Need for a pacemaker after transfemoral transcatheter aortic valve replacement (TAVR) with a self-expanding device was both common and impactful for mortality, but the risk appeared to be modifiable, international registry data showed.
Of patients treated with an Acurate neo/neo2 (approved outside the U.S.) or Evolut PRO/PRO+ valve, 11.3% needed new permanent pacemaker implantation (PPI) in the 30 days after the procedure, reported Antonio Mangieri, MD, of Humanitas University in Milan, and colleagues in JACC: Cardiovascular Interventions.
New PPI recipients had a mortality rate of 16.9% at 1 year compared with a rate of 10.8% among other patients, which was a significant 66% elevated relative risk even after adjustment for other factors. This risk was particularly concentrated in patients with baseline left ventricular (LV) ejection fraction under 40% (P=0.049 for interaction).
The verdict on prognostic significance of PPI has been mixed in prior studies, noted Hasan Jilaihawi, MD, of Cedars-Sinai Medical Center in Los Angeles, in an accompanying editorial.
“Many of the earlier TAVR studies that did not find a prognostic association with PPI may have either excluded patients with LV dysfunction or may have had a lower threshold to implant PPI, thus resulting in lower frequencies of right ventricular pacing in less significant conduction disturbances, potentially accounting for the disparities seen,” he wrote.
The researchers concluded that “careful THV [transcatheter heart valve] selection and implantation seem crucial in patients at risk for new PPI, and alternative therapeutic options such as cardiac resynchronization therapy may be relevant in patients with LV dysfunction needing PPI after TAVR.”
Their study utilized the retrospective NEOPRO registry of real-world use of the Acurate neo or Evolut PRO devices at 24 centers internationally from January 2012 to March 2018, as well as the NEOPRO-2 registry that expanded the included devices to the latest-generation Acurate neo2 and Evolut PRO or PRO+ devices at 20 international centers from August 2017 to December 2021. All were consecutive cases done via transfemoral access for symptomatic severe aortic stenosis in a native aortic valve.
Altogether, there were 3,211 patients without a prior pacemaker or implantable cardioverter-defibrillator who underwent TAVR with Acurate neo (n=1,090), Acurate neo2 (n=665), Evolut PRO (n=1,312), or Evolut PRO+ (n=144).
PPI rates were 8.8%, 7.7%, 15.2%, and 10.4%, respectively, for the four valve types.
Jilaihawi highlighted that the rates with the latest-generation self-expanding TAVR were “either close to or even
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