Early clinical and procedural outcomes in large series of 34‐mm self‐expanding transcatheter aortic valve replacement

OBJECTIVES: We aimed to evaluate early clinical and procedural outcomes with the 34-mm Evolut R transcatheter aortic valve replacement (TAVR) prosthesis. BACKGROUND: The 34-mm Evolut R (Medtronic, Minneapolis, MN) self-expanding TAVR prosthesis was designed to treat patients with larger annuli. METHODS: Clinical, demographic, procedural, and echocardiographic data on consecutive patients who underwent TAVR with a 34-mm Evolut R prosthesis at our institution were collected and analyzed. RESULTS: One hundred ninety-six patients underwent TAVR with this prosthesis from November 2016 to July 2018, a majority (n = 188, 96%) through transfemoral access and with conscious sedation (n = 182, 93%). Mean age, Society of Thoracic Surgery risk score, and follow-up were 82 +/- 8 years, 5.4 +/- 5%, and 8.2 +/- 5.3 months, respectively. Mean aortic valve (AV) peak velocity was 4.0 +/- 0.6 m/s, mean AV gradient was 38 +/- 13 mmHg, AV area was 0.79 +/- 0.23 cm(2) ; calcium score was 3,503 +/- 1,970 Agatston units, and perimeter was 85 +/- 4.3 mm. Device implantation was successful in all but one patient. Postprocedure mean AV peak velocity, AV mean gradient, and AV area were 1.9 +/- 0.4 m/s, 7 +/- 3 mmHg, and 2.6 +/- 0.7 cm(2) , respectively. New pacemaker requirement rate was 16%, and moderate paravalvular leak was present in six patients (3%), which improved to mild in three patients at 6-month follow-up. In-hospital, 30-day, 6-month, and 12-month survival rates were 98%, 96% (hospital discharge), 96% (30-day), 89% (6-month), and 83% (12-month). CONCLUSION: These data demonstrate high success and good procedural, echocardiographic, and clinical outcomes of 34-mm Evolut R in patients with large annuli.