Remote-control Interrogation, Testing, and Reprogramming of Cardiac Implantable Electronic Devices with Telehealth Protocol for the Management of Patients at Home: The DOMUM REMOTUS Study.

Remote control (RC) of cardiac implantable electronic devices (CIEDs) has been tested as safe and effective in the magnetic resonance imaging space. We sought to evaluate RC applications of patients at home. RC of cardiac devices in patients' homes is feasible, safe, and effective, with consistent patient satisfaction. Patients with CIEDs using the CareLink™ network (Medtronic, Minneapolis, MN, USA) participated in a pair of home RC sessions. A technician visited the patient's house and set up a telehealth tablet and a programmer, which included inputting a session key enabling programmer access via a third-party host. The investigator video-conferenced with the patient and remotely controlled the programmer for device testing and data assessment, using a cellular hotspot for Internet connection. Reprogramming was performed as necessary. In all cases, an RC session legend was programmed in the device information field as a control. The patients then completed an experience questionnaire. One hundred fifty patients (99 pacemakers and 51 implantable cardioverter-defibrillators) completed 2 RC sessions, for 300 RC sessions in total. There were no complications or communication interruptions once the system communication proved stable after the first minute. In 26 sessions, initial communication was interrupted upon device interrogation, requiring communication to be re-established (which sometimes necessitated switching to an alternative carrier). Clinically driven parameter reprogramming was performed in 58 RC sessions (39%). Programming of notations concerning RC sessions was performed in all 300 sessions. The average duration of the RC sessions was 11 min. Patients' satisfaction scored 4.5 out of 5 points. In conclusion, RC management of cardiac devices at patients' homes is safe, effective, convenient, and associated with high patient satisfaction. This technology may prove very useful in a changing health care delivery system, especially amid the coronavirus disease 2019 pandemic.

Incidental Cardiac Computed Tomography Findings in Patients Undergoing Atrial Fibrillation Catheter Ablation.

BACKGROUND: Catheter ablation (CA) is an effective technique for the management of atrial fibrillation (AF). Cardiac computed tomography (CCT) is a non-invasive imaging modality that is used as a crucial part of planning before CA procedures which can detect other incidental findings and require further diagnostic investigations. OBJECTIVES: We sought to assess the prevalence and distribution of incidental CCT findings in patients with AF undergoing CA. METHODS: Retrospective analysis over a three-year period (2013-2016) of 218 patients undergoing CCT prior to AF CA. CCT findings were analyzed and incident clinically important findings were reported. RESULTS: Over the three-year period, 218 patients had undergone CCT. Of these, 28.8% showed clinically significant incidental findings in the chest and upper abdomen. Incidental findings included coronary artery disease (CAD), incomplete cor triatriatum, pericardial effusion, pleural effusion, pulmonary nodules, pulmonary infiltrates, pulmonary mass, thoracic aortic aneurysm, mediastinal nodes, abdominal mass, and liver nodules. CONCLUSIONS: CCT is a cornerstone investigation prior to AF CA and can show multiple incidental findings, thus potentially functioning as a screening method for the detection of other significant conditions. There is still a debate whether further workup is needed or not as most findings will eventually be benign and further investigations could mean financial burden and clinical risks to the patients. Further larger prospective studies are needed with long-term follow-up to determine whether incidental findings on CCT have an impact on the long-term outcomes of patients.

Treatment of Cryptogenic Stroke Patients with Atrial Fibrillation Detected by Insertable Cardiac Monitors Reduces Recurrent Stroke Risk to Background Levels.

