Clinical Research in Cardiology最新文献

Background: SELUTION Sustained Limus Release (SEL, Cordis, Miami, Florida, USA) is a novel biodegradable polymer microsphere sirolimus-coated balloon (SCB) characterized by sustained coronary drug retention. A head-to-head comparison to currently available paclitaxel-coated balloons (PCB) is lacking.

Objective: To compare clinical outcomes after percutaneous coronary intervention (PCI) with SEL SCB and iopromide-based SeQuent Please/NEO (SEQ, B. Braun, Melsungen, Germany) PCB.

Methods: Consecutive all-comer patients undergoing PCI with SEL SCB or SEQ PCB for both de novo lesions and in-stent restenosis between January 2021 and December 2024 at two Italian centers were included in this observational, retrospective, cohort study. The primary endpoint was target lesion failure (TLF), defined as the composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization (TLR) at 12-month follow-up. Inverse probability of treatment weighting was applied to adjust for baseline differences.

Results: A total of 487 patients (589 lesions) were included: 250 patients (302 lesions) treated with SEL SCB and 237 patients (287 lesions) with SEQ PCB. At a median follow-up of 403 [223-617] days, the 12-month rate of TLF was similar between SEL SCB and SEQ PCB (4.3% vs. 4.0%; adjusted hazard ratio [aHR]: 0.97; 95% confidence interval [CI]: 0.37-2.52). No significant differences were observed in cardiac death, target vessel MI, or TLR (aHR: 1.23; 95% CI: 0.21-7.19). Results were consistent across prespecified subgroups and sensitivity analyses.

Conclusions: The SELSEQ study suggests comparable outcomes at 12-month follow-up among patients undergoing PCI with the biodegradable polymer microsphere SEL SCB and the iopromide-based SEQ PCB.

Background: Renal dysfunction might affect outcomes in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel coronary artery disease (MVD) undergoing percutaneous coronary intervention (PCI).

Methods: In MULTISTARS AMI, patients with STEMI and MVD were randomized to immediate or staged PCI of non-culprit lesions. In this pre-specified analysis, patients were stratified according to the presence of renal dysfunction at baseline, defined at an estimated glomerular filtration rate (eGFR) of 60 ml/min/1.73 m². Patients with an eGFR < 30 ml/min/1.73 m² were excluded from the trial. The primary endpoint was a composite of death, non-fatal myocardial infarction, stroke, unplanned revascularization, or hospitalization for heart failure at 1 year.

Results: In MULTISTARS AMI, 108 (13%) of 832 patients had renal dysfunction. The primary endpoint occurred more frequently in patients with renal dysfunction (19.4% vs. 11.2%, unadjusted HR 1.82, 95% CI 1.13-2.94), primarily driven by higher rates of death. Among patients with renal dysfunction, the rates of the primary end point were 14.5% and 24.5% in the immediate and staged PCI groups (unadjusted HR 0.55, 95% CI 0.23-1.33). There was no interaction between renal dysfunction and the randomized treatment assignment with respect to the primary end point (adjusted HR 1.30, 95% CI 0.8-2.20, p_int 0.82). The occurrence of acute renal insufficiency was statistically similar in patients with renal dysfunction who underwent immediate and staged PCI (10.9% vs. 18.9%, unadjusted HR 0.61, 95% CI 0.22-1.72, p_int 0.09). Renal dysfunction at baseline emerged as a strong risk factor for the development of acute renal insufficiency (adjusted HR 5.0, 95% CI 2.30-10.70, p < 0.01).

Conclusions: Outcomes with immediate compared to staged multivessel PCI did not appear significantly altered by the presence of renal dysfunction at baseline. (Supported by Boston Scientific; MULTISTARS AMI ClinicalTrials.gov number, NCT03135275).

Aims: Fabry disease (FD) is a multisystemic disease affecting the heart and the kidneys of affected patients. In addition to FD-specific treatment, patients require concomitant medication for cardio- and nephroprotection. Sodium-dependent glucose transporter 2 inhibitors (SGLT2i) are recommended for patients with heart failure and/or kidney disease, but efficacy data for FD are scarce.

