**6.1 SAPIEN 3 Ultra (Edwards Lifesciences)**

The balloon-expandable SAPIEN 3 Ultra transcatheter aortic valve is the fifthgeneration valve in the Sapien series and is available in four sizes (20, 23, 26, and 29 mm). Its design consists of three bovine pericardial tissue leaflets with a

cobalt-chromium frame. The novel modifications of this device include the polyethylene terephthalate cuff that has significantly minimized the rate and degree of paravalvular leaks. The Ultra has a greater frame height than the previous generation, allowing an even greater reduction of paravalvular leaks [36]. It is neither retrievable nor repositionable. The Commander Delivery System (Edwards Lifesciences) consists of an inner balloon on which the valve is crimped prior to advancement. A transfemoral approach is preferred using a 14 or 16 French (F) Edwards eSheath and crimper. In cases in which femoral access is not feasible or appropriate, a transaortic or transapical approach may also be utilized. In such cases, a Certitude delivery system is needed. This system is compatible with 18 and 21-F sheaths. The 21-F sheath is reserved for the larger 29 mm valve. The PARTNER trials are the largest clinical trials that have reported outcomes of the SAPIEN 3 which led to FDA approvals in all four risk profiles. When compared to the SAVR cohort from PARTNER II, TAVR with the SAPIEN 3 valve demonstrated lower rates of mortality (7% vs. 12.4%) and stroke (4.5% vs. 7.9%) at 1-year follow up in low-risk patients [13].

### **6.2 Myval (Meril Life Sciences)**

The balloon expandable Myval heart valve obtained its CE mark in 2019. It consists of a tri-leaflet made of bovine pericardium on a cobalt alloy frame as well as a polyethylene terephthalate cuff similar to the SAPIEN 3 that is in place both internally and externally to reduce paravalvular leaks. It comes in nine sizes (20, 21.5, 23, 24.5, 26, 27.5, 29, 30.5, and 32 mm). The valves should be crimped over Navigator THV Balloon Delivery System (Meril Life Sciences) prior to advancement through the introducer.

#### **6.3 Evolut PRO+/FX (Medtronic)**

The self-expanding supra-annular Evolut Pro+ is a new generation FDA-approved valve in the Evolut series and offers the lowest delivery profile for 23–29 mm valves, capable of treating vessels down to 5.0 mm. Valves from this series have been the most extensively studied and most commonly implanted. It is available in four sizes (23, 26, 29, and 34 mm). Its design consists of three porcine pericardial tissue leaflets mounted on a frame made of nitinol. The novel modification of this device is the newly added porcine external skirt which minimizes paravalvular leaks [37]. Valves of the Evolut series have been shown to cause greater rates of conduction disturbances and pacemaker dependency compared to some of the other valves [38]. However, the data available on the Pro+ thus far has shown lower rates of pacemaker implantation. The delivery system allows the valve to be recaptured up to three times. In the US Evolut PRO Study, zero patients experienced moderate paravalvular leak during the same follow-up period used in the PARTNER II SAPIEN 3 trial, in which moderate paravalvular leak was seen in 3.4% of patients. In 2022, Medtronic announced their next generation of Evolut valve—the Evolut FX. They have significantly improved commissural alignment which we anticipate will allow better coronary flow and access when needed. The FX also allows for easier tracking as it now has gold markers built into the frame. These prototype modifications should overall help improve alignment

and allow for symmetric implantations. Multicenter studies are ongoing but preliminary data has thus far shown favorable outcomes.

#### **6.4 ACURATE Neo/Neo2 (Boston Scientific)**

The ACURATE Neo2 is a self-expanding supra-annular nitinol alloy stent available in three sizes: small (21–23 mm), medium (23–25 mm), and large (25–27 mm). Its design consists of porcine leaflets mounted on a large-cell nitinol frame that allows for easy coronary access. An 18-F sheath is required for transfemoral approach. A simple two-step deployment provides the operator with greater ease of deployment. The global SAVI registry revealed very positive outcomes in terms of pacemaker implantation rates and stroke (8.2% and 1.9% respectively) [39].
