improvement. Two were asymptomatic and nine showed clear clinical improvement. Only one knee showed no clinical improvement. MRI revealed a defect filling with newly formed cartilage characterized by a less compact and heterogeneous signal. Cartilage degradation or joint damage was observed in two knees, and bone formation within the plate was identified in four. AMIC significantly improved patients' VAS pain, KOOS, EuroQol-5D and Kujala scores compared to preoperative baseline for up to 5 years postoperatively. Satisfactory clinical outcomes and new cartilage formation, as observed by MRI, are achieved with AMIC at mid-term follow-up for ICRS grade 3-4 in small-to-medium-sized patellar defects in patients under 52 years of age, with improvements maintained for up to 5 years. Level III.

Incident atrial fibrillation prediction using ECG-based deep learning at a specialized tertiary cardiac care center

Abstract Background Deep learning (DL) applied to electrocardiograms (ECG) is an emerging modality in the prediction of incident atrial fibrillation or atrial flutter (AF). The generalizability of such methods to a tertiary heart center (THC) population has not yet been formally explored. Purpose Evaluate the performance of DL in predicting 5-year incident AF using a resting 12-lead ECG in sinus rhythm acquired at a THC. Methods In a retrospective study, we examined 1.4 million ECGs acquired from over 250,000 adults at a THC between 2004 and 2022. ECGs were excluded if they were performed within 30 days of cardiac surgery, captured a rhythm other than sinus rhythm, or were acquired in patients with pre-existing AF. Incident AF at 5 years was modelled as a binary outcome and was determined on the basis of available outpatient and inpatient clinical databases and ECG diagnoses. Included ECGs were randomly split by distributing patients into training (70%), validation (10%), and test (20%) sets. A ResNet-50 model was trained using the training set. Hyperparameters were optimized using the validation set. The tuned model's performance is reported on the test set. The results at the patient level were derived by averaging the model's probability outputs for ECGs grouped according to both their AF outcome and the patient's identity. Bootstrapping was used to report confidence intervals (CI). Sensitivity and specificity are reported at a classification threshold based on the Matthews correlation coefficient. Saliency maps were used to enhance the model’s explainability. Results A total of 669,782 ECGs (47% of the screened ECGs) were included among 145,323 patients. Mean age was 63±15 years and 62% were male. The 5-year incident AF outcome was observed in 12% of ECGs and 16% of patients. The performance of the tuned model was first evaluated at the ECG level on the test set demonstrating an area under the receiver operating curve (AUC) of 0.75 (95% CI: 0.745-0.753) and an integrated calibration index of 0.009 (95% CI: 0.008-0.011). When testing the model at the patient level to simulate a deployment scenario, the AUC improved to 0.78 (95% CI: 0.768-0.783) with a sensitivity of 50% (95% CI: 49-52) and specificity of 87% (95% CI: 86.5-87.3). Stratified results by sex showed a better AUC in females, 0.81 (95% CI: 0.80-0.82), compared to males, 0.75 (95% CI: 0.74-0.76). Subgroup analyses revealed a trend of improved performance at the patient level with an increasing number of ECGs. Saliency maps highlighted the P-wave area as having the highest influence on the model’s prediction, thereby enhancing the model’s plausibility and explainability. Conclusion A unimodal ECG-based deep learning model showed promising 5-year incident AF prediction performance in a cohort of all-comer patients at a tertiary heart center. Further studies could explore the use of multimodal prediction models that integrate ECGs with other clinical and imaging data.

Influence of acute kidney injury and chronic kidney disease on 3-year clinical outcomes in patients with AMI treated by contemporary PCI and optimal medical therapy; insights from J-MINUET study

