Real-world Characterization and Use of Insertable Cardiac Monitor Remote Programming.

Remote device programming may enable workflow efficiencies and reduce resource strains on clinics as well as patients. Although the remote patient management ecosystem has evolved, several challenges remain, and the role of remote device programming for an insertable cardiac monitor (ICM) has yet to be described in a real-world setting. The purpose of this study was to characterize the initial real-world use of remote programming of an ICM. The cohort included 8,238 patients with the LUX-Dx™ ICM (Boston Scientific, Marlborough, MA, USA) during the first year of commercial use, which is also the first year that remote programming was available for an ICM. A descriptive review of reprogramming events revealed that 24% of devices were reprogrammed and that 82% of all reprogramming events occurred remotely. Over 74% of first reprogramming events occurred within the first 30 days following device insertion, and nearly 80% of devices only had 1 reprogramming event. These early data support the hypothesis that remote programming of an ICM is a clinically useful tool that may improve the clinical experience of device programming optimization, especially within the first month following device insertion.

A new algorithm to reduce inappropriate therapy in the S-ICD system.

INTRODUCTION: The subcutaneous ICD system (S-ICD) has been shown to be a safe and effective treatment for patients at risk for sudden cardiac death. This device reliably detects ventricular tachyarrhythmias with a low incidence of inappropriate shocks for supraventricular arrhythmias. However, T-wave oversensing (TWOS) is more common with the S-ICD compared with transvenous systems. We developed a novel discrimination algorithm to reduce TWOS without compromising tachyarrhythmia discrimination. METHODS AND RESULTS: The algorithm was developed using a database of recorded episodes, including 244 appropriate therapies for ventricular arrhythmias and 133 episodes with an inappropriate detection due to TWOS, and using a computer model that simulates the S-ICD system. An independent set of data of 161 TWOS episodes, 137 ventricular and 328 supraventricular episodes, was used to validate the algorithm on actual device hardware. The S-ICD performance with the new algorithm was compared with the S-ICD without the new algorithm. Development results showed a decrease in inappropriate charge due to TWOS by 30.7 ± 18%. All ventricular arrhythmias were appropriately detected and the time to appropriate charge initiation was not increased. System validation showed that the new algorithm avoided an inappropriate charge due to TWOS by 39.8 ± 11.4%. No decrease in ventricular arrhythmia sensitivity and no significant change in supraventricular specificity were observed. CONCLUSIONS: A new algorithm that uses correlation of the existing complex to previous complexes reduced TWOS episodes by approximately 40%. The algorithm has potential for a clinically meaningful decrease in inappropriate shocks.

Acute and chronic response to CRT in narrow QRS patients.

Previous studies suggest that CRT may benefit narrow QRS patients with mechanical dyssynchrony (MD). We conducted an acute and chronic study, evaluating the response of heart failure patients with a narrow QRS to cardiac resynchronization therapy (CRT). ESTEEM-CRT was a multi-center, single-arm, feasibility study that evaluated ICD-indicated, medically-optimized patients with EF ≤ 35%, NYHA class III heart failure, QRS duration <120 ms, and MD as defined by the standard deviation of time to peak systolic velocity of 12 segments (Ts-SD). Sixty-eight patients received a CRT defibrillator, exercise testing, and echo exams, and 47 of these patients underwent invasive hemodynamic testing at implant. Follow-up was at 6 and 12 months. The average maximal improvement in LV dP/dt(max) was minor (2 ± 2%). NYHA and quality of life scores were substantially improved at 6 and 12 months (P < 0.001), while exercise capacity and LV volumes were unchanged. The echo indices of MD were difficult to collect, discordant, and failed to predict clinical outcomes. ESTEEM-CRT patients with a narrow QRS and MD as defined in this study did not improve as measured by acute hemodynamics, chronic exercise performance, or reverse remodeling. These multi-center results support the notion that dyssynchrony indices are ineffective or at least require greater refinement for the selection of narrow QRS patients for CRT.

Glycated collagen cross-linking alters cardiac mechanics in volume-overload hypertrophy.

Alteration of hemodynamic loading induces remodeling that includes changes in myocardial properties and extracellular matrix structure. We investigated the hypothesis that cardiac hypertrophy due to volume overload produces changes in myocardial diastolic mechanics and stiffness that are in part due to alterations in advanced glycation end-product (AGE) collagen cross-linking. Rats developed volume overload induced by arteriovenous fistula (AVF). To assess the dependence of AGE cross-linking on mechanics, we prevented AGE formation by administering the drug aminoguanidine (AG) to one group of AVF rats (AG+AVF). Volume overload did not modify collagen concentration. Right ventricular AGE cross-links were modestly elevated in AVF hearts but were significantly reduced by AG. AVF rats exhibited significantly increased septal AGE cross-links that were inhibited in the AG+AVF group. AVF-induced increases in left ventricular longitudinal stiffness and septal circumferential stiffness were prevented in AG+AVF hearts. Volume overload appears to regionally modify AGE collagen cross-linking and stiffness, and AG treatment prevented these increases, demonstrating that AGE cross-linking plays a role in mediating diastolic compliance in volume-overload hypertrophy.