Aims Patients with a pacemaker or implantable cardioverter-defibrillator are often considered for cardiac resynchronization therapy (CRT). However, limited comprehensive data are available regarding their long-term outcomes. Methods and results Our retrospective registry included 2524 patients [1977 (78%) de novo, 547 (22%) upgrade patients] with mild to severe symptoms, left ventricular ejection fraction ≤35%, and QRS ≥ 130ms. The primary outcome was the composite of all-cause mortality, heart transplantation (HTX), or left ventricular assist device (LVAD) implantation; secondary endpoints were death from any cause and post-procedural complications. In our cohort, upgrade patients were older [71 (65–77) vs. 67 (59–73) years; P < 0.001], were less frequently females (20% vs. 27%; P = 0.002) and had more comorbidities than de novo patients. During the median follow-up time of 3.7 years, 1091 (55%) de novo and 342 (63%) upgrade patients reached the primary endpoint. In univariable analysis, upgrade patients exhibited a higher risk of mortality/HTX/LVAD than the de novo group [hazard ratio (HR): 1.41; 95% confidence interval (CI): 1.23–1.61; P < 0.001]. However, this difference disappeared after adjusting for covariates (adjusted HR: 1.12; 95% CI: 0.86–1.48; P = 0.402), or propensity score matching (propensity score-matched HR: 1.10; 95% CI: 0.95–1.29; P = 0.215). From device-related complications, lead dysfunction (3.1% vs. 1%; P < 0.001) and pocket infections (3.7% vs. 1.8%; P = 0.014) were more frequent in the upgrade group compared to de novo patients. Conclusion In our retrospective analysis, upgrade patients had a higher risk of all-cause mortality than de novo patients, which might be attributable to their more significant comorbidity burden. The occurrence of lead dysfunction and pocket infections was more frequent in the upgrade group.

BackgroundDistal radial access (DRA) was recently introduced in the hopes of improving patient comfort by allowing the hand to rest in a more ergonomic position throughout percutaneous coronary interventions (PCI), and potentially to further reduce the rate of complications (mainly radial artery occlusion, [RAO]). Its safety and feasibility in chronic total occlusion (CTO) PCI have not been thoroughly explored, although the role of DRA could be even more valuable in these procedures.MethodsFrom 2016 to 2021, all patients who underwent CTO PCI in 3 Hungarian centers were included, divided into 2 groups: one receiving proximal radial access (PRA) and another DRA. The primary endpoints were the procedural and clinical success and vascular access-related complications. The secondary endpoints were major adverse cardiac and cerebrovascular events (MACCE) and procedural characteristics (volume of contrast, fluoroscopy time, radiation dose, procedure time, hospitalization time).ResultsA total of 337 consecutive patients (mean age 64.6 ± 9.92 years, 72.4% male) were enrolled (PRA = 257, DRA = 80). When compared with DRA, the PRA group had a higher prevalence of smoking (53.8% vs. 25.7%, SMD = 0.643), family history of cardiovascular disease (35.0% vs. 15.2%, SMD = 0.553), and dyslipidemia (95.0% vs. 72.8%, SMD = 0.500). The complexity of the CTOs was slightly higher in the DRA group, with higher degrees of calcification and tortuosity (both SMD >0.250), more bifurcation lesions (45.0% vs. 13.2%, SMD = 0.938), more blunt entries (67.5% vs. 47.1%, SMD = 0.409). Contrast volumes (median 120 ml vs. 146 ml, p = 0.045) and dose area product (median 928 mGy×cm2 vs. 1,300 mGy×cm2, p < 0.001) were lower in the DRA group. Numerically, local vascular complications were more common in the PRA group, although these did not meet statistical significance (RAO: 2.72% vs. 1.25%, p = 0.450; large hematoma: 0.72% vs. 0%, p = 1.000). Hospitalization duration was similar (2.5 vs. 3.0 days, p = 0.4). The procedural and clinical success rates were comparable through DRA vs. PRA (p = 0.6), moreover, the 12-months rate of MACCE was similar across the 2 groups (9.09% vs. 18.2%, p = 0.35).ConclusionUsing DRA for complex CTO interventions is safe, feasible, lowers radiation dose and makes dual radial access more achievable. At the same time, there was no signal of increased risk of periprocedural or long-term adverse outcomes.

