Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Zhang, Yi; Xiong, Tian-Yuan; Li, Yiming; Yao, Yijun; He, Jingjing; Yang, Hao-Ran; Zhu, Zhongkai; Chen, Fei; Ou, Yuanweixiang; Wang, Xi; Liu, Qi; Li, Xi; Li, Yijian; Liao, Yanbiao; Huang, Fang‐Yang; Zhang, Zhengang; Li, Qiao; Wei, Xin; Peng, Yong; He, Sen; Wei, Jiafu; Zhou, Wenxia; Zheng, Maojun; Bao, Yun; Zhou, Xuan; Tang, Hong; Meng, Wei; Feng, Yuan; Chen, Mao

doi:10.3389/fcvm.2022.794850

Cited by 6 publications

(4 citation statements)

References 67 publications

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“…Now the evidence of TAVI safety and efficacy in TAV anatomy is strong enough [ 1 , 2 ], so one of the suggested study designs is the comparison of TAVI in BAV to TAV. Multiple retrospective studies with and without propensity score matching have been published in a trial to propose such a study and to present more trustable results [ 11 , 25 ].…”

Section: Discussionmentioning

confidence: 99%

One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis—A Multicentre Real-World Experience

Elkoumy

Jose

Terkelsen

et al. 2023

JCM

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Background: Bicuspid aortic valve (BAV) affects approximately 1.5% of the general population and is seen in nearly 50% of candidates for aortic valve replacement (AVR). Despite increasingly utilised transcatheter aortic valve implantation (TAVI) in aortic stenosis (AS) patients, its use among patients with severe bicuspid AS is limited as BAV is a heterogeneous disease associated with multiple and complex anatomical challenges. Aim: To investigate the one-year outcomes of TAVI using the balloon-expandable Myval transcatheter heart valve (THV) (Meril Life Sciences Pvt. Ltd., Vapi, India) in patients with severe bicuspid AS. Methods and results: We collected data from consecutive patients with bicuspid AS who underwent TAVI with the Myval THV and had at least one-year follow-up. Baseline characteristics, procedural, and 30-day echocardiographic and clinical outcomes were collected. Sixty-two patients were included in the study. The median age was 72 [66.3, 77.0] years, 45 (72.6%) were males, and the mean STS PROM score was 3.2 ± 2.2%. All TAVI procedures were performed via the transfemoral route. The median follow-up duration was 13.5 [12.2, 18.3] months; all-cause mortality was reported in 7 (11.3%) patients and cardiovascular hospitalisation in 6 (10.6%) patients. All-stroke was reported in 2 (3.2%), permanent pacemaker implantation 5 (8.3%), and myocardial infarction 1 (1.6%) patients. The echocardiographic assessment revealed a mean pressure gradient of 10 [8, 16.5] mmHg, effective orifice area 1.7 [1.4, 1.9] cm2, moderate AR in 1 (2%), mild AR in 14 (27%), and none/trace AR in 37 (71%). In total, 1 patient was diagnosed with valve thrombosis (2.1%), Stage II (moderate) haemodynamic deterioration was seen in 3 (6.4%), and stage III (severe) haemodynamic deterioration in 1 (2.1%) patient. Conclusions: TAVI with the Myval THV in selected BAV anatomy is associated with favourable one-year hemodynamic and clinical outcomes.

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Section: Discussionmentioning

confidence: 99%

One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis—A Multicentre Real-World Experience

Elkoumy

Jose

Terkelsen

et al. 2023

JCM

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“…The bicuspid aortic valve (BAV) is the most common congenital defect with a prevalence ranging between 0.5 and 2.0% [1] and male predominancy (3:1). Classified into three types, according to Sievers [2], the BAV shows geographical variability, with type 1 dominance in Europe/USA and type 0 in China [3]. BAV anatomy frequently coexists with enlarged aortic dimensions [4], and due to the asymmetricity-induced increased wall shear stress confirmed by MRI [5], aortic stenosis or aortopathy may develop at a younger age.…”

Section: Introductionmentioning

confidence: 99%

“…It should be mentioned that early-and new-generation SEV and BEV devices impact safety endpoints in favor of new-generation devices [3]. BAV patients are mainly in the low surgical risk profile due to their younger age.…”

Section: Introductionmentioning

confidence: 99%

Single-Center Experience with the Balloon-Expandable Myval Transcatheter Aortic Valve System in Patients with Bicuspid Anatomy: Procedural and 30-Day Follow-Up

