Clinical Research in Cardiology最新文献

Background: Safety and efficacy have been well demonstrated for Micra™ leadless cardiac pacemakers (LCPs). However, the presence of sex-specific disparities remains unclear.

Methods: The aim of this single-centre observational study was to assess the sex-specific short- and long-term outcomes in patients undergoing LCP implantation.

Results: In total, 378 LCPs were implanted in 127 women (33.6%) and 251 men (66.4%). The most frequent indications included atrial fibrillation with slow conduction (women: 31.5%, men: 44.6%), third-degree atrioventricular block (women: 31.5%, men: 33.5%) and sick sinus syndrome (women: 21.3%, men: 9.6%). Electrical performance parameters of LCPs were similar between sexes. Procedure-related complications during LCP implantation occurred more frequently in women (3.1%) compared to men (0.4%), though no difference was observed for all complications during the index stay (women: 3.9%, men: 1.6%, p = 0.18). In-hospital mortality was low for women (0.8%) and men (0.8%, p = 0.96). A multivariable logistic regression analysis adjusted for sex, age, diabetes, chronic kidney disease, coronary artery disease and transcatheter and surgical valve replacement revealed concomitant lead extraction (OR 9.153, p = 0.001) as the only predictor for complication or death during index stay. All-cause mortality was 30.7% in women (n = 39) and 27.5% in men (n = 69, p = 0.28) during a median follow-up of 41 months (IQR 22-65 months).

Conclusions: No sex-specific disparities were observed with respect to complications during index stay, in-hospital and all-cause mortality. Less frequent use of LCP therapy in women may relate to differing indications between sexes. Further prospective studies may help to develop sex-specific recommendations for LCP therapy.

Background: PR-interval reflects atrioventricular timing but does not well characterize adverse hemodynamics. Novel ECG parameters of conduction may identify benefit from non-dyssynchronous ventricular pacing to correct long atrioventricular conduction delays.

Objective: Evaluating novel ECG parameters to identify risk of heart failure (HF)/death and benefit vs harm by CRT-D in MADIT-CRT non-LBBB patients.

Methods: We analyzed intervals from ECGs in 535 non-LBBB patients enrolled in MADIT-CRT, using ImageJ. Onset of atrial activation, P wave zero crossing in V1, latest P offset, earliest QRS onset, and time to the first R peak in V1 and V6 were determined. Endpoints included HF or death. Associations between novel conduction measures and clinical outcomes in ICD patients (n = 209), and CRT-D (n = 326) vs. ICD benefit, were assessed using Kaplan-Meier and multivariable Cox regression analyses.

Results: We identified the delay from P zero crossing to the first R peak in V1 (P0PV1) at quintile 5 as the strongest risk predictor in ICD patients (n = 159, 30%), over PR-interval, for all endpoints (p < 0.001), with a more than threefold risk increase. In this group, CRT-D was associated with a 66% lower risk of HF/Death (95% CI: 0.22-0.68, p = 0.001) vs. an ICD. However, in patients with a P0PV1 < 201 ms, CRT-D vs. an ICD was associated with a 64% increased risk of HF/death (95% CI: 1.12-2.55, p = 0.012), with significant bidirectional interaction (p-value < 0.001).

Conclusions: We propose a novel variable, P0PV1, to identify risk and benefit vs. harm from CRT-D in HF patients with non-LBBB. Prospective studies are warranted to confirm our findings.

Background: Central venous access for cardiac implantable electronic device (CIED) implantations is conventionally acquired via the cephalic or subclavian vein. Controlled data suggest that axillary vein access may reduce complications.

Objectives: We, therefore, shifted institutional practice from subclavian vein access to ultrasound (US)-guided axillary vein access for new implantations and revisions or upgrades and report on implant success rates, learning curves and periprocedural complications.

Methods: Between January 2021 and August 2023, all patients undergoing CIED implantations, revisions or upgrades were analyzed. US-guided axillary access was introduced starting with one operator and spreading to most operators and trainees thereafter. Periprocedural outcomes and complications (pocket hematoma, hemothorax, and pneumothorax) of transcutaneous US-guided axillary vein access were compared to the subclavian vein access.

