April 22, 2026Journal of the American College of Cardiology189 citations
View Full PaperBleeding Complications After Surgical Aortic Valve Replacement Compared With Transcatheter Aortic Valve Replacement
Key Result
Major bleeding complications within 30 days were significantly less frequent after TAVR (11.3% transfemoral, 8.8% transapical) compared with SAVR (22.7%, p<0.0001) in high-risk aortic stenosis.
Key Points
- This study aimed to evaluate the incidence and predictors of bleeding complications after SAVR compared to TAVR and their impact on long-term prognosis.
- Randomized controlled trial (PARTNER I) with 657 high-risk patients assigned to SAVR or TAVR.
- Assessment of 30-day major bleeding complication rates and association with 1-year mortality.
- Use of first-generation Edwards SAPIEN valves for TAVR procedures.
- Major bleeding complications occurred in 22.7% after SAVR, 11.3% after TF-TAVR, and 8.8% after TA-TAVR (p < 0.0001).
- Transfusion rates at 30 days: SAVR 17.9%, TF-TAVR 7.1%, TA-TAVR 4.8% (p < 0.0001).
- Major bleeding complications were the strongest independent predictor of 1-year mortality, with greater impact following SAVR.
Study Design
Type
RCT (n=657)
Randomization
Randomized
Structured PICO
Does TAVR reduce 30-day major bleeding complications compared to SAVR in operable high-risk patients with aortic stenosis?
P
Population
657 operable high-risk patients with aortic stenosis from cohort A of the PARTNER I trial
I
Intervention
Transcatheter aortic valve replacement (TAVR) via transfemoral or transapical access using first-generation Edwards SAPIEN valves
C
Comparator
Surgical aortic valve replacement (SAVR)
O
Outcome
30-day rates of major bleeding complications (modified Valve Academic Research Consortium definitions)safety
Major bleeding complications are significantly more common after SAVR than TAVR in high-risk patients and are a strong independent predictor of 1-year mortality.
Main Result
p-value: p=< 0.0001
Abstract
OBJECTIVES: This study sought to identify the incidence, predictors, and prognostic impact of bleeding complications (BC) after surgical aortic valve replacement (SAVR) compared with transcatheter aortic valve replacement (TAVR). BACKGROUND: Bleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis. METHODS: In the randomized controlled PARTNER (Placement of Aortic Transcatheter Valve) I trial, 657 patients from cohort A (operable high risk) were randomly assigned to SAVR or TAVR (transfemoral TF if iliofemoral access was suitable or transapical TA if not) and received the designated treatment. First-generation Edwards SAPIEN valves and delivery systems (Edwards Lifesciences, Irvine, California) were used for TAVR, through a 22- or 24-F sheath. The 30-day rates of major BC (modified Valve Academic Research Consortium definitions), predictors of BC, and their association with 1-year mortality were assessed. RESULTS: A total of 71 (22.7%), 27 (11.3%), and 9 (8.8%) patients had major BC within 30 days of the procedure after SAVR, TF-TAVR, and TA-TAVR, respectively (p < 0.0001). SAVR was associated with a significantly higher 30-day rate of transfusion (17.9%) than either TF-TAVR (7.1%) or TA-TAVR (4.8%; p < 0.0001). Independent predictors of major BC were the occurrence of major vascular complications and use of intraprocedural hemodynamic support among TF-TAVR patients, severe procedural complications requiring conversion to open surgery among TA-TAVR patients, and the presence of low hemoglobin at baseline among SAVR patients. Major BC was identified as the strongest independent predictor of 1-year mortality among the full cohort. However, risk-adjusted analyses demonstrated a significant interaction between BC and treatment strategy with respect to mortality, suggesting that BC after SAVR have a greater impact on prognosis than after TAVR. CONCLUSIONS: Among high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial, BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis. (THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial; NCT00530894).