Abstract Background The influence of acute kidney injury (AKI) and chronic kidney disease (CKD) on long-term outcomes following AMI in the era of modern primary PCI with optimal-medical-therapy (OMT) is still in debate. Methods A total of 3,281 patients with acute myocardial infarction (AMI) were enrolled in the J-MINUET registry with primary PCI of 93.1% in STEMI Consecutive patients hospitalized within 48 h of onset of AMI at 28 Japanese medical institutions were enrolled in the J-MINUET study (UMIN000010037). AKI was defined as an increase in serum-creatinine ≥0.3mg/dL or ≥50% within-48h during-hospitalization. CKD was defined as estimated glomerular filtration-rate [eGFR]&amp;lt;60mL/min/1.73m2. Major adverse cardiac event (MACE) was defined as a composite of all-cause death, cardiac-failure, MI and stroke. Patients were divided into 4 groups based on the presence or absence of CKD and the occurrence or non-occurrence of AKI. The parameters were assessed by the Cox proportional hazards model. Differences were considered statistically significant at P&amp;lt;0.05. Results Of the 3,281 patients with AMI, 3220 patients had complete data set. The average age was 69±13 years old and 75.3% of the patients were male. Of the 3220 patients, 1375 patients had CKD (42.7%) and AKI occurred in 365 patients (11.3%) during the initial hospital stay. AKI more frequently occurred in 305 CKD patients (22.2%) than 60 non-CKD patients (3.3%) (p&amp;lt;0.0001). A total of 898 MACE occurred (27.4%) during follow-up period (median of 768days). Kaplan-Meier curves illustrated event-free survival for MACE over 3 years stratified by the 4 groups (Figure). Conclusions While both CKD without AKI and non-CKD with AKI showed similar effect on the incidence of MACE, the worst clinical outcome was observed in patients having AKI on pre-existed CKD.

Long-term mortality outcomes of southeast asian patients with aortic stenosis

Abstract Background Limited data exists on mortality outcomes of aortic stenosis (AS) in Southeast Asians. Insights into this may confer prognostic benefits and affect therapeutic targets. Purpose Our study aims to provide insights into 10-year mortality outcomes and prognostic indicators of AS in this cohort. Methods Consecutive patients (n = 703) with echocardiographic diagnoses of AS at a tertiary academic hospital in Southeast Asia were studied. Demographics, co-morbidities and outcomes were collected. Multivariate Cox regression model was constructed. Results 55.2% (n = 388) of patients had mild AS, 29.3% (n = 206) had moderate AS, and 15.5% (n = 109) had severe AS. Out of 431 deaths, 35.8% (n = 86) of known cases were cardiovascular. The leading cause of cardiovascular mortality was coronary-linked in 20.8% (n = 50); 7.9% (n = 19) was valvular aortic stenosis; 2.5% (n = 6) was cardiac failure, 1.3% (n = 3) was sudden cardiac death, and 2.9% (n = 7) was ischaemic stroke. Of 154 (64.2%) non-cardiovascular mortality, sepsis caused 40% (n = 97) of deaths, malignancy in 11.7% (n = 28), renal failure in 5% (n = 12) and respiratory failure in 1.7% (n = 4). 44.3% (n = 191) of cases were unknown. Higher proportions of AS patients with cardiovascular death had hyperlipidaemia (p = 0.027) and coronary artery disease (p = 0.028). Multivariable Cox regression showed age (HR 1.041, 95% CI: 1.020-1.062, p &amp;lt; 0.001), anaemia (HR 2.121, 95% CI: 1.535-2.930, p &amp;lt; 0.001) and prior cardiovascular hospitalisation (HR 1.420, 95% CI: 1.040-1.938, p = 0.027) to be significant predictors of all-cause mortality. Aortic valve replacement was a significant protective factor of all-cause mortality after adjustments for age, gender, comorbidities, and echocardiographic findings (HR 0.313, 95% CI 0.131-0.747, p = 0.009). Conclusions Non-cardiovascular death was the leading cause of mortality in Southeast Asians with AS. Ischaemic heart disease was the commonest cause of cardiovascular mortality. Predictors of all-cause mortality included age, anaemia and prior cardiovascular hospitalisation. Valvular replacement was protective of all-cause mortality in AS.

Long-term validation of AtherosSlerosis CardioVascular Disease (ASCVD) risk score and the role of aspirin for primary Cardiovascular prevention in Korean patients with over ASCVD 20% risk score

