Annular size and interaction with trans-catheter aortic valves for treatment of severe bicuspid aortic valve stenosis: Insights from the BEAT registry

doi:10.1016/j.ijcard.2021.11.055

International Journal of Cardiology

Volume 349, 15 February 2022, Pages 31-38

https://doi.org/10.1016/j.ijcard.2021.11.055 Get rights and content

Highlights

•
TAVR can be successfully performed in severe bicuspid aortic stenosis.
•
However, interaction between annular size and THV type is still unclear.
•
We compared BEV and SEV hemodynamics by aortic annulus size in BAV patients.
•
In large annuli a higher rate of PVLs was observed SEVs compared to BEVs.
•
No differences in clinical outcomes were observed according to annular size nor THV.

Abstract

Background

Transcatheter aortic valve replacement (TAVR) is safe and feasible in patients with bicuspid aortic valve (BAV), but whether annular size may influence TAVR results in BAV patients remains unclear. We aimed at evaluating the impact of aortic annular size on procedural and clinical outcomes of BAV patients undergoing TAVR, as well as potential interactions between annular dimension and trans-catheter heart valve (THV) type (balloon-expandable (BEV) vs. self-expanding (SEV).

Methods

BEAT is a multicenter registry of consecutive BAV stenosis undergoing TAVR. For this sub-study patients were classified according to annular dimension in small-annulus (area < 400 mm² or perimeter <72 mm), medium-annulus (area ≥ 400 and < 575 mm², perimeter ≥72 mm and< 85 mm), large-annulus (area ≥ 575 mm² or perimeter ≥85 mm). Primary endpoint was Valve Academic Research Consortium-2 (VARC-2) device success.

Results

45(15.5%) patients had small, 132(45.3%) medium, and 114(39.2%) large annuli. Compared with other groups, patients with large annuli were more frequently male, younger, with higher body mass index, larger aortic valve area, higher rate of moderate-severe calcification, lower mean trans-aortic valve gradient and lower left ventricular ejection fraction. In large-annuli SEVs were associated with a lower VARC-2 device success (75.9% vs. 90.6%, p = 0.049) driven by a higher rate of paravalvular valvular leak (PVL) compared to BEVs (20.7% vs. 1.2%, p < 0.001). However, no differences in clinical outcomes were observed according to annular size nor THV type.

Conclusions

TAVR in BAV patients is feasible irrespective of annular size. However in patients with large aortic annulus SEVs were associated with a significantly higher rate of PVLs compared to BEVs.

Introduction

Transcatheter aortic valve replacement (TAVR) is not any longer an established option exclusively for elderly patients with increased surgical risk, but also for those exhibiting low and intermediate risk scores. [1,2] Additionally, thanks to advances in technology and increased operator experience TAVR has shown to be feasible and safe also in patients with complex anatomical features [[3], [4], [5], [6]]. Indeed, the proportion of potential TAVR candidates is constantly increasing and great interest has recently been focused on the extension of TAVR indication, especially to patients with severe bicuspid aortic valve (BAV) stenosis.

Several potential challenges must be considered when treating severe BAV stenosis with TAVR. BAVs have an asymmetrical valve orifice with more calcified and bulky leaflets and often calcified raphe which increase the risk of annular rupture and trans-catheter heart valve (THV) under-expansion, suboptimal hemodynamics, and impaired THV durability. Moreover, BAVs may frequently present with large annular dimension and non-cylindric configuration which may interfere with complete apposition and sealing of the valve thus resulting in greater degree of paravalvular leak (PVL) after TAVR [7]. Finally, aortic disease, often associated with BAV, increases the risk of procedure-related aortic dissection or rupture.

Increasing data on real-world TAVR use for the treatment of patients with severe BAV stenosis suggest that this procedure can be successfully performed with acceptable clinical outcomes [[8], [9], [10], [11]]. However, up to date whether annular size may influence TAVR results in BAV patients remains unclear. The aim of our study was to evaluate the impact of aortic annular dimension on procedural and clinical outcomes of patients with severe BAV stenosis undergoing TAVR with new generation THVs, as well as potential interactions between annular dimension and THV type (BEV vs. self-expanding (SEV)).

