title: Angiographic outcome after intracoronary X-Sizer helical atherectomy and thrombectomy: first use in humans.
abstract: The objective of this study was to evaluate the early angiographic outcome in the first human subjects who underwent intracoronary atherectomy and thrombectomy using the X-Sizer helical cutting and aspiration system. Percutaneous coronary interventions in patients with thrombo-occlusive disease or friable degenerative saphenous vein grafts are associated with considerable periprocedural morbidity and mortality, predominantly related to microscopic distal embolization. X-Sizer catheter system is a novel atherectomy and thrombectomy device that consists of a helix cutter connected to a handheld motor drive unit and a vacuum collection chamber for aspiration of excised atheroma, thrombus, and debris. Quantitative coronary angiography was obtained in 14 patients before and after X-Sizer extraction atherectomy with adjunctive balloon angioplasty and stenting. Thirteen native coronary arteries and one saphenous vein graft were treated. Mean preprocedural reference vessel diameter was 3.06 +/- 0.66 mm. There were 71.4% AHA/ACC type B2 and C lesions. Preprocedural thrombus was present in nine patients and total occlusion in 64% of cases. Minimal luminal diameter was increased from 0.29 +/- 0.47 mm to 1.32 +/- 0.64 mm, a gain of 1.04 +/- 0.69 mm after atherectomy. Final total gain was 1.47 +/- 0.61 mm. Mean diameter stenosis was reduced from 89.3% to a final residual stenosis of 14.4%. Postatherectomy distal embolization occurred in one patient who had heavy preprocedural thrombus burden. No episodes of perforation, distal coronary spasm, abrupt closure, or slow/no-reflow occurred. The angiographic analysis of the first cohort of human subjects suggests that X-Sizer helical atherectomy is a feasible method of removing occlusive tissue or thrombus in coronary artery disease with a low angiographic complication rate. A large-scale randomized phase II clinical trial is underway to determine the ultimate safety and efficacy of this device in thrombo-occlusive native coronary arteries and saphenous vein grafts.
authors.affiliation: Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA. vohkwok@netvigator.com
authors.forename: On-Hing
authors.initials: OH
authors.lastname: Kwok
authors.forename: Ross
authors.initials: R
authors.lastname: Prpic
authors.forename: Jorge
authors.initials: J
authors.lastname: Gaspar
authors.forename: Detlef G
authors.initials: DG
authors.lastname: Mathey
authors.forename: A
authors.initials: A
authors.lastname: Escobar
authors.forename: Atoussa
authors.initials: A
authors.lastname: Goldar-Najafi
authors.forename: Nicolaus
authors.initials: N
authors.lastname: Reifart
authors.forename: Thomas A
authors.initials: TA
authors.lastname: Ischinger
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Popma
mesh_terms: D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation; D017225:Atherectomy, Coronary / Q000295:instrumentation*; D001807:Blood Vessel Prosthesis; D002408:Catheters, Indwelling; D017023:Coronary Angiography / Q000009:adverse effects; D023921:Coronary Stenosis / Q000150:complications / Q000000981:diagnostic imaging / Q000601:surgery; D003328:Coronary Thrombosis / Q000150:complications / Q000000981:diagnostic imaging / Q000628:therapy; D004867:Equipment Design; D005060:Europe / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D012008:Recurrence; D012086:Reoperation; D012501:Saphenous Vein / Q000000981:diagnostic imaging / Q000637:transplantation; D013020:South America / Q000453:epidemiology; D015607:Stents; D017131:Thrombectomy / Q000295:instrumentation*; D016896:Treatment Outcome; D014743:Videotape Recording