Clinical Research in Cardiology最新文献

Background: Modern contemporary percutaneous coronary intervention (PCI) techniques with drug-eluting stents (DES) have high procedural success rates in chronic total occlusion (CTO) but with a high prevalence of repeat revascularization. The use of drug-coated balloons (DCBs) in CTO is an alternative treatment strategy. The evidence for DCBs in CTO is, therefore, of interest, and we provide a structured and comprehensive review of the evidence available in terms of the use of DCBs in CTO, including de novo and in-stent (IS) CTO lesions.

Objectives: We conducted a systematic review and meta-analysis on the use of DCBs in the management of coronary CTO.

Methods: Electronic databases (PubMed, Embase and Ovid) were systematically searched from inception to April 2024 for DCB CTO studies. A meta-analysis was undertaken using a random-effects inverse-variance method due to heterogeneity. The primary outcome is target lesion revascularization (TLR). Secondary outcomes are major adverse cardiac events (MACE) as a composite of target lesion revascularization (TLR), cardiac death (CD), and any myocardial infarction (MI) including procedural and non-procedural MI, target vessel revascularization (TVR), angiographic outcomes such as late lumen loss (LLL), binary restenosis, and reocclusion.

Results: A total of 10 studies consisting of 1,695 patients were systematically reviewed. This showed that late luminal changes in terms of lumen gain and minimal lumen loss were consistently seen in CTO cohorts 7-12 months after DCB treatment. Five studies were included for meta-analysis with 1,474 patients. There were no significant differences in TLR between treatment strategies such as DCB, DES, and hybrid (DES + DCB) in both de novo and IS-CTO populations as follows: DCB vs DES [OR, 0.71; 95% CI 0.49-1.02], DCB vs DES in IS-CTO [OR, 0.78; 95% CI 0.45-1.34], DCB vs Hybrid [OR, 0.96; 95% CI 0.39-1.43], and hybrid vs DES [OR, 0.76; 95% CI 0.15-3.84]. Similar findings were seen with the MACE outcome. A sensitivity analysis showed no difference between the above-mentioned groups in terms of MI, CD, and TVR.

Conclusion: The limited initial evidence on DCB in coronary CTO-PCI suggests a safe and effective alternative treatment strategy and suggests RCTs are, therefore, required.

Background: Cardiac implantable electronic devices (CIEDs) are increasingly implanted in older patients with multiple comorbidities. The impact of comorbidities on procedural complications and clinical outcomes during and after defibrillator implantation remains a subject of ongoing debate.

Aim: To investigate the associations of the comorbidity burden on baseline characteristics, periprocedural complications, and on outcomes in patients with implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy with defibrillator (CRT-D) implantations or revisions.

Methods: Patients who underwent ICD or CRT-D implantations or revisions at 50 centers were prospectively enrolled in the German Device Registry. Data on patient characteristics, periprocedural complications, and outcomes were collected. Patients were categorized into four groups based on cardiometabolic comorbidities (stroke, chronic kidney disease (CKD), diabetes, hypertension): group I (no comorbidities), group II (one), group III (two), and group IV (three or four). Primary outcomes included 1-year all-cause mortality, major adverse cardiac and cerebrovascular events (MACCE), and arrhythmic/non-arrhythmic events. The Kaplan-Meier analysis was used to determine 1-year mortality.

Results: Overall, 5329 patients (mean age 65.2 years) underwent 3794 ICD and 1535 CRT-D implantations. Median follow-up was 17 months. Periprocedural complications (group I: 2.1%, group II: 1.5%, group III: 2.1%, group IV: 2.4%; p = 0.91) and in-hospital MACCE (group I: 0.2%, group II: 0.4%, group III: 0.6%, group IV: 0.4%; p = 0.25) were not related to comorbidity burden. Higher comorbidity burden was associated with a higher 1-year all-cause mortality (p < 0.001), but ICD shocks did not differ between groups (p = 0.97). The MADIT-ICD non-arrhythmic mortality score increased with comorbidities (p < 0.001), while the VT/VF score remained unchanged.

Conclusions: Periprocedural complications do not appear to be affected by cardiometabolic comorbidities in patients undergoing ICD or CRT-D implantation in Germany. As expected, multimorbidity was associated with a higher risk of mortality and MACCE without detectable effects on ventricular arrhythmias.

Background: Mineralocorticoid receptor antagonists (MRA) have proven efficacy in heart failure and post-infarct left ventricular dysfunction, but their broader impact in acute coronary syndrome (ACS) remains uncertain.

Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing MRA versus placebo in patients following ACS. The primary endpoint was a composite of cardiovascular death, heart failure, or significant arrhythmia. Secondary endpoints included individual cardiovascular outcomes, recurrent myocardial infarction, stroke, all-cause mortality, ventricular remodeling parameters, and adverse events. PROSPERO registry CRD420251149760.

