Transcatheter Aortic Valve Implantation for Pure Noncalcified Native Aortic Valve Regurgitation

Objectives: Transcatheter aortic valve implantation (TAVI) in patients with pure noncalcified aortic regurgitation (AR) is challenging but can be successfully performed in selected patients. The aim of this study was to analyze feasibility and early outcomes of patients who were treated for such an indication.

Methods: Between May 2012 and June2019, thirty-four high-risk patients (58.8% male; mean age 71.3 ± 11.8 years; Society of Thoracic Surgeons (STS)/logistic European System for Cardiac Operative Risk Evaluation (Euroscore) II score of 6.1 ± 4.1%/5.7 ± 4.7%) underwent TAVI for severe pure noncalcified AR. Acute procedural and early clinical outcomes were analyzed in accordance with standardized VARC-2 definitions.

Results: Implantation of TAVI was conducted via transapical (19/34, 55.9%) or transfemoral (15/34, 44.1%) access. Types of transcatheter heart valve (THV) used were as follows: Jena Valve (22/34, 64.7%; JenaValve Technology GmbH, Munich, Germany), Acurate Neo (7/34, 20.6%; Boston Scientific, Marlborough, Massachusetts, USA), Edwards Sapien (3/34, 8.9%; Edwards Lifesciences, Irvine, California, USA), and Direct Flow (2/34, 5.8%; Direct Flow Medical Inc., Santa Rosa, California, USA). Choice of THV size followed an adjusted sizing algorithm. Procedure and fluoroscopy times were 114.3 ± 50.9 and 6.3 ± 11.9 minutes respectively, and amount of contrast agent used was 208.8 ± 98.7 mL. Pre- and post–balloon expansions were performed in 5.8% (2/34) and 11.7% (4/34). Postprocedure echocardiography showed no relevant aortic regurgitation > trace and mean transvalvular gradients of 9.0 ± 4.5 mm Hg.

The rate of VARC-2 device success and early safety was 91.1% (31/34). One patient required sequential transcatheter heart valve (THV) implantation for malpositioning and two patients were converted to open surgery due to residual severe aortic regurgitation and valve migration. Overall 30-day mortality was 2.9% (1/34). Bleeding complications and new permanent pacemaker were observed in 5.8% (2/34), respectively. Stroke and acute kidney injury occurred in 2.9% (1/34) and 17.6% (6/34).

Conclusion: TAVI for pure noncalcified AR remains a challenging pathology. Preliminary results suggest TAVI using THV designed for aortic stenosis is technically feasible and safe with excellent hemodynamic results in carefully selected patients. Currently, no dedicated devices are available for this clinical entity.