Methods and results: In this multicenter study (n = 8), the effects of SGLT2i therapy after 12 months of treatment in 48 patients (12 females) on FD-specific therapy were examined. Patients were retrospectively analyzed at three time points (before SGLT2i: T_-1; SGLT2i start: T₀; and end of observation: T₊₁). Patients showed advanced cardiac manifestations with a high frequency of left ventricular hypertrophy (LVH) (females: 81.8% and males: 90.0%) at T₀. Males presented with a significantly lower left ventricular ejection fraction LVEF (56 [29-73]% versus 65 [38-78]%; p = 0.0113). There were no treatment-related adverse events or Fabry-associated clinical events (FACEs) between T₀ and T₊₁. Females showed a stable disease course independent of the concomitant treatment with SGLT2i. Males showed an eGFR decrease of 3.7 ml/min/1.73 m² per year (p = 0.0018) before and an ameliorated decrease of 2.7 ml/min/1.73 m² per year (p = 0.0182) after SGLT2i initiation. Importantly, a slight but significant improvement of LVEF by 0.6% per year (p = 0.0319) was observed, which was more prominent in males with a reduced LVEF (< 50%) at baseline.

Conclusion: Treatment with SGLT2i of FD patients was safe and patients presented with stable disease courses. Especially males with reduced LVEF might benefit from SGLT2i treatment.

Objectives: This study investigated the safety and tolerability of regadenoson for pharmacologic stress testing in the context of myocardial scintigraphy under routine clinical conditions in a cardiology practice in 5780 consecutive patients.

Background: The drug regadenoson was approved in Germany in 2010 for pharmacological stress testing in myocardial scintigraphy for patients who are unable to undergo adequate physical exercise. Previously, only dipyridamole or adenosine were available for diagnostic pharmacological vasodilation, but they were not approved for this indication.

Methods: Data on safety and tolerability were prospectively collected from consecutive patients referred for the assessment of myocardial ischemia using myocardial scintigraphy. Data were immediately entered into a dedicated computer program.

Results: After injection of regadenoson, there was a significant mean increase in heart rate from 70.2 ± 12.3 to a maximum of 94.6 ± 17.3 bpm. Systolic blood pressure dropped from 128.9 ± 16.2 to a minimum of 123.3 ± 20.3 mmHg. 86% of patients experienced any adverse effects, with the most frequent being dyspnea (64.2%), followed by headaches (20.7%), a sensation of warmth (20.2%), and numerous other, less frequent sensations. Bronchospasms were not observed, notably not in the 508 patients with COPD/ bronchial asthma. Asystole of > 6 s occurred in 2 patients (0.03%), which were both successfully terminated immediately with theophylline and atropine. There were no fatalities.

Conclusion: Overall, regadenoson demonstrated very good tolerability. The development of the selective A_2A adenosine receptor agonist regadenoson, compared to classical non-selective adenosine, represents a significant advancement in non-invasive imaging diagnostics of myocardial ischemia, using myocardial scintigraphy and other modalities such as MRI. Since adenosine is contraindicated in patients with bronchial asthma/COPD, regadenoson has become the diagnostic agent of choice in these cases, although it must be considered that very rare instances (< 0.1%) of life-threatening events can occur, necessitating that antidotes such as theophylline and atropine be readily available.

Background and aims: Tissue remodelling and extracellular matrix (ECM) changes are primary consequences of ST-elevated myocardial infarction (STEMI), leading to an increased risk of developing heart failure and mortality. Collagen type I is the top constituent of the cardiac ECM and is rapidly degraded at sites of tissue injury occurring in STEMI. We aimed to investigate the prognostic potential of a novel biomarker of a collagen type I-derived signalling peptide (C1SIG) shown to be involved in left ventricular remodelling after MI and compare this against another collagen type I fragment quantified by the established C1M assay in a large STEMI cohort.

Methods: Plasma C1SIG and C1M were quantified using specific enzyme-linked immunosorbent assays in 1616 individuals upon admittance to hospital with STEMI. Patients were then followed up for all-cause mortality over 1 year, and survival analyses were performed.

