Outcomes for TAVR vs. SAVR in Low-Risk Aortic Stenosis Patients

Quick Takes

  • In patients ≥70 years with severe symptomatic aortic stenosis at low surgical risk, TAVR compared to SAVR was associated with similar clinical outcomes in terms of all-cause mortality, stroke, or MI; and similar risks of bioprosthetic valve failure.
  • In the same cohort, TAVR was associated with superior hemodynamics and lower risk of structural valve deterioration.
  • The ability to extrapolate these findings to other low-risk populations might be limited by the advanced age of the study cohort (mean age 79 years) and the predominant use of surgically implanted bioprostheses with known issues related to hemodynamics or durability.

Study Questions:

Are there clinical outcome or valve durability differences 8 years after intervention between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) among patients with severe symptomatic aortic stenosis at low surgical risk?

Methods:

The NOTION (Nordic Aortic Valve Intervention) trial is an investigator-initiated, unblinded, randomized clinical trial conducted at hospitals in Denmark and Sweden in which patients ≥70 years old with symptomatic severe aortic valve stenosis were randomized to TAVR (first-generation self-expanding Medtronic CoreValve) or bioprosthetic SAVR (St Jude Medical Epic [29%], Medtronic Mosaic [27%], St Jude Medical Trifecta [24%], Carpentier-Edwards Perimount [10%], and Sorin Mitroflow [10%]). Standardized definitions were used to assess clinical status, echocardiography, structural valve deterioration (SVD), and bioprosthetic valve failure (valve-related death, severe hemodynamic SVD, or aortic valve reintervention).

Results:

A cohort of 280 patients was randomized to TAVR (n = 145) or SAVR (n = 135). Baseline characteristics were similar, including mean age of 79.1 ± 4.8 years and a mean Society of Thoracic Surgeons (STS) score of 3.0 ± 1.7%. At 8-year follow-up, the estimated risk of the composite outcome of all-cause mortality, stroke, or myocardial infarction (MI) was 54.5% after TAVR and 54.8% after SAVR (p = 0.94). The estimated risks for all-cause mortality (51.8% vs. 52.6%, p = 0.90), stroke (8.3% vs. 9.1%, p = 0.90), or MI (6.2% vs. 3.8%, p = 0.33) were similar after TAVR and SAVR. TAVR compared to SAVR was associated with a lower mean gradient and a larger effective orifice at every yearly follow-up interval through 8 years (p < 0.05). The risk of SVD was lower after TAVR than after SAVR (13.9% vs. 28.3%, p = 0.0017), whereas the risk of bioprosthetic valve failure was similar (8.7% vs. 10.5%, p = 0.61).

Conclusions:

In patients with severe aortic valve stenosis at low surgical risk randomized to TAVR or SAVR, the authors concluded that there were no significant differences in the risk for all-cause mortality, stroke, or MI; or the risk of bioprosthetic valve failure after 8 years of follow-up.

Perspective:

These relatively long-term follow-up data from a multicenter, randomized trial of TAVR vs. SAVR in patients ≥70 years of age with severe symptomatic aortic stenosis at low operative risk suggest similar clinical outcomes in terms of all-cause mortality, stroke, or MI; superior hemodynamics and lower risk of SVD after TAVR; and similar risk between groups of bioprosthetic valve failure. Although reassuring for the use of TAVR in low-risk patients, the study is limited by two factors. First, longer-term outcomes among a study cohort with an average age of 79 years at the time of intervention might not be applicable to younger patients who have fewer competing morbidity and mortality risks. Second, the devices used might not be representative of those commonly used today. Understandably, TAVR utilized a first-generation device, which might not be representative of devices currently implanted. Of greater concern, the surgically implanted bioprostheses predominantly (90%) included devices with either known poor hemodynamic profiles or known issues with durability, biasing the surgical comparison group toward anticipated less favorable hemodynamics and higher rates of SVD.

Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound

Keywords: Aortic Valve Stenosis, Bioprosthesis, Cardiac Surgical Procedures, Diagnostic Imaging, Echocardiography, Geriatrics, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Morbidity, Myocardial Infarction, Risk, Stroke, Transcatheter Aortic Valve Replacement


< Back to Listings