Multicenter clinical evaluation of a new SSIR pacemaker.
A multicenter clinical evaluation of Sorin Swing 100, a new SSIR pacemaker with a gravimetric sensor, was performed by seven different centers enrolling a total of 89 patients, 56 men and 33 women, mean age 73.1 years, for pacemaker implantation (73 patients) or pacemaker replacement (16 patients). Pacing mode was VVIR in 73 patients and AAIR in 16. The behavior of pacing rate was evaluated 3 months after the implant by performing a 24-hour Holter monitor, an exercise stress test, and tests for the assessment of mechanical external interference (MEI). A physiological behavior of the paced rate was always observed during Holter monitoring. In 52 completely paced patients mean diurnal, nocturnal, and maximal heart rate were, respectively, 74.9 +/- 5.7 ppm, 58.1 +/- 5.8 ppm, and 113.4 +/- 12.7 ppm; a paced rate exceeding 100 ppm was reached on the average 5.6 times/Holter monitor. In all but two patients the sleep rate (55 ppm) was reached during the night or long resting time. During exercise stress test a direct correlation between the increase in pacing rate and the increase in workload was observed; the mean maximal heart rate reached in 49 completely paced patients was, respectively, 102.8 +/- 9 ppm in 17 patients who accomplished stage 1, 116.2 +/- 13.6 ppm in 28 patients who accomplished stage 2, and 133 +/- 6.7 ppm in 10 patients who accomplished stage 3 of the Bruce protocol. MEI testing never increased the pacing rate over the noise rate (10 ppm over the basic rate). In only seven patients the results obtained suggested to change the nominal set up of the pacemaker.(ABSTRACT TRUNCATED AT 250 WORDS)
D000054:Acceleration; D000368:Aged; D001281:Atrial Fibrillation / Q000628:therapy; D002304:Cardiac Pacing, Artificial / Q000379:methods*; D015716:Electrocardiography, Ambulatory; D004867:Equipment Design; D005069:Evaluation Studies as Topic; D015444:Exercise / Q000502:physiology; D005080:Exercise Test; D005260:Female; D006327:Heart Block / Q000628:therapy; D006339:Heart Rate / Q000502:physiology*; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial; D012680:Sensitivity and Specificity; D012804:Sick Sinus Syndrome / Q000628:therapy