Results: Short-term biomarker changes assessed in a subgroup (n = 140) showed increased circulating C1M and C1SIG in the short period from admission with STEMI up to 12 h post-admission (both, p < 0.0001). High C1M levels, defined by the highest quartile, and high C1SIG levels, defined by the median, were associated with reduced survival probability at 1 year (both, p < 0.0001) post-admission. The association was further supported in univariate and maintained for C1M only in multivariate Cox proportional hazard regression models adjusted for multiple confounders (HR [95% CI] 1.46 [1.15-1.85]). Added value analysis determined the additional predictive value of C1M to the clinically used GRACE risk score for cardiovascular event prediction (p = 0.0002).

Conclusion: C1M and C1SIG are dynamic biomarkers of collagen type I degradation, where C1SIG is also suspected to be a collagen signal. C1M is an independent predictor of all-cause mortality within a year of a MI.

Objectives: To investigate the long-term outcomes and risk factors for morbidity and mortality in patients with Ebstein's anomaly, including the effects of type and timing of valve surgery.

Methods: For this retrospective, record-based study, all patients with Ebstein's anomaly enrolled in the German National Register for Congenital Heart Defects up to June 2021 were eligible for inclusion.

Results: Non-surgical patients (n = 194/49% of 398 patients) had less tricuspid valve regurgitation (p < 0.001) and heart failure symptoms (p < 0.001) than surgical patients (n = 204/51%). Postoperative survival at 10, 20, and 30 years was 97%, 93%, and 80%. Eighty-one (40%) patients underwent multiple surgeries. Re-operation rates were lowest in patients with first valve surgery during adolescence (p = 0.0076). Postoperative NYHA class > I was more frequent with surgery delayed to older age (p < 0.001). Initial corrective surgery was complicated by complete atrioventricular block (CAVB) in 17 (9%) of patients. CAVB was more likely with older age (p = 0.001), and tricuspid valve replacement compared to reconstruction (p = 0.029). CAVB was associated with all-cause death (p < 0.001). Cone reconstruction reduced the risk of CAVB (p = 0.008) and tricuspid valve regurgitation (p < 0.001) compared to monocusp reconstruction.

Conclusions: This registry-based study of Ebstein's anomaly corroborates good surgical long-term results, while re-operation rates remain high. Patients operated before adolescence were at the highest risk of re-operation, while older age at the time of the first surgery increased the risk of CAVB. The cone reconstruction was associated with improved tricuspid valve function and a lower risk of CAVB compared to monocusp reconstructions. Choosing an optimal time window for surgery and use of the cone reconstruction may therefore further improve outcomes.

Background: Heart failure with reduced ejection fraction (HFrEF) causes reduced functional capacity, impaired quality of life, and frequent rehospitalisation. Although guidelines recommend cardiac rehabilitation (CardRehab), referral rates remain low. The MEDIAN Heart Failure Registry evaluated short- and midterm outcomes of inpatient CardRehab in routine practice.

Methods: A prospective multicentre registry included 808 patients with clinically stable HFrEF (LVEF ≤ 40%) undergoing inpatient cardiac rehabilitation across 17 German centres (2019-2020). Clinical outcomes-6-min walk test, bicycle ergometry, echocardiographic LVEF, NYHA class, NT-proBNP (subset), and patient-reported outcomes (KCCQ, HADS)-were assessed at admission, discharge, and 6 months post-discharge. A structured follow-up survey evaluated adherence to lifestyle changes and the sustainability of effects after the 22.8-day inpatient stay.

Results: A total of 808 patients (mean age, 65 years; 16.6% females) showed significant improvements in physical and psychosocial parameters. Mean LVEF increased from 31.1% (SD 9.0) to 35.9% (SD 10.7; p < 0.01), mean 6-min walk distance from 306 m (SD 136) to 388 m (SD 158; p < 0.01), and mean bicycle ergometry from 27.8 W (SD 15.4) to 49.5 W (SD 26.4; p < 0.01). Mean NT-proBNP decreased (p < 0.01). KCCQ and HADS scores improved significantly. Inpatient mortality rate during rehabilitation was 0.6% (5/808), and the rehospitalisation rate due to heart failure was 2.8% (23/808). There were two documented cancellations of rehabilitation. At 6-month follow-up, benefits remained stable with high adherence to recommended behaviours.

Conclusions: Cardiac rehabilitation was associated with improvements in physical capacity, left ventricular function, psychological well-being, and quality of life in patients with chronic heart failure, alongside low observed rehospitalisation rates during follow-up.