All-comer Patients Research Articles

Prediction Model for POstoperative atriaL fibrillAtion in caRdIac Surgery: The POLARIS Score.

Background: New-onset postoperative atrial fibrillation (POAF) is the most common complication after cardiac surgery, occurring approximately in one-third of the patients. This study considered all-comer patients who underwent cardiac surgery to build a predictive model for POAF. Methods: A total of 3467 (Center 1) consecutive patients were used as a derivation cohort to build the model. The POLARIS score was then derived proportionally from the odds ratios obtained following multivariable logistic regression (MLR). The Brier Score, the area under the receiver operating characteristic curve, and the Hosmer-Lemeshow goodness-of-fit test were used to validate the model. Then, 2272 (Center 2) consecutive patients were used as an external validation cohort. Results: In the overall population (n = 5739), POAF occurred in 32.7% of patients. MLR performed in the derivation cohort showed that age, obesity, chronic renal failure, pulmonary hypertension, minimally invasive surgery, and aortic and mitral valve surgery were predictors of POAF. The derived POLARIS score was used to further stratify the population into four risk clusters: low (1.5-3), intermediate (3.5-5), high (5.5-7), and very high (7.5-9), each progressively showing an increase in POAF incidence. This was confirmed in a correlation analysis (Spearman's rho: 0.636). Conclusions: The POLARIS score is a simple-to-use tool to stratify patients at higher risk of POAF. Precise identification of such patients might be used to implement clinical practice with the introduction of preoperative antiarrhythmic prophylaxis, further reducing the incidence of POAF and, potentially, its clinical sequelae, despite further investigations being warranted to test this model in prospective studies.

Ten-Year Outcomes and Predictors of Mortality Following Catheter Ablation of Ventricular Tachycardia.

Catheter ablation is the primary treatment option for idiopathic ventricular tachycardia (VT). It plays a key role in acute therapy of electrical storm, treatment of VTs in patients with structural heart disease (SHD), and can reduce VT burden. Here we report on 10-year clinical outcomes following VT ablation from patients enrolled in the prospective German Ablation Registry. Long-term follow-up was conducted on 334 patients undergoing VT ablation (118/334, 35%) with structurally normal hearts and 216 out of 334 (65%) with SHD, including 161 out of 216 (75%) with ischemic heart disease at 38 centers. Follow-up was completed in 94.8% of patients. Median observation time was 10.8 (4.3-12.3) years, with a 10-year all-cause mortality rate of 39.4%. VT ablation in patients with SHD was associated with worse outcome when compared with patients with structurally normal hearts (estimated 10-year mortality for SHD 54.8% versus structurally normal hearts 12.1%). Estimated 10-year mortality following VT ablation was highest in patients with ischemic heart disease (62.4%). Significant predictors of mortality following VT ablation included age (hazard ratio [HR], 2.35 [1.90-2.92] per decade), left ventricular ejection fraction ≤30% (HR, 2.11 [1.44-3.10]), diabetes (HR, 1.73 [1.14-2.61]), incessant VT (HR, 2.96 [1.74-5.03]), linear lesion (HR, 1.46 [0.99-2.16]), and acute procedural failure (HR, 2.57 [1.39-4.77]). Procedural failure was the only statistically significant predictor for VT recurrence during follow-up (HR, 3.76 [1.59-8.91]). Within an all-comer patient cohort, estimated 10-year all-cause mortality following VT ablation is 39.4%. Mortality after VT ablation is worse in patients with SHD and highest for patients with ischemic heart disease. Acute procedural success plays a major role in predicting VT recurrence and long-term mortality.

Clinical outcome after bleeding events following coronary stenting in patients with and without comorbid peripheral arterial disease.

