Open Heart最新文献

Background: Primary percutaneous coronary intervention (PCI) has significantly improved outcomes for ST-segment elevation myocardial infarction (STEMI) patients. However, the long-term durability of PCI in terms of target lesion failure (TLF) remains unknown.

Objectives: This study investigates the long-term incidence, predictors and clinical impact of TLF over a 10-year follow-up in STEMI patients treated with primary PCI.

Methods: From the DANAMI-3 trial, we analysed STEMI patients treated with primary PCI. TLF was defined as a composite of cardiovascular death, target lesion myocardial infarction or target lesion revascularisation. Independent predictors of TLF were identified by Cox regression. Outcomes in high-risk and low-risk groups were evaluated using cumulative incidence functions with competing risk analysis.

Results: Of 2217 patients (median follow-up of 10.7 years), 443 (20.0%) experienced TLF. TLF occurred in 5.6% within the first year after PCI and continued at a constant annual rate of 1.6% thereafter. All-cause mortality, any MI or any revascularisation occurred in 961 (43%) patients, and TLF constitutes 46% of the total patient-oriented events. Multivariable Cox regression identified age, hypertension, previous AMI and Killip class II-IV as independent predictors of an increased risk of TLF, whereas PCI with drug-eluting stents was associated with a reduced risk of TLF. Patients with ≥1 high-risk feature had a twofold greater risk of TLF compared with those without (HR 2.05, 95% CI 1.65 to 2.55, p<0.001).

Conclusions: One in five STEMI patients treated with primary PCI experiences TLF within 10 years, accounting for a significant proportion of any mortality, any MI or any revascularisation, with sustained occurrence rates beyond the first year.

Trial registration number: NCT01960933.

Introduction: European valvular heart disease guidelines define women as a 'special group'. To explore what factors have led us to consider more than 50% of the global population special, we assessed access to transcatheter aortic valve implantation (TAVI) by sex on national and local levels and studied post-TAVI outcomes by sex within our centre.

Methods: Population statistics from census data were compared against British Cardiovascular Intervention Society (BCIS) audit and local data.Using the National Institute for Cardiovascular Outcomes Research TAVI database, a retrospective analysis of 1049 consecutive patients from 2013 to 2023 was conducted at our UK tertiary centre.Primary outcomes were all-cause death, a three-point composite of major adverse cardiac events (MACE) comprising death, non-fatal myocardial infarction and non-fatal stroke during TAVI admission, and post-TAVI survival.

Results: Nationally, females comprise 60% of over 75-year-olds; however, TAVI was performed more frequently in males: nationally (55.2% vs 44.8%, p<0.01) and locally (53.2% vs 46.8%, p<0.01). Males were 1.82 times more likely to undergo TAVI.Locally, females undergoing TAVI were older and had worse renal function, higher frailty and greater transvalvular gradients. Males had more cardiovascular comorbidity.In-hospital mortality and MACE did not differ by sex. Median survival was longer in females (1350 days vs 1728 days, p=0.02). Regression analysis demonstrated female sex as a predictor of increased survival (HR 0.73, 95% CI 0.61 to 0.88, p<0.01). Chronic obstructive pulmonary disease, atrial fibrillation, frailty and poor mobility were identified as predictors of reduced survival.

Conclusion: In this retrospective, observational study, we have demonstrated an under-representation of females undergoing TAVI. This observation is likely of multifactorial cause, including different disease recognition, referral, investigation and treatment practices.We observed no difference in procedural death or MACE, but longer female survival, despite higher baseline age, frailty and renal impairment.

Background: Guidelines strongly recommend reperfusion therapy, including thrombolysis and percutaneous coronary intervention, for ST-elevation myocardial infarction but contraindicate its use in most non-ST-elevation acute coronary syndromes (ACS). This practice largely stems from the landmark fibrinolytic therapy trialists (FTT) meta-analysis, which reported no benefit in patients without ST elevation (STE). However, the FTT included a subgroup from the ISIS-3 trial with substantial methodological issues, potentially obscuring a genuine treatment effect.

Methods: We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) comparing thrombolysis vs placebo or no thrombolysis in ACS. Patients were grouped by ECG findings: STE, ST depression (STD) or absence of STE. All-cause mortality was extracted from each trial's short-term follow-up (typically 21-35 days). We reassessed outcomes with and without inclusion of the ISIS-3 'uncertain diagnosis' subgroup.