Results: In this study, 986 patients (median age: 75 years, interquartile range (IQR) 64-82 years, 35% women) with 87% new implantations and 13% revisions or upgrades were included. Transcutaneous US-guided axillary access was successful in 535/578 patients (93%), subclavian vein access in 400/408 patients (98%) (p < 0.001). For device upgrades or revisions specifically, axillary access was successful in 69/79 patients (87%), versus 45/47 patients (96%) with subclavian access (p = 0.208). The learning curve for axillary access was steep with success rates of 93 after 30 cases per operator. Complications occurred in 2/578 patients (0.3%) undergoing axillary vein access versus 17/408 patients (4.2%) (p < 0.001) undergoing subclavian vein access.

Conclusion: The implementation of transcutaneous US-guided axillary vein access for implantation, revisions and upgrades of cardiac electronic devices is feasible in a large tertiary care center. The periprocedural complications are rare.

Background: Tricuspid regurgitation (TR) is associated with increased morbidity and mortality. Since surgical treatment of tricuspid regurgitation in elderly, multimorbid patients is associated with high risk, less invasive therapies such as tricuspid transcatheter edge-to-edge repair (T-TEER) and transcatheter tricuspid valve replacement (TTVR) have been developed.

Objectives: This study aimed to compare 30-day clinical and echocardiographic outcomes of T-TEER and TTVR in high-risk patients with severe TR.

Methods: T-TEER was performed in 104 patients and TTVR in 10 patients based on anatomical suitability. All procedures were guided by transesophageal echocardiography and fluoroscopy. Primary endpoints included TR reduction, NYHA functional class, and safety events according to TVARC criteria.

Results: At 30 days, TR reduction to grade 0/I was achieved in 44.9% of T-TEER and 80% of TTVR patients (p < 0.001). NYHA class I/II was present in 63.2% after T-TEER and 70% following TTVR (p = 0.69). Major bleeding occurred more frequently in the TTVR group (20%) than in the T-TEER group (1.96%; p = 0.041). One patient in the TTVR group required a new pacemaker. No deaths, strokes, or surgical conversions occurred in either group.

Conclusions: T-TEER and TTVR are effective for treating severe TR in high-risk patients. TTVR achieved greater TR reduction but was associated with more access site bleeding. T-TEER demonstrated a favorable safety profile. Careful patient selection remains essential to optimize outcomes.

Background: Oxidative modification of apolipoprotein B-100 (apoB) containing particles and subsequent immune responses contribute to the pathogenesis of atherosclerosis. Circulating IgG and IgM apoB-containing immune complexes (apoB-IC) and autoantibodies to a malondialdehyde mimotope (anti-MDA-mimotope) serve as biomarkers of oxidative stress and immune activation in atherosclerotic cardiovascular disease. Elevated lipoprotein(a) [Lp(a)] is associated with increased oxidative burden and immune activation.

Purpose: To investigate the effect of lipid-lowering medications on IgG and IgM apoB-IC and IgG and IgM autoantibodies to an MDA-mimotope in individuals with elevated lipoprotein(a) [Lp(a)] concentrations.

Methods: In this prospective study, patients (n = 70) with Lp(a) levels ≥ 75 nmol/L were assigned to 3 treatment regimens according to current guidelines: high-intensity statin monotherapy (n = 28), ezetimibe added to high-intensity statin (n = 31) and proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) added to high-intensity statin plus ezetimibe (n = 11). IgG and IgM apoB-IC and IgG and IgM anti-MDA-mimotope were measured at baseline and 3 months after treatment initiation.

Results: Patients had a mean age of 51 ± 15 years and 40% were male. Significant reductions in IgG apoB-IC levels were observed following treatment with high-intensity statins, add-on ezetimibe and add-on PCSK9i (by 18.3%, 17.5% and 25.5%, respectively, all p < 0.05). No significant changes in IgM apoB-IC, or IgG and IgM anti-MDA-mimotope levels were observed in any treatment group.

Conclusions: In individuals with Lp(a) levels ≥ 75 nmol/L, high-intensity statins, add-on ezetimibe and add-on PCSK9i reduced IgG apoB-IC but did not affect IgM apoB-IC, or IgG and IgM anti-MDA-mimotope levels. The clinical significance of these findings warrants further investigation.

Aims: The aim of this study was to evaluate the short-term potential of very-high-intensity lipid-lowering therapy on lesion-level atheroma burden.