Results: Nine trials with 16,882 patients were included. Treatment with MRA significantly reduced the risk of the composite cardiovascular endpoint (RR 0.89, 95% CI 0.83-0.96; p = 0.001). This effect was primarily driven by reductions in cardiovascular mortality and heart failure events; no significant effect was observed for arrhythmias. Also, MRA lowered all-cause mortality (RR 0.88, 95% CI 0.80-0.97; p = 0.009) and improved left ventricular remodeling indices (increase in LVEF, reductions in LVESV/LVEDV). MRA did not significantly affect recurrent myocardial infarction or stroke. Safety analysis showed an increased risk of hyperkalemia (RR 2.14, 95% CI 1.45-3.16; p < 0.001) but no significant differences in overall or serious adverse events versus placebo.

Conclusions: In patients with ACS, MRA therapy confers a significant reduction in composite cardiovascular events and all-cause mortality, with favorable remodeling effects and a safety profile consistent with known risks (notably hyperkalemia). These results support guideline-aligned use of MRA in post-ACS management, with appropriate monitoring strategies.

Aim: This study evaluated the efficacy and safety of the subcutaneous implantable cardioverter defibrillator (S-ICD) in patients with obesity.

Methods: In this bicentric, retrospective study, S-ICD recipients were divided into two groups based on body mass index (BMI: < 30 kg/m² and ≥ 30 kg/m²). Defibrillation testing (DFT) failure, shock impedance, rates of appropriate and inappropriate shock, long-term complications, survival, and device-related or cardiac rehospitalizations were compared.

Results: Of the 120 patients included, most baseline characteristics were similar between patients with (n = 30) and without obesity (n = 90), except for a higher prevalence of diabetes in the group with obesity. The first shock during DFT was similarly effective (99 vs. 100%), although, shock impedance was significantly higher in patients with obesity (59 vs. 74 Ω; p = 0.011). There was no difference between the groups regarding the incidence of appropriate (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.21-2.34, p = 0.584), and inappropriate shocks (HR 0.92, 95% CI 0.23-3.48, p = 0.902). Non-infectious complications occurred numerically more often in obese patients (16.7% vs. 4.9%, p = 0.058), while device-associated infections were more frequent among non-obese patients (7.4% vs. 0%, p = 0.188). The risk of all-cause mortality (HR 0.32; 95% CI 0.11-0.97; p = 0.141), device-related (HR 0.52; 95% CI 0.14-1.90; p = 0.395) or cardiac rehospitalization (HR 1.06; 95% CI 0.48-2.32; p = 0.890) were similar between the groups.

Conclusion: Despite higher shock impedance during DFT at S-ICD implantation, shock efficacy remained stable during implantation and follow-up in both groups. Fewer infectious but more system-specific complications may manifest in patients with obesity compared to non-obese patients.

Introduction: Early integration of palliative care (EIPC) has been proposed to improve quality of life in heart failure (HF), but evidence is mixed and potential differences by HF subtype remain unclear. This exploratory secondary analysis of the EPCHF trial examined whether patient-reported outcomes differed between patients with and without reduced EF.

Methods: A total of 205 patients with symptomatic HF were randomized 1:1 to EIPC or standard care in the EPCHF trial. For this exploratory analysis, patients were stratified by left ventricular ejection fraction (≤ 40% vs > 40%). Patient-reported outcomes were assessed over 12 months using the Kansas City Cardiomyopathy Questionnaire (KCCQ), Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-PAL), Hospital Anxiety and Depression Scale (HADS), MIDOS, and FACIT-SP12.

Results: KCCQ scores, HADS-anxiety, and MIDOS symptom intensity improved significantly over 12 months in both EIPC and control groups, with no significant between-group differences in either EF subgroup. Reductions in HADS-depression occurred only in patients with HFrEF, with similar improvements in both EIPC (-1.37; 95% CI: -2.31 to -0.44; p = 0.004) and control (-1.99; 95% CI: -2.89 to -1.09; p < 0.001). Among patients with LVEF > 40%, EIPC produced a significant improvement in spiritual well-being compared with standard care (mean difference 3.47; 95% CI: 0.32 to 6.62; p = 0.031), whereas the control group showed no improvement. Mortality and hospitalization rates did not differ between groups.

Conclusion: In this exploratory EF-stratified analysis of EPCHF trial, EIPC did not improve overall HRQOL, mood, or symptom burden compared with standard care. A significant effect was observed only for spiritual well-being in patients with LVEF > 40%, suggesting that this subgroup may have distinct supportive-care needs warranting further investigation.

Background: Rheumatoid arthritis (RA) increases heart failure (HF) risk. Left atrial strain (LAs) may allow early detection of cardiac disease but has been seldom studied in RA. This study evaluated associations between LAs, clinical, laboratory, and echocardiographic parameters, and outcomes in RA patients without known cardiac disease.

Methods: In this prospective observational study, RA patients underwent LAs analysis and were stratified into two groups by the median left atrium reservoir strain (LARs). The primary endpoint was a composite of myocardial infarction, stroke, atrial fibrillation, HF hospitalization, or cardiovascular death; secondary endpoints were its individual components and all-cause mortality. Median follow-up was 6.2 years.