Abstract Background Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of death worldwide. The ASCVD risk score can be a great tool for preventing ASCVD in the future. There is a mediation recommendation depending on calculated risk called United States Prevention Services Task Force (USPSTF) aspirin (ASA) recommendation. However, the validation studies of long-term clinical outcomes in Korean population using the ASCVD risk score and of the effect of ASA in Korean patients using USPSTF recommendation are limited. Methods A total of 7,249 patients with any chest pain who underwent coronary spasm provocation tests between January 2004 and December 2021 were enrolled. Patients were divided into four groups, based on the ASCVD risk score: &amp;lt; 5% group (Low Risk, n = 2,534), 5 - 10% group (Borderline Risk, n=1,681), 10 - 20% group (Intermediate Risk, n = 1,896) and ≥ 20% group (High Risk, n = 1,138). The primary endpoint was Major Adverse Cerebral and Cardiovascular Event (MACCE1), including stroke and MACE. The secondary endpoint was MACCE 2, defined as composite of MACE and recurrent angina requiring follow-up coronary angiography (CAG). The third endpoint was the effect of aspirin in patients who have over 20% ASCVD risk. Results Long term (10-year) ASCVD risk score was well-validated from the "Low Risk" group to the "High Risk" group by 1.87%, 7.44%, 14.09%, and 30.61%, respectively (P &amp;lt; 0.001). In baseline characteristics, the calculation factors of ASCVD risk score is also well-stratified, showing the more adverse clinical profiles in the "High Risk" group than the "Low Risk" group. In 10-year clinical outcomes, although MACCE1 and MACCE2 showed an increasing trend numerically, stroke was observed to significantly increase according to ASCVD risk score. There was no effect of ASA prescribed in accordance with USPSTF recommendation. The group with the highest rate of 20% or more failed to show the aspirin prevent effect on the occurrence of CV events, but also increased the incidence (MACCE1; HR: 1.647, P-Value: 0.283, 95% CI: 0.662 - 4.100, MACCE2; HR: 1.819, P-Value: 0.025, 95% CI: 1.078 - 3.068). Conclusion Long term ASCVD risk score was associated with higher risk of stroke. However, MACCE1 and MACCE2 only showed an increasing trend numerically. Furthermore, the effect of ASA prescribed based on the USPSTF ASA use recommendation statement were not observed in Korean population. Consequently, additional research is needed to ensure the utility of ASCVD risk score and the effect of ASA in high-risk patients to prevent future CV events in Korean population.

Biolimus A9 DEB for the Treatment of In-Stent Restenosis. 1-year outcomes of the REFORM trial

Abstract Background In recent years, drug-coated balloons (DCB) have established themselves as another tool in the arsenal of interventional cardiology devices for the treatment of in-stent restenosis (ISR) lesion. Aims The study was designed to compare the biolimus DCB to the paclitaxel-coated SeQuent PleaseTM DCB. Method This was a prospective, non-inferiority, randomized, multicenter, study conducted at 20 centers in 6 countries. The primary endpoint was in-segment % diameter stenosis (%DS) at six months. The study was powered to enrol 201 patients in at 2:1 randomization to either the biolimus DCB (BCB) or the SeQuent PleaseTM DCB (SQP). Key secondary endpoints included, late-lumen loss, binary restenosis, and target lesion failure (TLF) and myocardial infarction at 1 year. Results A total of 202 patients were randomised with 135 in the BCB group and 67 in the SQP group. Mean patient age was 68.9 ± 9.9 years in the BCB group compared to 68.2 ± 10.5 years in the SQP group. At 6 months, %DS was 41.8 ± 21.3 in the BCB group compared to 31.4 ± 17.7 in the SQP group (95% confidence for the difference: 3.5-16.9, p-value for non-inferiority 0.32). At 12 months, TLF was 23.74%, in the BCB group vs 17.07% in the control group, hazard ratio (HR) of 1.44 [95% CI: 0.72-2.88], p=0.28. There were more clinically driven revascularization in the BCB group (21.61%) compared to SQP (15.61%) [HR: 1.46, 95% CI: 0.71-3.01], p=0.29. More myocardial infarction were observed in the SQP group (BCB: 7.59% vs SQP: 3.77%, [HR: 0.48, 95% CI: 0.14-1.68], p=0.24)(see Figure). Conclusions In ISR patients, the REFORM study was not able to demonstrate non-inferioirity of the biolimus DCB compared to the SeQuent Please DCB.

