PARTNER: Bleeding More Prevalent, Dangerous with Surgery vs. TAVR

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Among patients with high-risk aortic stenosis, bleeding complications are less common after transcatheter aortic valve replacement (TAVR) compared with surgery, according to a subanalysis of the PARTNER I trial published online November 27, 2013, ahead of print in the Journal of the American College of Cardiology. In addition, bleeding is associated with worse long-term prognosis, especially in those who undergo surgical replacement.

Researchers led by Martin B. Leon, MD, of Columbia University Medical Center (New York, NY), looked at the incidence and impact of bleeding in 657 patients from cohort A (operable high risk) who were randomized to transfemoral (n = 240) or transapical TAVR (n = 104) with the Sapien valve (Edwards Lifesciences, Irvine, CA) or surgery (n = 313). Bleeding complications, as defined by the modified criteria of the Valve Academic Research Consortium (VARC), were classified as either major or minor.

More Bleeding with Surgery

Major bleeding was more common in the surgical cohort (22.7%) than either the transfemoral (11.3%) or transapical (8.8%) TAVR groups (P < 0.0001 for trend).

After 30 days, transfusion rates were higher in the surgery group (17.9%) compared with either transfemoral (7.1%) or transapical (4.8%) TAVR (P < 0.0001 for trend). Major bleeding was associated with different adverse clinical outcomes at 30 days after each procedure:

  • Transfemoral TAVR: higher rates of major vascular complications (P < 0.0001) with a trend toward a higher rate of renal failure requiring dialysis (P = 0.21)
  • Transapical TAVR: trend toward higher rates of major vascular complications (P = 0.34) and CV mortality (P = 0.35)
  • Surgery: higher rates of acute kidney failure requiring dialysis (P = 0.05), major vascular complications (P = 0.0002), and all-cause (P < 0.0001) and CV (P = 0.01) mortality

Overall, major bleeding at 30 days was associated with increased 1-year mortality in Kaplan-Meier analysis. When patients were stratified by treatment, major bleeding had a substantial impact on 1-year mortality in the surgical group, while there was no interaction in either TAVR group (table 1).

Table 1. One-Year Mortality: Major Bleeding vs. No Major Bleeding

 

HR (95% CI)

P Value

Overall

2.14 (1.50-3.06)

< 0.001

Surgery

2.85 (1.81-4.48)

< 0.001

TA TAVR

1.79 (0.62-5.13)

0.27

TF TAVR

1.11 (0.47-2.60)

0.81


Multivariate analysis found major vascular complications and severe intraprocedural complications leading to the use of hemodynamic support to be independent predictors of major bleeding complications in the transfemoral TAVR group. Similarly, the need for conversion to open surgery was the most significant predictor for transapical TAVR. For surgically treated patients, low baseline hemoglobin was the only independent predictor of major bleeding.

After adjustment for preprocedural predictors, major bleeding within 30 days was strongly and independently associated with 1-year mortality overall (adjusted HR 2.49; 95% CI 1.85-3.37; P < 0.001). This association differed according to procedure—major bleeding tended to be associated with higher mortality with surgery (adjusted HR 1.95; 95% CI 0.95-4.01; P= 0.07) but not TAVR (adjusted HR 0.86; 95% CI 0.60-1.25; P = 0.43).

The study “shows that rates of major [bleeding complications] and transfusion were 2 to 3 times more frequent in the [surgery] group than in the TAVR group,” Dr. Leon and colleagues write. “This finding is not particularly surprising, given the more invasive nature of surgical [replacement] as well as the well-documented coagulopathy that occurs after cardiopulmonary bypass.”

Difference in Major Bleeding a Surprise

However, “the apparent differential prognostic impact of major [bleeding] among patients treated with TAVR or [surgery] was unexpected,” they continue. “One possible explanation for this finding is that [bleeding complications] after [surgery] appear to be more severe, leading to transfusion of a higher number of red blood cell (RBC) units, acute renal failure needing dialysis, reoperation, and consequently, a higher death rate.”

Causes of the higher transfusion rates after surgery remain unclear, the authors report. “The only identifiable predictor of major bleeding after [surgery] in the current report was the presence of baseline anemia. Paired with procedural blood loss and compensated by equivalent blood transfusion, these 2 factors potentially remain the main determinant of major bleeding events after [surgery]. Strategies to better capture, characterize, and prevent these blood losses/transfusions after [surgery] are warranted.”

Note: Several study coauthors are faculty members of the Cardiovascular Research Foundation, which owns and operates TCTMD.

 


Source:
Généreux P, Cohen DJ, Williams MR, et al. Bleeding complications after surgical aortic valve replacement compared with transcatheter aortic valve replacement: Insights from the PARTNER I trial (Placement of Aortic Transcatheter Valves). J Am Coll Cardiol. 2013;Epub ahead of print.

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Disclosures
  • PARTNER was funded by Edwards Lifesciences.
  • Dr. Leon reports receiving travel reimbursements from Edwards Lifesciences.

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