Europace Advance Access published online on October 19, 2007
Europace, doi:10.1093/europace/eum231
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A randomized trial comparing two different approaches of pacemaker selection
Division of Cardiology, University Hospital Basel, Petersgraben 4, 4031 Basel, Switzerland
Aims: 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.
Methods and 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).
Conclusion: 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.
Key Words: Atrioventricular block, Sick-sinus-syndrome, Atrial-based pacing, Ventricular-based pacing
* Corresponding author. Tel: +41 61 328 62 22; fax: +41 61 265 45 98. E-mail address: bschaer{at}uhbs.ch
The first two authors contributed equally to this paper.
Manuscript submitted 19 July 2007. Accepted after revision 24 September 2007.