A sex-specific comparison of valve-in-valve transcatheter aortic valve implantation

Abstract Introduction Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) is a viable and less-invasive alternative to open heart surgery in selected patients with bioprosthetic valve dysfunction. Since patients receiving initially a new bioprosthetic aortic valve are predominantly male, data on a sex-specific comparison of ViV-TAVI is scarce. Thus, we compared patient characteristics, procedural outcomes, and 1-year outcomes of female (F) versus male (M) patients with failing bioprosthetic aortic valves undergoing ViV-TAVI. Methods A total of 375 Patients at 3 German centres were included in this analysis. The 1-year mortality was the primary outcome measure, secondary outcomes included VARC-3 defined technical and device success and early safety. Results Overall, 160 (42.6 %) women and 215 (57.4 %) men were included. Women were older (F 81 (77; 84), p &amp;lt; 0.001), had a greater surgical risk (STS PROM F: 9.1 (6.1; 13,9) %, p &amp;lt; 0.001) and a higher rate of previous coronary bypass surgery (F: 25.6 % vs M: 40 %, p = 0.004), while presenting mostly failed valve sizes &amp;lt; 20 mm (F: 59.4 % vs M: 33.4 %, p &amp;lt; 0.001) and therefore higher gradients (F: 40 (31; 50) mmHg vs M: 32 (25; 42) mmHg, p &amp;lt; 0.001). Aortic regurgitation was the mode of failure in 7.5 % of F vs. 14.4 % of M. The number of stentless valves was higher in men (F: 8,1 % vs M: 14 %, p = 0.08). Patients received a self-expanding TAVI prostheses in 79.4 % and 75.8 % respectively in F and M patients. The rates of technical success (F: 75.6 % vs M: 83.3 %, p =0.06), device success (F: 52.5 % vs M: 58.2 %, p = 0.27) and early safety (F: 67.5 % vs M: 67 %, p = 0.91) were comparable between genders. Residual mean gradients were higher in F (F: 15 (11;22) mmHg vs M: 15 (10; 20) mmHg, p = 0.03), while the rates of residual regurgitations were greater in M patients (F: 1 (0.6 %) vs M: 11 (5.1 %), p = 0.04). The Kaplan-Meier estimated 30-day mortality rate (F: 2.5% vs M: 3.3%, p = 0.66) and 1-year mortality rates (F: 10 % vs M: 92.6 %, p = 0.37) were comparable between genders. Conclusion: F and M patients treated by ViV-TAVI have comparable short-term outcomes according to VARC-3-defined endpoints and similar mortality rates after 30 days and 1 year. The residual gradients in F and residual regurgitations in M could be explained by structural features of their failed valves. Further large scale studies are needed to determine, if such procedural outcomes are truly sex-specific.

Comparative outcomes of drug-coated balloon angioplasty versus second-generation drug-eluting stent for in-stent restenosis: a real-world data analysis

Abstract Background Coronary in-stent restenosis (ISR) poses a significant challenge in interventional cardiology, with optimal treatment strategies being the subject of ongoing debate. Current clinical guidelines offer a choice between drug-coated balloon angioplasty (DCB) and repeat stenting with second-generation drug-eluting stents (DES), each with distinct implications for long-term patient outcomes. Purpose The aim of this study is to compare 1-year outcomes between DCB angioplasty and second-generation DES in the treatment of ISR. Longitudinal real-world data are used from the OBSERVABLE database, which comprises German health claims data between 2012 and 2021. Methods A total of 10,440 ISR individuals undergoing DCB or DES intervention were identified. After exclusion of bare-metal stents, first generation stents and non-DCBs, 3,810 propensity score-matched individuals remained. The primary outcome was the composite of all-cause mortality and myocardial infraction (MI). Secondary outcomes included all-cause death, MI, and bleeding as a safety outcome. Results At 1-year follow-up, the primary outcome of all-cause mortality and MI was observed in 246 individuals (12.9%) in the DES group, compared with 201 individuals (10.6%) in the DCB group (HR, 1.27; 95% CI, 1.06-1.53). Sensitivity analysis confirmed the robustness of these findings. Secondary outcomes revealed higher all-cause mortality in the DES group (7.9%) compared to the DCB group (6.3%) (HR, 1.31; 95% CI, 1.03-1.66), with no difference in MI. Bleeding events were comparable between the two treatments, with 244 individuals (12.8%) in the DES group and 206 individuals (10.8%) in the DCB group (HR, 1.17; 95% CI, 0.89-1.53). Conclusion This real-world data analysis demonstrated a higher incidence of the primary composite endpoint of all-cause mortality and MI within one year, after treatment with DES compared to DCB. Our results support prior findings about the safety profile of repeated DES implantation and strengthen DCB as a potential superior alternative to DES in ISR management.

