While periprocedural safety of transcatheter aortic valve replacement (TAVR) procedures has improved, late bleeding complications may still be an issue.
The study published Dec. 23 in the Journal of the American College of Cardiology explored bleeding complications through the first year following TAVR. Patients in the study were pooled from cohorts of the PARTNER (Placement of Aortic Transcatheter Valves) trials and two continued-access registries, one randomized and one nonrandomized.
Researchers found that while fewer patients are experiencing complications during procedures, particularly if transfemoral routes are used, up to one year later, patients were at elevated risk for bleeding complications. On average, the greatest risk appeared to be around four months after initial TAVR procedure.
Philippe Généreux, MD, from Columbia University Medical Center and New York Presbyterian in New York, and colleagues wrote that there were four predictors for major late bleeding complications. These included atrial fibrillation or flutter between baseline and 30 days, low baseline hemoglobin, greater left ventricular mass at 30 days and severe paravalvular leak at 30 days.
Approximately 6 percent of patients experienced major late bleeding complications that put them at increased risk for hospitalization or death. Gastrointestinal complications were the most frequent type of major late bleeding complication at around 40.8 percent. Neurological complications and traumatic falls were also identified among the more frequent causes for late bleeding complications at 15.5 percent and 7.8 percent, respectively.
Patients with major late bleeding complications following TAVR had a nearly fourfold increased risk of death in the period between 30 days and one year.
These findings highlight the need to shift focus from procedural improvements to long-term outcomes, wrote Dhruv S. Kazi, MD, MSC, MS, from the cardiology division at San Francisco General Hospital in San Francisco, in an editorial. Kazi wrote that as physicians improve TAVR on the whole, the findings from Généreux et al showed that “Small refinements in the TAVR protocol could yield valuable clinical and economic dividends by reducing delayed complications,” especially in long-term patient care.
Généreux et al wrote that with the four groups at most risk for late bleeding complications in mind, “Better individualized and risk adjusted antithrombotic therapy after TAVR is urgently needed.”