New insertable cardiac monitors show high diagnostic yield and good safety profile in real-world clinical practice. results from the international prospective observational SMART Registry

Aims: Insertable cardiac monitors (ICMs) are indicated for long-term monitoring of unexplained syncope or palpitations, and for detection of bradycardia, ventricular tachycardia, and/or atrial fibrillation (AF). The aim of our study was to evaluate the safety and clinical value associated with a new generation ICM (Confirm Rx™, Abbott, Illinois, USA), featuring a new remote monitoring system based on smartphone patient applications. Methods and results: The SMART Registry is an international prospective observational study. The main endpoints were ICM safety (incidence of serious adverse device and procedure-related events (SADEs) at 1 month), ICM clinical value (incidence of device-detected true arrhythmias and of clinical diagnoses and interventions), and patient-reported experience measurements (PREMs). A total of 1400 subjects were enrolled. ICM indications included syncope (49.1%), AF (18.8%), unexplained palpitations (13.6%), risk of ventricular arrhythmia (6.6%), and cryptogenic stroke (6.0%). Freedom from SADEs at 1 month was 99.4% (95% Confidence Interval: 98.8-99.7%). In the 6-month monitoring period, the ICM detected true cardiac arrhythmias in 45.7% of patients and led to clinical interventions in a relevant proportion of patients; in particular, a pacemaker implant was performed after bradycardia detection in 8.9% of subjects who received an ICM for syncope and oral anticoagulation therapy was indicated after AF detection in 15.7% of subjects with cryptogenic stroke. PREMs showed that 78.2% of subjects were satisfied with the remote monitoring patient app. Conclusion: The evaluated ICM is associated with an excellent safety profile and high diagnostic yield. Patients reported positive experiences associated with the use of their smartphone for the device remote monitoring

176-71: Insights into electrical delay between right and left ventricular leads in cardiac resynchronization therapy patients: effect of right ventricular pacing vs. normal sinus rhythm

Purpose: The nature and significance of electrical delay between right (RV) and left ventricular (LV) pacing leads are poorly understood. We evaluated differences in RV-LV electrical delay and LV activation pattern along a quadripolar LV lead during RV pacing (RVP) and normal sinus rhythm (NSR). Methods: Electrical delays between the RV and all 4 poles of the LV lead (D1, M2, M3, and P4, distal to proximal) were measured during RVP and NSR in 234 pts (73% male, 46% ischemic, QRS 155 ms, 68 ± 12 yrs) receiving a CRT implant with a quadripolar lead. The activation pattern was defined by the order of earliest to latest LV electrode activation, either sequential distal-to-proximal, or sequential proximal-to-distal, or non-sequential. Results: The average RV-LV electrical delay was significantly longer during RVP than NSR (each p ≤ 0.001, Fig A). The latest activating electrode was frequently D1 or P4 during both RVP (D1: 27%, P4: 51%) and NSR (D1: 30%, P4: 40%) (Fig B), while the earliest activating electrode was most frequently D1 for both RVP (61%) and NSR (56%) (Fig C). A non-sequential activation pattern was observed in 100/234 (43%) patients during RVP and 112/234 (48%) during NSR (Fig D). A difference in activation pattern between RVP and NSR was observed in 190/234 (81%) patients. RVP produced greater electrical delay between the latest and earliest activating LV electrodes than NSR (27 ± 21 vs. 21 ± 13 ms, p \u3c0.001). Conclusion: Activation pattern along a quadripolar LV lead was frequently different between RV pacing and normal sinus rhythm, with RV pacing producing greater delay between early and late sites. These results may have important implications for using conduction delays to optimize CRT programming with a quadripolar LV lead

MultiPole pacing in non-responders to cardiac resynchronization therapy: Results from the QP ExCELs/MPP sub-study

BACKGROUND: Multisite LV stimulation therapy allows for stimulation of two different left ventricular pacing vectors within a single LV lead and may improve responsiveness to cardiac resynchronization therapy (CRT). This study prospectively evaluated the safety and efficacy of the MultiPole Pacing (MPP) feature in CRT non-responder patients. METHODS AND RESULTS: CRT non-responders with a standard CRT-D indication were eligible for enrollment into the MPP Sub-Study. Patient status, NYHA classification, Patient Global Assessment (PGA), and adverse events were collected at follow-up. A clinical composite score (CCS) was determined at the 6 month follow-up visit. The primary objective was defined as the proportion of patients with an improved CCS. Safety was evaluated as freedom from MPP system related adverse events requiring additional invasive intervention to resolve. A total of 53 patients were enrolled across 26 U.S. centers. The cumulative follow-up duration was 24.1 years. CCS was improved in 35.6% of patients (p \u3c .0001 when compared to a performance goal of 3%) after 6 months of MPP therapy. When incorporating patient feedback into a modified CCS, 60.0% of patients showed an improvement. Three patients (5.7%) experienced hospitalization for heart failure, and three patient deaths occurred over the follow-up period. No MPP system-related events were reported for an AE-free rate of 100% (95% CI 93.28% to 100.0%). CONCLUSIONS: The results of this small, non-randomized study suggest that the MPP feature is safe, and may be effective at converting a percentage of CRT non-responders to responders. Larger, randomized studies are needed to confirm this result

Smartphone-based cardiac implantable electronic device remote monitoring: improved compliance and connectivity.