Outcomes by race and ethnicity in patients undergoing percutaneous coronary intervention of chronic total occlusion

Abstract Background Percutaneous coronary intervention (PCI) of chronic total occlusion (CTO) carries increased risk for worse outcome. There is limited data on whether race and/or ethnicity affect outcomes. Materials and methods We included patients who underwent CTO intervention from 2012 to 2017 at The Mount Sinai Hospital (New York). Data were collected prospectively but examined retrospectively. The patients were stratified by race/ethnicity in Caucasians, African Americans, Asians and Hispanics. The primary end point was major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction (MI), and target vessel revascularization (TVR) at 1 year follow-up. Secondary outcomes included individual components of the MACE (death, MI or TVR), and bleeding. Results A total 1,684 patients were included of which (49.8%) were Caucasians, 168 (10%) were African Americans, 396 (23.5%) were Asians and 281 (16.7%) were Hispanics. African Americans had the highest proportion of female patients (39%) and more often had a history of smoking (26.2%) and insulin-dependent diabetes mellitus (46.6%) compared to the other groups. They had the highest prevalence of in-stent restenosis as the target lesion (Table 1). Caucasians were older (65.9±11.1 years) with more calcified lesions and longest lesion length compared to the other groups. Asians had highest prevalence of multi-vessel coronary disease. Caucasians and Asians had higher Syntax score and more stents implanted. Procedural success was similar between the groups (Table 1). Adjusted analyses did not show any differences in clinical outcomes between groups (Table 2). Conclusion In spite of many differences between racial/ethnical groups in baseline and procedural characteristics, procedural success of CTO intervention and 1-year MACE rates were similar between groups.Procedural characteristicsAdjusted 1-year outcomes

Catheter-induced ostial coronary artery dissection during percutaneous coronary intervention assessed by intravascular ultrasound

Abstract Background Catheter-induced ostial coronary artery dissection is one of the possible complications of percutaneous coronary intervention (PCI), sometimes resulting in serious consequences. The incidence of catheter-induced ostial coronary artery dissection has been assessed by coronary angiography, but rarely by intravascular ultrasound (IVUS). Prognosis of ostial coronary artery dissection is also unclear. Purpose To determine the incidence and prognosis of catheter-induced ostial coronary artery dissection during PCI by IVUS assessment. Methods The study population consisted of 1468 consecutive patients undergoing PCI at our institution between January 2019 and March 2020. Patients who had previously received a stent in the ostial coronary artery to be treated and patients who were scheduled to receive a stent in the ostial coronary artery during the procedure were excluded. The analysis was performed on 246 patients undergoing IVUS assessment of the ostial coronary artery at the end of the procedure. The 1-year cumulative rates of all-cause death, nonfatal myocardial infarction, and any revascularization procedure were compared between patients with and without ostial coronary artery dissection (dissection and nondissection groups). Results Ostial coronary artery dissection was detected by coronary angiography in 13 patients (5.2%) and by IVUS in 49 patients (19.9%). There were no significant differences between the dissection and nondissection groups (49 patients vs. 197 patients) in the percentage of the treated coronary artery (right coronary artery: 34.7% vs. 36.0%, p = 0.86), acute coronary syndrome (30.6% vs. 41.6%, p = 0.15), or the use of a backup catheter (32.7% vs. 20.8%, p = 0.09). The dissection group had more moderate to severe calcified lesions than the nondissection group (42.9% vs. 22.3%, p&amp;lt;0.01). There were no significant differences between the dissection and nondissection groups in the 1-year cumulative incidence of all-cause death (6.1% vs. 6.6%, p = 0.88), nonfatal infarction (6.1% vs. 4.1%, p = 0.54), or any revascularization procedure (10.2% vs. 8.6%, p = 0.72). Eight patients (16%) in the dissection group received additional intervention for ostial coronary artery dissection and had a significantly higher rate of dissection detected by coronary angiography than conservatively treated patients (75.0% vs. 17.1%, p&amp;lt;0.01). In addition, no conservatively treated patients received additional intervention for worsening dissection within one year of the index procedure. Conclusion IVUS may be more useful than coronary angiography in detecting ostial coronary artery dissection. With proper management, ostial coronary artery dissection may not lead to worse 1-year outcomes, and many dissections detected by IVUS may not require additional intervention.