Methods: The investigator-initiated, double-blind, placebo-controlled FITTER trial (enrollment November 2020 to August 2023) randomized patients presenting with acute coronary syndrome (ACS) and relevant non-culprit coronary artery disease (fractional flow reserve: 0.67-0.85) to receive either evolocumab or placebo for 12 weeks in addition to high-intensity statin therapy to evaluate the short-term potential of lipid-lowering therapy on non-culprit plaque features. Present lesion-level analysis assessed the effects on coronary segments with advanced atherosclerotic plaque characteristics with increased cardiovascular risk and includes all patients who underwent successful serial intravascular ultrasound-near-infrared spectroscopy (IVUS-NIRS) imaging and with presence of IVUS-derived atherosclerotic lesions.

Results: A total of 126 lesions were identified in 85 patients (mean age 65.1 ± 8.3, 18.8% female), of which 65 lesions were found in the evolocumab group (44 patients) and 61 in the placebo group (41 patients). Compared to placebo, patients treated with evolocumab did not demonstrate significant reductions in maximum lipid core index within any 4 mm segment (maxLCBI_4mm, between-group difference, -9.6 [95% CI, -52.8 to 33.6]; p = 0.7) or percent atheroma volume (PAV, between-group difference, 1.0% [95% CI, -1.3 to 3.2]; p = 0.4). However, an overall reduction in maxLCBI_4mm (overall change, -54.2 [95% CI, -89.6 to -18.7]; p = 0.003) and PAV (overall change, -2.0% [95% CI, -3.9 to -0.1]; p = 0.04) was observed.

Conclusions: Compared with placebo, the addition of evolocumab did not yield incremental improvements in lesion-level atheroma burden in the first 12 weeks after ACS. However, in the pooled analysis, significant short-term reductions in atheroma volume and plaque lipid content were observed.

Trial registration number: clinicaltrials.gov NCT04141579.

Introduction: Management of aortic stenosis, particularly with preserved left ventricular ejection fraction (LVEF) and discordant or borderline echocardiographic findings, remains challenging, both in assessing the true severity of stenosis and in isolating the valvular contribution to symptoms amidst comorbid conditions. This study evaluates the feasibility and physiological insight obtained from invasive pressure measurements across the aortic valve at rest and during exercise in symptomatic patients with aortic stenosis (AS).

Methods: This prospective cross-sectional study included patients with symptomatic high-gradient severe, low-gradient severe, and moderate aortic stenosis. They underwent invasive pressure gradient measurements across the aortic valve (pressure catheters in the left ventricle and ascending aorta) with concurrent right heart catheterization at rest and during peak supine bicycle exercise.

Results: Of 28 patients included, invasive measurements during exercise were feasible in 25 patients. Overall, exercise induced increases in aortic valve gradient, flow, and opening area, but there was considerable heterogeneity in individual hemodynamic responses. Notably, of the 14 patients in the low-gradient severe group based on echocardiography, nine demonstrated divergent physiological responses consistent with either moderate or high-gradient severe during exercise. All patients - irrespective of stenosis severity - had differential causes of symptoms during exercise with at least one of the following: chronotropic incompetence, abnormal increase in pulmonary artery or left ventricular end-diastolic pressures, or peripheral impairment of oxygen extraction or utilization.

Conclusion: These findings demonstrate the safety and feasibility of invasive hemodynamic exercise testing in patients with aortic stenosis and highlight heterogeneity in pressure-flow responses during exercise. Invasive hemodynamic assessment during exercise may help elucidate alternative contributing mechanisms to exertional dyspnea, particularly in patients with aortic stenosis and discordant symptoms and findings.

Background: The systemic inflammatory response index (SIRI)-an inflammatory index derived from neutrophil, monocyte, and lymphocyte counts-has shown potential in predicting cardiovascular risk. However, its prognostic value in patients with acute coronary syndrome (ACS) treated with primary percutaneous coronary intervention (pPCI) remains unclear. This study was aimed at evaluating the prognostic significance of SIRI in this specific high-risk population.

