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  • TELEMONITORING IN CARDIOLOGY Juan C. Chachques, MD, PhD. European Hospital Georges Pompidou. University of Paris. France. BACKGROUND Congestive heart failure (HF) is a serious public health problem by virtue of its prevalence, high mortality, high morbidity, and the expense of ongoing therapy. High cardiac filling pressures and concomitant volume overload are frequently the cause of hospital admission for heart failure. Effective management of heart failure is partly aimed on lowering the filling pressures and improving ventricular performance. Heart failure is associated with a high rate of hospitalization and poor prognosis. Telemonitoring could help implement and maintain effective therapy and detect worsening HF and its cause promptly to prevent medical crises. OBJECTIVE Several potential strategies to control fluid volume status are used in the daily practice. Clinic visits for assessment of filling pressure by physical examination, multiple types of noninvasive measurements, and repeated cardiac catheterization may be employed. There is considerable cost and inconvenience for the patient associated with these strategies and, more importantly, these methods represent pressure and volume status only as one discrete point in time without the perturbance of daily activities or stress. To overcome this limitation, the role of continuous ambulatory hemodynamic information in the management of heart failure is currently under investigation. The use of implantable hemodynamic monitors (IHMs) may assist in the management of heart failure by providing continuous ambulatory filling pressure status for optimal hemodynamic management. Measurement of intracardiac hemodynamic parameters has been limited to brief periods in the acute care setting. Implantable hemodynamic monitor that is capable of measuring chronic right ventricular oxygen saturation and pulmonary artery pressure are in development. METHODS The devices consist of an electronic controller placed subcutaneously and two transvenous leads placed in the right ventricle (reflectance oximeter) and pulmonary artery (variable capacitance pressure sensor). Current devices (e.g. Chronicle® system) include an implanted monitor, a pressure sensor lead with passive fixation, an external pressure reference (EPR), and data retrieval and viewing components. These implantable hemodynamic monitors (IHM) continuously measures and stores multiple intracardiac pressure measurements, heart rate, and activity. Systems are implanted using the same technique as a single-chamber pacemaker with preferential placement of the pressure sensor lead tip near the right ventricular (RV) outflow tract, to minimize risk of sensor tissue encapsulation. CLINICAL FEASIBILITY STUDIES Primary Aim: Will determine whether telemonitoring by community-based cardiology office practices will reduce the risk of hospital readmission (for any cause) or death after an initial “index hospitalization” for HF. The hypothesis is that, among patients recently discharged after a hospitalization for HF, telemonitoring will decrease the rate of rehospitalization or death over 6 months. Secondary Aims: Will determine whether telemonitoring is capable of: 1
  • 1. Reduce the rate of all-cause hospital readmission. 2. Reduce the rate of hospital readmission for HF. 3. Reduce the total number of all-cause and HF-specific hospital readmissions. 4. Increase office visits with the clinician receiving information from the telemonitoring system. 5. Improve survival after index hospitalization. 6. Reduce the cost of inpatient medical care. 7. Improve health status. 8. Improve patient satisfaction with care. 9. Improve patients’ self-management of HF. PRELIMINARY RESULTS Chronic measurement of hemodynamic parameters in the outpatient setting with implantable sensor technology appears to be feasible. The devices are well tolerated without significant untoward effects, and the sensors generally function well over time, providing reliable information. PACEMAKER & DEFIBRILLATOR MONITORING The sensitivity of patient/parent capacity to detect pacemaker problems or dysrhythmias based on clinical findings is still a critical issue. The specificity of routine monthly telemonotoring to screen for asymptomatic pacemaker dysfunction or new-onset dysrhythmias is actually under evaluation. Financial charges for use of telemonitoring seem to be significantly less than comparable outpatient visits. Recent developed implantable cardioverter defibrillator (e.g. Lumax® ICD) contains not only a defibrillator that can deliver life-saving electric shocks to the heart, but also integrates a technology that monitors the functions of both the heart and the device itself. The device automatically transfers all important diagnostic data to the cardiologist over a mobile phone network — once a day, and immediately in the case of a critical event. The physician just needs to log in through a secure Internet site to be informed of the patient’s current cardiac status. Moreover, the home monitoring technology automatically sends a SMS, email or fax to the physician in case of a critical change in the patient’s heart rhythm. A high-definition intracardiac ECG sent over the GPRS network enables the physician to detect arrhythmias in time. As an additional feature, the system also detects possible technical malfunctions in the device, such as a decreasing signal quality that could impair the precision of future therapies. The physician can clearly distinguish interfering signals from cardiac events on a computer and contact the patient for correction of the technical problem. The cardiologist may analyze the ICD’s programming at any time using the Internet. Another asset of this technology is the considerable improvement of the ICDs’ service time as a result of the reduced number of electric shocks. PEDIATRIC PACEMAKER MONITORING Recommended as part of a comprehensive pacemaker follow-up protocol, the diagnostic and cost- effectiveness of routine telephone monitoring (TM) in children is under evaluation. Patient age and size with inherent age-related problems and potential inability to correlate symptoms with pacemaker performance places the pediatric patient in a unique category, different from that of the adult. ANOTHER APPLICATIONS OF TELEMONITORING PULMONARY ARTERY HYPERTENSION In patients with pulmonary artery hypertension, the desired outcome of pharmacological treatments is a reduction of pulmonary pressure, which can be measured by right-heart catheterization or Doppler echocardiography. However, both techniques provide only snapshots of the hemodynamic state. The aim of telemonitoring in these cases is to test the usability of implantable hemodynamic monitors 2
