Subclinical atrial fibrillation (AF) is associated with increased risk of progression to clinical AF, stroke, and cardiovascular death. We hypothesized that in pacemaker patients requiring dual-chamber rate-adaptive (DDDR) pacing, closed loop stimulation (CLS) integrated into the circulatory control system through intra-cardiac impedance monitoring would reduce the occurrence of atrial high-rate episodes (AHREs) compared with conventional DDDR pacing. Patients with sinus node dysfunctions (SNDs) and an implanted pacemaker or defibrillator were randomly allocated to dual-chamber CLS (n = 612) or accelerometer-based DDDR pacing (n = 598) and followed for 3 years. The primary endpoint was time to the composite endpoint of the first AHRE lasting ≥6 min, stroke, or transient ischaemic attack (TIA). All AHREs were independently adjudicated using intra-cardiac electrograms. The incidence of the primary endpoint was lower in the CLS arm (50.6%) than in the DDDR arm (55.7%), primarily due to the reduction in AHREs lasting between 6 h and 7 days. Unadjusted site-stratified hazard ratio (HR) for CLS vs. DDDR was 0.84 [95% confidence interval (CI), 0.72–0.99; P = 0.035]. After adjusting for CHA₂DS₂-VASc score, the HR remained 0.84 (95% CI, 0.71–0.99; P = 0.033). In subgroup analyses of AHRE incidence, the incremental benefit of CLS was greatest in patients without atrioventricular block (HR, 0.77; P = 0.008) and in patients without AF history (HR, 0.73; P = 0.009). The contribution of stroke/TIA to the primary endpoint (1.3%) was low and not statistically different between study arms. Dual-chamber CLS in patients with SND is associated with a significantly lower AHRE incidence than conventional DDDR pacing.

Background: During the COVID‐19 pandemic in‐person visits for patients with cardiac implantable electronic devices should be replaced by remote monitoring (RM), in order to prevent viral transmission. A direct home‐delivery service of the RM communicator has been implemented at 49 Italian arrhythmia centers.Methods: According to individual patient preference or the organizational decision of the center, patients were assigned to the home‐delivery group or the standard in‐clinic delivery group. In the former case, patients received telephone training on the activation process and use of the communicator. In June 2020, the centers were asked to reply to an ad hoc questionnaire to describe and evaluate their experience in the previous 3 months.Results: RM was activated in 1324 patients: 821 (62%) received the communicator at home and the communicator was activated remotely. Activation required one additional call in 49% of cases, and the median time needed to complete the activation process was 15 min [25th‐75th percentile: 10–20]. 753 (92%) patients were able to complete the correct activation of the system. At the time when the questionnaire was completed, 743 (90%) communicators were regularly transmitting data. The service was generally deemed useful (96% of respondents) in facilitating the activation of RM during the COVID‐19 pandemic and possibly beyond.Conclusions: Home delivery of the communicator proved to be a successful approach to system activation, and received positive feedback from clinicians. The increased use of a RM protocol will reduce risks for both providers and patients, while maintaining high‐quality care.

This study aimed to compare the peri-procedural success and complication rate within a large registry of intra-cardiac echocardiography (ICE)- vs. transesophageal echocardiography (TEE)-guided left atrial appendage occlusion (LAAO) procedures with a Watchmann FLX device. Data from 772 LAAO procedures, performed at 26 Italian centers, were reviewed. Technical success was considered as the final implant of a Watchmann FLX device in LAA; the absence of pericardial tamponade, peri-procedural stroke and/or systemic embolism, major bleeding and device embolization during the procedure was defined as a procedural success. One-year stroke and major bleeding rates were evaluated as outcome. ICE-guided LAA occlusion was performed in 149 patients, while TEE was used in 623 patients. Baseline characteristics were similar between the ICE and TEE groups. The technical success was 100% in both groups. Procedural success was also extremely high (98.5%), and was comparable between ICE (98.7%) and TEE (98.5%). ICE was associated with a slightly longer procedural time (73 ± 31 vs. 61.9 ± 36 min, p = 0.042) and shorter hospital stay (5.3 ± 4 vs. 5.8 ± 6 days, p = 0.028) compared to the TEE group. At one year, stroke and major bleeding rates did not differ between the ICE and TEE groups. A Watchmann FLX device showed high technical and procedural success rate, and ICE guidance does not appear inferior to TEE.

