Comparison of arrhythmia prevalence in NUVANT Mobile Cardiac Telemetry System patients in the US and India.

The Corventis NUVANT™ Mobile Cardiac Telemetry System provides continuous monitoring of symptomatic and asymptomatic cardiac abnormalities to help physicians diagnose and treat non-lethal cardiac arrhythmias. Analysis of a sample of 2231 US and 1053 Indian NUVANT patients has revealed interesting statistics on the prevalence of various cardiac arrhythmias in the patient populations of the two nations. The population is non-randomized and consists of US patients where often a traditional Holter Monitor study was negative and self-pay Indian patients. Mean age was 61.3 for the US and 57.8 for India with 57% of US patients and 32% of India patients being female. Presentation of specific arrhythmia types was similar across populations with the exception of atrial fibrillation and flutter being more prevalent in the older US population as well as increased prevalence of symptomatic atrial and ventricular ectopic rhythms in all patients and SVT for female patients in India. Utilization as defined by the number of patient triggers was 50% higher for Indian patients.

Study of arrhythmia prevalence in NUVANT Mobile Cardiac Telemetry system patients.

The Corventis NUVANT™ Mobile Cardiac Telemetry system is an innovative solution in the field of continuous monitoring of symptomatic and asymptomatic cardiac abnormalities to help physicians diagnose and treat non-lethal cardiac arrhythmias. As an FDA cleared product on the market for more than 2 years, the collected body of patient data represents a unique and powerful source of clinical information. Analysis of a sample of 951 NUVANT patients has revealed interesting statistics on the prevalence of various cardiac arrhythmias in the patient population. The population is non-randomized and largely consists of US patients where a traditional Holter Monitor study was negative. The analysis here is focused on classifying the detected arrhythmias using potential therapy solutions as a classifier. Across the total population, 2.2% of patients presented arrhythmias indicating assessment for clinically significant tachycardia, 19% indications of potential bradycardia, 20% had indications of atrial fibrillation, 1% indicating arrhythmias requiring other conditional treatment, and 58% presenting arrhythmias likely not requiring treatment.

Design of the Multi-Sensor Monitoring in Congestive Heart Failure (MUSIC) study: prospective trial to assess the utility of continuous wireless physiologic monitoring in heart failure.

BACKGROUND: Remote monitoring of heart failure (HF) patients may help in the early detection of acute HF decompensation before the onset of symptoms. Appropriate early intervention in these patients may reduce HF-related hospitalizations and costs. METHODS: The MUSIC (Multi-Sensor Monitoring in Congestive Heart Failure) study comprises 2 multicenter nonrandomized phases (MUSIC-Development and MUSIC-Validation) designed to develop and validate an algorithm for the prediction of acute HF decompensation using multiple physiologic signals obtained from an external, adherent, multisensor system capable of intermittent transmission of physiologic signals. Data obtained from MUSIC-Development will be used to develop the algorithm to predict HF decompensation. The algorithm will be validated in MUSIC-Validation with the objectives of ≥ 60% sensitivity for correctly predicting an acute HF event, a false-positive patient status signal rate of ≤ 1.0 per patient-year, and a safety endpoint of ≤ 5% of patients experiencing significant adverse skin conditions related to the prolonged wearing of the adherent device. A total of 542 patients in New York Heart Association functional class III-IV HF, with ejection fraction ≤ 40% and a recent HF admission, are enrolled in MUSIC-Development (n = 180) and MUSIC-Validation (n = 362). All patients are remotely monitored for 90 days using the Corventis multisensor system that transmits bioimpedance, electrocardiogram, and accelerometer data. RESULTS: The MUSIC study has completed patient enrollment and follow-up in both phases. Once algorithm development is complete from the MUSIC-Development phase, the sequestered data set from the MUSIC-Validation phase will be used for algorithm validation.