Patients undergoing percutaneous coronary intervention (PCI) may experience bleeding events. Bleeding risk is increased in patients with comorbid peripheral arterial disease (PADs). To evaluate whether PCI patients with PADs have worse outcome after bleeding, we assessed pooled patient-level data of 5,989 randomized all-comer trial participants and identified those who had a bleeding (BIO-RESORT:NCT01674803, BIONYX:NCT02508714). Major adverse cardiac events (MACE) and mortality were assessed from bleeding until 3years after PCI. Of all 313 PCI patients with bleeding events, patients with PADs (n = 34, 10.9%) were older and had more complex lesions than those without PADs (n = 279, 89.1%). In patients with PADs, bleeding occurred more often during the first year after PCI (79.4% vs.57.3%, p = 0.013). The proportion of major bleeding, and the severity and location of bleeding were similar between both groups. Multivariate analysis found no statistically significant between-group difference in MACE (43.1% vs.34.7%, p = 0.53; adj.HR:0.86, 95%CI 0.45-1.63, p = 0.64) and mortality (33.5% vs.22.3%, p = 0.12; adj.HR:1.45, 95%CI 0.73-2.91, p = 0.29). Bleeding occurred significantly more often during the first year after PCI in all-comer patients with concomitant PADs than in those without PADs, while we observed no significant between-group difference in bleeding severity and location, and the risk of adverse events after bleeding.

Feasibility of three dimensional and strain transthoracic echocardiography in a single-centre dedicated NHS cardio-oncology clinic

BackgroundFollowing the publication of international cardio-oncology (CO) imaging guidelines, standard echocardiographic monitoring parameters of left ventricular systolic function have been endorsed. Recommendations highlight that either two-dimensional (2D) or three-dimensional (3D) left ventricular ejection fraction (LVEF), alongside global longitudinal strain (GLS) should be routinely performed for surveillance of patients at risk of cancer therapy-related cardiac dysfunction (CTRCD). We studied the feasibility of 3D-LVEF, 2D-GLS and 2D-LVEF in a dedicated CO service.MethodsThis was a single-centre prospective analysis of consecutive all-comer patients (n = 105) referred to an NHS CO clinic. Using a dedicated Philips EPIQ CVx v7.0, with X5-1 3D-transducer and 3DQA software, we sought to acquire and analyse 2D- and 3D-LVEF and 2D-GLS, adhering to the British Society of Echocardiography (BSE) and British Cardio-Oncology Society (BCOS) transthoracic echocardiography protocol.ResultsA total of 105 patients were enrolled in the study; 5 were excluded due to carcinoid heart disease (n = 5). Calculation of 3D-LVEF was achieved in 40% (n = 40), 2D-GLS in 73% (n = 73), and 2D-LVEF in 81% (n = 81). LV quantification was not possible in 19% (n = 19) due to poor myocardial border definition. Strong correlation existed between 2D-LVEF and 3D-LVEF (r = 0.94, p < 0.0001). Bland–Altman plot demonstrated no statistical differences in that the mean deviation between 2D-LVEF and 3D-LVEF were consistent throughout a range of LVEF values. The most persistent obstacle to 3D-LVEF acquisition was insufficient myocardial border tracking (n = 30, 50%).ConclusionThis study demonstrates the high feasibility of 2D-GLS and 2D-LVEF, even in those with challenging echocardiographic windows. The lower feasibility of 3D-LVEF limits its real-world clinical application, even though only a small difference in agreement with 2D-LVEF calculation was found when successfully performed.

Readmissions after next-day discharge following transcatheter aortic valve implantation.