Methods: We conducted a systematic search of PubMed, Embase, and The Cochrane Library up to June 2025 to identify all relevant studies about SIRI applied to patients with ACS after pPCI. The primary outcome was all-cause mortality. Among major adverse cardiovascular events (MACE), new-onset acute myocardial infarction (AMI), revascularization, and stroke were included as secondary outcomes. Risk estimates were pooled as odds ratios (OR) with 95% confidence intervals (CI).

Results: A total of nine studies involving 7679 patients were included. The pooled analysis demonstrated that an elevated SIRI was a significant predictor for both all-cause mortality (OR 3.32; 95% CI 1.29 to 8.54; p = 0.01), MACE (OR 2.45; 95% CI 1.74 to 3.45; p = 0.001), new-onset AMI (OR 1.86; 95% CI 1.25 to 2.77; p = 0.001), and myocardial revascularization (OR 1.64; 95% CI 1.35 to 1.98; p = 0.001).

Conclusions: Our meta-analysis demonstrates that an elevated SIRI is a useful predictor of all-cause mortality, MACE, new-onset AMI, and revascularization in patients with ACS undergoing PCI. As a simple and cost-effective index, SIRI shows significant potential for early risk stratification and may help guide clinical management in this patient population.

Background and aims: Surgical bailout during transcatheter aortic valve replacement (TAVR) is rare but highly critical. We evaluated the impact of hospital infrastructure, procedural setting, timing metrics, and haemodynamic stability on patients requiring emergent surgical bailout.

Methods: A single-centre analysis was conducted on consecutive TAVR cases requiring emergent surgical bailout between 2009 and 2024. Two eras were compared: Era 1 (2009-2016), with procedures performed in a conventional catheterisation laboratory (CCL) requiring transfer to a distant operating room, and Era 2 (2017-2024), using a purpose-built hybrid operating room (HOR) with all disciplines on site. The primary endpoint was in-hospital mortality. Secondary endpoints included time to extracorporeal life support (ECLS) initiation and surgical incision.

Results: Of 3039 TAVR procedures, 16 patients (0.53%) required surgical bailout (10 in Era 1, 6 in Era 2). In-hospital mortality was 100% in the CCL group versus 33.3% in the HOR group (P < 0.01). While time to ECLS was similar, time to surgical intervention was significantly shorter in the HOR group. All HOR patients received definitive surgical treatment, whereas 60% of CCL patients died before surgery could be initiated. Haemodynamic instability prior to conversion differed significantly between groups.

Conclusions: Surgical bailout during TAVR is rare, but associated mortality remains high. Bailout performed in a HOR was associated with shorter delays to surgical incision and improved outcomes, with haemodynamic stability at the time of conversion emerging as an important factor associated with survival. These findings highlight the potential relevance of minimising time to surgery through optimised infrastructure, such as a HOR.

Background: The increasing prevalence of heart failure with preserved ejection fraction (HFpEF) is often accompanied by mitral regurgitation (MR). Transcatheter edge-to-edge repair (M-TEER) is established for treating MR in heart failure with reduced ejection fraction (HFrEF), but its impact in patients with HFpEF phenotype is unclear.

Aim: To investigate the effect of M-TEER in patients with HFpEF phenotype and concomitant MR based on diagnostic criteria according to current ESC guidelines and established HFpEF scores.

Methods: 181 patients with severe MR underwent M-TEER at our center with HFpEF phenotype. Echocardiography, symptom burden (NYHA class), quality of life (MLWHFQ, SF-PCS, and functional capacity (6MWD) were assessed before and 30 days after M-TEER. Survival and rehospitalisation rates were assessed at long-term follow-up.

Results: M-TEER in patients with HFpEF phenotype significantly reduced MR grade and improved symptom burden, quality of life, and exercise capacity. Patients with either primary or secondary MR experienced clinically relevant symptomatic improvement for MLWHFQ (69%) and SF-PCS (60%) as well clinically relevant increase (44%) of the 6MWD. The clinical outcome between patients with primary or secondary MR was comparable. Severe tricuspid regurgitation (TR) complicating HFpEF was independently linked to an increased mortality risk (HR 3.66, 95%CI 1.32-10.15, p = 0.013).

Conclusion: M-TEER is an effective treatment for both severe primary and secondary MR in patients with HFpEF phenotype, significantly reducing MR and improving symptoms. The independent association of severe TR with increased all-cause mortality highlights the importance of timely intervention to prevent right heart failure and worse outcomes.