Accurate Neo prosthetic valve for percutaneous treatment of pure aortic regurgitation

Abstract Introduction The evidence regarding the outcomes of Accurate Neo in pure aortic insufficiency is limited. Methods This is an investigator-initiated multicenter study that retrospectively enrolled patients with severe pure AR treated with the Accurate Neo valve. The results of Accurate Neo in aortic regurgitation have been compared with those reported in the multicenter PRECISA registry. Results 71 patients with severe pure AR treated with the Accurate Neo valve were included (33.8% Accurate Neo; 63.4% Accurate Neo 2; 2.8% Accurate Prime). The mean age was 77.8 years, and 83.1% were women. A total of 16.9% had an estimated glomerular filtration rate 30 ml/min. Most patients (70.4%) were in NYHA class III, while 14.1% were in NYHA class IV. 85.9% of the patients underwent the procedure electively, while the remaining 14.1% required an urgent procedure. The mean EuroScore II was 6.3%, and the average left ventricular ejection fraction (LVEF) was 51.5%. Only 5.6% presented with valvular calcification, and just one patient (1.4%) had a bicuspid valve. The mean annulus perimeter was 73.4 mm. The therapeutic approach was predominantly transfemoral (94.4%), followed by transapical in 3 cases (4.2%) and trans-subclavian in 1 case (1.4%). Procedural success was achieved in 69 patients (97.2%). One patient died during the procedure, and another required an emergency intervention due to critical status, where valve deployment was not possible due to extreme hemodynamic instability after crossing the valve with the wire. No cases of coronary obstruction or annular rupture were reported. No patients required a second valve implantation, surgery, or reintervention. Post-dilatation with a balloon was required in 7.0% of cases. There were no instances of prosthetic valve embolization, and only one case (1.4%) required slight repositioning using a snare. No patients experienced residual AR ≥ moderate, and the mean transvalvular gradient post-implantation was 6.3 mmHg. The pacemaker implantation rate was 9.9%. Thirty-day mortality was 4.2%, and one-year follow-up mortality was 8.5%. When compared to patients treated with Accurate Neo for severe aortic stenosis, no differences were found in procedural success (97.2% vs 98.3%; p = 0.533), pacemaker rate (9.9% vs 8.8%; p = 0.776), or 30-day mortality (4.2% vs 3.0%; p = 0.614). However, a significantly lower incidence of residual aortic regurgitation ≥ moderate was observed (0.0% vs 6.4%, p = 0.028). Conclusions The Accurate Neo prosthetic aortic valve is associated with a high procedural success rate in treating pure aortic regurgitation, along with a low incidence of residual aortic regurgitation, device embolization, and the need for second-valve implantation, compared to previously reported outcomes in patients with aortic stenosis.