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Self-expanding TAVR yields better systolic valve performance, less patient-prosthesis mismatch vs. surgical AVR
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Transcatheter aortic valve replacement with a self-expanding bioprothesis was associated with better systolic valve performance, less right ventricular systolic dysfunction, similar left ventricular remodeling and more paravalvular regurgitation compared with surgical aortic valve replacement in patients with severe aortic stenosis at high surgical risk, according to new data from the CoreValve US High-Risk Clinical Study.
For the overall trial, 747 high-risk patients with severe aortic stenosis and NYHA class II or higher HF were randomly assigned to undergo TAVR with the self-expanding CoreValve (Medtronic) or surgical AVR. Investigators obtained echocardiograms at baseline, upon discharge and at 30 days, 6 months and 1 year for the new analysis; all echocardiograms were analyzed at a central core laboratory.
At discharge and 1 year, patients who underwent TAVR had significantly lower mean aortic valve gradient and larger valve area compared with those who underwent surgical AVR (P < .001 for both). At 1 year, the TAVR group also had a lower incidence of patient-prosthesis match: 27% (6.2% severe) vs. 56.3% (25.7% severe).
After the procedure, patients assigned TAVR exhibited “significant favorable change[s]” in LV end-systolic diameter (–0.09 cm; P = .005), LV end-systolic volume (–4.9 mL; P = .026) and LV ejection fraction (2.4%; P < .0001) from discharge to baseline; no change in LV end-diastolic diameter and LV end-diastolic volume from baseline to 1 year; and a significant increase in Doppler stroke volume at 1 year (P < .05). Patients assigned surgical AVR exhibited significant reductions in LV end-diastolic diameter (–0.21 cm; P < .0001), LV end-systolic diameter (–0.12; P = .006), LV end-diastolic volume (–18.3 mL; P = .001), LV end-systolic volume (–9.7 mL; P = .002) and Doppler stroke volume (–12 mL; P < .0001) from discharge to baseline, and a significant improvement in LVEF from discharge to 1 year (2.6%; P < .001).
In other results, patients assigned TAVR and surgical AVR both experienced significant reductions in LV mass, LV mass index, and interventricular and posterior wall thickness from baseline to 1 year. Only those assigned TAVR experienced a significant reduction in concentric LV remodeling from baseline to 1 year. Right ventricular systolic function was similar in both groups at baseline, but was significantly reduced in the surgical AVR group at discharge and 1 month. The investigators reported no significant difference in right ventricular function between the two groups at any time point.
At 1 year, all-cause mortality was 14.2% in the TAVR group vs. 19.1% in the surgical AVR group. Before the procedure, mild or greater aortic regurgitation was associated with reduced mortality for those who underwent TAVR (HR = 0.48; 95% CI, 0.27-0.85) and surgical AVR (HR = 0.53; 95% CI, 0.32-0.87). After the procedure, mild or greater aortic regurgitation was associated with greater risk for all-cause mortality (HR = 1.95; 95% CI, 1.08-3.53).
The TAVR group had a higher incidence of mild, moderate or severe paravalvular regurgitation compared with the surgical AVR group at all time points (P < .001). From discharge to 1 year, 76% of patients in the TAVR group with moderate to severe paravalvular regurgitation at discharge had an improvement of at least one grade. – by Jennifer Byrne
Disclosure: The study was funded by Medtronic. One researcher reports serving on the speaker’s bureau for St. Jude Medical, receiving grant support from Abbott Vascular and receiving institution support from Medtronic. Please see the full study for a list of all other researchers’ relevant financial disclosures.
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