Procedural effectiveness of a novel 1.20 mm diameter angioplasty catheter: clinical and angiographic outcomes.
OBJECTIVE
To evaluate clinical and angiographic outcomes using a 1.20 mm diameter angioplasty catheter as part of a predilation strategy for coronary lesion treatment.


BACKGROUND
Development of an angioplasty catheter with low crossing profile and small balloon diameter represents an opportunity to facilitate percutaneous revascularization of complex coronary disease.


METHODS
Clinical and angiographic outcomes were evaluated following a predilation treatment strategy using a low profile, 1.20 mm angioplasty catheter. The primary end-point of procedural success was defined as successful device delivery, performance and lesion treatment without occurrence of perforation, flow-limiting dissection, reduction in baseline TIMI grade, or clinically significant arrhythmias, and with final achievement of TIMI 3 flow. In-hospital major adverse events were also determined.


RESULTS
Among 71 patients (83 lesions), angiographic characteristics included: de novo lesion, 75.9%; saphenous vein graft 9.6%; lesion length (mean ± standard deviation), 12.27 ± 5.96 mm; reference vessel diameter, 2.61 ± 0.57 mm; lesion classification B2/C, 59.0%; baseline TIMI 0/1 flow, 4.8%. Procedural success was achieved for 98.5% (66/67) of patients. Catheter delivery to the target lesion was achieved in all patients, and the rate of device success with luminal improvement after predilation was 96.2% (75/78). No acute procedural complications were observed, and in-hospital target lesion failure occurred in 6 patients (8.5%) related to peri-procedural non-Q wave myocardial infarction.


CONCLUSIONS
Coronary lesion predilation with a low profile, 1.20 mm angioplasty catheter is associated with favorable procedural safety and efficacy and may represent an effective treatment for complex coronary anatomy.
Piedmont Heart Institute, Suite 300, 275 Collier Road, Atlanta, GA 30309, USA. david.kandzari@piedmont.org
David E
DE
Kandzari
Paul S
PS
Teirstein
Dean J
DJ
Kereiakes
Louis A
LA
Cannon
Steven E
SE
Hearne
Hai-Chien
HC
Kuo
Shih-Wa
SW
Ying
Wai-Fung
WF
Cheong
Jeffrey J
JJ
Popma
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002404:Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D017023:Coronary Angiography / Q000379:methods*; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D011183:Postoperative Complications / Q000453:epidemiology*; D011446:Prospective Studies; D016896:Treatment Outcome