title: Intravascular ultrasound assessment of the novel AngioSculpt scoring balloon catheter for the treatment of complex coronary lesions.
abstract: BACKGROUND
  Despite the advances in interventional cardiology, stent expansion remains an important predictor of success, impacting restenosis and thrombosis rates after either bare-metal (BMS) or drug-eluting stent implantation. Especially for the treatment of complex lesions (e.g., calcified lesions, in-stent restenosis, etc.), adequate lesion preparation might help improve procedural results as well as clinical outcomes. We sought to investigate the safety, feasibility and mechanism of action of a new scoring-balloon catheter, the AngioSculpt, comprised of a semicompliant balloon and a nitinol spiral cage designed to address complex lesions.
  
  
  METHODS
  A total of 60 consecutive patients at two centers were prospectively enrolled in this first-in-man coronary study and divided into two groups according to the type of lesion treated: Group I: patients with de novo coronary lesions (n = 47) as a pretreatment strategy before BMS implantation, and Group II: patients with BMS restenosis (n = 17) as a standalone therapy. A subgroup of patients in each cohort was assigned to intravascular (IVUS) analysis. Patients in Group II were submitted to routine 6-month follow-up angiography. In Group I, angiographic restudy was contingent upon the presence of ischemia. Lesions longer than 20 mm in very tortuous vessels, in arterial or vein grafts, in the setting of acute myocardial infarction or with visible thrombus were excluded from this study.
  
  
  RESULTS
  Success was achieved in all cases. The mean age of the study populations was 62 +/- 11.6 years (Group I) and 53 +/- 9.4 years (Group II), with 26% and 18% diabetics, respectively. In Group I, 73% of lesions were diffuse and fibrocalcified, while in Group II, 72% were classified as diffuse. No serious complications were observed in either group. Balloon slippage (or the "watermelon seed" phenomenon) was not observed. Significant acute gain was achieved in both groups (0.7 mm in Group I and 1.64 mm in Group II). A minimum final area (in-stent) 6.5 mm2 was achieved in 85% of the cases in Group I and in 82% of the cases in Group II.
  
  
  CONCLUSIONS
  In this preliminary in vivo study, the use AngioSculpt(R) proved to be feasible and safe for the treatment of complex coronary lesions. Six-month results suggest the use of this novel device as an attractive option for the percutaneous approach of restenotic coronary lesions and should be assessed in a larger, more complex cohort of patients.
authors.affiliation: Instituto Dante Pazzanese de Cardiologia, Sao Paulo-SP, Brasil.
authors.forename: Alberto
authors.initials: A
authors.lastname: Fonseca
authors.forename: José de Ribamar
authors.initials: Jde R
authors.lastname: Costa
authors.forename: Alexandre
authors.initials: A
authors.lastname: Abizaid
authors.forename: Fausto
authors.initials: F
authors.lastname: Feres
authors.forename: Andrea S
authors.initials: AS
authors.lastname: Abizaid
authors.forename: Ricardo
authors.initials: R
authors.lastname: Costa
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Staico
authors.forename: Luis Alberto
authors.initials: LA
authors.lastname: Mattos
authors.forename: Amanda G R M
authors.initials: AG
authors.lastname: Sousa
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.forename: J Edouardo
authors.initials: JE
authors.lastname: Sousa
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000295:instrumentation* / Q000379:methods; D002404:Catheterization; D023903:Coronary Restenosis / Q000517:prevention & control; D023921:Coronary Stenosis / Q000000981:diagnostic imaging* / Q000628:therapy*; D054855:Drug-Eluting Stents; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018570:Risk Assessment; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D015607:Stents; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D014654:Vascular Patency