No data compare newer-generation transcatheter heart valves (THVs) in terms of next-day discharge (NDD) following transfemoral (TF) transcatheter aortic valve implantation (TAVI). We aimed to evaluate the safety of NDD in unselected patients who received ACURATE (neo/neo2), Evolut (PRO/PRO+/FX) and the SAPIEN (3/Ultra) THVs. This multicentre registry included patients who underwent TF-TAVI without a preprocedural permanent pacemaker implantation (PPI) and were discharged the next day without a new PPI. The primary endpoint was unplanned readmissions at 30 days. Multinomial gradient-boosted inverse probability of treatment-weighted (IPTW) propensity scores (stage 1) followed by the modified Poisson regression (stage 2) approach were used to compare the average effects of the THVs on the primary outcome. A total of 963 all-comer patients (ACURATE=264, Evolut=306, and SAPIEN=393) were included in this study. ACURATE patients were older (p<0.001) and included a greater proportion of females (p<0.001), whereas Evolut patients had a higher risk profile as assessed by the Society of Thoracic Surgeons score (p=0.01). There were no differences between the groups in terms of right or left bundle branch block (p=0.75). At 30 days, the overall readmission rate was 8%, and there were no differences in cardiac (ACURATE 4.6% vs Evolut 4.2% vs SAPIEN 3.1%; p=0.56) or non-cardiac readmissions (ACURATE 4.6% vs Evolut 3.3% vs SAPIEN 4.6%; p=0.64). Readmission for new PPI was 2.7%, 1.0% and 1.8% (p=0.32) and for heart failure (HF) was 1.5%, 2.0% and 1.3% (p=0.76) in ACURATE, Evolut and SAPIEN patients, respectively. The IPTW propensity score model followed by modified Poisson regression indicate that, using ACURATE as the reference, no significant differences were found in 30-day readmissions (relative risk [RR] 0.76, 95% confidence interval [CI]: 0.38-1.52; p=0.38 for Evolut and RR 0.74, 95% CI: 0.44-1.22; p=0.28 for SAPIEN). In pacemaker-naïve patients undergoing TF-TAVI with newer-generation THVs, NDD was not associated with a negative impact on overall 30-day readmissions, cardiac or non-cardiac readmissions, readmissions for PPI or HF after discharge, or mortality, regardless of the type of THV.

Ultra-low contrast strategy for routine coronary procedures via distal transradial access: real-world experience with consecutive all-comers patients from the DISTRACTION registry.

The association of contrast volume to the risk of contrast-related acute kidney injury (CR-AKI) appears to have resulted in a change in daily practice toward using lower contrast volume for all patients. Distal transradial access (dTRA) has advantages in terms of faster haemostasis and lower rates of proximal radial artery occlusion. The present study aimed to describe the authors' experience with the combination of ultra-low contrast (ULC) strategy and dTRA for routine coronary procedures in a real-world and broad population of all-comers patients. Of 6852 patients consecutively included into the DISTRACTION registry from February 2019 to July 2024, successful ULC coronary procedures via dTRA were achieved in 4328 (63.2%). Related data were retrospectively assessed. Most patients were male with acute coronary syndromes, and the mean patient age was 63.6 ± 15 years. Access-site crossover occurred in only 3% of cases. Right dTRA was the most frequently utilized primary access site, and was almost always performed with standard 6-French radial sheaths. ULC strategy was feasible for every scenario, with the overall contrast volume less than or equal to 40 mL for 96.4% of all patients, regardless of coronary bypass surgical grafts presence, percutaneous coronary intervention immediately following coronary angiography, anatomical or clinical complexity, or unavailability of intravascular ultrasound guidance. Neither major complications nor major adverse cerebrovascular and cardiac events directly related to dTRA were recorded. The rates of CR-AKI were very low (1.1%). When performed by experienced operators, the minimalist combination of ULC strategy and dTRA for routine coronary procedures, regardless of baseline creatinine clearance, appears to be safe and feasible.

High long-term mortality in ischaemic heart disease accentuated among ethnic minorities in Eastern Europe: findings from a prospective all-comers percutaneous coronary intervention registry in Romania

BackgroundLong-term outcomes in cardiovascular diseases are historically under-reported in Eastern Europe. Our aim was to report long-term survival and to identify survival predictors in a prospective Romanian percutaneous coronary intervention...

Contemporary Single-Center Experience of Complete Aortic Arch Replacement Employing the Frozen Elephant Trunk Technique in Patients with Extensive Aortic Disease.

