What is the clinical evidence from this study?

Study design: Cohort. Population: Transcatheter aortic valve implantation (TAVI) (n=2531). Intervention: Prior or new permanent pacemaker (PPM) vs. No PPM. Primary outcome: 1-year all-cause mortality (HR 1.31, 95% CI 1.08 to 1.60, p=0.006).

August 10, 2015

Chronic pacing and adverse outcomes after transcatheter aortic valve implantation

Q: What does this research mean for the field?

Prior or new permanent pacemakers after transcatheter aortic valve implantation are independently associated with higher 1-year all-cause mortality compared to having no pacemaker. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Key Result

Prior or new permanent pacemakers after TAVI were independently associated with higher 1-year all-cause mortality compared to no pacemaker (prior PPM HR 1.31; 95% CI 1.08-1.60; P=0.006).

Study Design

Type

Cohort (n=2,531)

Multicenter

Yes

Structured PICO

Does chronic pacing (prior or new permanent pacemaker) or LBBB worsen clinical outcomes and LVEF recovery in patients undergoing TAVI?

Population

2,531 patients undergoing transcatheter aortic valve implantation (TAVI) in the PARTNER trial and registries

Intervention

Prior permanent pacemaker (PPM) (n=586), new PPM (n=173), or left bundle branch block (LBBB) without PPM (n=160)

Comparator

No permanent pacemaker (n=1612)

Outcome

1-year all-cause mortalityhard clinical

Prior or new permanent pacemakers and chronic LBBB are associated with worsened 1-year mortality and reduced LVEF recovery after TAVI, likely due to ventricular dyssynchrony from chronic right ventricular pacing.

Main Result

Effect estimate: HR 1.31 (95% CI 1.08 to 1.60)

Absolute Event Rate: 27.4% vs 20%

p-value: p=0.006

Abstract

OBJECTIVE: Many patients undergoing transcatheter aortic valve implantation (TAVI) have a pre-existing, permanent pacemaker (PPM) or receive one as a consequence of the procedure. We hypothesised that chronic pacing may have adverse effects on TAVI outcomes. METHODS AND RESULTS: Four groups of patients undergoing TAVI in the Placement of Aortic Transcatheter Valves (PARTNER) trial and registries were compared: prior PPM (n=586), new PPM (n=173), no PPM (n=1612), and left bundle branch block (LBBB)/no PPM (n=160). At 1 year, prior PPM, new PPM and LBBB/no PPM had higher all-cause mortality than no PPM (27.4%, 26.3%, 27.7% and 20.0%, p88%). CONCLUSIONS: In the PARTNER trial, prior PPM, along with new PPM and chronic LBBB patients, had worsened clinical and echocardiographic outcomes relative to no PPM patients, and the presence of a PPM was independently associated with 1-year mortality. Ventricular dyssynchrony due to chronic RV pacing may be mechanistically responsible for these findings. TRIAL REGISTRATION NUMBER: (ClinicalTrials.gov NCT00530894).

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