Results: Of 364 patients enrolled, 260 underwent LAs analysis and comprised the final cohort (median LARs 37.4%). LARs ≤ median (n = 131, 50.4%) was associated with older age, shorter 6-min walk distance, higher troponin-T and NT-proBNP, higher E/e', and lower left-ventricular global longitudinal strain. Primary endpoint incidence was numerically higher in patients with LARs ≤ median, but did not differ significantly between groups (15.5 vs 10.3 events/1000 patient-years; HR 0.64 [0.26-1.57]; p = 0.33). A trend toward higher all-cause mortality was observed in the lower LARs group (12.5 vs 3.75 events/1000 patient-years; HR 0.29 [0.078-1.04]; p = 0.06), with no significant differences in other secondary endpoints.

Conclusion: In RA patients, LARs ≤ 37.4% was associated with shorter walked distances, more pronounced cardiac structural, functional and biomarker alterations. While not significantly associated with adverse cardiovascular outcomes, the findings underscore the need for larger prospective studies to further explore this potential relationship.

Background: Clonal hematopoiesis of indeterminate potential (CHIP), commonly involving TET2 and DNMT3A mutations, is increasingly recognized as a cardiovascular risk factor, but its prognostic role in severe aortic valve stenosis (AVS) remains unclear. This study aimed to systematically evaluate the impact of CHIP on survival in AVS patients undergoing valve replacement.

Methods: A systematic search of PubMed, Embase, Web of Science, and Scopus through May 2025 identified observational studies of CHIP in AVS patients undergoing valve replacement. Eligible studies used validated genomic sequencing methods to identify CHIP and reported mortality outcomes. Two reviewers independently extracted study characteristics, outcomes, and related variables. Pooled hazard ratios (HRs) were calculated, with subgroup analyses by mutation type and geographic region, and meta-regression to assess effect modifiers. Risk of bias was assessed using the Newcastle-Ottawa Scale, and sensitivity and publication bias analyses were also assessed.

Results: Five studies with 1,175 patients were included. CHIP showed a non-significant trend toward increased all-cause mortality (HR = 1.58; 95% CI: 0.97-2.57; P = 0.0687; I² = 64.8%). When defined by TET2 mutations, CHIP was significantly associated with worse survival (HR = 1.91; 95% CI: 1.43-2.56; P < 0.001, I² = 0%), whereas DNMT3A mutations were not. In Western cohorts, CHIP was significantly associated with increased mortality (HR = 1.65; 95% CI: 1.28-2.12; P < 0.0001; I² = 38.7%). Meta-regression identified body mass index (BMI) as a significant modifier of the CHIP-mortality association (P = 0.0069).

Conclusions: CHIP, particularly TET2-related mutations, is associated with poorer survival in patients with severe AVS undergoing valve replacement. In Western populations, CHIP was significantly associated with increased mortality. Higher BMI further strengthened this association across all patients. These findings indicate that CHIP may be a potential marker for risk stratification and preventive strategies, but confirmation in larger and more diverse cohorts is required.

Background: Primary PCI is the standard of care for STEMI, but whether interhospital transfer (IHT) to a PCI-capable center worsens outcomes versus direct admission (DA) is uncertain.

Methods: We systematically searched PubMed, EMBASE, Scopus, and Web of Science for comparative studies of IHT vs DA among STEMI patients undergoing primary PCI. The primary outcome was in-hospital mortality; secondary outcomes included 30-day, 6-month, and 12-month mortality, major adverse cardiovascular events (MACE), stroke, bleeding, target-vessel revascularization (TVR), heart-failure hospitalization, left-ventricular ejection fraction (LVEF), and reperfusion time metrics. A random effects model was used when heterogeneity was significant (I² > 50%).

Results: Sixteen cohort studies (n = 183,422; 10 retrospective, 6 prospective) were included. In-hospital mortality was lower with IHT (RR 0.82, 95% CI 0.71-0.94), whereas 6-month mortality favored DA (RR 1.34, 95% CI 1.25-1.43). MACE, stroke, bleeding, TVR, heart-failure hospitalization, and 30-day/12-month mortality did not differ significantly. LVEF was modestly lower with IHT (MD - 1.79%, 95% CI - 3.33 to - 0.24). DA shortened symptom-to-admission (MD ≈103 min), symptom-to-PCI (MD ≈94 min), and total ischemic time (MD ≈70 min). Although transferred patients achieved a shorter in-hospital D2B (MD ≈ - 8.4 min) and were more likely to meet the < 90-min benchmark (RR 1.08), these gains were outweighed by longer pre-PCI delays. After weighting on covariates, in-hospital mortality was essentially identical between groups. Time-dependent Cox regression similarly showed that LVEF differences were driven by clinical severity (Killip class) rather than transfer itself.

Conclusions: In current STEMI networks, IHT was not associated with consistently worse clinical outcomes than DA despite longer pre-PCI delays. Apparent early survival advantages for IHT and small LVEF decrements likely reflect timing patterns and selection/survivor bias. Minimizing prehospital delays remains essential.