Objective: This study aimed to examine contemporary results of the frozen elephant trunk (FET) procedure in an all-comers patient cohort. Methods: Between January 2017 and May 2024, a total of 132 consecutive patients with either aortic aneurysm (n = 32), acute aortic dissection (n = 32), or chronic aortic dissection (n = 68) underwent total aortic arch replacement employing the FET technique. In-hospital data were collected prospectively and included preoperative characteristics, intraoperative data, and follow-up results. Results: The median cardiopulmonary bypass time, cardiac ischemia time, and selective antegrade cerebral perfusion time were 180 (161-205), 89 (70-113), and 45 (38-54) min, respectively. Total 30-day mortality rate was 7.6% (n = 10). The rate of major postoperative neurological complications was 6.8% (n = 9) for perioperative stroke and 2.3% (n = 3) for permanent spinal cord injury. Five patients (3.8%) required hemofiltration at the time of discharge due to postoperative kidney injury. Rates of subsequent endovascular and open aortic repair following primary FET were 40.9% (n = 54) and 3.8% (n = 5), respectively. The median time to reintervention was 86 (30-439) days. The median follow-up time was 25 (8-52) months, and overall survival rates at 1, 2, and 3 years were 89%, 89%, and 87%, respectively. Conclusions: Our data are consistent with current reports, indicating that the FET technique is a valuable adjunct in treating extensive aortic arch pathologies. The procedure provides an increasingly safe and effective option for complete aortic arch replacement, even in patients requiring a redo procedure.

Implementation of prasugrel and prognostic outcomes after percutaneous coronary intervention for myocardial infarction: a nationwide observational study

Abstract Background Prasugrel has shown superior efficacy and similar safety compared to ticagrelor for patients with acute coronary syndrome treated with percutaneous coronary intervention (PCI) in a randomised setting. Since 2020, prasugrel has been recommended over ticagrelor in our country. It remains unknown if these recommendations have been implemented, and if the findings from the randomised trial can be expanded to an all-comer population. Purpose To assess the implementation of prasugrel and compare effectiveness and safety between prasugrel and ticagrelor in PCI-treated, all-comer patients with myocardial infarction (MI). Methods From January 1st, 2019, to December 31st, 2021 patients with MI treated with PCI were identified by use of nationwide health registries. We included patients who were alive and claimed a prescription of prasugrel or ticagrelor within 7 days from discharge. Incidence rates per 100 person-years (IRs) 6 months from discharge were calculated for a composite outcome of all-cause mortality, recurrent MI (&amp;gt;28 days after index MI), and stroke (MACE), all-cause mortality alone, ischaemic events (a composite of recurrent MI and stroke) and bleeding leading to hospitalisation. We illustrated a Kaplan Meier curve with log-rank test and a cumulative incidence curve with Gray’s test and performed Cox models to assess adjusted comparative differences of the outcomes between prasugrel and ticagrelor after adjusting for age, sex, relevant comorbidities, and calendar year. Results We identified 14,365 PCI-treated patients with MI, of whom 13,887 (96.7%) were alive 7 days from discharge. After excluding patients who did not collect a P2Y12 inhibitor (n=1097 [7.9%]) or collected clopidogrel within 7 days from discharge (n=2696 [21.1%]), the final study population counted 10,094 patients of whom 2045 (20.3%) patients collected prasugrel and 8049 (79.7%) ticagrelor. Figure 1 shows the temporal use of P2Y12 inhibitors. The mean age was 64.4 (±11.7) years and 23.9% were female. Patients with prasugrel were less often ≥75 years old (16.3% vs. 23.2%), female (22.1% vs. 24.3%), and had fewer comorbidities (hypertension, hypercholesterolemia, diabetes, stroke or transient ischaemic attack, bleeding, and prior PCI) than ticagrelor-treated patients. Figure 2 illustrates IRs of the outcomes and Kaplan Meier and cumulative incidence curves. Prasugrel treatment was associated with reduced risk of MACE (HR 0.67 [95% CI 0.47-0.95]) and ischaemic events (HR 0.68 [0.47-0.97]) compared with ticagrelor after adjustment, and there were no differences in all-cause mortality or bleeding (Figure 2). Conclusion Prasugrel use increased from 1% to 44% from 2019 to 2021, but most all-comer patients with MI were treated with ticagrelor after PCI. Prasugrel showed lower risk of MACE and ischaemic events without excess in bleeding 6 months post-discharge compared to ticagrelor, consistent with the findings of a previous randomised trial.Temporal use of potent P2Y12 inhibitorsSix-months outcomes of potent P2Y12i

