Ielasi Alfonso, Moscarella Elisabetta, Mangieri Antonio, Giannini Francesco, Tchetchè Didier, Kim Won-Keun, Sinning Jean-Malte, Landes Uri, Kornowski Ran, De Backer Ole, Nickenig Georg, De Biase Chiara, Søndergaard Lars, De Marco Federico, Bedogni Francesco, Ancona Marco, Montorfano Matteo, Regazzoli Damiano, Stefanini Giulio, Toggweiler Stefan, Tamburino Corrado, Immè Sebastiano, Tarantini Giuseppe, Sievert Horst, Schäfer Ulrich, Kempfert Jörg, Wöehrle Jochen, Latib Azeem, Calabrò Paolo, Medda Massimo, Tespili Maurizio, Colombo Antonio
Clinical and Interventional Cardiology Unit, Istituto Clinico Sant'Ambrogio, Milan, Italy, Italy.
Department of Translational Medical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.
Int J Cardiol. 2021 Feb 15;325:109-114. doi: 10.1016/j.ijcard.2020.10.050. Epub 2020 Oct 22.
BACKGROUND: Although bicuspid aortic valve (BAV) is not considered a "sweet spot" to trans-catheter aortic valve replacement (TAVR), a certain number of BAV underwent TAVR. Whether BAV phenotype affects outcomes following TAVR remains debated. We aimed at evaluating the impact of BAV phenotype on procedural and clinical outcomes after TAVR using new generation trans-catheter heart valves (THVs). METHODS: patients included in the BEAT registry were classified according to the BAV phenotype revealed at multi-slice computed tomography (MSCT) in type 0 (no raphe) vs. type 1 (1 raphe). Primary end-point was Valve Academic Research Consortium-2 (VARC-2) device success. Secondary end-points included procedural complications, rate of permanent pacemaker implantation, clinical outcomes at 30-day and 1-year. RESULTS: Type 0 BAV was present in 25(7.1%) cases, type 1 in 218(61.8%). Baseline characteristics were well balanced between groups. Moderate-severe aortic valve calcifications at MSCT were less frequently present in type 0 vs. type 1 (52%vs.71.1%,p = 0.05). No differences were reported for THV type, size, pre and post-dilation between groups. VARC-2 success tended to be lower in type 0 vs. type 1 BAV (72%vs86.7%;p = 0.07). Higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 group (24%vs6%,p = 0.007). No differences were reported in the rate of post-TAVR moderate-severe aortic regurgitation and clinical outcomes between groups. CONCLUSIONS: Our study confirms TAVR feasibility in both BAV types, however a trend toward a lower VARC-2 device success and a higher rate of mean transprosthetic gradient ≥20 mmHg was observed in type 0 vs. type 1 BAV.
背景：尽管二叶式主动脉瓣（BAV）不被认为是经导管主动脉瓣置换术（TAVR）的“最佳适应症”，但仍有一定数量的BAV患者接受了TAVR。BAV的表型是否会影响TAVR后的结果仍存在争议。我们旨在使用新一代经导管心脏瓣膜（THV）评估BAV表型对TAVR术后手术和临床结果的影响。 方法：纳入BEAT注册研究的患者根据多层计算机断层扫描（MSCT）显示的BAV表型分为0型（无嵴）和1型（1条嵴）。主要终点是瓣膜学术研究联盟-2（VARC-2）定义的器械成功。次要终点包括手术并发症、永久起搏器植入率、30天和1年时的临床结果。 结果：0型BAV有25例（7.1%），1型有218例（61.8%）。两组间基线特征均衡。MSCT显示0型BAV中中度至重度主动脉瓣钙化的发生率低于1型（52%对71.1%，p = 0.05）。两组间THV类型、尺寸、预扩张和后扩张情况无差异。0型BAV的VARC-2成功率倾向于低于1型（72%对86.7%；p = 0.07）。0型组平均跨瓣压差≥20 mmHg的发生率高于1型组（24%对6%，p = 0.007）。两组间TAVR术后中度至重度主动脉瓣反流发生率和临床结果无差异。 结论：我们的研究证实了两种类型的BAV行TAVR均可行，然而，与1型BAV相比，0型BAV的VARC-2器械成功率有降低趋势，且平均跨瓣压差≥20 mmHg的发生率更高。
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