Transcatheter aortic valve replacement using newer-generation devices was associated with improved procedural outcomes in treating patients with pure native aortic regurgitation compared to TAVR with early generation devices, new research shows. Sung-Han Yoon, MD, of Cedars-Sinai Heart Institute in Los Angeles, assessed the outcomes of 331 patients from the pure native AR TAVR multicenter registry with a mean Society of Thoracic Surgeons (STS) score of 6.7 (intermediate to high surgical risk profile). Early generation devices were used in 119 patients (36%) and new-generation devices were used in 212 patients (64%). There was a trend of lower surgical risk scores in the new-generation device group compared with the early generation device group. Compared with the early generation devices, new-generation devices were associated with a significantly higher device success rate (81.1% vs. 61.3%, p<0.001) due to lower rates of second-valve implantation (12.7% vs. 24.4%, p=0.007) and postprocedural AR ≥ moderate (4.2% vs. 18.8%, p<0.001), Yoon and colleagues found in the paper, which was published in the Dec. 5 issue of the Journal of the American College of Cardiology. There were no significant differences in major 30-day endpoints between the 2 groups; however, new-generation devices tended to be associated with a higher rate of stroke (5.7% vs. 1.7%, p=0.08) but a lower rate of stage 2 or 3 acute kidney injury (6.1% vs. 11.8%, p=0.07). At 1-year follow-up, there were no significant differences in all-cause mortality between the early and new-generation device groups (28.8% vs. 20.6%; log-rank p=0.13); however, the new-generation devices were associated with a lower 1-year cardiovascular mortality (9.6% vs. 23.6%, log-rank p=0.008). The overall cumulative event rate or rehospitalization at 1-year follow-up was 30.5%, with a significantly higher rate of rehospitalization in patients with postprocedural AR ≥ moderate compared with those with postprocedural AR ≤ mild (66.0% vs. 27.1%, log-rank p=0.003), the authors found. “Compared with the early-generation devices, TAVR using the new-generation devices was associated with improved procedural outcomes in treating patients with pure native AR,” the authors concluded. “In patients with pure native AR, significant post-procedural AR was independently associated with increased mortality.” In an accompanying editorial, Patricia A. Pellikka, MD, of Mayo Clinic in Rochester, Minn., and George Dangas, MD, PhD, of Mount Sinai Hospital in New York, congratulated the colleagues for their findings but raised several questions. Pellikka and Dangas noted that surgical aortic valve replacement (SAVR) is the current standard of care for most patients with symptomatic severe AR, and that surgeons with special expertise can repair, rather than replace, aortic valves “in some patients with AR caused by dilated aortic root, cusp perforation, or prolapsed if the valve is not heavily calcified or deformed.” The editorialists asked what other factors not accounted for by the STS score made these patients ineligible for surgery, and they asked if there was an upper limit for aortic annulus dimension. (Patients in this study were classified according to annulus diameter <25.2 mm versus ≥25.2 mm.) They also asked, “If all patients had pure AR without stenosis, why was balloon pre-dilation performed in 7.9%?” “Presently, the outcomes for patients undergoing TAVR for severe AR are worse compared with those with on-label indications,” the editorialists wrote. “But with continued modifications in TAVR prostheses, including anchoring mechanisms, sealing cuffs, additional sizes, and capacity for retrievability and repositioning; refinements in best practices, such as optimal periprocedural imaging, patient sedation, and prosthesis sizing (perhaps using oversizing with decreasing levels of calcification but also avoiding cases with too little calcium); and patient selection, including refinements in risk assessment that incorporate frailty, outcomes will improve. “Percutaneous aortic valve replacement will eventually become a standard therapy for isolated severe regurgitation and will save lives.”