Moscardelli Silvia, Caminiti Rodolfo, Montonati Carolina, Ceresa Fabrizio, De Blasio Giuseppe, Vizzari Giampiero, Pellegrini Dario, Pellicano Mariano, Guagliumi Giulio, Patanè Francesco, Tespili Maurizio, Micari Antonio, Ielasi Alfonso
U.O. Cardiologia Ospedaliera, IRCCS Ospedale Galeazzi Sant'Ambrogio, 20157 Milan, Italy.
Divisione di Cardiologia, Policlinico Madonna della Consolazione, 89124 Reggio Calabria, Italy.
J Clin Med. 2024 Oct 8;13(19):5986. doi: 10.3390/jcm13195986.
: Balloon aortic valvuloplasty (BAV) is currently used as pre-treatment for patients undergoing trans-catheter aortic valve replacement (TAVR) as well as a stand-alone option for subjects with significant contraindications to TAVR. Mammoth is a newly available non-compliant balloon catheter (BC) included in the balloon-expandable Myval THV system (Meril Life Sciences Pvt. Ltd., India). As limited data on the performance of this BC are available, we here report the results following its use for BAV as pre-dilatation during TAVR or as a stand-alone procedure. : A retrospective, single-center cohort analysis was performed on patients with severe aortic valve stenosis (AS) treated with the Mammoth BC at IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy. The primary endpoint was technical success defined as successful Mammoth BC advancement across the AS followed by its full and homogeneous inflation without major complications such as aortic root/left ventricular outflow tract injury and/or stroke. : A total of 121 patients were treated by BAV with Mammoth BC during the study period. Among these, 105 patients underwent BAV pre-dilatation before TAVR while 16 patients underwent a stand-alone BAV procedure. Mammoth BC was delivered and successfully inflated at the target site in all of the 121 cases without BC-related complications (100% technical success). However, in the BAV "stand-alone group", three patients required two different balloon sizes while in nine patients multiple rounds (two to three) of balloon inflation were needed to significantly lower the transvalvular gradient. No cases of aortic root injury or massive aortic regurgitation due to Mammoth BC-related aortic leaflet injury were reported while one major stroke occurred late after TAVR. No intra-procedural deaths occurred nor bleeding (BARC 3-4) or major vascular complication. : Mammoth BC use in patients with severe AS proved safe and effective, either before TAVR or as a stand-alone procedure, expanding the range of available tools for structural operators.
球囊主动脉瓣成形术（BAV）目前用作经导管主动脉瓣置换术（TAVR）患者的预处理方法，也是TAVR存在严重禁忌证患者的独立治疗选择。Mammoth是一种新上市的非顺应性球囊导管（BC），包含在球囊可扩张的Myval经导管心脏瓣膜系统（印度梅里尔生命科学有限公司）中。由于关于这种BC性能的可用数据有限，我们在此报告其在TAVR期间用作BAV预扩张或作为独立手术使用后的结果。：对意大利米兰IRCCS加尔azzi圣安布罗焦医院接受Mammoth BC治疗的严重主动脉瓣狭窄（AS）患者进行了一项回顾性单中心队列分析。主要终点是技术成功，定义为Mammoth BC成功穿过AS并完全均匀膨胀，且无主动脉根部/左心室流出道损伤和/或中风等主要并发症。：在研究期间，共有121例患者接受了使用Mammoth BC的BAV治疗。其中，105例患者在TAVR前接受了BAV预扩张，16例患者接受了独立的BAV手术。在所有121例病例中，Mammoth BC均成功送达并在目标部位成功膨胀，无BC相关并发症（技术成功率100%）。然而，在BAV“独立组”中，3例患者需要两种不同尺寸的球囊，9例患者需要多轮（两到三轮）球囊膨胀才能显著降低跨瓣压差。未报告因Mammoth BC相关的主动脉瓣叶损伤导致的主动脉根部损伤或大量主动脉瓣反流病例，而1例严重中风发生在TAVR术后晚期。术中无死亡病例，也无出血（BARC 3 - 4级）或重大血管并发症。：事实证明，在TAVR前或作为独立手术时，将Mammoth BC用于严重AS患者是安全有效的，这扩大了结构操作者可用工具的范围。