  • (IHM). For this purpose, the device is implanted into patients with pulmonary hypertension who are receiving long-term treatment with new drugs. MONITORING SLEEP APNEA Nearly 20% of heart-failure patients present problems with respiration. When stratified by the severity of apnea, investigators report that patients with >15 apnea episodes per hour had a significantly lower rate of survival from cardiac death than those with <15 apnea episodes per hour, confirming that sleep apnea is a risk for mortality in heart-failure patients. These phases of apnea result in decreases in oxygenation of the blood, causing problems for the heart, resulting in more arrhythmias and fatigue, as well as also being associated with higher mortality. Normal clinical practice often does not take sleep apnea into account because it is very difficult to recognize. However, apnea is an important risk factor that is important to monitor and to treat. INTERNET MONITORING A user-friendly home based electronic device may register weight, blood pressure, heart rate and rhythm by means of ECG, ventilation frequency and oxygen saturation of the blood. In addition, the patient can use a schematic code to enter details on his subjective state of health, changes of medication and an optional contact request. Once per day the information can be sent via e-mail to a Telemedical Centre where it is evaluated. If the critical limits of individually defined parameters are crossed the primary care provider is promptly notified by fax. So treatment can be adjusted before heart failure deteriorates and hospital admissions becomes necessary. TRANS-TELEPHONIC MONITORING In-home communication systems allow patients to transmit information to their clinicians and provides education to enable patients to actively participate in managing their condition. These systems use conventional telephone lines and does not require the patient to have Internet access. Patients are asked a pre-programmed series of questions and the system automatically uploads the responses to a secure data center. A clinician in each practice can then log on to a secure Internet site using a Web browser to review the patients’ responses. The system thus serves as an interface between patients at home and their clinicians, facilitating monitoring of chronic conditions and patient education. Phone monitoring is simple to use, does not require any equipment in patients’ homes and substantial preliminary data suggest high patient and clinician satisfaction with its use. CONCLUSIONS Optimal management of patients with chronic heart failure has to detect emerging symptoms of a beginning hemodynamic imbalance in time and to administer an appropriate therapy in order to avoid decompensation and hospital admission. Telemonitoring of physiological and clinical parameters supplies valuable information to improve health care of HF patients. Current studies demonstrated that telemonitoring of haemodynamic data from an IHM was feasible. Patient survey showed that the technology was user-friendly and that the training material provided sufficient information for patients and their families to install and use the transmission equipment at home. It also suggested that transmission success was independent of patient age or gender. With the monitoring system, physicians and medical institutions can receive all the information about patients while they are at home. Patient management before symptoms get to a point that they are dangerous and would require hospitalization. By altering therapy based on the information cardiologists receive from home, it will be possible to provide better care than simply having the patient come in for periodic visits. Telemonitoring, which bridges clinicians and patients with communication technology, holds promise for closing the gap in HF care. This technology has the potential for standardized, widespread implementation (and long-term maintenance) in the near future because it can be easily applied to large patient populations and integrated into the current medical care system, home telemonitoring can be easily exported to different healthcare systems across Europe. Supporting this potential, 3
  • preliminary evaluations have suggested that telemonitoring is feasible across a broad spectrum of typical HF patients, relatively inexpensive on a per-patient basis, and highly effective in improving health outcomes. PERSPECTIVES A multicenter, randomized controlled trial should be organized to determine the effectiveness of a telemonitoring strategy in decreasing hospital readmissions and death in patients with HF. Many HF patients experience deterioration in their health status and an increase in weight and symptoms over a period of days and weeks before ultimately presenting to medical attention and requiring hospitalization. A frequent monitoring system can alert clinicians to the early signs and symptoms of decompensation, providing the opportunity for intervention before the patient becomes severely ill and requires hospitalization. Moreover, such a system can engage patients in their care and provide instruction about beneficial self-care strategies. This intervention is not intended to substitute for communication relating to acute care or acute, sudden changes in health status. In these cases, patients are instructed to make direct and immediate contact with their doctor or hospital. 4