Single-Center Study Evaluates On-Label and Off-Label TAVR Outcomes

July 1, 2014—Joel A. Lardizabal MD, et al conducted a single-center study to evaluate the efficacy, safety, and clinical consequences of on-label and off-label transcatheter aortic valve replacement (TAVR) in the real-world setting. The findings were published in Catheterization and Cardiovascular Interventions (2014;84:124–128). The investigators are from the Multi-Disciplinary Structural Heart Disease Program of the University of Miami’s Miller School of Medicine in Miami, Florida.

As noted by the investigators, the transcatheter heart valve (THV) was initially approved only for transfemoral (TF) delivery (on-label use) during TAVR in inoperable patients with severe aortic stenosis (AS). Because of a lack of alternative options in TAVR-eligible patients with inadequate TF access, other routes have been used for THV implantation (off-label use), the outcomes of which were previously unknown.

As summarized in Catheterization and Cardiovascular Interventions, consecutive patients with severe inoperable AS who underwent clinical TAVR at their institution were enrolled in a prospective database. Fifty patients underwent TF-TAVR (on-label group), while non-TF routes were used in 60 patients (off-label group). Procedural events, 30-day clinical outcomes, and 1-year all-cause mortality data were analyzed.

The investigators reported that technical device success was similar between on-label and off-label groups (88% vs 87%, respectively; P  = .92), as was the incidence of procedural complications and 30-day clinical events. The on-label group had a lower 1-year all-cause death rate (12%) compared to the off-label group (32%; P  = .02). The 1-year all-cause mortality in the off-label group was comparable to published clinical trial and registry data on TAVR and appeared lower than historical outcomes with conservative medical therapy.

On-label use of the THV in the real-world setting was associated with favorable survival outcomes compared to off-label TAVR and historical data. Off-label use of the THV appeared to be safe and effective when used in select patients with inoperable AS who are not eligible for TAVR via TF approach, concluded the investigators in Catheterization and Cardiovascular Interventions.