Both transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are associated with low reintervention rates after five years, according to new research published in JACC: Cardiovascular Interventions.[1] All TAVR patients included in the analysis received a CoreValve or Evolut device from Medtronic.
“Early intermediate-term data suggest similar durability of transcatheter aortic valves to surgical bioprosthetic valves,” wrote lead author Kendra J. Grubb, MD, surgical director of the Emory Structural Heart and Valve Center at Emory University in Atlanta, and colleagues. “More contemporary studies, out to 8 to 10 years, have demonstrated lower rates of hemodynamic structural valve deterioration after a self-expanding supra-annular transcatheter aortic valve compared to surgery and lower rates of bioprosthetic valve dysfunction. Understanding valve reintervention rates will help guide lifetime management decisions in younger and low-risk patients with aortic stenosis.”
Grubb et al. explored findings from nearly 6,000 TAVR patients and nearly 2,000 SAVR patients. Data came from a variety of previously completed studies. All patients presented with symptomatic severe aortic stenosis except for those who were included in the Evolut Low Risk trial—that study included both symptomatic and asymptomatic patients. Patients were excluded if reintervention or mortality occurred on the same day as the index procedure.
Reintervention was evaluated from three different perspectives—TAVR vs. SAVR, Evolut vs. CoreValve and Evolut vs. SAVR.
Overall, 7,757 patients were included in the team’s analysis. While 4,478 of those patients received a Medtronic CoreValve device, another 1,447 patients received an Evolut device and 1,832 patients underwent SAVR. After five years, a total of 99 reintervention events were reported; this included 69 events after TAVR with a CoreValve device, 11 events after TAVR with an Evolut device and 19 events after SAVR.
While most TAVR-related reinterventions occurred in the first year, most SAVR-related reinterventions occurred after that first year. A majority (75%) of TAVR-related reinterventions were managed percutaneously, but a majority (63%) of SAVR-related reinterventions were managed with another surgery. Paravalvular regurgitation (59%), central aortic regurgitation (21%) and endocarditis (6%) were the most common reasons for post-TAVR reintervention. Endocarditis (42%), aortic stenosis (32%) and paravalvular regurgitation (16%) were the most common reasons for post-SAVR reintervention.
Reinterventions after aortic valve replacement: TAVR vs. SAVR
To ensure baseline characteristics were similar, Grubb and colleagues only focused on patients from randomized controlled trials when comparing TAVR and SAVR. Based on data from 1,970 TAVR patients and 1,832 SAVR patients, they found that the cumulative incidence of intervention was 2.2% after TAVR and 1.5% after SAVR. In the first year after treatment, reinterventions were more common after TAVR than SAVR. In years two through five, reintervention rates were not significantly different.
Reinterventions after aortic valve replacement: Evolut vs. CoreValve
Using only randomized and single-arm studies, the group was able to compare data from 1,447 TAVR patients who received an Evolut device and 4,478 TAVR patients who received a CoreValve device. The mean patient age was 77.6 years old for Evolut patients and 82.6 years old for CoreValve patients, a sign of just the use of TAVR has evolved over time. Evolut patients also faced a lower surgical risk with fewer comorbidities. The cumulative incidence of reintervention after five years was 0.9% after TAVR with an Evolut device and 1.6% after TAVR with a CoreValve device. This difference was primarily due to a higher risk of early reinterventions among CoreValve patients.
“In this patient cohort, most reinterventions after index TAVR occurred within the first year, were related to paravalvular regurgitation and were performed on early-generation CoreValve devices,” the authors wrote. “The early occurrence of reintervention after TAVR suggests procedure-related causes, attributable to less-refined valve-sizing algorithms, early operator experience with implantation and a lack of an external ‘sealing skirt’ in early-generation valves. In addition, with the release of Evolut R, the valve was recapturable and repositionable, allowing implanters to adjust the position of the valve in the annulus. Using only the most advanced valves, refined sizing algorithms and current implantation techniques, the rate of paravalvular regurgitation is expected to be lower in current clinical practice.”
Reinterventions after aortic valve replacement: Evolut vs. SAVR
Researchers also compared data from the 1,447 TAVR patients who received an Evolut device with the 1,832 patients who underwent SAVR. Evolut patients were less likely to be male presented with lower mortality risks as determined by a Society of Thoracic Surgeons risk score. The cumulative incidence of reintervention after five years was 0.9% for Evolut patients and 1.5% for SAVR patients.
Looking ahead
“Longer-term follow-up is needed to better understand reintervention after TAVR and SAVR,” the authors concluded.
Medtronic provided funding for this research. Click here for the full study in JACC: Cardiovascular Interventions, a publication from the American College of Cardiology.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.