Atrial fibrillation (AF) is a known risk factor of ischemic stroke with a reported fivefold increase in incidence. However, it is not well established whether treatment with oral anticoagulation (OAC) in cryptogenic stroke patients with AF, detected by insertable cardiac monitors (ICMs), reduces the risk of recurrent stroke. We aimed to compare recurrent stroke rates between cryptogenic stroke patients who have AF detected by ICMs and thus started on OAC treatment and those without detected AF. We performed a combined retrospective and prospective analysis of consecutive patients who received an ICM indicated for cryptogenic stroke and were followed up with between July 2015 and November 2019. Patients with a prior documented history of AF were excluded. All patients were required to have a home remote monitoring system. We calculated the rates of AF detection and OAC initiation, then compared recurrent annualized stroke rates (ASRs) between patients with and without AF detected. A total of 298 patients with ICMs were included in the study [mean ± standard deviation age: 77 ± 11.7 years; female/male: 147/151; virtual CHA2DS2-VASc score: 4.96 ± 1.28 points]. AF was discovered in 91 patients (~30%) over a mean 19.3 months follow-up. Of those, 65 (71.4%) were started on OAC, 12 (13.2%) were already on OAC, and 10 (11%) remained non-anticoagulated. In four (4.4%) patients, OAC was started after recurrent stroke when AF was diagnosed. A total of 24 of 298 patients developed recurrent strokes (ASR: 5.0%). Among the 24 patients with recurrent strokes, four had new AF and were on OAC (ASR: 3.23%), six had new AF and were not anticoagulated (ASR: 26.62%), and 14 had no AF detected and no OAC (ASR: 4.20%). Our study found new AF detected by ICMs in almost one-third (30%) of cryptogenic stroke patients (consistent with previous studies), and the majority of them (89%) received OACs. There was no significant difference in the recurrent stroke rate among patients without AF detected and those with AF detected and on OAC. Rigorous arrhythmia monitoring using ICMs can increase new AF detection rates in cryptogenic stroke patients, thereby allowing early initiation of OACs, ultimately reducing the risk of recurrent stroke to background levels.

Impact of Remote Monitoring on Hospitalizations for Heart Failure: A Five-year Single-center Experience.

The impact of a provider-driven assessment and treatment algorithm based on remote OptiVol (Medtronic, Minneapolis, MN, USA) fluid index levels on hospitalizations for congestive heart failure (CHF) remains unknown. We implemented a physician-guided screening and educational strategy for elevated OptiVol fluid index levels measured on remote implantable cardioverter-defibrillator (ICD) monitoring and assessed clinical outcomes over a five-year period. Patients with CHF and a left ventricular ejection fraction (LVEF) of 40% or less with a previously implanted ICD underwent monthly remote monitoring from January 2015 to November 2019. An OptiVol fluid index of 60 Ω-days or more triggered a protocol-based CHF screening and therapy adjustment according to clinical presentation. Among 279 patients included in the study, 228 (81%) were male and 205 (73%) had ischemic cardiomyopathy. The average LVEF was 29% (± 7.3%). A total of 6,616 monthly transmissions were reviewed over five years; of those, 575 (8.7%) were associated with elevated OptiVol fluid index levels in 178 (64%) patients, and clinical follow-up data were available in 459 of 575 (80%) cases. Following abnormal OptiVol fluid levels on remote monitoring, CHF hospitalization occurred in 10 of 459 (2.2%) patient cases. In conclusion, monthly remote monitoring of OptiVol fluid index levels with a health care provider-guided CHF screening and an educational approach to abnormal OptiVol fluid index levels were associated with a low CHF hospitalization rate. This compared favorably to prior similar studies, and randomized controlled prospective studies evaluating similar algorithms are warranted.

Remote Control of Cardiac Implantable Electronic Devices: Exploring the New Frontier-First Clinical Application of Real-time Remote-control Management of Cardiac Devices Before and After Magnetic Resonance Imaging.

The purpose of the present study was to evaluate the performance of remote-control (RC) management of cardiac implantable electronic devices (CIEDs) in clinical practice using a new service model in patients undergoing magnetic resonance imaging (MRI) scans. The number of CIEDs is constantly growing, alongside the demands for prompt checks. Although remote CIED interrogation exists, ultimately, real-time remote management is the goal. In this study, patients with MRI-conditional devices suitable for RC interaction who required an MRI were enrolled. An onsite technician began the RC session by contacting the remote operator, applying the programmer wand, and keying in an access code. The device was remotely checked via encrypted Wi-Fi by an electrophysiologist using a laptop. An MRI-safe mode was programmed per a preestablished proprietary algorithm. Following the scan, patient devices were remotely reinterrogated and reprogrammed to baseline, with adjustments made as clinically necessary. Patients subsequently were asked to complete a survey. Ultimately, a total of 100 RC CIED reprogrammings were performed in 50 MRI sessions, prescan and postscan. The average RC time interaction was four minutes prescan and three minutes postscan, respectively. No complications occurred. Five patients had more than one MRI in this study and 15 patients had had previous MRIs. In eight patients, baseline settings were reprogrammed. Most patients (82%) were very satisfied, preferring device specialist remote management. Only 14 (32%) patients used home remote monitoring. In conclusion, RC management of CIEDs in the MRI setting is feasible, safe, and clinically relevant. Use of the MRI mode determination algorithm was safe, consistent, and efficient. Expanding RC in CIED management for service anytime, anywhere is the next challenge.