BACKGROUND: The role of atrial pacing support is unclear in patients receiving cardiac resynchronization therapy–defibrillator (CRT-D) without sinus node dysfunction. METHODS: We conducted a randomized, parallel-group, noninferiority trial to evaluate whether a 2-lead CRT-D capable of atrial sensing (but no pacing) by a floating dipole on the right ventricular lead (CRT-DX) is not inferior to a 3-lead CRT-D with a conventional atrial lead. Between October 17, 2018, and March 5, 2024, a total of 636 patients (68±10 years old, 28.6% women) with standard CRT-D indication, optimized medical therapy, and resting sinus rate ≥45 beats/min were randomized 1:1 to CRT-DX (atrial tracking without atrial pacing mode 35 beats/min) or CRT-D (atrial tracking with atrial pacing mode 50 beats/min) at 23 Italian sites. A centralized block-randomization procedure stratified by site was used, with patients and primary outcome assessors blinded to treatment assignment. The primary end point was a 1-year composite of all-cause mortality, cardiovascular hospitalization, and lead-related complications (loss of functionality not correctable by device reprogramming). Secondary end points included each individual component of the primary end point separately, echocardiographic reverse remodeling, and 6-minute walk test distance at 12 months. RESULTS: The primary end point occurred in 41 (13.1%) patients in the CRT-DX group and 47 (15.6%) patients in the CRT-D group, corresponding to a hazard ratio of 0.82 (95% CI, 0.54–1.25). This confirmed noninferiority (prespecified relative margin of 1.20) in both the per-protocol ( P =0.039) and intention-to-treat ( P =0.044) analyses. Individual components showed no significant differences, except for lead complications related to right atrial functionality (4 [1.3%] patients in the CRT-DX group versus 13 [4.2%] patients in the CRT-D group; P =0.040). Reverse remodeling responders were 203 (77.5% of 262) patients receiving CRT-DX and 190 (76.3% of 249) patients receiving CRT-D ( P =0.83). Walking distance did not differ between 2 study arms (404 versus 398 m; P =0.62). After a median follow-up of 2.4 years, only 1 patient receiving CRT-DX required implantation of a standard atrial lead. CONCLUSIONS: The 2-lead CRT-DX system without atrial pacing is noninferior to conventional 3-lead CRT-D, with fewer atrial lead–related complications. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT03587064.

Aims: International guidelines recommend specific antithrombotic strategies for acute myocardial infarction (AMI) patients undergoing percutaneous coronary intervention (PCI). However, real-world practice often diverges. This study aimed to assess antithrombotic therapy use in AMI patients admitted to cardiac care units (CCUs) across Italy. Methods and results: The EmploYEd Antithrombotic Therapies in Patients with Acute Coronary Syndromes Hospitalized in Italian Cardiac Care Units (EYESHOT-2) registry (NCT06316128) is an Italian nationwide, prospective study evaluating AMI management, focusing primarily on PCI-treated patients. Between 1 and 29 February 2024, 2806 patients were enrolled across 183 Italian CCUs. Percutaneous coronary intervention was performed in 83.5% of cases, while 16.5% received conservative treatment. Patients not undergoing PCI were older, more often female, had more comorbidities, and were more frequently diagnosed with NSTEMI. Pre-treatment with dual antiplatelet therapy before angiography was administered in 58.4% of PCI-treated patients. In the cath lab, most received oral P2Y12 inhibitors post-procedure. In-hospital outcomes favoured PCI, with lower rates of mortality, re-infarction, and major bleeding. Independent predictors of in-hospital bleeding among PCI patients included older age [odds ratio (OR) 1.05, 95% confidence interval (CI) 1.03–1.07, P < 0.0001], prior bleeding (OR 2.38, 95% CI 1.02–5.59, P = 0.046), recent surgery (OR 3.47, 95% CI 1.28–9.42, P = 0.01), Killip class III/IV (OR 1.75, 95% CI 1.00–3.05, P = 0.049), and femoral access (OR 2.85, 95% CI 1.80–4.49, P < 0.0001), while, among patients treated conservatively, included history of anaemia (OR 4.83, 95% CI 2.24–10.41, P < 0.0001) and peripheral vascular disease (OR 2.75, 95% 1.24–6.12, P = 0.01). Conclusion: This nationwide registry highlights improvements in AMI care in Italy but reveals persistent discrepancies between guideline-recommended and actual practice, underscoring the need for broader adoption of evidence-based strategies. Registration: URL: http://www.clinicaltrials.gov. NCT06316128.