Peri-device leak (PDL) following left atrial appendage closure (LAAC) can be diagnosed by both transesophageal echocardiography (TEE) and cardiac computed tomography (CCT). Yet, there is a substantial discrepancy in leak quantification. We propose a novel ABC classification of LAA sealing for TEE and CCT based on the pattern of intra-device thrombosis (IDT). A single-center observational study including patients undergoing LAAC with Watchman FLX or FLX-Pro between 2022 and 2024. Patients underwent CCT and TEE at 14days, 45 and 90days after LAAC. Images were analyzed by three blinded investigators. LAA sealing was classified by four distinct morphological patterns of IDT: Type A: Complete IDT (> 95% of the device). Type B: Incomplete IDT (50-95% of the device). Type B1: Incomplete thrombosis of the distal parts of the device. Type B2: Incomplete thrombosis in the proximal part near the atrial device surface. Type C: Partial IDT (< 50% of the device). Overall, 68 patients (mean age 76.1years, 37% female) with complete CCT follow-up were included. At 90-day IDT classifications by CCT were Type A (53.8%), Type B1 (29.2%), Type B2 (0%), and Type C (16.9%). Type B2 was present on 14days (1.5%) and 45days (3.1%). PDL was observed in only 2.9% (95% CI, 0.7%-14.5%) of Type A, 73.7% (95% CI, 52.4%-93.6%) of Type B1, and 100% of Type C. Inter- and intra-reader agreements were very high for CCT and substantial for TEE imaging. Type A was associated with sealing irrespective of imaging modality, while Type C was always an indicator of PDL. This unifying classification was highly reproducible across imaging modalities and among readers of differing levels of experience.

The prevalence of severe symptomatic aortic stenosis is increasing with population aging. Although surgical aortic valve replacement (SAVR) has traditionally been the standard treatment, transfemoral transcatheter aortic valve replacement (TF-TAVR) is increasingly used. The optimal treatment for patients aged 60-75 remains debated. This retrospective cohort study analyzed 28,805 German patients who underwent isolated SAVR or TF-TAVR (2018-2022). We applied double/debiased machine learning estimators that combined adaptive lasso variable selection with propensity score-based weighting across 21 baseline characteristics. Cost-effectiveness was assessed via incremental cost-effectiveness ratios (ICER) and cost-effectiveness acceptability curves from in-hospital and 1-year perspectives. Compared with SAVR, TF-TAVR was associated with a significant reduction in in-hospital mortality (causal risk ratio [RR] 0.65; p = 0.012), along with lower rates of bleeding (RR 0.29; p < 0.001), postoperative delirium (RR 0.32; p < 0.001), and mechanical ventilation > 48h (RR 0.39; p < 0.001). No significant difference was observed in acute kidney injury rates (RR 0.89; p = 0.150). However, reimbursement was substantially higher for TF-TAVR (€7071 more per case, p < 0.001). A hypothetical shift from SAVR to TF-TAVR was associated with an ICER of €857,413 (95% CI €472,195-€4,310,651) from the in-hospital perspective and €196,422 (95% CI €123,873-€457,813) from the 1-year perspective. Notably, unadjusted analyses indicated a narrowing cost gap over time: Reimbursement for TF-TAVR decreased by approximately 12% between 2018 and 2022, while SAVR costs remained stable. Consequently, TF-TAVR is becoming increasingly cost-effective. Given an estimated life expectancy of 11 to 25years in this population, the incremental costs per life saved associated with a hypothetical shift from SAVR to TF-TAVR appear justifiable. Nonetheless, individual patient circumstances must always be considered in decision-making.

To evaluate radiation exposure during pediatric cardiac catheterization over a 10-year period at a central European tertiary center and to establish contemporary, procedure-specific dose benchmarks and conversion factors for estimating effective dose (ED). All cardiac catheterization procedures in patients < 18years performed between 2015 and 2024 were retrospectively reviewed. For procedures with multiple components, cumulative dose area product (DAP) was proportionally allocated using weight-adjusted (DAP/BW) median values from single-intervention cases. ED was estimated in silico in randomly selected examinations using Monte Carlo simulation. Dose conversion factors between DAP and ED were derived. Additionally, a structured review of the literature on recently published data on radiation doses was performed. A total of 3683 procedures in 2494 patients (median age 3.8years) were included. Body weight showed a stronger association with DAP than age. Median DAP/BW was 11.7cGy·cm2/kg for diagnostic and 9.7cGy·cm2/kg for interventional procedures. For most procedure types, DAP/BW was substantially lower than previously published benchmarks. Simulated conversion factors declined logarithmically with increasing body weight and differed only slightly between posterior-anterior and lateral projections. Only 0.9% of patients exceeded a cumulative ED of 30mSv. Radiation exposure in contemporary pediatric cardiac catheterization is markedly lower than in earlier reports, with procedure complexity being the primary determinant of effective dose.

