Abstract
A dedicated super-high pressure noncompliant balloon (OPN NC; SIS Medical AG, Winterthur, Switzerland) has been designed to optimize dilatation of rigid coronary lesion with heavy calcification. A performance of this balloon either in in-stent restenosis or native coronary disease, both in elective cases and in acute coronary syndrome, has never been studied in our hospital. From September 2016 to August 2017 in Royal Alexandra Hospital, 13 consecutive patients with extremely calcified coronary stenotic lesions in which conventional dilatation with NC balloon at rated burst pressure remained incapable of obtaining adequate lumen gain necessitating further dilatation with OPN NC balloon were retrospectively evaluated. Residual luminal diameter stenosis <30% was considered angiographic success. We measured baseline, post NC balloon and post OPN NC balloon minimal lumen diameter (MLD) as well as percentage of diameter stenosis (%DS). 12 out of 13 extremely calcified lesions were successfully dilated (92.3%). In two patients with NSTEMI, the lesions were unable to be crossed with either such OPN NC balloon or any very low-profile balloon mandating rotational atherectomy. In one of these two patients, however, OPN NC balloon was still required for stent optimization after successful lesion preparation with rotational atherectomy. One extremely calcified lesion with in-stent restenosis in previously under deployed lesion even ruptured two OPN balloons, luminal dilatation was achieved perfectly, nevertheless. This balloon was also successfully applied in the case with acute lateral wall STEMI. With OPN NC balloon acute luminal gain were greater while %DS was lower. There was no evidence of complication observed regarding coronary dissection, vessel perforation or balloon entrapment. Additionally, no MACE was revealed immediately post dilatation as well as at 30-day follow up. In detail, our study illustrated mean lesion reference diameter of 3.32 mm(+/- 0.3), mean pretreatment MLD of 0.4mm(+/-0.2), mean diameter stenosis of 87.8% (+/- 7.3), mean lumen gain post conventional NC balloon of 1.79 mm (+/- 0.42), and mean lumen gain post OPN NC balloon of 2.67mm(+/-0.44) Very high-pressure dilatation resorting OPN NC balloon should be considered as not only effective but also safe approach when experiencing extremely calcified lesions undilatable by conventional high-pressure NC balloon. This strategy helped avoid employing rotational atherectomy in most cases; however, such atherectomy device remained indispensable in extremely rigid coronary lesions.
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