Tafamidis treatment for transthyretin amyloid cardiomyopathy: results from an open-label, early-access, long-term study extension in an all-comers population

Abstract Background In the pivotal Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT NCT01994889), tafamidis significantly reduced mortality and cardiovascular hospitalization in patients with transthyretin amyloid cardiomyopathy (ATTR-CM). Given the high clinical unmet need and the favorable benefit-to-risk profile of tafamidis, there was a justification to provide patients with an option for early access to treatment as part of the ATTR-ACT long-term extension study (LTE; NCT02791230). Purpose To assess long-term safety in an all-comers population receiving early access to tafamidis. Methods Following protocol amendment (20 July 2018), patients with ATTR-CM, not previously enrolled in ATTR-ACT, and without commercial access to tafamidis, were enrolled in the LTE early-access study arm in 13 countries. Patients received open-label, once-daily tafamidis free acid 61 mg for up to 60 months, until they gained product access by prescription or study discontinuation by the sponsor. All-cause and cardiovascular (CV)-related mortality, CV-related hospitalization, and treatment-emergent adverse events (TEAEs) were assessed. Results Of 1481 patients enrolled in the early-access cohort, 1476 received at least one dose of tafamidis and were included in the analysis. Mean (SD) age at enrollment was 76.5 (7.8) years old, 37.5% were ≥80 years old, and 88.8% were male. Most patients (85.6%) had wild-type ATTR-CM, and 14.9%, 52.9%, 30.8%, and 1.3% were in New York Heart Association (NYHA) Class I, II, III, and IV, respectively. Over a mean (SD) follow-up period of 17.7 (13.8) months, all-cause and CV-related mortality rates were 23.4% and 13.8%, respectively (Table). Mean frequency of CV-related hospitalization per year was 0.28 (0.60). Serious TEAEs and TEAEs leading to discontinuation of the study were observed in 0.6% of patients (both); no new safety signals were identified. Conclusions Findings from the early-access cohort of the ATTR-ACT LTE highlight the safety of tafamidis treatment in an all-comers ATTR-CM patient population.

Comparative clinical outcomes of amphilimus-eluting stents in diabetic versus non-diabetic patients

Abstract Background Patients with diabetes mellitus (DM) are at an increased risk of experiencing adverse events following percutaneous coronary intervention (PCI). The Cre8 EVO stent, which releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, has demonstrated clinical benefits specifically in diabetic populations. We aimed to explore the impact of DM on clinical outcomes in a large, real-world registry of all-comer patients treated with Cre8 and Cre8 EVO stents. Methods We did an investigator-initiated, prospective, single-arm observational trial at 28 sites in South Korea. The primary endpoint was a composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically-driven repeat revascularization at 12 months. All-cause mortality was a key secondary endpoint. Results A total of 2,045 patients (66.0 ± 11.5 years of age; 76.2% male) were analyzed. Diabetic patients (n = 774; 37.8%) were more likely to be older, female, and have hypertension, dyslipidemia, or chronic kidney disease. There were 39 cases of primary events, 17 (2.5%) in the DM group and 22 (1.9%) in the non-DM group (hazard ratio, 1.34; 95% confidence interval, 0.74–2.41; log-rank p = 0.33). Overall, the primary endpoint occurred in 2.1% of patients, with a cardiac death rate of 0.4%, a target vessel-related MI rate of 0.3%, and a clinically driven TLR rate of 1.8%. Among the secondary endpoints, the DM group exhibited a significantly higher all-cause mortality rate compared to the non-DM group (2.0% vs. 0.9%; hazard ratio, 2.20; 95% confidence interval, 1.04–4.65). Conclusion In this real-world registry, diabetic patients treated with amphilimus-eluting stents demonstrated excellent safety and effectiveness at 12 months, with a similar occurrence of MACE compared to non-diabetics. These results underscore the potential for amphilimus-eluting stents to become a preferred option for PCI in diabetic patients, prompting further investigation into their long-term benefits and mechanisms of action.

