1. Excimer Laser LEsion Modification to Expand Non-dilatable sTents: The ELLEMENT Registry
- Author
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Latib, Azeem, Takagi, Kensuke, Chizzola, Giuliano, Tobis, Jonathan, Ambrosini, Vittorio, Niccoli, Giampaolo, Sardella, Gennaro, DiSalvo, Maria Elena, Armigliato, Pietro, Valgimigli, Marco, Tarsia, Giandomenico, Gabrielli, Gabriele, Lazar, Lawrence, Maffeo, Diego, and Colombo, Antonio
- Subjects
Bioengineering ,Cardiovascular ,Heart Disease ,Heart Disease - Coronary Heart Disease ,Atherosclerosis ,Assistive Technology ,Aged ,Aged ,80 and over ,Angioplasty ,Balloon ,Laser-Assisted ,Contrast Media ,Coronary Angiography ,Coronary Restenosis ,Coronary Stenosis ,Coronary Thrombosis ,Feasibility Studies ,Female ,Humans ,Italy ,Lasers ,Excimer ,Male ,Middle Aged ,Myocardial Infarction ,Pilot Projects ,Prospective Studies ,Prosthesis Design ,Registries ,Stents ,Time Factors ,Treatment Outcome ,Ultrasonography ,Interventional ,Vascular Calcification ,In-stent restenosis ,Excimer Laser Coronary Angioplasty ,Cardiorespiratory Medicine and Haematology ,Cardiovascular System & Hematology - Abstract
Background/objectivesStent underexpansion is a risk factor for in-stent restenosis and stent thrombosis. Existing techniques to optimize stent expansion are sometimes ineffective. The aim of this study was to evaluate the effectiveness and feasibility of Excimer Laser Coronary Angioplasty (ELCA) in improving stent expansion when high-pressure non-compliant balloon inflation was ineffective.Methods and resultsECLA ablation was performed at high energy during contrast injection and only within the underexpanded stent. The primary endpoint of successful laser dilatation was defined as an increase of at least 1mm(2) in minimal stent cross-sectional area (MSA) on IVUS or an increase of at least 20% in minimal stent diameter (MSD) by QCA, following redilatation with the same non-compliant balloon that had been unsuccessful prior to ELCA. Secondary endpoints were cardiac death, myocardial infarction (MI) and target lesion revascularization. Between June 2009 and November 2011, 28 patients with an underexpanded stent despite high-pressure balloon inflation were included. The mean laser catheter size was 1.2±0.4 (range 0.9-2.0mm) and a mean of 62±12mJ/mm(2) at 62±21hertz were required for optimal expansion. Laser-assisted stent dilatation was successful in 27 cases (96.4%), with an improvement in MSD by QCA (1.6±0.6mm at baseline to 2.6±0.6mm post-procedure) and MSA by IVUS (3.5±1.1mm(2) to 7.1±1.9mm(2)). Periprocedural MI occurred in 7.1%, transient slow-flow in 3.6% and ST elevation in 3.6%. During follow-up, there were no MIs, there was 1 cardiac-death, and TLR occurred in 6.7%.ConclusionsThe ELLEMENT study confirms the feasibility of ELCA with contrast injection to improve stent underexpansion in undilatable stented lesions.
- Published
- 2014