Results: Nine RCTs (40 226 patients) were analysed. Thrombolysis significantly reduced mortality in patients without STE (excluding isolated STD) (risk ratio (RR): 0.799; 95% CI 0.668 to 0.956; I²=0%). Including the ISIS-3 'uncertain diagnosis' subgroup (representing 42% of the non-STE population) would have eliminated the statistical significance in non-STE patients (RR: 0.928; 95% CI 0.694 to 1.242) and markedly increased heterogeneity (I²=71%).

Conclusion: In historical RCTs, thrombolysis was associated with lower short-term mortality in non-STE presentations excluding isolated ST-segment depression, while isolated STD showed no benefit. Legacy conclusions hinge on outdated methods, delayed treatment and heterogeneous ECG definitions (and are sensitive to ISIS-3). This study exposes a material evidence gap in the foundation of current guidelines. Contemporary randomised trials with prespecified ECG criteria, rapid treatment windows and rigorous safety adjudication are needed.

Prospero registration number: CRD42024573681.

Background: Acute kidney injury (AKI) often complicates percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However, evidence on the incidence and prognostic impact of AKI after revascularisation for left main coronary artery disease (LMCAD) is scant, especially in terms of subsequent risk of persistent renal dysfunction (RD).

Methods: All consecutive patients undergoing PCI or CABG for LMCAD in two European institutions from 2015 to 2022 were enrolled. The coprimary endpoints were AKI, defined as an increase in serum creatinine (sCr) levels ≥0.3 mg/dL or increase by >50% as compared with baseline levels, and persistent RD, defined as a persistent increase of sCr at 1 year. The secondary endpoint was all-cause mortality. The risk of AKI with PCI versus CABG was assessed with multivariable logistic regression and inverse probability of treatment weighting (IPTW). The prognostic impact of transient and persistent RD at 1 year was evaluated with Cox regression analysis.

Results: 1047 patients were included (PCI: 617, CABG: 430). Patients undergoing PCI were older, more often male and affected by chronic kidney disease. AKI occurred in 17% and 28% of patients after PCI and CABG, respectively (adjusted OR 2.82; 95% CI 1.89 to 4.21). Consistent findings were observed after IPTW. AKI was associated with increased 1-year risk of all-cause death, irrespective of revascularisation strategy, but only persistent RD (HR 9.56; 95% CI 4.06 to 22.53) worsened patients' prognosis, unlike AKI with only transient RD (HR 0.65; 95% CI 0.08 to 5.04).

Conclusions: AKI is common after LMCAD revascularisation and occurred more frequently following CABG than PCI. AKI has a substantial prognostic impact irrespective of revascularisation modality, but only when resulting in persistent RD.

Background: Pulsed field ablation (PFA) has emerged as a promising non-thermal alternative to conventional atrial fibrillation (AF) ablation techniques. However, intravascular haemolysis has been increasingly recognised as a potential complication, with variable incidence and clinical significance.

Objective: To systematically review the available clinical evidence on PFA-related haemolysis, focusing on biochemical markers, clinical manifestations and device-specific differences.

Methods: PubMed, Embase and Cochrane databases were searched until 20 May 2025 for clinical studies evaluating primarily PFA-pulmonary vein isolation for AF that reported haemolysis, acute kidney injury (AKI) or relevant biomarker changes. The primary outcome was evaluation of incidence and biochemical evidence of PFA-related haemolysis. Secondary outcomes included incidence of AKI and its clinical consequences.

Results: 12 studies (≈20 000 patients) were included. Biomarker evidence of haemolysis was consistent, with postablation lactate dehydrogenase elevations of 250-438 U/L and bilirubin 15-48 µmol/L, often accompanied by reduced haptoglobin and elevated free haemoglobin. Incidence of haemolysis varied widely (0-94.3%), reflecting heterogeneity in definitions and reporting. Clinical sequelae were uncommon: haemoglobinuria was observed in five studies, and AKI occurred in 83 patients (0.4%), 12 requiring transient dialysis. All returned to baseline renal function except one patient with severe chronic kidney disease. Procedural factors and catheter design may influence haemolysis burden. Observations of lower haemolytic biomarker changes with devices such as PulseSelect, Affera and Volt are preliminary and require confirmation, given the predominance of Farawave data.