Safety profile, electrical performances and clinical outcomes of a novel leadless pacemaker; first results from real-world clinical practice in Saudi Arabia

Abstract Introduction Leadless pacemakers (LP) are emerging as an effective and safe alternative to transvenous pacemakers to reduce lead-related and pocket-related complications and to improve patient experience. A new LP system, the Aveir VR, has been approved in 2022 for US and other countries, and in 2023 for Europe, and features innovative characteristics such as the active fixation helix mechanism and the possibility to measure sensing/pacing parameters before LP deployment. Purpose Evaluate safety, electrical performances and clinical outcomes associated with the first Aveir VR LP implants in 2 Hospitals in Saudi Arabia. Methods We performed a prospective evaluation of all-comer patients who received Aveir VR LP. Decision for LP implant was based on conditions such as cardiac pacing indication, lack of upper extremity venous access, risk of device infection, and life expectancy, and using shared decision-making. Clinical and electrical data were collected at implant and at 1st and 6th month visits. Results A total of 54 patients (25 female, mean age 69 years) were included between December 2022 and October 2023. Pacemaker implant indication was AV block in 25 (46%) patients, sinus node disease in 19 (35%) patients, atrial fibrillation and slow ventricular response in 9 (17%) patients and left bundle branch block in 1 (2%) patient. Implant was successful in all attempted cases. Final device position was lower septum in 51/54 (94.4%) patients and mid-septum in 3/54 (5.6%) patients. Mean procedure time was 48±22 minutes and showed a decreasing trend as a function of operator experience with a mean of 55, 50 and 36 minutes in the first, second and third group of consecutive implants, respectively. Mean fluoroscopic time was 11±8 minutes and showed a decreasing trend as a function of operator experience with a mean of 13, 13 and 6 minutes in the first, second and third group of consecutive implants, respectively. Final device position was achieved at first attempt in 42/54 (77.8%) cases and at first or second attempt in 51/54 (94.4%) cases. At implant mean R wave sensing was 7.6±3.7 mV, mean impedance was 724±335 Ohm, mean threshold was 1.0±0.6 V at 0.4 ms. During implant there was one patient with pericardial effusion treated with pericardiocentesis. In a mean follow-up of 73 days there were no procedure-related or device-related complications, electrical parameters showed acceptable values, and all implanted devices performed as expected. Median longevity, estimated at last follow-up visit, was 19 years (interquartile range: 12-20 years). Conclusion First real-world cases of use of a novel leadless pacemaker in Saudi Arabia show optimal feasibility and good safety profile and electrical performances. Procedure and fluoroscopic times were acceptable and decreased as a function of operator experience. Longevity estimations predict very long service life-times.

