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Transcatheter Aortic Valve Implantation (TAVI) in Patients With Bicuspid Aortic Valve Stenosis – Systematic Review and Meta-Analysis

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Background

Transcatheter aortic valve implantation (TAVI) is a feasible interventional technique for severe aortic stenosis in patients who are deemed inoperable or at high surgical risk. There is limited evidence for the safety and efficacy of TAVI in patients with bicuspid aortic valves (BAV), the most common congenital valve abnormality. In many TAVI trials, patients with BAV have been contraindicated due to concerns surrounding abnormal valve geometry, leading to malfunction or malpositioning. A systematic review and meta-analysis was conducted in order to assess the current evidence and relative merits of TAVI in aortic stenosis patients with BAV.

Method

From six electronic databases, seven articles including 149 BAV and 2096 non-BAV patients undergoing TAVI were analysed.

Results

Between the BAV and no-BAV cohorts, there was no difference in 30-day mortality (8.3% vs 9.0%; P=0.68), post-TAVI mean peak gradients (weighted mean difference, 0.36 mmHg; P=0.55), moderate or severe paravalvular leak (25.7% vs 19.9%; P=0.29), pacemaker implantations (18.5% vs 27.9%; P=0.52), life-threatening bleeding (8.2% vs 13.9%; P=0.33), major bleeding (20% vs 16.8%; P=0.88), conversion to conventional surgery (1.9% vs 1.2%; P=0.18) and vascular complications (8.6% vs 10.1%; P=0.32).

Conclusions

Preliminary short and mid-term pooled data from observation studies suggest that TAVI is feasible and safe in older patients with BAV. While future randomised trials are not likely, larger adequately-powered multi-institutional studies are warranted to assess the long-term durability and complications associated with TAVI in older BAV patients with severe aortic stenosis.

Introduction

Percutaneous valve implantation technology was first introduced in 2000 [1], and led to the advent of the percutaneous transcatheter aortic valve implantation (TAVI) technique for aortic stenosis patients in 2002 [2]. Since then, leaps in technological advancements and robust randomised trials have reaffirmed the role of TAVI in patients deemed inoperable or at high surgical risk [3], [4], [5]. Recent evidence has supported TAVI as a safe and effective alternative treatment modality for severe aortic stenosis patients ineligible for conventional surgical aortic valve replacement [6]. However, there is limited evidence for the safety and efficacy of TAVI in patients with bicuspid aortic valves (BAV), the most common congenital valve abnormality occurring in 0.8-2% of patients [7], [8]. In randomised studies to date on TAVI, patients with BAV have been contraindicated regardless of transfemoral or transapical approaches. There are concerns surrounding the elliptical annular anatomy of BAVs which may predispose the patient to valve malfunction or malposition [9], [10]. Patients with BAV may also be at risk of incomplete sealing, severe paravalvular leak and aortic regurgitation [11], [12], [13]. Recent case reports and observational cohort studies suggest that TAVI in carefully selected patients with BAV may be feasible, safe and efficacious. A systematic review and meta-analysis was conducted in order to assess the current evidence and relative merits of TAVI in aortic stenosis patients with BAV.

Section snippets

Literature Search Strategy

Electronic searches were performed using Ovid Medline, PubMed, Cochrane Central Register of Controlled Trials (CCTR), Cochrane Database of Systematic Reviews (CDSR), ACP Journal Club, and Database of Abstracts of Review of Effectiveness (DARE) from their date of inception to January 2014. To achieve the maximum sensitivity of the search strategy, we combined the terms: “transcatheter aortic valve”, “TAVI”, “TAVR” and “bicuspid” as either key words or MeSH terms. The reference lists of all

Included Studies

A total of 1248 references were identified through six electronic database searches (Figure 1). After exclusion of duplicate or irrelevant references, 1222 potentially relevant articles were retrieved. After detailed evaluation of these articles, 30 studies remained for assessment. After applying the selection criteria, seven articles [12], [13], [16], [17], [18], [19], [20] were selected for qualitative and quantitative analysis. The study characteristics are summarised in Supplementary Table

Discussion

While bicuspid aortic valves is a congenital condition which occurs in approximately 1-2% of the general population, over 50% of resected aortic valves during surgical aortic valve replacement procedures have been observed to be bicuspid [21]. Over 33% of patients with bicuspid aortic valves will go on to develop complications [22], with some studies suggesting that the morbidity and mortality rates associated with BAV are greater than that of all other congenital heart defects combined [22],

Conflicts of interest

None declared.

Funding

None declared.

Acknowledgements

K.P. is supported by an Australian Postgraduate Award (APA) for postgraduate research studies.

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