Conclusions: Haemolysis is a reproducible biochemical outcome of PFA, but clinically significant events such as AKI are rare and usually reversible. Catheter design, energy delivery and patient baseline renal function are likely to modulate haemolysis risk. Standardised haemolysis definitions and prospective head-to-head comparisons across PFA platforms are needed to clarify clinical relevance and optimise safety.

Prospero registration number: CRD420251069612.

Objective: To investigate the diagnostic performance of coronary CT angiography (CCTA) for assessing significant coronary artery disease (CAD) in patients referred for surgical aortic valve replacement or transcatheter aortic valve implantation (TAVI)transcatheter aortic valve replacement (TAVR), with invasive coronary angiography (ICA) as the reference standard.

Methods: We performed a meta-analysis of 28 studies to compare CCTA with ICA for preoperative coronary evaluation. Studies were stratified into two subgroups: the first consisting of those which included only patients undergoing valve surgery (n=19) and the second including TAVI or mixed (TAVI and surgical) populations (n=9). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy were recorded or determined, and a summary diagnostic performance was obtained by a random effects model. Pooled forest plots and summary receiver operating characteristic curves were also analysed.

Results: The overall sensitivity of CCTA to diagnose significant CAD varied between 18 studies, ranging from 85% to 94%; the pooled sensitivity over all 28 studies was 91% (95% CI 88% to 93%) and the specificity was 88% (95% CI 84% to 91%). The pooled PPV was 78% (95% CI 72% to 83%), while the NPV was 95% (95% CI 93% to 97%). The diagnostic performance of the study was 89.8%.

Conclusions: CCTA is a trustworthy, non-invasive diagnostic option to rule out significant CAD in patients undergoing valve surgery. Its high specificity in surgical candidates favours its use as a 'gatekeeper' to ICA with a potential reduction in unnecessary invasive surgery.

Background: Stroke after transcatheter aortic valve implantation (TAVI) is an infrequent but serious complication with important impact on morbidity and mortality. Contemporary real-world evidence on the risk factors of early stroke after TAVI is scarce. We aimed to evaluate the incidence, temporal trends and predictors of in-hospital stroke after TAVI and to assess its association with mortality.

Methods: We conducted a retrospective, observational cohort study using data from the Netherlands Heart Registration of all TAVI procedures performed in the Netherlands between 2013 and 2023. The primary endpoint was the incidence of in-hospital stroke. The secondary endpoints were trends, mortality and risk factors associated with in-hospital stroke and early mortality as identified by logistic regression.

Results: Among 23 593 TAVI procedures, the overall incidence of in-hospital stroke was 2.0% and remained stable after an initial decline. Independent covariates associated with in-hospital stroke included female gender (OR 1.29; 95% CI 1.07 to 1.56), peripheral arterial disease (OR 1.55; 95% CI 1.24 to 1.93), non-transfemoral access (OR 1.54; 95% CI 1.21 to 1.93) and postdilation (OR 1.40; 95% CI 1.10 to 1.76). In-hospital stroke was strongly associated with an increased risk of mortality at 30 days (OR 8.54; 95% CI 6.56 to 11.02), and 1 year (OR 4.38; 95% CI 3.55 to 5.40).

Conclusions: In-hospital stroke remains an important complication after TAVI with a strong impact on mortality. Identification of high-risk patients and procedural optimisation is essential in optimisation of outcome.

Introduction: Takotsubo cardiomyopathy (TC) is a stress-induced catecholamine acute myocardial dysfunction in the absence of significant coronary disease. The pathophysiology of TC remains poorly understood, and the use of beta-blockers (β-Blockers) appears promising. However, the impact of β-blockers in acute-phase management remains uncertain.

Aims: We aimed to conduct a systematic review and meta-analysis evaluating the early use of β-Blocker in TC and its effects on in-hospital mortality.

Methods: PubMed, Embase and Cochrane were searched for studies that evaluated the use of BBs in TC patients and its short-term effects. Statistical analysis was performed using RevMan V,5.4.1. The results are expressed using HRs and 95% confidence intervals (CI) were extracted using a random-effects model. Heterogeneity was assessed with I².

