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.

Real-world performance of the atrial fibrillation monitor in patients with a subcutaneous ICD.

INTRODUCTION: The third-generation subcutaneous implantable cardioverter-defibrillator (S-ICD) (EMBLEM™ A219, Boston Scientific) contains a new diagnostic tool to detect atrial fibrillation (AF) in S-ICD patients, without the use of an intracardiac lead. This is the first study to evaluate the performance of the S-ICD AF monitor (AFM). METHODS: The AFM algorithm analyzes a subcutaneous signal for the presence of AF, similar to the signals collected by implantable and wearable diagnostic devices. The AFM algorithm combines heart rate (HR) scatter analysis with an HR histogram. The algorithm was tested against publicly available electrocardiogram databases (simulated performance). Real-world performance of the algorithm was evaluated by using the S-ICD LATITUDE remote monitoring (RM) database. RESULTS: The simulated performance of the AFM algorithm resulted in a sensitivity of 95.0%, specificity of 100.0%, and positive predictive value (PPV) of 100.0%. To evaluate the real-world performance of the AFM, 7744 S-ICD devices were followed for up to 30 months by RM, whereof 99.5% had the AFM enabled. A total of 387 AF episodes were randomly chosen for adjudication, resulting in a PPV of 67.7%. The main cause of misclassification was atrial and ventricular ectopy. CONCLUSION: The AFM exhibited a very high sensitivity and specificity in a simulated setting, designed to maximize PPV in order to minimize the clinical burden of reviewing falsely detected AF events. The real-world performance of the AFM, enabled in 99.5% of S-ICD patients, is a PPV of 67.7%.

Comparative evaluation of the effect of surface treatment of fiber-reinforced posts and prefabricated metal posts on adhesion of a resin-based luting cement: An in vitro study.

BACKGROUND: The purpose of this study was to evaluate the effect of surface treatment of fiber-reinforce post and metal post of adhesion of a resin luting cement. MATERIALS AND METHODS: Sixty methyl methacrylate specimens were fabricated with a customized metal rod. The samples were segregated into six groups (F1, F2, F3, M1, M2, and M3) of 10 specimens (n = 10) each. The first three groups (F1, F2, and F3) were for fiber posts and (M1, M2, and M3) were for metal posts. The postspace preparation was done with dedicated drills supplied by the postmanufacturers to a length of 14 mm. F1 and M1 were the control groups. The posts in F2 and M2 groups were treated with airborne-particle abrasion with 70 µm Al2O3 particles for 5 s at a constant distance of 20 mm, cleaned with alcohol and cemented in the postspace. The posts in the F3 and M3 groups were treated with airborne-particle abrasion followed by primer application. After cementing the posts into the postspace, the acrylic blocks were sectioned with a motor-driven jigsaw to obtain four specimens each of 3-mm thickness. These sections were then subjected to push-out tests on a universal testing machine. RESULTS: There was a statistically significant increase in the bond strength of both fiber and metal posts to resin cement after airborne-particle abrasion with Al2O3 particles and airborne abrasion followed by primer application. CONCLUSION: There is an increase in the bond strength of the resin cement with the prefabricated posts after the various surface treatments.

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.

Performance of an automatic arrhythmia classification algorithm: comparison to the ALTITUDE electrophysiologist panel adjudications.

INTRODUCTION: Adjudication of thousands of implantable cardioverter defibrillator (ICD)-treated arrhythmia episodes is labor intensive and, as a result, is most often left undone. The objective of this study was to evaluate an automatic classification algorithm for adjudication of ICD-treated arrhythmia episodes. METHODS: The algorithm uses a machine learning algorithm and was developed using 776 arrhythmia episodes. The algorithm was validated on 131 dual-chamber ICD shock episodes from 127 patients adjudicated by seven electrophysiologists (EPs). Episodes were classified by panel consensus as ventricular tachycardia/ventricular fibrillation (VT/VF) or non-VT/VF, with the resulting classifications used as the reference. Subsequently, each episode electrogram (EGM) data was randomly assigned to three EPs without the atrial lead information, and to three EPs with the atrial lead information. Those episodes were also classified by the automatic algorithm with and without atrial information. Agreement with the reference was compared between the three EPs consensus group and the algorithm. RESULTS: The overall agreement with the reference was similar between three-EP consensus and the algorithm for both with atrial EGM (94% vs 95%, P = 0.87) and without atrial EGM (90% vs 91%, P = 0.91). The odds of accurate adjudication, after adjusting for covariates, did not significantly differ between the algorithm and EP consensus (odds ratio 1.02, 95% confidence interval: 0.97-1.06). CONCLUSIONS: This algorithm performs at a level comparable to an EP panel in the adjudication of arrhythmia episodes treated by both dual- and single-chamber ICDs. This type of algorithm has the potential for automated analysis of clinical ICD episodes, and adjudication of EGMs for research studies and quality analyses.

Hysteroscopic treatment of symptomatic submucous fibroids using a bipolar intrauterine system: a feasibility study.

OBJECTIVE: To determine the feasibility (safety, potential efficacy and cost effectiveness) of a miniature endoscopic bipolar electrosurgical intrauterine system in the treatment of symptomatic submucous fibroids. STUDY DESIGN: A total of 37 women with symptomatic submucous fibroids were identified on outpatient hysteroscopy. All underwent hysteroscopic excision or ablation using a bipolar intrauterine system (Versapoint). The main outcomes measures were change in uterine bleeding symptoms measured on a continuous and ordinal scale, patient satisfaction, time of work and use of health service resources at 6 months following treatment. RESULTS: 36/37 (97%) women returned completed outcome questionnaires. The mean amount of abnormal uterine bleeding was reduced at 6 months compared to immediately prior to treatment (P=0.0001). Improvement in bleeding symptoms was reported by 28/36 (78%) women and satisfaction with treatment by 33/36 (92%) women. All procedures were successfully completed, there were no serious operative complications and at 6 months no repeat hysteroscopic procedures were necessary. The mean cost of diagnosis and treatment of submucous fibroids using an endoscopic bipolar intrauterine system was 40% cheaper at 6 months follow-up than a hysterectomy or open myomectomy ( pound 1266 versus pound 2123). CONCLUSION: Hysteroscopic treatment of symptomatic submucous fibroids appears to be safe, efficacious and cost effective. It seems feasible to launch a randomised controlled trial to confirm these provisional results in both the short and longer term.