Magyari,

Kittka,

Goják

et al. 2024

JCM

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Aims: To report our single-center data regarding the initial 52 consecutive patients with a bicuspid aortic valve who underwent a Transcatheter Aortic Valve Implantation (TAVI) procedure using the new balloon-expandable MYVAL system. The focus is on reporting procedural details and outcomes over the 30-day postoperative period. Methods: From December 2019 to July 2023, 52 consecutive patients underwent a TAVI procedure with bicuspid anatomy. All patients had moderate to-high surgical risk or were unsuitable for surgical aortic valve replacement based on the Heart Team’s decision. Outcomes were analyzed according to the VARC-2 criteria. The results of bicuspid patients were compared to patients with tricuspid anatomy in the overall study group, and further analysis involved a comparison between 52 pairs after propensity score matching. The device performance was evaluated using transthoracic echocardiography. Data collection was allowed by the Local Ethical Committee. Results: The mean age was 71 ± 7.1 years, and 65.4% were male. The mean Euroscore II and STS score were 3.3 ± 3.2 and 5.2 ± 3.3, respectively. Baseline characteristics and echocardiographic parameters were well balanced even in the unmatched comparison. Procedures were significantly longer in the bicuspid group and resulted in a significantly higher ARI index. All relevant anatomic dimensions based on the CT scans were significantly higher in bicuspid anatomy, including a higher implantation angulation, a higher rate of horizontal aorta and a higher proportion of patients with aortopathy. In the unmatched bicuspid vs. tricuspid comparison, postprocedural outcomes were as follows: in-hospital mortality 0% vs. 1.4% (p = 0.394), device success 100% vs. 99.1% (p = 0.487), TIA 1.9% vs. 0% (p = 0.041), stroke 1.9% vs. 0.9% (p = 0.537), major vascular complication 3.8% vs. 2.3% (p = 0.530), permanent pacemaker implantation 34% vs. 30.4% (p = 0.429), and cardiac tamponade 0% vs. 0.5% (p = 0.624). In the propensity-matched bicuspid vs. tricuspid comparison, postprocedural outcomes were as follows: in-hospital mortality 0% vs. 0%, device success 100% vs. 100%, TIA 1.9% vs. 0% (p = 0.315), stroke 1.9% vs. 0.9% (p = 0.315), major vascular complication 3.8% vs. 0% (p = 0.475), permanent pacemaker implantation 34% vs. 24% (p = 0.274), and cardiac tamponade 0% vs. 0%. There was no annular rupture nor need for second valve or severe aortic regurgitation in both the unmatched and matched comparison. The peak and mean aortic gradients did not differ at discharge and at 30-day follow-up between the two groups regardless of whether the comparison was unmatched or matched. There were no paravalvular leakages (moderate or above) in the bicuspid patients. Intermediate and extra sizes of the Myval THV system used a significantly higher proportion in bicuspid anatomy with a significantly higher oversize percentage in tricuspid anatomy. Conclusions: The TAVI procedure using the Myval THV system in patients with significant aortic stenosis and bicuspid aortic valve anatomy is safe and effective. Hemodynamic parameters do not differ between tricuspid and bicuspid patients. However, the permanent pacemaker implantation rate is higher than expected; its relevance on long-term survival is controversial.

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“…Recent studies have shown promising outcomes of TAVR in patients with bicuspid aortic valves (BAVs), but complications remain a concern [3][4][5][6][7]. BAVs have an elevated risk of procedural complications, because of their anatomical characteristics and the presence of calcium deposits [6,8].…”

Section: Introductionmentioning

confidence: 99%

Balloon Rupture during Pre-Dilation for Transcatheter Aortic Valve Replacement in Patients with a Bicuspid Aortic Valve: Classification, Treatment Strategies, and Prevention

Wu,

Wang

et al. 2023

CVIA

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Balloon rupture during transcatheter aortic valve replacement (TAVR) is a rare but serious complication. Here, we present two cases of balloon rupture in patients with severe aortic stenosis and type 0 bicuspid aortic valves. Three-dimensional models based on pre-procedure cardiac CT angiography were used to investigate these cases post hoc. The models revealed asymmetrical distribution of calcifications with sharply spiked features in the bicuspid aortic valves. The narrow calcified orifices resulted in uneven force distribution on the expanded balloon, thus leading to balloon rupture. We additionally review the classification and causes of balloon rupture, summarize methods for avoiding complications, and describe treatment options. Accurate pre-procedural anatomy evaluation and computer modeling are crucial for planning and managing TAVR procedures. Further investigation through computer simulation is necessary to determine the appropriate balloon size and inflation locations, to provide a reference for pre-procedural preparation.

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Patients With Bicuspid Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

Cited by 6 publications

References 67 publications

One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis—A Multicentre Real-World Experience

One-Year Outcomes after Myval Implantation in Patients with Bicuspid Aortic Valve Stenosis—A Multicentre Real-World Experience

Single-Center Experience with the Balloon-Expandable Myval Transcatheter Aortic Valve System in Patients with Bicuspid Anatomy: Procedural and 30-Day Follow-Up

Balloon Rupture during Pre-Dilation for Transcatheter Aortic Valve Replacement in Patients with a Bicuspid Aortic Valve: Classification, Treatment Strategies, and Prevention

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