TCT
TCT
September 23, 2018
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SOLVE-TAVI: Valves, anesthesia strategies confer similar outcomes in symptomatic aortic stenosis

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Holger Thiele

SAN DIEGO — A self-expanding valve was equivalent to a balloon-expandable valve for 30-day outcomes in patients with symptomatic aortic stenosis who underwent transfemoral transcatheter aortic valve replacement, according to data from the SOLVE-TAVI trial presented at TCT 2018.

In addition, local and general anesthesia strategies during TAVR resulted in similar outcomes, according to the study.

Patients assigned to the balloon expandable heart valve (Sapien 3, Edwards Lifesciences) may have resulted in higher stroke rates compared with those assigned the self-expanding valve (CoreValve Evolut R, Medtronic), but the valves were associated with similar 30-day rates of a composite of stroke, all-cause mortality, permanent pacemaker implantation and moderate or severe prosthetic valve regurgitation.

Holger Thiele, MD, director and full professor of internal medicine/cardiology at Heart Center Leipzig at University of Leipzig in Germany, and colleagues analyzed data from patients who were assigned to the self-expanding valve (n = 219; mean age, 82 years; 48% men) or the balloon-expandable valve (n = 219; mean age, 82 years; 50% men).

Patients were also assigned to local (n = 218; mean age, 82 years; 49% men) or general anesthesia (n = 220; mean age, 81 years; 49% men).

The primary endpoint for the valve strategy component of the trial was all-cause mortality, stroke, permanent pacemaker implantation and either moderate or severe prosthetic valve regurgitation at 30 days. This occurred in 27.2% of patients assigned to the self-expanding valve and 26.1% of those assigned to the balloon-expandable valve (rate difference = 1.14; 90% CI, 8.15 to 5.87; P for equivalence = .02; P for superiority = .83).

Regarding the individual components of the primary endpoint, the self-expanding valve and the balloon-expandable valve groups had low mortality rates (2.8% vs. 2.3%, respectively; P for equivalence < .001; P for superiority = .77). More patients assigned the balloon-expandable valve had a stroke vs. those assigned the self-expanding valve (4.7% vs. 0.5%; P for equivalence = .003; P for superiority = .01).

There were low rates of moderate-to-severe valve regurgitation (self-expanding group, 1.9%; balloon-expandable group, 1.4%; P for equivalence < .001; P for superiority > .99), although there were high rates of pacemaker implantation in both groups (self-expanding group, 22.9%; balloon-expandable group, 19%; P for equivalence = .06; P for superiority = .34).

The primary endpoint for the anesthesia strategy was stroke, all-cause mortality, MI, acute kidney injury and infection requiring antibiotic treatment at 30 days. This was seen in 27% of patients assigned local anesthesia and 25.5% of those assigned general anesthesia (rate difference = –1.52; 90% CI, –8.47 to 5.42; P for equivalence = .02; P for superiority = .74).

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For individual components of the primary endpoint for anesthesia strategy, the local anesthesia group and the general anesthesia group had similar rates of mortality (2.8% vs. 2.3%, respectively; P for equivalence < .001; P for superiority = .77), stroke (2.4% vs. 2.8%, respectively; P for equivalence = .002; P for superiority > .99), MI (0.5% for both groups; P for equivalence < .001; P for superiority > .99), infection requiring antibiotics (21% in both groups; P for equivalence = .005; P for superiority > .99) and acute kidney injury (8.9% vs. 9.2%, respectively; P for equivalence < .001; P for superiority > .99).

“General anesthesia is associated with a higher rate of catecholamine use, but does not affect procedure times, valve-related outcome or clinical outcome,” Thiele said during a press conference. – by Darlene Dobkowski

Reference:

Thiele H, et al. Late-Breaking Trials 3. Presented at: TCT Scientific Symposium; Sept. 21-25, 2018; San Diego.

Disclosure: Thiele reports no relevant financial disclosures.