Aims We aimed to assess the effect of cardiac resynchronization on left ventricular (LV) function, volumes, geometry, and mechanics in order to demonstrate reverse remodelling using cardiac magnetic resonance (CMR) with resynchronization on. Methods and results New York Heart Association (NYHA) Class II–III patients on optimal medical therapy with LV ejection fraction (LVEF) ≤35%, and complete LBBB with broad QRS (>150 ms) were prospectively recruited. Cardiac magnetic resonance examination was performed at baseline and at 6-month follow-up, applying both biventricular and AOO pacing. The following data were measured: conventional CMR parameters, remodelling indices, global longitudinal, circumferential, radial strain, global dyssynchrony [mechanical dispersion (MD) defined as the standard deviation of time to peak longitudinal/circumferential strain in 16 LV segments], and regional dyssynchrony (maximum differences in time between peak septal and lateral transversal displacement). Thirteen patients (64 ± 7 years, 38% male) were enrolled. Comparing the baseline and follow-up CMR parameters measured during biventricular pacing, significant increase in LVEF, and decrease in LV end-diastolic volume index (LVEDVi) and LV end-systolic volume index (LVESVi) were found. Left ventricular remodelling indices, global longitudinal, circumferential, and radial strain values showed significant improvement. Circumferential MD decreased (20.5 ± 5.5 vs. 13.4 ± 3.4, P < 0.001), while longitudinal MD did not change. Regional dyssynchrony drastically improved (362 ± 96 vs. 104 ± 66 ms, P < 0.001). Applying AOO pacing resulted in an immediate deterioration in LVEF, LVESVi, circumferential strain, global and regional dyssynchrony. Conclusion Cardiac magnetic resonance imaging during biventricular pacing is feasible and enables a more precise quantification of LV function, morphology, and mechanics. As a result, it may contribute to a better understanding of the effects of resynchronization therapy and might improve responder rate in the future.

Aims The aim of this study is to provide a thorough, quantified assessment of the substernal space as the site of extravascular implantable cardioverter-defibrillator (ICD) lead placement using computed tomography (CT) scans and summarizing adverse events and defibrillation efficacy across anatomical findings. Subcutaneous ICDs are an alternative to transvenous defibrillators but have limitations related to ICD lead distance from the heart. An alternative extravascular system with substernal lead placement has the potential to provide defibrillation at lower energy and pacing therapies from a single device. Methods and results A multi-centre, non-randomized, retrospective analysis of 45 patient CT scans quantitatively and qualitatively assessing bony, cardiac, vascular, and other organ structures from two human clinical studies with substernal lead placement. Univariate logistic regression was used to evaluate 15 anatomical parameters for impact on defibrillation outcome and adjusted for multiple comparisons. Adverse events were summarized. Substernal implantation was attempted or completed in 45 patients. Defibrillation testing was successful in 37 of 41 subjects (90%) using ≥10 J safety margin. There were two intra-procedural adverse events in one patient, including reaction to anaesthesia and an episode of transient atrial fibrillation during ventricular fibrillation induction. Anatomical factors associated with defibrillation failure included large rib cage width, myocardium extending very posteriorly, and a low heart position in the chest (P-values &lt;0.05), though not significant adjusting for multiple comparisons. Conclusion Retrospective analysis demonstrates the ability to implant within the substernal space with low intra-procedural adverse events and high defibrillation efficacy despite a wide range of anatomical variability.

Aims Clinical effects of rate-adaptive pacing in heart failure patients with chronotropic incompetence (CI) undergoing cardiac resynchronization therapy (CRT) remain unclear. Closed loop stimulation (CLS) is a new rate-adaptive sensor in CRT devices. We evaluated the effectiveness of CLS in CRT patients with severe CI, focusing primarily on key prognostic variables assessed by cardiopulmonary exercise (CPX) testing. Methods and results In the randomized, crossover, multicentre BIO|CREATE study, 20 CRT patients with severe CI and NYHA Class II/III (60%/40%) were randomized 1:1 to the sequence DDD-40 mode to DDD-CLS mode, or the sequence DDD-CLS mode to DDD-40 mode (1 month in each mode). Patients underwent symptom-limited treadmill-based CPX test in each mode. An improvement (decrease) of the ventilatory efficiency (VE) slope of ≥5% during CLS was regarded as positive response to CLS. Seventeen patients with full data sets had a mean intra-individual VE slope change of −1.8 ± 3.0 (−4.1%) with CLS (P = 0.23). Eight patients (47%) were CLS responders, with a −6.1 ± 2.7 (−16.4%) slope change (P = 0.029). Compared to non-responders, CLS responders had a higher left ventricular (LV) ejection fraction (46 ± 3 vs. 36 ± 9%; P = 0.0070), smaller end-diastolic LV volume (121 ± 34 vs. 181 ± 41 mL; P = 0.0085), smaller end-systolic LV volume (65 ± 23 vs. 114 ± 39 mL; P = 0.0076), and were predominantly in NYHA Class II (P = 0.0498). Conclusion The data of the present pilot study are compatible with the notion that CLS activation may improve VE slope in CRT patients with severe CI and less advanced heart failure. Further research is needed to determine the long-term clinical outcomes of CLS.