The effect of treatment srategy for acute myocardial infarction complicated by cardiac shock using Impella in accordance with institutional protocol

Abstract Backgrounds Team-based care for cardiogenic shock (CS) using mechanical circulatory support (MCS) including Impella in accordance with standardized protocol was reported to improve the prognosis of patients with CS. Methods Between February 2018 and September 2022, we performed percutaneous coronary intervention (PCI) in 63 patients with acute myocardial infarction (AMI) complicated by CS using Impella. We introduced institutional protocol (Figure 1) to standardize the treatment strategy for CS from June 2019, in which early Impella implantation preceding PCI was recommended. We retrospectively examined the incidence of Impella implantation preceding PCI, in-hospital outcomes including the rates of survival to Impella weaning and to discharge, and the incidence of major cardiovascular events (MACE) including all death, MI, and hospitalization for heart failure at 1-year before and after protocol introduction. Results The patients have a mean age of 67.1±13.2 years and 53 patients (84.1%) were male. The patients in preceding period were 16 cases, while 47 in latter period. The rate of Impella implantation preceding PCI was significantly higher in latter period than that in preceding period (61.7% vs. 25%, p=0.027) (Figure 2A). The rate of survival to Impella weaning was significantly higher in latter period than that in preceding period (83% vs. 56.3%. p=0.043). There was no difference in the rate of survival to discharge between each period (50% in preceding period vs. 68.1% in latter period, p=0.236). However, the cumulative MACE free survival rate was significantly higher in latter period than that in preceding period (56.9% vs. 31.3%, Log-rank p=0.020) (Figure 2B). Conclusion The introduction of institutional standardized protocol of MCS use might improve 1-year outcomes of patients with AMI complicated by CS treated with Impella.Figure 1Figure 2

Transcatheter mitral replacement: what are the outcomes of un-eligible patients compared to treated?

Abstract Background/Introduction Transcatheter mitral valve replacement (TMVR) is emerging in recent years as a promising tool to treat mitral regurgitation, however its applicability in the real world remains limited. Purpose The aim of the study is to assess the real-world screening success rate of TMVR in native anatomy and the 1-year outcomes of both accepted and refused patients as well as clinical results. Methods Retrospective analysis was performed on all patients screened for TMVR at our Valve Center, eligible for 1-year follow-up. In-hospital data of all patients admitted to our Department are prospectively collected. Follow-up was done through outpatient visits and/or telephone calls. Results Out of 3400 patients referred to mitral treatment at our department between January 2016-January 2022, 92 were submitted to screening for TMVR. Among these, 48 patients (49%) were accepted and treated with TMVR while 44 (44.8%) were refused (RG). The main reasons for rejection were anatomy unfeasibility in 25 patients (59%) and frailty in 5(11%). Main reasons for anatomy unfeasibility were risk LVOT obstruction (n=15; 60%), annular dimension (n=8; 33%) and ventricular dimension (n=2; 8,3%).Major baseline characteristics between groups were similar including age (85 vs 84), STS (12 vs 13), ejection fraction and LVEDD. However, refused patients had higher filtration rate than TMVR (80 vs 45 ml/min respectively (p=0.001)).All patients accepted were treated with TMVR: 7 patients received Tiara and 24 Tendyne. Procedure success in the TMVR group was 96% (46/48). Patients refused from TMVR were treated with Mitraclip in 5(11%) cases, 37(84%) were left in medical therapy and 2 (4,5%) underwent surgery. 1-year overall survival 65.2±51.3 vs 54.8±36.5 in TMVR and refused group respectively (p=0.002)(Figure 1). 6 deaths (2 cardiac, 33%) occurred in the TMVR compared to 37 (32 cardiac, 86%) in the refused group. Freedom from Cardiac death was 98±19% TMVR vs 75±65% (p&amp;lt;0.001)(Figure 2). NYHA class improved in 98% of cases in TMVR group but worsened in 80% in refused group, (p&amp;lt;0.001). TMVR screening failure is associated with increased cardiac death (HR 12 [1,51;95], p&amp;lt;0,019) and death for any causes (HR 17,5 [6,02;51], p&amp;lt;0,001). Conclusion(s) In the present experience, approximately 50% of patients screened for TMVR were accepted. The most frequent reasons for screening failure were anatomical issues. With a baseline similar clinical profile, treatment with TMVR provided significant 1-year survival and symptoms improvement compared to those of patients refused, whose prognosis is indeed remarkably poor. These data underline the importance of proper patient selection for TMVR to achieve good outcomes but also the need for technological improvement of devices to expand the proportion of patients who can be treated. Given the small numbers currently available, more data are needed to confirm the present findings, which must be considered hypothesis-generating.Figure 1Figure 2