Section snippets

Methods

The BEAT (Balloon vs. Self-Expandable valve for the treatment of bicuspid Aortic valve sTenosis) registry is an international, multicenter registry including 353 consecutive patients with BAV and symptomatic severe AV stenosis undergoing TAVR using second-generation THVs (Sapien 3, Edwards Lifesciences, Irvine, California; or Evolut R/PRO systems, Medtronic Inc., Minneapolis, Minnesota) between June 2013 and October 2018. Main results of the registry have been already reported elsewhere [[12],

Results

Among our patients, 45 (15.5%) had small-annulus, 132 (45.3%) medium-annulus and 114 (39.2%) large-annulus (Fig. 1). Patients with large annulus, were more frequently male, at younger age, and had lower STS score and higher body mass index. Moreover, echocardiography showed that patients in the large-annulus group had larger aortic valve area (AVA), lower mean trans-aortic valve gradient, lower left ventricular ejection fraction, but higher rate of moderate-severe aortic valve calcification. No

Discussion

The main findings of our study can be summarized as follows:

1-
Among patients presenting with severe BAV stenosis, a large annular size was observed in almost 40% of the cases.
2-
In large annulus a lower VARC-2 device success mainly driven by a higher rate of PVLs was observed with SEV compared to BEV.
3-
No differences in clinical outcomes were observed at 1-year according to annular size nor THV type.

Surgical valve replacement represents the treatment of choice in patients with severe symptomatic BAV

Limitations

Our study suffers from the obvious limitations of an observational multicenter registry where adverse events were not adjudicated by an independent committee. Nevertheless, the lack of a centralized core lab for the analysis of the baseline CT scan represents a major limitation with possible limitation on data homogeneity. Moreover, annular size was measured at the virtual basal ring, while the supra-annular perimeter, the inter-commissural distance, and raphe-specific measurements (length,

Conclusions

Our study confirms the feasibility of TAVR in severe BAV stenosis irrespective of annular size. However, a significant interaction was observed between THV type and annular dimension. In fact, while in patients with small or medium annuli improved hemodynamic results were observed with the use of the supra-annular SEVs, in large annuli the use of the SEVs was associated with a significantly higher rate of PVLs compared to BEVs. Therefore, more than the annular size per se, the interaction

Disclosures, funding sources

None.

Declaration of Competing Interest

None

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Cited by (5)

Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Implantation in Patients With Small Aortic Annulus: A Meta-Analysis
2023, American Journal of Cardiology
Although transcatheter aortic valve implantation (TAVI) is considered a superior option to surgery in patients with small aortic annulus (SAA), it is not clear which type of transcatheter heart valve (THV) has better results in terms of echocardiographic hemodynamics and clinical outcomes. A random-effects meta-analysis was performed comparing balloon-expandable valves (BEVs) and self-expanding valves (SEVs) in patients with SAA who underwent TAVI regarding their impact on hemodynamic and clinical outcomes at short- and midterm follow-up. Relative risk (RR) and mean difference (MD) with 95% confidence interval (95% CI) were measured for the outcomes, as appropriate. Subgroup analyses were performed based on the generation type of devices and study designs. A total of 16 articles comprising 1 randomized trial, 3 propensity-matched studies, and 12 observational studies including 4,341 patients (1,967 in BEV and 2,374 in the SEV group) with SAA were included. The implantation of BEVs correlated with a lower indexed effective orifice area (MD −0.19 [−0.25 to −0.13]) and higher transvalvular mean pressure gradient (MD 3.91, 95% CI 2.96 to 4.87). Compared with SEVs, BEVs had increased risk of prosthesis-patient mismatch (PPM; RR 2.09, 95% CI 1.79 to 2.45) and severe PPM (RR 2.16, 95% CI 1.48 to 3.15). However, BEV had lower moderate and severe paravalvular leak (RR 0.45, 95% CI 0.29 to 0.69), risk of stroke (RR 0.57, 95% CI 0.42 to 0.76), and permanent pacemaker implantation (RR 0.63, 95% CI 0.44 to 0.91). The 1-year all-cause mortality (RR 1.13, 95% CI 0.86 to 1.49) and cardiac-related mortality (RR 1.53, 95% CI 0.24 to 9.81) were not different between the 2 groups. In conclusion, SEVs were associated with larger indexed effective orifice area and lower PPM but higher paravalvular leak. In contrast, patients with SEVs were more likely to develop stroke and required permanent pacemaker implantation. Both THVs did not show difference in terms of early and midterm all-cause and cardiac mortality. Because both types of THVs show similar results regarding mortality data, hemodynamics should be among the factors considered in decision making for patients with SAA who underwent TAVI.
Three-Year Outcomes of Balloon-Expandable Transcatheter Aortic Valve Implantation According to Annular Size
2023, American Journal of Cardiology
Data on the association between annular size and transcatheter aortic valve implantation (TAVI) outcomes beyond 1 year are limited. The present study assessed the association between the aortic annulus size and TAVI clinical and hemodynamic outcomes at 3 years of follow-up. Patients were classified according to the aortic annulus size as having small, intermediate, and large annuli (size <400, 400 to 574, and ≥575 mm², respectively). The co-primary endpoints were all-cause mortality and heart failure hospitalization. Further, the changes in hemodynamic outcomes over the follow-up period (median 37, interquartile range: 26 to 45 months) were assessed. The present analysis included 850 patients, with 182 patients (21.4%), 538 patients (63.3%), and 130 patients (15.3%) in the small, intermediate, and large-sized aortic annulus groups, respectively. The groups had comparable age and pre-TAVI pressure gradients; however, patients with small annuli had higher Society of Thoracic Surgeons risk scores. Adjusted Cox regression analysis showed that compared to patients with intermediate-sized annuli, patients with small and large annuli had similar all-cause mortality (hazard ratio [HR] = 1.11, 95% confidence interval [CI] 0.72 to 1.69 and HR = 0.74, 95% CI 0.48 to 1.16, respectively) and heart failure hospitalization rates (HR = 0.96, 95% CI 0.55 to 1.69 and HR = 1.26, 95% CI 0.73 to 2.17, respectively). However, patients with small annuli had consistently higher mean and peak pressure gradients and a higher risk of patient-prosthesis mismatch. The risks of moderate-to-severe regurgitation and structural valve deterioration were similar between the three groups. In conclusion, although patients with small annuli had higher transvalvular gradients, there was no significant association between the aortic annulus size and TAVI clinical outcomes at 3 years of follow-up. Future studies should compare the performance of transcatheter valve types in patients with different aortic annulus sizes.
Transcatheter aortic valve implantation in bicuspid aortic valve stenosis
2023, Trends in Cardiovascular Medicine
New-generation Ultra and PRO devices: Latest device iterations but old valve type effects
2022, International Journal of Cardiology
Valve type selection for bicuspid aortic valves in TAVR: Does the key lie in the annular size?
2022, International Journal of Cardiology

View full text

Annular size and interaction with trans-catheter aortic valves for treatment of severe bicuspid aortic valve stenosis: Insights from the BEAT registry

Highlights

Abstract

Background

Methods

Results

Conclusions

Introduction

Section snippets

Methods

Results

Discussion

Limitations

Conclusions

Disclosures, funding sources

Declaration of Competing Interest

J. Am. Coll. Cardiol.

Int. J. Cardiol.

J. Am. Coll. Cardiol.

Int. J. Cardiol.

J. Am. Coll. Cardiol.

JACC Cardiovasc. Interv.

J. Thorac. Cardiovasc. Surg.

JACC Cardiovasc. Interv.

J. Thorac. Cardiovasc. Surg.

Int. J. Cardiol.

JACC Cardiovasc. Interv.