TAVR with mechanically expandable prostheses: Is balloon aortic valvuloplasty really necessary?

BACKGROUND: The fully retrievable and repositionable Lotus Valve System uses a unique mechanical expansion mechanism. Balloon aortic valvuloplasty (BAV) is recommended before valve deployment. There are no studies focusing on feasibility and efficacy of Lotus Valve implantation without previous BAV. METHODS AND RESULTS: Thirty consecutive patients (63.3% female; mean age, 80±6.2years) underwent transcatheter aortic valve replacement (TAVR) with the Lotus Valve without preparatory BAV. Mean baseline aortic valve area was 0.41±0.14cm2/m2; mean transvalvular gradient was 50.2±16.2mmHg. All patients were successfully implanted, with 96.6% device success (VARC-2 definition) and 0% intra-procedural mortality. Partial and full valve repositioning were performed in 11 (36.7%) and 2 (6.7%) cases, respectively. Mean 30-day transprosthetic gradient was 11.3±3.6mmHg, with an effective aortic orifice area of 1.0±0.2cm2/m2, and more than mild paravalvular leakage (PVL) in only one patient. At 30days, cardiac mortality was 3.3%, and 96.3% of subjects were NYHA Class I or II. The rate of life-threatening bleeding was 10%; one patient experienced disabling stroke. Ten patients underwent new pacemaker implantation (38%). CONCLUSIONS: TAVR with the mechanically expandable Lotus Valve seems feasible without performing preparatory BAV. Valve hemodynamics at 30-days were favorable, and clinical outcomes were similar to studies employing routine preparatory BAV.