The risk of major stroke was higher in the 30 days following surgical aortic valve replacement (SAVR) compared to transfemoral TAVR, according to a propensity-matched analysis from the PARTNER trials published Nov. 12 in the Journal of the American College of Cardiology.
Major strokes in both groups were associated with a decline in quality of life at one year post-procedure, hammering home the importance of preventing these events.
“Although improvements in quality of life after SAVR and TAVR have been well documented, data are scarce about the relationship between post-procedure stroke and changes in health status,” wrote lead author Samir R. Kapadia, MD, with the department of medicine at the Cleveland Clinic, and colleagues. “Neurological complications remain a concern after both open-heart surgery and catheter-based interventions, and further study of the possible effect of post-procedure neurological events on patient-reported outcomes is essential to guide treatment strategies.”
Kapadia et al. propensity-matched 1,204 pairs of patients treated with SAVR versus transfemoral TAVR from the PARTNER trials. The procedures spanned from April 2007 to October 2014. Patients were 82 years old on average, and 82 percent of them had New York Heart Association functional class III or IV symptoms at baseline.
The SAVR group had higher 30-day rates of stroke (5.1 percent versus 3.7 percent) and neurological events (5.4 percent versus 4.2 percent), but those differences weren’t statistically significant. However, the difference in major strokes at 30 days—3.9 percent versus 2.2 percent—was statistically significant.
The 1.7 percent absolute risk reduction for major stroke with transfemoral TAVR corresponded to a number needed to treat of 59 patients to prevent one event, the authors reported. Major strokes were classified as a modified Rankin scale score of 2 or higher 90 days after the event.
Kapadia and colleagues noted there was an “early peaking” in stroke events for both procedures; the stroke risk was highest in each group within a day of the procedure and dropped significantly after that.
“The present analysis corroborates the typical pattern of instantaneous stroke risk within the periprocedural window that differentiates TAVR and SAVR,” wrote the authors of a related editorial, led by Stephan Windecker, MD, with the University of Bern in Switzerland. “Specifically, patients undergoing SAVR are at higher risk for stroke late during the first post-procedural day, whereas in the setting of TF-TAVR (transfemoral TAVR), the risk is greatest during the procedure.
“These temporal patterns are probably explained by different mechanisms underlying brain damage during transcatheter or surgical valve interventions, and may be affected by general anesthesia as opposed to conscious sedation concealing early neurological events, particularly in patients undergoing SAVR.”
The researchers noted a dip in quality of life among patients in both groups who experienced a major stroke. Median Kansas City Cardiomyopathy Questionnaire scores at one year post-procedure, on a scale of 0 to 100, were 79 among SAVR patients without major stroke and 64 among those with major stroke. Likewise, at one year after TAVR, median scores were 78 and 60, respectively, for those who avoided major strokes versus those who didn’t.
Among the TAVR group, 41 percent of patients were treated with Sapien first-generation valves, 43 percent with the Sapien XT valve and 16 percent with the Sapien 3 valve, all manufactured by Edwards Lifesciences, which funded the PARTNER trials. Kapadia and coauthors noted newer devices with smaller delivery profiles have led to safety improvements and better post-procedural outcomes.
Previous studies also included a mix of access approaches for TAVR, they said, but this is the first large prospective study to report on neurological safety of SAVR versus transfemoral TAVR, which is the preferred technique in most cases.
“Recent data from the PARTNER-2 S3 trial demonstrated a 30-day risk of major or disabling stroke of ≤1.0% and 1-year disabling stroke of 2.0% with the third-generation Sapien 3 valve,” the authors wrote. “Improvements in post-TAVR stroke observed in clinical trials over time may be related to more refined patient selection, increasing experience, improved devices, or all 3 factors.”
Cerebral embolic protection devices and periprocedural antiplatelet and antithrombotic therapies may allow for post-TAVR neurological events to be reduced even further, the authors noted. Additional research is needed to quantify the effectiveness of those strategies.