RESULTS
Ten subjects requiring a diagnostic right and left heart catheterization were screened and enrolled in the study. All ten subjects were successfully paced in AV sequential synchrony with the TAVPS catheter (Table 1). The duration of time that the pacing catheter was left in the patient averaged 24 minutes (range of 10-48 minutes), including positioning, deployment, the pacing of the right ventricle, right atrium, synchronous atrioventricular pacing, and removal. That sequence was followed in all cases. Four catheters were inserted and positioned without fluoroscopy; five were done with fluoroscopy guidance and one with the use of echocardiography.
Echocardiography showed a mean ventricular longitudinal dimension of 6.1 cm, mean right atrial minor dimension of 4.1 cm, and mean right atrial area of 15.89cm2 (ranging from 8.21cm2 to 26.60cm2) (Table 2). All subjects were assessed for any complications with trans thoracic echocardiogram at all times during the procedure. There were no adverse events during the pacing procedure. At discharge the following day, there were no adverse events reported. Patients were followed up as per standard of care after discharge.
In all ten patients, the pacing catheter achieved an excellent pacing threshold and impedance except for one. (Table 1). Patient number 7 had adequate thresholds and impedance in the ventricular leads but poor performance in the atrial leads.