COMPLICATIONS RELATED TO CARDIAC RHYTHM MANAGEMENT DEVICES (CRMD'S) THERAPY AND THEIR FINANCIAL IMPLICATION-A PROSPECTIVE SINGLE-CENTER TWO YEARS SURVEY
Author(s)
Fanourgiakis J1, Simantirakis E1, Kanoupakis E2, Chrysostomakis S1, Chlouverakis G1, Vardas P2
1University of Crete, Heraklion, Greece, 2University Hospital, Heraklion, Greece
OBJECTIVES: Cardiac rhythm management devices (CRMD’s) have proven their clinical effectiveness for patients with heart rhythm disorders. Little is known about safety and complication rates during implantations of these devices. This study demonstrated the complications rates related to implantations of CRMD’s, and estimated the additional hospital stay and cost associated with managing these complications. METHODS: During a period of one year in total 464 consecutive recipients were subjected to CRMD’s implantation and furthermore were recruited and followed up for 2 years. Finally, data were analyzed for 398 patients who completed the two year’s follow up, resulting in a total of 796 patient-years. RESULTS: From the 201 patients with initial pacemaker (PM) implantations, 6 (2,99 %) patients had seven complications (5 patients had lead’s dislodgement, 1 of them twice and 1 patient developed pocket infection), while from the 117 PMs replacements 1 (0,85 %) patient developed a complication (pocket erosion). 2 patients with complication (1 with an initial PM and 1 with replacement) died before they complete the follow up from reasons unrelated to cardiac causes. There weren’t any complications neither in initial implantations (69 patients) nor in replacements (11 patients) of implantable cardioverter defibrillator (ICD). The average prolongation of the hospital stay was 7 days ranging from 1 to 35 days, resulting in of total additional direct hospital cost. CONCLUSIONS: This study provides relatively low rates of complications in patients subjected to PMs implantation, initial or replacement, in our center compared with others studies. In the case of ICD implantations, initials or replacements, there weren’t any complication. The additional hospitalization days and cost attributed to these complications depends on the nature of complication.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PCV3
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Cardiovascular Disorders