Outcomes of Patients with Significant Obesity Undergoing TAVR or SAVR in the Randomized PARTNER 2 Trial
Shmuel Chen1, Bjorn Redfors1, Ori Ben-Yehuda1, Aaron Crowley1, Danny Dvir2, John Webb3, Sung-Han Yoon4, Raj Makkar4, Vinod Thourani5, Murat Tuzcu6, Michael Mack7, Tamim Nazif8, Isaac George8, Susheel Kodali8, Martin B. Leon8.
1Cardiovascular Research Foundation, New York, NY, USA, 2University of Washington, Seattle, WA, USA, 3St. Paul's Hospital, Vancouver, BC, Canada, 4Cedars-Sinai Medical Center, Los Angeles, CA, USA, 5Medstar Washington Hospital Center, Washington, DC, USA, 6Cleveland Clinic, Cleveland, OH, USA, 7Baylor Scott & White Health, Plano, TX, USA, 8Columbia University Medical Center, New York, NY, USA.
OBJECTIVE: Patients with severe aortic stenosis (AS) at intermediate surgical risk, treated with transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) have similar 2-year survival. Significant obesity, (BMI ≥ 35 kg/m2) has been associated with increased surgical risk and post-operative complications. We compare outcomes after SAVR vs. TAVR in patients with significant obesity.
METHODS: In the PARTNER 2 trial, 2032 patients with severe AS and intermediate surgical risk (STS 4-8) were randomized to TAVR with SAPIEN XT or SAVR. 2000 patients were included in the current analysis (32 patients who had very low BMI <18.5 kg/m2 were excluded), categorized by baseline BMI. 2-year outcomes (primary endpoint = composite of all-cause mortality and disabling stroke) were compared using Kaplan-Meier rates; association of obesity with outcomes was assessed using Cox proportional hazards.
RESULTS: 250 patients (12.5%) were significantly obese (BMI ≥ 35) and these patients were younger, more often female, and more frequently diabetic. Mean STS score was similar in obese and non-obese patients. Overall, there were no significant differences between patients with BMI above or below 35 kg/m2 in rates of the 2-year primary endpoint (17.4% vs 20.4%; p=0.25) or its components, nor in cardiovascular mortality (10.3% vs 10.6%; p=0.86). However, a significant interaction was observed between obesity and treatment arm; patients with BMI < 35 kg/m2 treated with SAVR or TAVR had similar rates of cardiovascular mortality (10.7% vs 10.6%, respectively; p=0.91), but patients with BMI ≥ 35 kg/m2 had significantly higher rates of cardiovascular mortality after SAVR compared with TAVR (15.4% vs 5.7%; p=0.01) (Figure) (p for interaction = 0.03). All-cause mortality was also higher in patients with BMI ≥ 35 kg/m2 undergoing SAVR versus TAVR (20.32% vs 11.21%); however, this difference did not reach statistical significance (p=0.06) (p for interaction = 0.09).
CONCLUSIONS: In the PARTNER 2 trial, intermediate-risk patients with severe AS and BMI ≥ 35 kg/m2 undergoing SAVR experienced significantly higher cardiovascular mortality than similar patients undergoing TAVR.
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