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Predictors and 5-Year Outcomes of Pacemaker After TAVR
Quick Takes
- In patients with aortic stenosis treated with TAVR using third-generation SAPIEN valve, new PPM within 30 days occurred in 12.5% of patients.
- In patients who underwent SAPIEN 3 TAVR, PPM implantation is not associated with worse 5-year clinical outcomes, including mortality. Nevertheless, new PPM is associated with a sustained decrease in LV systolic function.
Study Questions:
What are the rates of a permanent pacemaker (PPM) implantation, the predictors of needing a PPM, and long-term clinical outcomes of the third-generation balloon-expandable SAPIEN 3 (S3) transcatheter heart valve (THV)?
Methods:
The authors employed PARTNER 2 S3 registries to identify patients without prior PPM. They looked for predictors and 5-year clinical outcomes of new PPM implanted within 30 days of TAVR.
Results:
Among 857 patients, 107 patients (12.5%) received a new PPM within 30 days after TAVR. By multivariable analysis, predictors of PPM included increased age, pre-existing right bundle branch block, larger THV size, greater THV oversizing, moderate or severe annulus calcification, and implantation depth >6 mm. At 5 years, new PPM was not associated with increased rates of all-cause mortality or repeat hospitalization. Patients with new PPM had a decline in left ventricular (LV) ejection fraction, at 1 year and persistent at 5 years (55 vs. 60, p = 0.02).
Conclusions:
The authors conclude that PPM was required in 12.5% of patients who underwent TAVR with S3 valve in the PARTNER 2 S3 registries. PPM was not associated with worse clinical outcomes, including mortality, at 5 years. Modifiable factors to reduce PPM rate include bioprosthetic valve oversizing, prosthesis size, and implantation depth.
Perspective:
Needing PPM implantation is the most common complication of TAVR, and some prior studies showed that PPM implantation was associated with adverse clinical outcomes. The frequency of new PPM implantation varies between transcatheter valves, and there are patient-specific differences in potentially needing a PPM. The current study looks at long-term (5-year) outcomes of the third-generation SAPIEN valve, and it suggests that PPM implantation following TAVR in this setting is not associated with adverse outcomes, including mortality; however, it is associated with the development of mild LV dysfunction (pacing-mediated cardiomyopathy). It is not evident why the outcomes data are different in this study. A large group of patients recover conduction after PPM implantation, and the impact of PPM depends on the pacing burden. S3 valve has been developed to mitigate undesirable effects of the prior generation of valves. Further large studies are required to confirm the lack of association between new PPM implantation after TAVR and adverse long-term clinical outcomes, as well as to determine whether these results are generalizable to patients treated with other valve types.
Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Arrhythmias and Clinical EP
Keywords: Pacemaker, Artificial, Transcatheter Aortic Valve Replacement
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