Clinical Research
Interventional Cardiology
Impact of Permanent Pacemaker Implantation on Clinical Outcome Among Patients Undergoing Transcatheter Aortic Valve Implantation

https://doi.org/10.1016/j.jacc.2012.03.054Get rights and content
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Objectives

This study sought to assess the impact of permanent pacemaker (PPM) implantation on clinical outcomes among patients undergoing transfemoral transcatheter aortic valve implantation (TAVI).

Background

TAVI is associated with atrioventricular-conduction abnormalities requiring PPM implantation in up to 40% among patients treated with self-expanding prostheses.

Methods

Between 2007 and 2010, 353 consecutive patients (mean age: 82.6 ± 6.1 years, log EuroSCORE: 25.0 ± 15.0%) with severe aortic stenosis underwent transfemoral TAVI at 2 institutions. Clinical outcomes were compared among 3 groups: (1) patients requiring PPM implantation after TAVI (PPM after TAVI), (2) patients without PPM before or after TAVI (no PPM), and (3) patients with PPM before TAVI (PPM before TAVI). The primary endpoint was all-cause mortality at 12 months, and an age-, sex-, and origin-matched standardized population served as controls.

Results

Of 353 patients, 98 patients (27.8%) belonged to the PPM after TAVI group, 48 patients (13.6%) belonged to the PPM before TAVI group, and 207 patients (58.6%) belonged to the no PPM group. The PPM before TAVI patients had a significantly higher baseline risk compared with the PPM after TAVI and no PPM patients (coronary artery disease: 77.1% vs. 52.7% and 58.2%, respectively, p = 0.009; atrial fibrillation: 43.8% vs. 22.7% and 20.4%, respectively, p = 0.005). At 12 months of follow-up, all-cause mortality was similar in all 3 groups (PPM after TAVI group: 19.4%, PPM before TAVI group: 22.9%, no PPM group: 18.0%) in unadjusted analyses (p = 0.77) and adjusted analyses (p = 0.90). Compared with the standardized population, adjusted hazard ratios for death were 2.37 (95% confidence interval [CI]: 1.51 to 3.72) for the PPM after TAVI group, 2.75 (95% CI: 1.52 to 4.97) for the PPM before TAVI group, and 2.24 (95% CI: 1.62 to 3.09) for the no PPM group.

Conclusions

Although prognosis remains impaired compared with an age-, sex-, and origin-matched standardized population, periprocedural PPM implantation does not seem to affect clinical outcomes adversely among patients undergoing transfemoral TAVI.

Key Words

clinical outcome
pacemaker implantation
transcatheter aortic valve implantation

Abbreviations and Acronyms

AV
atrioventricular
CI
confidence interval
ESP
Edwards Sapien/Sapien XT prosthesis
HR
hazard ratio
MCV
Medtronic CoreValve prosthesis
PPM
permanent pacemaker
TAVI
transcatheter aortic valve implantation

Cited by (0)

Dr. Buellesfeld is a consultant and proctor for Medtronic. Dr. Wenaweser is a proctor and receives honoraria from Medtronic CoreValve and Edwards LifeSciences. Dr. Khattab has received speaker honoraria and proctor fees from Medtronic CoreValve and Edwards LifeSciences. Dr. Meier has received research grants from Medtronic and Abbott. Dr. Jüni is an unpaid member of steering groups and executive committees of trials funded by Abbott Vascular, Biosensors, Cordis, and Medtronic. Drs. Grube, Boekstegers, and Gerckens are proctors and consultants for Medtronic. Dr. Windecker has received honoraria and consultant fees from Edwards LifeSciences and Medtronic CoreValve. Dr. Eberle has received honoraria from Medtronic Corevalve. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Buellesfeld and Stortecky contributed equally to this work.