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滑翔机注册库。

The Glider registry.

作者信息

Secco Gioel Gabrio, Rittger Harald, Hoffmann Stefan, Richardt Gert, Abdel-Wahab Mohamed, Reinecke Holger, Lotan Chaim, Werner Gerald, Sievert Horst, Foin Nicolas, Di Mario Carlo

机构信息

Department of Clinical and Experimental Medicine, University of Eastern Piedmont, Novara, Italy.

Medizinische Klinik 2, Universitätsklinikum Erlangen, Erlangen, Germany.

出版信息

Catheter Cardiovasc Interv. 2017 Jan;89(1):E1-E6. doi: 10.1002/ccd.25040. Epub 2016 Oct 5.

DOI:10.1002/ccd.25040
PMID:23729282
Abstract

BACKGROUND

Provisional stenting of the side-branch (SB) is the universally accepted gold standard while there is still controversy on the usefulness of routine dilatation of the SB ostium. Recrossing the struts of a previously deployed stent with a wire and a balloon can prove challenging and is occasionally unsuccessful, mainly because the balloon tip hits a stent strut. This prospective multicenter international registry tested the crossing ability procedural results of a new-dedicated ultrashort balloon specifically designed for side branch dilatation (Glider, TriReme Medical, Pleasanton, CA, USA).

METHODS

One hundred and twenty five patients (for a total of 131 bifurcation lesions) were enrolled in the registry between January 2009 and May 2012. The Glider was used as first choice in alternative to conventional balloon (group I, 72%) or as bail-out after unsuccessful previous attempt at crossing with small conventional low-profile balloons (group II, 28%). Postprocedural coronary artery dissections and in-hospital MACE (death, myocardial infarction and repeat revascularization) were assessed. Technical success was defined as the ability of the Glider to recross the struts of a previously deployed stent while procedural success was defined as less of residual 50% diameter stenosis at the origin of the SB with a final TIMI 3 and/or freedom from in-hospital MACE.

RESULTS

Technical success was achieved, respectively, in 92% (group I), and 83% (group II). Clinical and angiographic procedural success was achieved in 98% of the lesions. In Group II, no other balloon of the same size could cross in cases where Glider could not. A total of 13 complications were observed, including nine ostial SB dissection four of which needed a second stent on the SB, one stent loss, two severe coronary spasms, and two by thrombus formation.

CONCLUSION

The unique possibility offered by this short dedicated balloon to orientate its beveled tip provides an effective strategy for recrossing stent struts when conventional low profile balloons fail achieving greater SB ostial expansion thus reducing the incidence of strut malapposition during provisional treatment of bifurcational lesions. © 2016 Wiley Periodicals, Inc.

摘要

背景

侧支血管(SB)的临时支架置入是普遍接受的金标准,而对于SB开口处常规扩张的作用仍存在争议。用导丝和球囊再次穿过先前置入支架的金属支架小梁可能具有挑战性,且偶尔会失败,主要原因是球囊尖端会碰到支架小梁。这项前瞻性多中心国际注册研究测试了一种专门为侧支血管扩张设计的新型超短球囊(Glider,TriReme Medical,美国加利福尼亚州普莱森顿)的穿过能力和手术结果。

方法

2009年1月至2012年5月期间,125例患者(共131处分叉病变)被纳入该注册研究。Glider作为首选替代传统球囊(I组,72%),或在先前尝试用小型传统低轮廓球囊穿过失败后作为补救措施(II组,28%)。评估术后冠状动脉夹层和院内主要不良心血管事件(MACE,死亡、心肌梗死和再次血运重建)。技术成功定义为Glider能够再次穿过先前置入支架的金属支架小梁,而手术成功定义为SB开口处残余直径狭窄小于50%,最终TIMI血流3级和/或无院内MACE。

结果

I组和II组的技术成功率分别为92%和83%。98%的病变实现了临床和血管造影手术成功。在II组中,Glider无法穿过的情况下,没有其他相同尺寸的球囊能够穿过。共观察到13例并发症,包括9例SB开口处夹层,其中4例需要在SB上置入第二个支架,1例支架脱落,2例严重冠状动脉痉挛,以及2例血栓形成。

结论

这种短的专用球囊独特的斜角尖端定向可能性为传统低轮廓球囊失败时再次穿过支架小梁提供了一种有效策略,实现了更大的SB开口扩张,从而降低了分叉病变临时治疗期间支架小梁贴壁不良的发生率。© 2016威利期刊公司

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