Remote monitoring (RM) is the standard of care for follow up of patients with cardiac implantable electronic devices. The aim of this study was to compare smartphone-based RM (SM-RM) using patient applications (myMerlinPulse™ app) with traditional bedside monitor RM (BM-RM).info:eu-repo/semantics/publishe

Ventricular activation patterns during intrinsic conduction and right ventricular pacing in cardiac resynchronization therapy patients

International audienceBackground Cardiac resynchronization therapy (CRT) involves stimulation of both right ventricle (RV) and left ventricle (LV). LV pacing from the sites of delayed electrical activation improves CRT response. The RV-LV conduction is typically measured in intrinsic rhythm. The differences in RV-LV conduction patterns and timing between intrinsic rhythm and during paced RV activation, these differences are not fully understood. Methods Enrolled patients were implanted with a de novo CRT device and quadripolar LV lead, with lead implant locations at the implanting physician's discretion. QRS duration and conduction delay between the RV lead and each of the four LV electrodes (D1, M2, M3, and P4) were measured during intrinsic conduction and RV pacing. Results Conduction measurements were collected from 275 patients across 14 international centers (68 +/- 13 years of age, 73% male, 45% ischemic, 158 +/- 22 ms QRS duration). Mean RV-LV conduction time was shorter during intrinsic conduction versus RV pacing by 59.6 ms (106.5 +/- 36.5 versus 166.1 +/- 32.1 ms, p < 0.001). The intra-LV activation delay between the latest and earliest activating LV electrode was also shorter during intrinsic conduction versus RV pacing by 6.6 ms (20.6 +/- 13.1 vs. 27.2 +/- 21.2 ms, p < 0.001). Intrinsic conduction and RV pacing resulted in a different activation order in 72.7% of patients, and the same LV activation order in 27.3%. Conclusions Differences in RV-LV conduction time, intra-LV conduction time, and activation pattern were observed between intrinsic conduction and RV pacing. These findings highlight the importance of evaluating intrinsic versus paced ventricular activation to guide LV pacing site selection in CRT patients

Antibacterial Envelope to Prevent Cardiac Implantable Device Infection

Background Infections after placement of cardiac implantable electronic devices (CIEDs) are associated with substantial morbidity and mortality. There is limited evidence on prophylactic strategies, other than the use of preoperative antibiotics, to prevent such infections. Methods We conducted a randomized, controlled clinical trial to assess the safety and efficacy of an absorbable, antibiotic-eluting envelope in reducing the incidence of infection associated with CIED implantations. Patients who were undergoing a CIED pocket revision, generator replacement, or system upgrade or an initial implantation of a cardiac resynchronization therapy defibrillator were randomly assigned, in a 1:1 ratio, to receive the envelope or not. Standard-of-care strategies to prevent infection were used in all patients. The primary end point was infection resulting in system extraction or revision, long-term antibiotic therapy with infection recurrence, or death, within 12 months after the CIED implantation procedure. The secondary end point for safety was procedure-related or system-related complications within 12 months. Results A total of 6983 patients underwent randomization: 3495 to the envelope group and 3488 to the control group. The primary end point occurred in 25 patients in the envelope group and 42 patients in the control group (12-month Kaplan-Meier estimated event rate, 0.7% and 1.2%, respectively; hazard ratio, 0.60; 95% confidence interval [CI], 0.36 to 0.98; P=0.04). The safety end point occurred in 201 patients in the envelope group and 236 patients in the control group (12-month Kaplan-Meier estimated event rate, 6.0% and 6.9%, respectively; hazard ratio, 0.87; 95% CI, 0.72 to 1.06; P<0.001 for noninferiority). The mean (+/- SD) duration of follow-up was 20.7 +/- 8.5 months. Major CIED-related infections through the entire follow-up period occurred in 32 patients in the envelope group and 51 patients in the control group (hazard ratio, 0.63; 95% CI, 0.40 to 0.98). Conclusions Adjunctive use of an antibacterial envelope resulted in a significantly lower incidence of major CIED infections than standard-of-care infection-prevention strategies alone, without a higher incidence of complications