The Axillary Fossa: An Uncovered Hidden Site as a New Alternative for Cardiac Pacemaker and Defibrillator Implantation.

Inadequate thickness of subcutaneous tissue, pectoralis muscle wasting, and/or a lack of availability of subpectoral space can become significant issues in patients with or requiring cardiovascular implantable electronic devices (CIEDs). This is particularly concerning but not exclusive in the elderly population, who may experience discomfort and hypersensitivity of the site as well as the potential for erosion and an increased risk of infection. Thus, the use of an alternative location, the axillary fossa, offers several advantages that make it a suitable option. Specifically, it usually has a preserved fat pad (even in thin patients); is unperturbed by arm movement; is not directly exposed to contact; is easily accessed with no significant compromise of neurovascular structures; and is near the conventional subclavicular sites, with enough lead length to reach in case of the need for generator replacement. Here, we present a series of five patients, including details of their anatomy and the implant techniques used. Two underwent device replacements, with one of them presenting with significant ongoing site discomfort and the other with extreme tissue thinning, respectively. Two patients with no significant fat layer or pectoral muscle wasting had new pacemakers implanted. Lastly, a biventricular implantable cardioverter-defibrillator generator was reimplanted in a younger patient who had issues with protrusion and discomfort in the setting of thin subcutaneous tissue and the subpectoral space being occupied by a large breast implant. In conclusion, the use of the axillary fossa as a new alternative CIED implantation site, using the proposed implant technique, appears feasible and safe and demonstrated excellent results related to patient comfort and adequate device cover in five cases.

Is dual-chamber programming inferior to single-chamber programming in an implantable cardioverter-defibrillator? Results of the INTRINSIC RV (Inhibition of Unnecessary RV Pacing With AVSH in ICDs) study.

BACKGROUND: The INTRINSIC RV (Inhibition of Unnecessary RV Pacing with AVSH in ICDs) study tested the hypothesis that dual-chamber rate-responsive (DDDR) with atrioventricular search hysteresis (AVSH) 60-130 programming is not inferior to single-chamber (VVI)-40 programming in an implantable cardioverter defibrillator with respect to all-cause mortality and heart failure hospitalizations using an equivalence margin of 5%. METHODS AND RESULTS: At 108 centers, 1530 patients with an implantable cardioverter defibrillator indication received a VITALITY AVT (Guidant Corporation, St. Paul, Minn) implantable cardioverter defibrillator programmed consistently to DDDR AVSH 60-130 for the first week. Of those, 988 patients with <20% right ventricular pacing at 1 week were randomized to DDDR AVSH 60-130 or to VVI-40 programming. Among those randomized, 502 were assigned to DDDR AVSH and 486 to VVI. Groups were similar with regard to coronary disease (68%), gender (21% female), and New York Heart Association functional class >I (79%). A total of 32 patients (6.4%) in the DDDR AVSH arm and 46 patients (9.5%) in the VVI arm died or were hospitalized for heart failure during a mean follow-up of 10.4 months (relative risk=0.67, P=0.072 in favor of DDDR AVSH). DDDR AVSH was not inferior to VVI programming (P<0.001). All-cause mortality was not significantly different between the DDDR AVSH arm (3.6%) and the VVI arm (5.1%; P=0.23). The mean percent right ventricular pacing in the DDDR AVSH arm was 10% (median 4%) versus 3% (median 0%) in the VVI arm. CONCLUSIONS: In the INTRINSIC RV trial, among those randomized, DDDR AVSH was associated with similar outcomes as with VVI backup pacing.