Results: We included five cohort studies, with a total of 5428 patients. The vast majority were women (81%) with a mean age of 70.1±12.6 years. More than half of the patients (52.0%) had previous hypertension. ST-elevation in the first ECG was observed in 37.3% of the patients. Early administration of β-blockers was not associated with a statistically significant reduction in in-hospital mortality (HR 0.78, 95% CI 0.59 to 1.02, p=0.07), and this finding was consistent across different β-blocker types, doses and routes of administration.

Conclusion: Early β-Blocker therapy did not significantly influence in-hospital mortality in patients with TC. Future randomised studies are essential to clarify beta-blockers' role in this setting.

Prospero registration number: CRD420251055617.

Background: Atrial fibrillation (AF) is a prevalent arrhythmia associated with adverse outcomes, often presenting paroxysmally. The lack of an efficient method to promptly detect paroxysmal AF and the absence of a unified screening approach necessitate exploring novel solutions. Artificial intelligence (AI) models show promise in addressing this gap, enabling early intervention. This study assessed the effectiveness of AI in detecting AF using baseline sinus rhythm-ECG (SR-ECG) and factors influencing their performance.

Methods: A systematic review was conducted across eight databases and registries (International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY) registration: INPLASY202530059). References up to May 2024 were double-screened for eligibility. Included studies used AI to detect AF from baseline SR-ECGs in patients without prior AF confirmation. Quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Performance metrics were summarised using medians with subgroup analyses by AI type and AF confirmation timeframe.

Results: 14 studies and 33 AI models were analysed. Participant data were available for 13 studies, totalling 1459653 patients, with one study providing only testing dataset data. Median (95% CI) performance metrics were: accuracy 58.0% (55.0 to 62.0), sensitivity 62.0% (57.0 to 70.2), specificity 57.8% (51.0 to 61.1), precision 52.0% (47.0 to 56.0) and area under the receiver operating characteristic curve (AUC) 0.740 (0.630 to 0.830). Deep learning (DL) models outperformed traditional machine learning in sensitivity (72.6% vs 54.5%; q=0.027) and AUC (0.830 vs 0.610; q<0.001). Models using a 31-day confirmation window showed higher accuracy (83.2% vs 56.0%; q=0.010) and AUC (0.851 vs 0.630; q<0.001) than those using a 1-year timeframe. 11 studies (78.6%) cited possible negative cases misclassification as a limitation, and nine (64.3%) were deemed 'high risk of bias' in at least one domain.

Conclusions: AI-enhanced SR-ECG for identifying AF patients holds growing potential. Our findings show that DL and models incorporating a 31-day confirmation window are more effective in this context. Further research is needed to explore clinical benefits and cost-effectiveness.

Background: Birth weight (BW) has been linked to cardiometabolic diseases, but causal associations with a comprehensive range of cardiovascular outcomes and underlying metabolic mechanisms remain unclear.

Methods: We applied a two-sample Mendelian randomisation (MR) approach to evaluate causal relationships between genetically predicted BW and 16 distinct cardiovascular diseases (CVD). We further conducted a two-step MR mediation analysis to quantify the mediating roles of 24 metabolic traits covering body composition, glucose metabolism, lipid metabolism, blood pressure, fatty acids and amino acids.

Results: Genetically lower BW was associated with higher risks of coronary heart disease (OR 0.72, 95% CI 0.65 to 0.81), myocardial infarction (OR 0.71, 95% CI 0.63 to 0.80) and angina pectoris (OR 0.81, 95% CI 0.72 to 0.90). These effects were partly mediated by type 2 diabetes, systolic blood pressure, total cholesterol and triglycerides, explaining 11.76-33.33% of the total associations. In contrast, genetically higher BW increased the risk of aortic aneurysm (OR 1.46, 95% CI 1.21 to 1.75), venous thromboembolism (OR 1.22, 95% CI 1.09 to 1.36) and atrial fibrillation (OR 1.34, 95% CI 1.21 to 1.48). These associations were partly explained by body composition traits, with appendicular lean mass and body mass index mediating 10.53-26.32% of the effect on aortic aneurysm, 15.79-68.42% of the effect on venous thromboembolism and 10.34-58.62% of the effect on atrial fibrillation.

Conclusions: Our study provides robust evidence of distinct causal pathways linking BW with adult cardiovascular risks through specific metabolic mediators. These findings highlight the importance of optimal fetal growth and lifelong metabolic health management as critical strategies to reduce CVD burden.