Among patients who underwent transcatheter aortic valve replacement (TAVR), late serious complications were uncommon and late mortality was mostly attributed to noncardiac causes, according to a study published in the Journal of the American College of Cardiology.
TAVR is used to treat patients with aortic stenosis who are high risk for or who cannot undergo surgical intervention. Measuring the long-term outcomes after TAVR is important in order to guide clinical management of high-risk aortic stenosis. However, the currently available data are derived from small populations with limited follow-up.
The FRANCE 2 (French Aortic National CoreValve and Edwards) investigators, led by Martine Gilard, MD, PhD, of Brest University Hospital in France, evaluated late outcomes among patients who underwent TAVR in the FRANCE-2 registry. The primary outcome was defined as all-cause death at several time points within 5 years.
A total of 4201 patients were evaluated. Median follow-up was 3.8 years, and nearly all (97.2%) patients had clinical data available at 3 years. The rate of all-cause mortality at 3 years was 42%, less than half of which was accounted for by death from cardiovascular causes (17.5% of all patients).
Risk factors for 3-year all-cause mortality included atrial fibrillation (P <.001), New York Heart Association (NYHA) functional class III or IV (P <.001), and need for permanent pacemaker implantation (P =.02). Compared with a transfemoral approach, using a transapical or subclavian approach also increased the risk for all-cause mortality (P <.001 for both comparisons).
Serious adverse events were most common within the first month after TAVR and dropped to less than 2% per year thereafter. The majority (90%) of patients who were still alive at 3 years had mild or no symptoms related to aortic stenosis (NYHA functional class I or II).
Mean valve area, gradient, and residual aortic regurgitation remained stable over a follow-up period of 3 years. No re-interventions were performed due to structural valve failure.
“The strength of our findings lies in the fact that the FRANCE-2 is the largest database examined for late outcomes after TAVR,” Dr Gilard told Cardiology Advisor. “In FRANCE-2, the number of patients with an echocardiographic follow-up is sizeable, with data in over 1000 patients for up to 3 years. In contrast, serial echocardiography over 3 years has been performed in only 180 patients in prior studies.”
“Late mortality after TAVR was mostly due to noncardiac causes, and clinical improvement after TAVR was preserved long-term. These findings should reinforce the use of TAVR in high-risk aortic stenosis patients and possibly support its use in a lower-risk population,” Dr Gilard said.
Disclosures: Funding for the FRANCE-2 registry was provided by Edwards Lifesciences and Medtronic. Drs Eltchanioff, Lefevre, Himbert, Cribier, Meneveau, Doisy, and Iung reported financial relationships with Edwards Lifesciences. In addition, Drs Pascal, Carrie, Teiger, Himbert, and Souteyrand reported financial relationships with Medtronic. Drs Meneveau, Souteyrand, and Doisy have also served as consultants for St. Jude Medical. Dr Souteyrand has consulted for Abbott and Terumo and Dr Iung has received consulting fees from Boehringer Ingelheim.
Gilard M, Eltchaninoff H, Donzeau-Gouge P, et al; for the FRANCE 2 Investigators. Late outcomes of transcatheter aortic valve replacement in high-risk patients: the FRANCE-2 Registry [published online October 3, 2016]. J Am Coll Cardiol. 2016;68(15):1637-1647. doi: 10.1016/j.jacc.2016.07.747.