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IMPACT Registry: Increased Use of TPVR With Balloon-Expandable Valves

Use of transcatheter pulmonary valve replacement (TPVR) with balloon-expandable valves, notably for the treatment of regurgitant native right ventricular outflow tracts (RVOTs) with the SAPIEN valve, has increased over time, according to a recent study published in JACC: Cardiovascular Interventions.

Ada C. Stefanescu Schmidt, MD, MSc, FACC, et al., evaluated data captured by the ACC’s IMPACT Registry from April 2016 to March 2021 to explore the use and clinical outcomes of balloon-expandable TPVR. The authors looked at 4,513 patients (median age 19 years, 57% Melody valve, 43% SAPIEN valve), with most care facilities performing <10 procedures annually.

Of all the TPVR procedures analyzed, one-third were placed into homograft conduits, another third were into bioprosthetic valves, 25% were in native or patched RVOTs and 6% were into Contegra conduits. Over the five-year study period, SAPIEN valve use increased from about 25% to 60%, largely due to patients undergoing implants with a native or patched RVOT.

When looking at procedural outcomes, acute success was seen in 95% of cases – 95.7% in homografts, 96.2% in bioprosthetic valves, 94.2% in native RVOTs, 95.4% in Contegra valves – while major adverse events were observed in 2.4% of cases and were more likely to occur in patients with a homograft (2.9%) or native RVOT (3.4%) valve than those with a bioprosthetic valve (1.4%; p=0.004).

The study authors note “this study ended before commercial approval of self-expanding TPV platforms designed specifically for large native/patched RVOTs, so future analysis of IMPACT and other registries will be needed to see how utilization trends are affected by the availability of new valves.”

“Although the investigators’ main objective was to describe ‘the real world’ of TPVR, its routine practice in large RVOT is probably underestimated,” add Sébastien Hascoet, MD, PhD, Clément Karsenty, MD, PhD, and Alain Fraisse, MD, PhD, in their accompanying editorial comment. “Indeed, without the exclusion of the newer self-expandable valve implants, which are predominantly used in large native RVOT, this patient population would certainly be higher.”

Clinical Topics: Cardiac Surgery

Keywords: Registries, Heart Valve Prosthesis, Pulmonary Valve, IMPACT Registry, National Cardiovascular Data Registries


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