Sex differences in severe aortic stenosis undergoing surgical replacement

Abstract Background Aortic stenosis (AS) is the most common valvular heart disease in developed countries. Sex differences have been described in AS pathophysiology and left ventricular (LV) remodelling, as well as clinical presentation and response to therapies (1). However, sex differences in LV function parameters, namely global longitudinal strain (GLS), have been scarcely explored so far. Purpose To investigate sex differences, taking into account GLS, in patients with severe AS referred to surgical aortic valve replacement (SAVR). Methods The study population was from a single centre, prospective registry of patients with severe native valve AS who were referred for SAVR between June 2020 to October 2022. Severe AS was defined by standard guideline criteria (2). All patients underwent an echocardiogram immediately before and at least 3 months after surgery. Results Table 1 recapitulates sex differences in our population (n=119, 43% women). No differences in age or cardiovascular (CV) risk factors were noted. Clinical presentation and AS etiology were also similar. At baseline, women had lower EuroSCORE (p=0.039), creatinine (p &amp;lt;0.001), and haemoglobin levels (p=0.001). The echocardiogram showed a higher mean aortic valve gradient in women (Gmean, 62 vs. 50 mmHg, p=0.002). Women also had higher relative wall thickness (RWT, 0.49 vs. 0.42, p=0.037), despite lower LV mass index (124.9 vs. 136.6 g/m², p=0.037). Regarding LV function, women showed higher EF (64% vs. 60%, p=0.002) and GLS (16.5% vs. 14.6%, p=0.006) values. This is partially explained by the higher prevalence of concomitant coronary artery disease (CAD) in men, more frequently subjected to a concomitant coronary artery bypass graft than women (CABG, 38% vs. 8%, p &amp;lt;0.001). Post-operative complications had similar rates in men and women. After a median follow-up of 16 (6-18) months, death from any cause (6.0% vs. 1.5%, p=0.186) and rehospitalization for CV causes (14.0% vs. 4.0%, p=0.055) tended to be more frequent among women. When considering patients with severe AS alone (n=89), women had higher Gmean (64 vs. 53 mmHg, p=0.035) and EF (65% vs. 62%, p=0.045) but similar GLS (16.9% vs. 16.6%, p=0.230) as compared to men (Figure 2). At follow-up, EF and GLS failed to improve in both sexes and no differences were noted between women and men (EF 60% vs. 60%, p=0.476; GLS 15.9% vs. 16.0%, p=0.976). Conclusions In a population of all-comers patients with severe AS undergoing SAVR, women showed higher Gmean, EF, and GLS values. This is partially due to the higher prevalence of a concomitant CAD in men. When considering patients with AS alone, women still had higher EF and Gmean than men, despite a similar GLS. Future larger prospective studies with longer follow-up are needed in order to further characterize such differences and correlate them with specific outcomes.

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.

Distal Transradial Access for Coronary Procedures: Insights from 6,800 Consecutive All-Comers Patients from the DISTRACTION Registry

Distal Transradial Access for Coronary Procedures: Insights from 6,800 Consecutive All-Comers Patients from the DISTRACTION Registry

Comparative efficacy and safety of talazoparib plus enzalutamide and other first-line treatments for metastatic castration-resistant prostate cancer.

Talazoparib plus enzalutamide (TALA + ENZA) has demonstrated antitumor activity in the phase 3 clinical trial (TALAPRO-2; NCT03395197) as first-line (1L) therapy in men with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC). Although many active interventions are available, randomized controlled trials (RCTs) involving talazoparib have only been conducted to assess its efficacy and safety compared to enzalutamide. To estimate comparisons between all relevant interventions, indirect comparisons are needed. To estimate the comparative efficacy and safety of TALA + ENZA in 1L patients with mCRPC by conducting a systematic literature review and network meta-analyses (NMAs). Databases were searched using Ovid, along with several gray literature sources to identify RCTs evaluating treatments in 1L mCRPC (PROSPERO registration: CRD42021283512). Feasibility assessment evaluated trial suitability for NMA inclusion and Bayesian or frequentist NMAs were conducted for evaluable efficacy and safety outcomes, respectively. Thirty-three RCTs met the eligibility criteria and were feasible for NMAs. Across multiple efficacy outcomes assessed, except for overall survival (OS), TALA + ENZA was ranked the most efficacious treatment. For OS, TALA + ENZA showed the second-highest probability of being the most effective treatment; second to docetaxel 50mg plus prednisolone 10mg. With respect to safety outcomes, TALA + ENZA, in general, showed increased rates of hematological adverse events. TALA + ENZA showed favorable results across multiple efficacy endpoints, but not across hematological toxicities compared with other 1L treatments in asymptomatic or mildly symptomatic mCRPC in the all-comers patient population.