The Systemic Immune-Inflammation Index (SII), calculated as neutrophils × platelets / lymphocytes, reflects the interplay between systemic inflammation and immune status. Its prognostic relevance in patients undergoing transcatheter aortic valve implantation (TAVI) remains poorly understood. To evaluate the prognostic significance of preprocedural SII in patients undergoing TAVI. This retrospective cohort study included 1822 patients undergoing TAVI for severe aortic stenosis between 2014 and 2023 at two TAVI centers in Germany. Patients were divided into derivation and validation cohorts. Preprocedural SII was calculated from differential blood counts. In the derivation cohort, patients were stratified into tertiles based on preprocedural SII. Using receiver operating characteristics (ROC) analysis an optimized cut-off value for the validation cohort was identified to stratify patients into high- and low-risk groups. A generalized linear model (GLM) was used to identify clinical predictors of SII. In the derivation cohort, multivariate analysis showed that SII was independently associated with both major adverse cardiovascular events (MACE) (hazard ration [HR]: 1.0001 [1.00001; 1.00002], p = 0.020) and stroke (HR: 1.0003 [1.00002; 1.00004], p < 0.001). In the GLM, SII positively correlated with age (p = 0.013) and C-reactive protein (p < 0.001), and inversely with mean aortic gradient (p = 0.022) and hemoglobin (p = 0.011). In the external validation cohort, high risk patients (cut-off > 1204) showed an increased risk for one-year all-cause mortality (HR: 2.19 [1.59; 3.02], p < 0.001). Higher preprocedural SII was independently associated with increase rates of MACE and stroke at one-year following TAVI. A SII cut-off of 1204 effectively stratifies patients into high- and low-risk groups and may provide additional value for preprocedural risk stratification.

Preliminary studies have demonstrated the feasibility of pulsed field ablation (PFA) for the treatment of paroxysmal supraventricular tachycardia (PSVT); however, direct comparative data between PFA and radiofrequency ablation (RFA) with longer-term follow-up are lacking. This study aimed to compare the safety and efficacy profiles of PFA and RFA in PSVT treatment through propensity score matching over a 12-month follow-up period. This multicenter prospective study enrolled 621 consecutive patients with PSVT who underwent catheter ablation with PFA (n = 212) or RFA (n = 409) across 8 centers in China. Propensity score matching was performed separately for atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular reentrant tachycardia (AVRT) patients, yielding 107 and 67 matched pairs. The primary and secondary end points were acute ablation and 12-month follow-up success rates, respectively. The acute procedural success rate was 100% for both modalities in all matched patients. The 12-month success rates were comparable between the PFA and RFA groups for both AVNRT (97.2% vs. 96.3%, P = 0.701) and AVRT (92.5% vs. 89.6%, P = 0.545). In the AVNRT cohort, all PFA recurrences were observed between 6 and 12months. Although PFA required more ablation applications (AVNRT: 11.5 vs. 9.0, P < 0.001; AVRT: 15.5 vs. 7.0, P < 0.001), the overall procedure time remained comparable to that of RFA. Transient first-degree AV block was observed in one patient per group in the matched AVNRT cohort and in one RFA-treated patient in the matched AVRT cohort. All patients resolved spontaneously without permanent complications. PFA demonstrated safety and efficacy outcomes comparable to those of RFA, supporting its potential role as an alternative therapeutic option for PSVT management. These findings should be considered hypothesis-generating, and further large-scale randomized trials with longer follow-up and different PFA systems are required for confirmation.

Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy with defibrillation-function (CRT-D) are widely used in patients with life-threatening arrhythmias or heart failure. We aim to investigate the impact of sex-specific differences on defibrillation-capable cardiac devices' implantation and outcomes. The German DEVICE registry is a prospective, multicentre database of ICD and CRT device implantation. A total of 5330 patients receiving a defibrillation-capable device were prospectively enrolled in 44 centres between March 2007 and February 2014 and followed for 17 (13, 23) months. A minority of patients in this registry was female 1017 (19.1%). The rate of CRT-D use among the defibrillator recipients was higher in women (32.4% vs. 28.0%; p = 0.006). The incidence of major periprocedural complications and in-hospital complications were higher in women (3.3% vs. 1.6%; p = 0.001 and 5.5% vs. 3.6%; p = 0.017, respectively). The 1-year all-cause mortality was 5.5% for women and 7.4% for men (p = 0.039), while the 1-year cardiovascular mortality was 4.1% and 6.2%, respectively (p = 0.012). Less women received device shocks during 1-year follow-up (10.7% vs. 13.8%; p = 0.023). Women receiving CRT-D had a lower non-device-related cardiovascular hospitalization rate than men. System revision until discharge, in-hospital death and non-fatal complications during follow-up were comparable for men and women. Similar rates of all-cause and cardiac rehospitalizations were found. In this real-life patient cohort only a minority of patients was female. Female patients had a higher risk of major periprocedural complications and in-hospital complications but a lower all-cause and cardiovascular mortality. Less women experienced device-shocks during follow-up.

Safety and efficacy have been well demonstrated for Micra™ leadless cardiac pacemakers (LCPs). However, the presence of sex-specific disparities remains unclear. The aim of this single-centre observational study was to assess the sex-specific short- and long-term outcomes in patients undergoing LCP implantation. 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). 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.

Data on premature ventricular complex (PVC) burden after pulmonary vein isolation (PVI) for atrial fibrillation (AF) are inconsistent and often limited to selected populations. We retrospectively analyzed patients undergoing successful first-time PVI for paroxysmal or persistent AF between January 2019 and June 2023. PVC burden was quantified by long-term ECG at baseline, 3months, and 12months. Ablation energy sources included cryoballoon, radiofrequency, and pulsed field ablation. Among 1,069 patients, median PVC burden decreased from 6.82/h at baseline to 1.44/h at 3months and 3.75/h at 12months. In patients with complete follow-up (n = 165), PVC burden declined significantly overall (Friedman test p < 0.001). Post-hoc analyses confirmed reductions from baseline to 3 and 12months, with a modest increase between 3 and 12months (all p < 0.01). PVC burden was similar regardless of AF recurrence or ablation energy. At 12months, 4.6% of patients had high PVC burden (> 5%). Diabetes mellitus (OR = 4.43; 95% CI: 1.49-13.17; p = 0.007) and reduced left ventricular ejection fraction (OR = 6.36; 95% CI: 2.03-19.91; p = 0.002) were independently associated with elevated burden, while other covariates were not significant. PVI significantly reduces PVC burden in most patients, independent of AF recurrence or ablation modality. Diabetes and impaired ventricular function identify patients at risk of persistent high PVC burden. PVI may particularly benefit AF patients with symptomatic PVCs, but larger prospective studies are needed to validate these findings and assess clinical outcomes.

The SLCO1B1 c.521T > C variant, which reduces hepatic statin uptake, has been linked to an increased risk of statin-associated muscle symptoms (SAMS), particularly with simvastatin. This study aimed to assess its association with SAMS and prescription of contemporary lipid-lowering therapy in patients with severe hypercholesterolemia. We included 219 patients with a mean age of 53.9 ± 12.7years who attended our outpatient lipid clinic and were genotyped for the SLCO1B1 c.521T > C variant. Treating physicians and patients were unaware of genotyping results. Six patients (2.7%) were homozygous and 68 patients (31.1%) were heterozygous for the c.521T > C variant. After treatment optimization, the median LDL cholesterol levels were 63 (IQR 40-124) mg/dL and 74 (IQR 43-129) mg/dL in mutation carriers and non-carriers, respectively (p = 0.35). Self-reported SAMS did not differ between mutation carriers and non-carriers (25.7% vs. 27.6%; p = 0.76). In addition, statin usage (70.3% vs. 73.1%; p = 0.66) and prescription rates of proprotein convertase subtilisin/kexin type-9 inhibitors (PCSK9i) (32.4% vs. 31.0%; p = 0.83) did not differ according to mutation status. In patients with severe hypercholesterolemia on contemporary statin therapy, the SLCO1B1 c.521T > C variant was not associated with SAMS, reduced statin use, or increased prescription of PCSK9 inhibitors. The SLCO1B1 c.521T > C variant appears to have no clear clinical relevance, but testing for it may potentially be harmful, as fear of side effects could result in statin undertreatment.