Long-term outcomes of aortic stenosis patients with different flow/gradient patterns undergoing transcatheter aortic valve implantation

Abstract Background Few data exist on the comparative long-term outcomes of severe aortic stenosis (AS) patients with different flow-gradient patterns undergoing transcatheter aortic valve implantation (TAVI). This study sought to evaluate the impact of the pre-TAVI flow-gradient pattern on long-term clinical outcomes after TAVI. Methods Consecutive patients with severe AS undergoing TAVI in our institution were screened and prospectively enrolled. Patients were divided into four subgroups according to pre-TAVI flow/gradient pattern: (i) low flow—low gradient (LF-LG): stroke volume indexed (SVi) ≤ 35 mL/m2 and mean gradient (MG) &amp;lt; 40 mmHg); (ii) normal flow—low gradient (NF-LG): SVi &amp;gt; 35 mL/m2 and MG &amp;lt; 40 mmHg; (iii) low flow—high gradient (LF-HG): Svi 35 mL/m2 and MG ≥ 40 mmHg and (iv) normal flow—high gradient (NF-HG): SVi &amp;gt; 35 mL/m2 and MG ≥ 40 mmHg. Clinical follow-up was obtained at 12 months, and yearly thereafter until 5-year follow-up was complete for all patients. Results A total of 272 patients with complete echocardiographic and clinical follow-up were included in our analysis. Their mean age was 80 ± 7 years and the majority of patients (N = 138, 50.8%) were women. 62 patients (22.8% of the study population) were distributed in the LF-LG group, 98 patients (36%) were LF-HG patients, 95 patients (34.9%) were NF-HG, and 17 patients (6.3%) were NF-LG. There was a greater prevalence of comorbidities among LF-LG AS patients. One-year all-cause mortality differed significantly between the four subgroups of AS patients (log-rank p: 0.022) and was more prevalent among LF-LG patients (25.8%) compared to LF-HG (11.3%), NF-HG (6.3%) and NF-LG patients (18.8%). At 5-year follow-up, global mortality remained persistently higher among LF-LG patients (64.5%) compared to LF-HG (47.9%), NF-HG (42.9%), and NF-LG patients (58.8%) (log-rank p: 0.029) (Figure 1). At multivariable Cox hazard regression analysis, baseline SVi (HR: 0.951, 95% C.I.; 0.918–0.984), the presence of at least moderate tricuspid regurgitation at baseline (HR: 3.091, 95% C.I: 1.645–5.809) and at least moderate paravalvular leak (PVL) post-TAVI (HR: 1.456, 95% C.I.: 1.106–1.792) were significant independent predictors of late global mortality. Conclusions Patients with LF-LG AS have acceptable 1-year outcomes, but exhibit exceedingly high 5-year mortality following TAVI. The presence of low transvalvular flow and at least moderate tricuspid regurgitation at baseline and significant paravalvular leak post-TAVI were associated with poorer long-term outcomes in the entire cohort of AS patients.

AI-enabled cardiac chambers volumetry in coronary calcium scans (AI-CAC) predicts heart failure and outperforms NT-proBNP: The Multi-Ethnic Study of Atherosclerosis

Abstract Introduction Coronary artery calcium (CAC) scans contain useful information beyond the Agatston CAC score that is not currently reported. We recently reported that artificial intelligence (AI)-enabled cardiac chambers volumetry in CAC scans (AI-CAC) predicted incident atrial fibrillation in the Multi-Ethnic Study of Atherosclerosis (MESA). In this study, we investigated the performance of AI-CAC for prediction of incident heart failure (HF) and compared it with 10 known clinical risk factors, NT-proBNP, and the Agatston CAC score. Methods We applied AI-CAC to 5750 CAC scans of asymptomatic individuals (52% women, White 40%, Black 26%, Hispanic 22% Chinese 12%) free of known cardiovascular disease at the MESA baseline examination (2000-2002). We used the 15-year outcomes data and compared the time-dependent area under the curve (AUC) of AI-CAC versus NT-proBNP, Agatston score, and 10 known clinical risk factors (age, gender, diabetes, current smoking, hypertension medication, systolic and diastolic blood pressure, LDL, HDL, total cholesterol, and hs-CRP) for predicting incident HF over 15 years. Results Over 15 years of follow-up, 256 HF events accrued. The AUC for predicting HF with AI-CAC (0.826) was significantly higher than NT-proBNP (0.742) and Agatston score (0.712) (p&amp;lt;.0001), and comparable to clinical risk factors (0.818, p=0.4141). AI-CAC category-free Net Reclassification Index (NRI) significantly improved on clinical risk factors (0.32), NT-proBNP (0.46), and Agatston score (0.71) for HF prediction at 15 years (p&amp;lt;0.0001). Conclusion AI-CAC significantly outperformed NT-proBNP and the Agatston CAC score, and significantly improved the AUC and category-free NRI of clinical risk factors for incident HF prediction.

