TAVI Using a Balloon-Expandable Transcatheter Heart Valve in Patients with Aortic Annuli Exceeding Formally Approved Dimensions

Background: Transcatheter aortic valve implantation (TAVI) is aortic annuli >29 mm represent a special technical challenge since common balloon-expandable (BE) transcatheter heart valves (THV) are approved for aortic annuli ≤29 mm. However, treatment of aortic annuli above this limit is possible by overfilling of the deployment balloon of the most common BE THV. The aim of this study was to analyze outcomes of patients undergoing TAVI using BE THV and aortic annuli >29 mm.

Method: Between 2012 and 2021, a total of 45 patients with aortic annuli ˃29 mm were identified from our TAVI database including a total of 4.340 patients. Annular dimensions were assessed using preprocedural multi-slice computed tomography (MSCT). Acute procedural and early clinical outcomes were adjudicated in accordance with standardized VARC-3 definitions.

Results: Implantation of THV was conducted via transfemoral (41/45, 91.1%), transapical (2/45, 4.5%), transcaval (1/45, 2.2%) or transaxillary (1/45, 2.2%) access. Annular dimensions were > 29.0 to < 30.0 mm in 66.7% (30/45), > 30.0 to < 31.0 mm in 22.2% (10/45) and > 31.0 mm in 11.1% (5/45) of patients. THV were implanted using nominal filling volumes in 42.2% (19/45) of cases and increased filling volumes in 57.8% (26/45). Adjusted filling volumes were: 1.0 mL ± 1.1 mL for > 29 to <30 mm, 1.3 mL ± 1.2 mL for >30 to < 31 mm and 2.6 mL ± 1.6 mL for >31 mm.

Technical success, device success and early safety were 100% (45/45), 97.8% (44/45) and 66.7% (30/45), respectively. One patient required open heart surgery due to bleeding complications in the area of the left ventricular outflow tract. All-cause 30-day mortality was 0% (0/45). Postprocedure echocardiography showed paravalvular leakage (PVL) > mild in 0% (0/45). Mean transvalvular gradient was 9.5 ± 3.6 mm Hg.

Conclusion: Prevalence of aortic annuli > 29 mm is low. The herein presented results suggest technical feasibility and clinical safety. However, additional anatomical factors like calcification pattern of the aortic valve complex should be taken into preprocedural considerations to be discussed within the heart team. In the entire cohort no relevant incidence of significant PVL or central aortic regurgitation was documented. Whether overexpanded valve stents contribute to accelerated valve deterioration should be subject of further investigation.

Publication History

Article published online:
28 January 2023