Palliative Balloon Valvuloplasty for Late Stenosis of a Degenerated Transcatheter Heart Valve: Proof of Concept

A 74-year-old male Jehovah’s Witness with bicuspid aortic stenosis and advanced underlying cardiomyopathy underwent transcatheter aortic valve replacement (TAVR) with a 34-mm Evolut R CoreValve (Medtronic Inc). He remained well until 5 years later when he was admitted with heart failure. Transesophageal echocardiogram (TEE) demonstrated severe structural valve degeneration (SVD) with stenosis (peak: 58 mm Hg, mean: 34 mm Hg, Vmax 3.8 m/s, effective orifice area of 0.85 cm2, and LVOT/AV VTI ratio of 0.16), and ejection fraction of 20%. (Figure 1A, B, and Supplemental Videos 1 and 2). Computed tomography (CT) showed a reasonably well-expanded valve but with eccentric expansion toward the right sinus (Figure 1C, D). CT indicated high risk of right coronary artery (RCA) obstruction with redo-TAVR due to low height of RCA (around node 5 of the Evolut Valve) and risk of the sinus sequestration from “neoskirt” extension above the sino-tubular junction and valve to RCA distance <2 mm. In addition, CT revealed proximity of 1 of the commissures to the RCA orifice which precluded the use of leaflet modification techniques. (Figure 1E-G). Cardiac catheterization confirmed low height of the RCA and effaced right sinus (Figure 1H, Supplemental Video 3). As the patient was not a surgical candidate for TAVR explant, our heart team decided on palliative balloon valvuloplasty of the Evolut valve to improve leaflet mobility. The RCA was protected with a coronary wire and balloon during the procedure to avoid debris or pinned Evolut leaflet obstructing the coronary flow. Balloon valvuloplasty with a 26 mm balloon was decided based on preindex TAVR CT analysis of the native anatomy. The Impella left ventricular support system (Abiomed), and balloon expandable Sapien-3 Ultra valve (Edwards Lifesciences) with a size of 29 mm were kept as a backup in the event of the development of massive aortic regurgitation (AR) requiring rapid transcatheter heart valve (THV) replacement. Balloon valvuloplasty with a 26 mm Sapien 3 system (Edwards Lifesciences) was performed with cerebral embolic protection (Claret Sentinel Cerebral Protection System, Boston Scientific). Simultaneous aortography revealed complete nonopacification of the right sinus and RCA (Figure 1I, Supplemental Video 4). Following valvuloplasty, the mean/peak transvalvular gradient decreased to 10/17 mm Hg; however, TEE initially showed severe transvalvular AR (Figure 1J, Supplemental Video 5). Given that the prosthetic leaflet might have been stuck in the open position, the RCA guide catheter was used to manipulate the leaflets to a closed position, reducing the AR to trivial. (Figure 1K; Supplemental Video 6). The postprocedural course was uneventful, and the patient was discharged home with a mean gradient of 10mm Hg, AVA 1.3cm2, Post LVOT/AV VTI ratio of 0.66, and trivial AR (Figure 1L, Supplemental Videos 7, 8). He remained well at the 30-day and 3-month follow-ups with no change in echocardiographic findings. Numerous clinical and bench studies have provided evidence of stable THV hemodynamics and long-term durability, with follow-up durations of up to 8 and 25 years, respectively. Nevertheless, THV can occasionally fail, necessitating either TAVR explant or redo-TAVR as treatment options.1Jørgensen T.H. Thyregod H.G.H. Ihlemann N. et al.Eight-year outcomes for patients with aortic valve stenosis at low surgical risk randomized to transcatheter vs. surgical aortic valve replacement.Eur Heart J. 2021; 42: 2912-2919https://doi.org/10.1093/eurheartj/ehab375Crossref PubMed Scopus (103) Google Scholar,2Sathananthan J. Hensey M. Landes U. et al.Long-term durability of transcatheter heart valves: insights from bench testing to 25 years.JACC Cardiovasc Intv. 2020; 13: 235-249https://doi.org/10.1016/j.jcin.2019.07.049Crossref Scopus (19) Google Scholar Redo-TAVR can pose challenges due to the risk of coronary obstruction. Implanting a THV inside a failing THV pins the leaflets of the first valve in the open position, creating a “neoskirt.” Bench studies have demonstrated that low implantation of a short-stent frame THV in a prior THV provides a shorter neoskirt height, which may facilitate coronary access after redo-TAVR.3Akodad M. Sellers S. Landes U. et al.Balloon-expandable valve for treatment of Evolut valve failure: implications on neoskirt height and leaflet overhang.JACC Cardiovasc Intv. 2022; 15: 368-377https://doi.org/10.1016/j.jcin.2021.12.021Crossref Scopus (17) Google Scholar However, this is not feasible if the primary mechanism of failure is stenosis, as in our case, because the leaflet overhang of the failed stenotic THV may impact the hydrodynamic performance of the second THV. In addition, the proximity of 1 of the commissures to the RCA orifice on CT precluded us from using leaflet modification (BASILICA) or leaflet removal techniques. Due to the above factors associated with a high risk of RCA obstruction associated with redo-TAVR and high surgical risk for TAVR explant, the patient was considered for palliative late balloon valvuloplasty, which was safely and effectively performed. Balloon valvuloplasty in non-SVD after TAVR is a recognized treatment option.4Akodad M. Blanke P. Chuang M.A. et al.Late balloon valvuloplasty for transcatheter heart valve dysfunction.J Am Coll Cardiol. 2022; 79: 1340-1351https://doi.org/10.1016/j.jacc.2022.01.041Crossref Scopus (7) Google Scholar We describe a successful case of late balloon valvuloplasty of a failed stenotic THV. However, long-term results and risks associated with this procedure are unknown. Therefore, it can be considered as an option in a patient where redo-TAVR or TAVR explant is not feasible. Further investigations are needed to determine if this bailout option can be applied to all stenotic transcatheter valves.