Coronary artery calcium scans powered by artificial intelligence (AI-CAC) predicts atrial fibrillation and stroke comparably to cardiac magnetic resonance imaging: MESA

Abstract Background AI-CAC provides more actionable information than the Agatston coronary artery calcium (CAC) score. We have recently shown in the Multi-Ethnic Study of Atherosclerosis (MESA) that AI-CAC automated left atrial (LA) volumetry enabled prediction of atrial fibrillation (AF) as early as one year. In this study we evaluated the performance of AI-CAC LA volumetry versus LA measured by human experts using cardiac magnetic resonance imaging (CMRI) for predicting AF and stroke, and compared them with CHARGE-AF risk score, Agatston score, and NT-proBNP. Methods We used 15-year outcomes data from 3552 asymptomatic individuals (52.2% women, age 61.7±10.2 years) who underwent both CAC scans and CMRI in the MESA baseline examination. CMRI LA volume was previously measured by human experts. Data on BNP, CHARGE-AF risk score and the Agatston score were obtained from MESA. Discrimination was assessed using the time-dependent area under the curve (AUC). Results Over 15 years follow-up, 562 cases of AF and 140 cases of stroke accrued. The AUC for AI-CAC versus CMRI for AF and stroke were not significantly different (0.802 vs. 0.798 and 0.762 vs. 0.751 respectively, p=0.60). AI-CAC significantly improved the continuous Net Reclassification Index (NRI) for prediction of AF and stroke when added to CHARGE-AF risk score (0.28, 0.21), NT-proBNP (0.43, 0.37), and Agatston score (0.69, 0.41) respectively (p for all&amp;lt;0.0001). Conclusion AI-CAC automated LA volumetry and CMRI LA volume measured by human experts similarly predicted incident AF and stroke over 15 years. Further studies to investigate the clinical utility of AI-CAC for AF and stroke prediction are warranted.

Five-year outcomes with self-expanding versus balloon-expandable transcatheter aortic valve replacement in patients with left ventricular systolic dysfunction

Abstract Background The importance of transcatheter heart valve (THV) design on clinical outcome in patients with aortic stenosis (AS) and left ventricular (LV) systolic dysfunction remains unknown. Objectives We aimed to compare 5-year outcomes of patients with severe AS and reduced LV ejection fraction (LVEF), undergoing transcatheter aortic valve replacement (TAVR) with balloon-expandable vs. self-expanding THVs. Methods In an institutional TAVR registry, patients with LVEF &amp;lt;50% who underwent TAVR with either balloon-expandable or self-expanding THVs were included. A 1:1 propensity-score matching was performed to account for baseline differences between groups. Results A total of 759 patients were included between August 2007 and December 2022, and propensity-score matching resulted in 134 pairs. Technical success was achieved in over 85% of patients, and was similar in both groups. Self-expanding THVs were associated with a lower mean transvalvular gradient (7.1 ± 3.7 mmHg vs. 9.9 ± 4.3 mmHg; P &amp;lt;0.001) and a higher incidence of ³mild-to-moderate paravalvular regurgitation (36.3% vs. 11.3%; P &amp;lt;0.001) compared to balloon-expandable THVs. At 5 years, patients treated with a self-expanding THV had higher all-cause mortality than those with a balloon-expandable THV (67.8% vs. 55.8%, Adjusted Hazard Ratio: 1.44; 95% CI: 1.02-2.03; P = 0.037). There were no significant differences in other clinical outcomes up to 5 years between groups. Conclusions In the setting of LV systolic dysfunction, patients treated with a self-expanding THV had higher risk of 5-year mortality compared to patients treated with a balloon-expandable THV.