Abstract # D-04

Cardiac Pacemaker Utilization in the U.S.: Results of a National Survey. W. Randolph Daley, Ronald G. Kaczmarek. CDRH, FDA, Rockville, MD

The objective of this study is to estimate the total numbers of patients receiving implantable cardiac pacemakers initially or as replacement devices in non-federal U.S. hospitals, and to determine the age, sex, and cardiovascular health status of recipients. Projected numbers and characteristics of hospitalized patients receiving pacemaker implantation were determined using a massive, nationally representative inpatient discharge database. An estimated 151,166 patients (53% male, 47% female) had cardiac pacemakers implanted in U.S. community hospitals in 1992. Of these, 21,747 (14%) had previously implanted devices replaced. The age distribution of pacemaker recipients was as follows: under 20 (1%), 20-39 (1%), 40-59 (6%), 60-69 (16%), 70-79 (38%), 80-89 (32%), over 90 (6%). An estimated 115 patients received a replacement device subsequent to an initial implant during the same hospital stay. Atrial fibrillation was diagnosed in 29% and atrio-ventricular block in 42% of patients. Death occurred in 2% of pacemaker recipients before discharge. In conclusion, a significant proportion of pacemaker implants are replacement devices. Substantial differences in age and cardiac health status exist among pacemaker recipients.