Defibrillator implantation early after myocardial infarction.

BACKGROUND: The rate of death, including sudden cardiac death, is highest early after a myocardial infarction. Yet current guidelines do not recommend the use of an implantable cardioverter-defibrillator (ICD) within 40 days after a myocardial infarction for the prevention of sudden cardiac death. We tested the hypothesis that patients at increased risk who are treated early with an ICD will live longer than those who receive optimal medical therapy alone. METHODS: This randomized, prospective, open-label, investigator-initiated, multicenter trial registered 62,944 unselected patients with myocardial infarction. Of this total, 898 patients were enrolled 5 to 31 days after the event if they met certain clinical criteria: a reduced left ventricular ejection fraction (< or = 40%) and a heart rate of 90 or more beats per minute on the first available electrocardiogram (ECG) (criterion 1: 602 patients), nonsustained ventricular tachycardia (> or = 150 beats per minute) during Holter monitoring (criterion 2: 208 patients), or both criteria (88 patients). Of the 898 patients, 445 were randomly assigned to treatment with an ICD and 453 to medical therapy alone. RESULTS: During a mean follow-up of 37 months, 233 patients died: 116 patients in the ICD group and 117 patients in the control group. Overall mortality was not reduced in the ICD group (hazard ratio, 1.04; 95% confidence interval [CI], 0.81 to 1.35; P=0.78). There were fewer sudden cardiac deaths in the ICD group than in the control group (27 vs. 60; hazard ratio, 0.55; 95% CI, 0.31 to 1.00; P=0.049), but the number of nonsudden cardiac deaths was higher (68 vs. 39; hazard ratio, 1.92; 95% CI, 1.29 to 2.84; P=0.001). Hazard ratios were similar among the three groups of patients categorized according to the enrollment criteria they met (criterion 1, criterion 2, or both). CONCLUSIONS: Prophylactic ICD therapy did not reduce overall mortality among patients with acute myocardial infarction and clinical features that placed them at increased risk. (ClinicalTrials.gov number, NCT00157768.)

Performance of a rate responsive accelerometer-based pacemaker with autocalibration during standardized exercise and recovery.

The rate responsiveness of a single chamber, accelerometer-based pacemaker with an autocalibration function (Opus G VVIR pacemaker, ELA Medical) was studied with a daily life protocol developed to automatically optimize the programming of accelerometer-based sensors. This new sensor was compared with two other body activity sensors that were manually optimized patient by patient. Forty-three pacemaker recipients (mean age 71 +/- 11 years), paced > 95% of the time, underwent a daily life protocol consisting of rapid walking for 6 minutes (W), climbing upstairs for 1.5 minutes (U), and downstairs for 1.5 minutes (D), alternated by recovery phases. The results were compared with performances measured in a control population of healthy subjects and in two paced patient populations (one equipped with a Dash Intermedics VVIR pacemaker and the other equipped with a Sensolog III Pacesetter/St. Jude VVIR pacemaker). Sex distribution and mean age between paced patients and control subjects were statistically comparable. The mean heartrate achieved by all paced patients at each time sample was compared with the normograms, assigning acceleration (slope) and rate (rate) scores for exercise and recovery phases. Scores ranged from -10 (hypochronotropic) to +10 (hyperchronotropic). Zero represents exact concordance with the responses of healthy individuals, and values between -2.5 and +2.5 were considered statistically similar to normal. During W, although the overall performances of the Dash, Sensolog, and Opus G did not statistically differ from healthy controls, the scores obtained by the Opus G were significantly closer to controls than those of the two other pacemakers (P = 0.02). For U, the three sensors were hypochronotropic (P = 0.03), though the Opus G was associated with a heart rate response closer to that of healthy controls (P = 0.04). D provided similar mean heart rate scores for the Opus G and the Dash compared with healthy controls, in contrast with the hyperchronotropic behavior of the Sensolog (P = 0.02). Opus G revealed a physiological modulation of the heart rate for W and D tests with a slightly hypochronotropic behavior during U. The Opus G autocalibration function provided daily life performances closer to those of healthy controls than two other pacemakers equipped with a body activity sensor that were manually optimized.