CoreValve: Cost-Effectiveness of TAVR vs. SAVR; Long-Term Outcomes of TAVR Using a Self-Expanding Bioprosthesis in Extreme-Risk Patients

With modest reductions in the cost of transcatheter aortic valve replacement (TAVR) using a self-expanding prosthesis, the value of TAVR compared with surgical aortic valve replacement (SAVR) in high-risk aortic stenosis patients would be high, according to results from a new study presented Sept. 13 as part of TCT 2014.

Additional Resources
  • TCT 2014 Meeting Coverage
  • CoreValve US High Risk Clinical Trial Update
  • CoreValve US High Risk Presentation Slides
  • CoreValve US Pivotal Presentation Slides
  • The study aimed to quantify “in-trial” survival, quality of life, quality-adjusted survival, resource use and costs for both TAVR and SAVR based on patients enrolled in the CoreValve US Pivotal High Risk Trial. Overall results found that TAVR provided meaningful clinical benefits relative to SAVR, improving one-month quality of life and 12-month survival. Study authors noted that, based on projections, TAVR added ~0.24 life years and 0.20 quality-adjusted life years (QALYs) per patient.

    In terms of costs, index admission costs were higher with TAVR by approximately $11,000 per patient, and lifetime costs were projected to be higher by about $13,700. Projected lifetime incremental cost-effectiveness ratios were approximately $67,000 per QALY gained and $57,000 per life year gained. According to the study authors, results were “slightly more favorable for patients eligible for iliofemoral access and slightly less favorable, though still acceptable, for patients not eligible for iliofemoral access.”

    “In this high-risk population, TAVR provided meaningful clinical benefits relative to SAVR, with incremental costs considered acceptable from a US perspective,” said Matthew Reynolds, MD, MSc, FACC, who presented the trial results. He suggested that slight reductions in costs would make the benefits of TAVR even higher.

    Meanwhile, in a separate CoreValve Trial update also presented at TCT 2014, investigators found that patients with severe aortic stenosis deemed at extreme risk for surgery whom underwent TAVR using a self-expanding bioprosthesis, continued to see low rates of all-cause mortality and stroke two years after the procedure.

    The original CoreValve Extreme Risk study was based on 489 patients over the age of 83 in whom an iliofemoral implant procedure was attempted. Patients in the study had a high frequency of medical co-morbidities including coronary artery disease, peripheral vascular disease, previous myocardial infarction and severe STS Chronic Lung Disease. They were also extremely frail, had a low body mass index, poor grip strength and dependence on home oxygen.

    One-year results from the study presented at TCT 2013 supported the safety and efficacy of the self-expanding bioprosthesis in patients unsuitable for surgical aortic valve replacement. The new results, based on 305 patients at two years out, continue to confirm the survival benefits associated with this treatment.

    According to study investigators, not only were there low rates of all-cause mortality and major stroke, patients also saw improvements in NYHA classifications and hemodynamic valve performance. In addition, there were low rates of moderate or severe aortic insufficiency and no association of mild or moderate paravalvular regurgitation on mortality.

    Keywords: Heart Valve Prosthesis, Stroke, Myocardial Infarction, Peripheral Vascular Diseases, Hemodynamics, Hand Strength, Body Mass Index, Bioprosthesis, Quality of Life, Oxygen, Quality-Adjusted Life Years, Lung Diseases

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