A randomized trial comparing two different approaches of pacemaker selection.
OBJECTIVE
DDD-pacemakers are favoured in patients with sick-sinus-syndrome or AV-block. However, AAI-pacemakers for sick-sinus-syndrome or VDD-pacemakers for AV-block may provide similar benefit with lower costs. The aim is to show that a tailored approach (TA) with arrhythmia-specific pacemaker selection was equal to a standard approach (SA) regarding quality of life (QoL) at lower costs.


RESULTS
The study was prospective and randomized with QoL as primary endpoint. Secondary endpoints were a combined endpoint of all-cause mortality, worsening heart failure or angina, atrial fibrillation (AF), stroke, these endpoints individually and costs. Of 198 patients (age 77 +/- 10 years, 43% female, ejection fraction 54 +/- 12%, follow-up 38 +/- 15 months), 94 were randomized to SA and 104 to TA. Thirty-two patients (34%) died in the SA group vs. 25 (24%) in the TA (P= ns). QoL showed no differences in all dimensions. The combined secondary endpoint was reached more frequently with SA (51%) compared to TA (37%, P = 0.045). There was no difference regarding all single secondary endpoints. Hardware costs were reduced by 15% (P < 0.0001).


CONCLUSIONS
In long-term follow-up, a TA is equal to SA regarding the primary endpoint QoL and secondary endpoints as AF and mortality. Depending on the healthcare system, it may significantly reduce costs.
Kühne
M
M
Division of Cardiology, University Hospital Basel, Petersgraben 4, 4031 Basel, Switzerland.
Schaer
B
B
Kaufmann
C
C
Moulay
N
N
Cron
T
T
Cueni
T
T
Weiss
P
P
Schindler
C
C
Sticherling
C
C
Osswald
S
S
D000368:Aged; D000369:Aged, 80 and over; D001281:Atrial Fibrillation / Q000209:etiology; D054537:Atrioventricular Block / Q000628:therapy*; D023381:Endpoint Determination; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial / Q000191:economics; D011446:Prospective Studies; D011788:Quality of Life; D012307:Risk Factors; D012804:Sick Sinus Syndrome / Q000628:therapy*; D016896:Treatment Outcome