Potential role of telemedical service centers in managing remote monitoring data transmitted daily by cardiac implantable electronic devices: results of the early detection of cardiovascular events in device patients with heart failure (detecT-Pilot) study.

OBJECTIVE: Implantable cardioverter-defibrillators (ICDs) alone or combined with cardiac resynchronization therapy (CRT-Ds) featuring automatic home monitoring (HM) function can be monitored remotely on a daily basis. Different ways of implementing HM into clinical routines are possible, with efficient patient management being the main objective. In this study, a concept using a telemedical service center (TmSC) to manage HM data was developed and investigated regarding patients' satisfaction, physicians' satisfaction, and alert filtering. SUBJECTS AND METHODS: Fifty-five ICD or CRT-D patients with symptomatic heart failure were enrolled. The TmSC received HM data, identified "actionable parameters" (APs) by following protocol-defined procedures, conducted structured patient interviews, and forwarded selected APs to the respective follow-up clinic. Satisfaction of patients and physicians with the TmSC was evaluated at the end of the study by purpose-designed questionnaires. RESULTS: During a mean follow-up of 402±200 days, 3,831 APs were identified and analyzed at the TmSC (5.28 per patient-month). Most APs were triggered by a pilot detection algorithm for worsening heart failure (2.80 per patient-month), followed by atrial tachyarrhythmia episodes (1.10 per patient-month) and ventricular pacing issues (0.87 per patient-month). The TmSC forwarded 682 APs (18% of all APs) to 10 study sites. Approximately 65% of physicians and patients deemed the TmSC improved patient care. CONCLUSIONS: The TmSC-based management concept was well accepted and appreciated by the majority of physicians and patients. It may be helpful in gaining symptomatic information on top of automatic HM data and in supporting smaller clinics in the follow-up of their device patients.

Clinical observations with Closed Loop Stimulation pacemakers in a large patient cohort: the CYLOS routine documentation registry (RECORD).

AIMS: Closed Loop Stimulation (CLS) pacemakers couple pacing rate to myocardial contraction dynamics by monitoring unipolar right ventricular impedance on a beat-to-beat basis. The aim of this large-scale registry was to evaluate the safety and efficacy of the CLS therapy under clinical routine conditions. METHODS AND RESULTS: A total of 706 patients was enrolled in the clinical investigation 'Registry: CYLOS Routine Documentation' (RECORD) at 57 investigational sites in Europe and Hong Kong. Not to interfere with clinical routine and therapeutic decisions of health care providers, the registry was implemented as a part of the standard follow-up schedule. Two follow-ups were conducted within 12 months of enrolment in order to evaluate typical programming of CLS-related parameters, reasons for their later reprogramming, frequency of patient intolerance to CLS, and physicians' satisfaction with medical benefits and technical performance of CLS in each patient. The investigators' medical and technical notes on CLS rated it excellent in ~80% of patients, poor in 1.4% (medical benefit) or 0.5% (technical performance), and adequate in rest of the patients. Closed Loop Stimulation functionality was not influenced by pacing site variation within the right ventricle (septal, outflow tract) or by advanced heart failure (New York Heart Association classes II-IV). Permanent or temporary CLS deactivation was undertaken for various reasons in 6.2% of patients. Signs of intolerance to CLS or rate-adaptive pacing were reported by 2.3% of patients. Reprogramming of CLS-related parameters was seldom undertaken, with >90% of pacemakers operating with default settings in the long term. CONCLUSION: Clinical performance of CLS was very satisfactory in the large cohort studied.

OMEGA, a randomized, placebo-controlled trial to test the effect of highly purified omega-3 fatty acids on top of modern guideline-adjusted therapy after myocardial infarction.

BACKGROUND: There is no randomized, double-blind trial testing the prognostic effect of highly purified omega-3 fatty acids in addition to current guideline-adjusted treatment of acute myocardial infarction. METHODS AND RESULTS: OMEGA is a randomized, placebo-controlled, double-blind, multicenter trial testing the effects of omega-3-acid ethyl esters-90 (1 g/d for 1 year) on the rate of sudden cardiac death in survivors of acute myocardial infarction, if given in addition to current guideline-adjusted treatment. Secondary end points were total mortality and nonfatal clinical events. Patients (n=3851; female, 25.6%; mean age, 64.0 years) were randomized in 104 German centers 3 to 14 days after acute myocardial infarction from October 2003 until June 2007. Acute coronary angiography was performed in 93.8% and acute percutaneous coronary intervention in 77.8% of all patients. During a follow-up of 365 days, the event rates were (omega and control groups) as follows: sudden cardiac death, 1.5% and 1.5% (P=0.84); total mortality, 4.6% and 3.7% (P=0.18); major adverse cerebrovascular and cardiovascular events, 10.4% and 8.8% (P=0.1); and revascularization in survivors, 27.6% and 29.1% (P=0.34). CONCLUSIONS: Guideline-adjusted treatment of acute myocardial infarction results in a low rate of sudden cardiac death and other clinical events within 1 year of follow-up, which could not be shown to be further reduced by the application of omega-3 fatty acids. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00251134.

Closed loop stimulation and accelerometer-based rate adaptation: results of the PROVIDE study.

AIMS: We compared pacing rate adaptation based on closed loop stimulation (CLS) or accelerometer sensor (AS) during acute mental and physical stress in the same patient. METHODS AND RESULTS: One month after Protos (Biotronik, Germany) pacemaker implantation, 131 chronotropically incompetent patients were randomized to AS or CLS for 3 months with crossover. Arithmetic and 6 min walk tests were performed in the non-rate-adaptive mode and AS and CLS rate-adaptive modes, respectively. At the end, patients had to select the individually preferred pacemaker sensor. Heart rate during mental stress was higher (3.0 +/- 9.2 bpm) in the CLS than in the AS mode (P = 0.004). Benefit in the walking distance compared with non-rate-adaptive pacing was similar for the two modes: added 27 +/- 96 m (AS, P = 0.013) and 30 +/- 116 m (CLS, P = 0.025). At the end of the walk, heart rate was higher by 4.8 +/- 21.4 bpm in AS than in CLS (P = 0.049). Twice as many patients preferred CLS over AS (P < 0.01). CONCLUSION: The arithmetic test was associated with a significantly higher heart rate for CLS than for AS, showing a greater sensitivity of CLS-based rate adaptation to mental stress. Performance during physical stress was comparable. Patients preferred CLS.