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.
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.
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