Experience with the ACURATE neo and neo2 transcatheter aortic valves in Spain. The PRECISA (PRospective Evaluation Complementing Investigation with ACURATE devices) registry.

BACKGROUND: Previous studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long-term clinical and hemodynamic outcomes of these patients. AIMS: This study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real-world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long-term effectiveness. METHODS: A prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second-generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow-up were compared between the two generations. RESULTS: A total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14.5%. The primary reason for the absence of device success was the presence of para-valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91.7% vs. 82%, p = 0.04), primarily due to a significantly lower rate of para-valvular regurgitation, which remained significant at 1 year. CONCLUSION: The use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL.

The routine use of surgical exposure approach for trans-femoral implantation of the balloon expandable aortic prosthesis is associated to a low rate of vascular complications.

BACKGROUND: The most frequent complications of transfemoral aortic valve implantation are vascular (15-25%) and are related to an increase in mortality. We sought to assess the rate of vascular complications, its treatment and outcomes using a surgical approach for transfemoral implantation of Edwards-SAPIEN (Edwards Lifescience, Irvine, CA, USA) aortic valve. METHODS: We have conducted a multicenter registry including 4 hospitals using a systematic surgical exposure approach. Vascular complications have been collected following the definitions of the Valve Academic Research Consortium. RESULTS: From 2008 to 2013 a total of 312 consecutive patients have been included. Vascular complications were reported in 22 (7%), among those 6 (1.9%) were major whereas 16 (5.1%) were minor. Patients suffering vascular complications had significantly more previous history of peripheral vascular disease. All but one major complications occurred in women, aged 82-88 and with chronic renal failure. Hospital stay was longer in cases suffering complications (17.8±11 days vs. 9±7 days; P<0.0001). The 30 days mortality was 13.6% in patients with vascular complications, 33.3% in patients with major complications and 5.5% in patients with no complications (P=0.05). CONCLUSIONS: In this registry, the systematic use of a surgical exposure of the femoral artery for TAVR has been associated with a lower rate of vascular complications.