TCT-83 Association of Regurgitant Fraction and of Liver Mapping Analysis Quantified by Cardiac Magnetic Resonance With Outcome in a Large Cohort of All-Comers Patients With Chronic Tricuspid Regurgitation

TCT-83 Association of Regurgitant Fraction and of Liver Mapping Analysis Quantified by Cardiac Magnetic Resonance With Outcome in a Large Cohort of All-Comers Patients With Chronic Tricuspid Regurgitation

Safety and performance of the ultrathin sirolimus-eluting coronary stent in an all-comer patient population: the S-FLEX UK-II registry

ObjectiveWe evaluated the clinical safety and performance of the ultrathin strut biodegradable polymer-coated Supraflex Cruz (Sahajanand Medical TechnologiesLtd., Surat, India) sirolimus-eluting stent (SES) in an all-comer patient population requiring coronary...

EV20/Omomyc: A novel dual MYC/HER3 targeting immunoconjugate

MYC is one of the most important therapeutic targets in human cancer. Many attempts have been made to develop small molecules that could be used to curb its activity in patients, but most failed to identify a suitable direct inhibitor. After years of preclinical characterization, a tissue-penetrating peptide MYC inhibitor, called Omomyc, has been recently successfully used in a Phase I dose escalation study in late-stage, all-comers solid tumour patients. The study showed drug safety and positive signs of clinical activity, prompting the beginning of a new Phase Ib combination study currently ongoing in metastatic pancreatic adenocarcinoma patients.In this manuscript, we have explored the possibility to improve Omomyc targeting to specific cancer subtypes by linking it to a therapeutic antibody. The new immunoconjugate, called EV20/Omomyc, was developed by linking a humanised anti-HER3 antibody, named EV20, to Omomyc using a bifunctional linker. EV20/Omomyc shows antigen-dependent penetrating activity and therapeutic efficacy in a metastatic model of neuroblastoma. This study suggests that directing Omomyc into specific cell types using antibodies recognising tumour antigens could improve its therapeutic activity in specific indications, like in the paediatric setting.

Associations Between Dual Antiplatelet Therapy Score and Long-Term Mortality After Percutaneous Coronary Intervention: Analysis of More Than 27,000 Patients

BackgroundThe dual antiplatelet therapy (DAPT) score was developed to identify patients undergoing percutaneous coronary intervention (PCI) who are likely to derive benefit (score ≥ 2) or harm (score < 2) from extended DAPT beyond 1 year after PCI in terms of ischemic and bleeding outcomes. We examined the associations between DAPT score at index PCI and long-term mortality from an all-comers PCI registry in patients receiving DAPT according to the standard of care. MethodsWe retrospectively examined prospectively collected data from the Melbourne Interventional Group PCI database (2005-2018) and grouped patients as having DAPT score ≥ 2 or < 2. Long-term mortality was assessed from the Australian National Death Index linkage. The primary end point was long-term mortality as determined using survival analysis. Secondary end points included in-hospital events and 30-day major adverse cardiac events (MACE), a composite of death, myocardial infarction, or target vessel revascularisation. ResultsOf 27,740 study patients, 9402 (33.9%) had DAPT score ≥ 2. Patients with DAPT score ≥ 2 were younger, included more women, and had a higher prevalence of cardiovascular risk factors. Patients with DAPT score ≥ 2 had higher in-hospital mortality (3.0% vs 1.0%), major bleeding (2.3% vs 1.6%), 30-day MACE (7.1% vs 3.1%), and long-term mortality at a median follow-up of 5.17 years (21.9% vs 16.5%) P < 0.001 for all. ConclusionsOne-third of all-comer patients undergoing PCI had a DAPT score ≥ 2 with greater short-term ischemic and bleeding risk, and higher long-term mortality. Risk assessment with the DAPT score may guide the duration and intensity of DAPT beyond the early post-PCI period.