br Recalls and advisories Managing

Recalls and advisories Managing components under advisory notices poses several daunting challenges. Fig. 5 illustrates the benefit of HM for the management of recalled components [29,32]. Advisories encompass disintegration of high-voltage circuitry, battery depletion, and lead failure—almost all of which are captured by currently evaluated event triggers [33,34]. In comparison, conventional detection methods, such as increasing the frequency of office visits [35] are impractical, burdensome, and likely to miss dangerous interim problems. Patient alert mechanisms, such as beeps, are insensitive and prone to false-positive evaluations [36]. In contrast, HM generators trigger immediate alerts when data deviate from established trends. This reduces the burden both for patients who frequently monitoring their own devices and for clinics who are responsible for large cardiac patient populations that have a low incidence of typically silent problems. The ability to collect detailed, device-specific data, and to assess component function daily and automatically archive the information, sets a precedent for the long-term evaluation of lead and generator performance. Technology differences may affect early detection capability. Early discovery can be improved with repeated messaging in the instance that the initial clinic notification was missed [27].
Disease management Recipients of ICDs and CRTs commonly have other comorbidities, e.g. coronary artery disease, which may be tracked. ST-segment shifts may be recorded from unipolar electrograms derived from right ventricular lead tip to can. When linked to automatic remote monitoring, this 10058-F4 cost feature may permit early diagnosis of myocardial ischemia and treatment or prevent unnecessary hospital presentation for non-cardiac chest pains (Fig. 6). The predictive value of this remote alert to enable clinical decisions is currently being evaluated in trials. Continuous monitoring may also aid management of the current epidemics of HF and AF [37].
Heart failure In CHF, non-implantable technologies, depending on patient compliance and following non-specific parameters, have been unhelpful [38]. Preliminary signals indicate benefit from remote monitoring e.g. the significant shortening of hospital length of stay and reduced overall hospital costs [18]. Device-based physiologic information and diagnostics indicate that several interdependent cardiovascular factors (arrhythmias and paced burden shifts, intrathoracic impedance, vagal withdrawal, intracardiac hemodynamics) may change several days to weeks before ultimate hospitalization [39] (Fig. 7). A combined risk score incorporating all of these individual factors may improve their predictive value [40], creating an opportunity for early pre-emptive intervention. Success will depend on accurate longitudinal parameter trends (preferably updated daily) and early notification for out-of-bounds parameter groups. These can be delivered by remote monitoring. Although results with thoracic impedance have been inconsistent [41], other sensors appear more positive [23] and provide notification of conditions that lead to decompensation and prompt rapid pre-emptive therapy for them. In this regard, CHAMPION trial results are sentinel, illustrating that action taken on remotely acquired data (from a CIED with no inherent therapeutic ability) reduced patient morbidity and averted hospitalization. This changes the paradigm of CIED function.
Atrial fibrillation AF event notifications are commonly received during automatic remote surveillance. These data may influence important clinical decisions to treat or prevent stroke, ventricular arrhythmias, and heart failure. However, diagnosing AF events is challenging. The ability to detect this evanescent and largely asymptomatic arrhythmia early, by automatic remote monitoring, may permit early treatment [10]. For example, starting anticoagulants, controlling heart rate for rapid ventricular rates that may elicit inappropriate shock therapy or lead to heart failure, or reversion to normal sinus rhythm. The potential benefit for stroke risk reduction by remote monitoring was modeled on a real population of 166 patients. The results suggested that daily monitoring may reduce the 2-year stroke risk by 9%–18% with an absolute reduction of 0.2% –0.6%9, compared to conventional inter-visit intervals of 6–12 months [42]. The COMPAS trial randomized 538 pacemaker patients and noted that the incidence of hospitalizations for atrial arrhythmias and related stroke was 0.073 in the control group and 0.024 in the remote monitoring group (p=0.02), with a stroke rate of 0.033 and 0.008 respectively [16]. However, COMPAS was not powered to test this hypothesis. The interaction of AF and HF is particularly deleterious. One large multicenter study (1193 CRT-D patients from 44 Italian centers) reported significantly higher freedom from the composite endpoint of death or heart transplantation or heart failure hospitalization in patients in sinus rhythm than in those with AF [43]. AF associated with periods of rapid ventricular conduction reduces benefits of CRT [44]. Withdrawal of ventricular pacing in CRT-D is immediately notified during remote monitoring (Fig. 7).