Clinical and angiographic procedural and mid-term outcome with new versus reused balloon catheters in percutaneous coronary interventions.
BACKGROUND
To reduce procedural cost, cardiac centers increasingly use resterilized balloon catheters for percutaneous coronary interventions. Data addressing the procedural and mid-term outcome in a prospective randomized trial comparing new and resterilized balloons are not available.


RESULTS
Percutaneous coronary interventions were performed at random in 238 consecutive patients with either new or 1-3 times reused balloon catheters. Crossing of the stenosis decreased from 96% with new balloon catheters to 93.2% (p=0.46), with 1 time reused balloon catheters to 81.8% (p=0.0056) with 2 times reused balloon catheters and to 80.8% (p=0.01) with 3 times reused balloon catheters. In all primary failures using resterilized balloon catheters, new ones of the same nominal diameter were successful. The 4.1 +/- 1.9 month angiographic follow-up rates were 96/124 (77.4%) for new balloon catheter, 35/44 (79.5%) for 1 time reused balloon catheters, 33/44 (75.0%) for 2 times reused balloon catheters, and 21/26 (80.8%) for 3 times reused balloon catheters (p for all >0.05). The late losses for new versus reused balloon catheters were 0.48 +/- 0.75 mm versus 0.73 +/- 0.79 mm (p=0.03). The percent stenosis was higher in reused versus new balloon catheters (51.9 +/- 23.2% v. 42.3 +/- 22.3%; p=0.0042) as was the restenosis rate [39/89 (43.8%] v. 31/96 (32.3%), p=0.13]. There was one death in reused balloon catheter category but no event of myocardial infarction. Rates of target lesion revascularizations were similar in stent recipients and more frequent after stand-alone balloon angioplasty with reused versus new balloon catheters [15/55 (27.3%) versus [5/59 (8.5%), p=0.01].


CONCLUSIONS
The use of two or three times resterilized balloon catheters of the type tested does not seem to be justified in stand-alone balloon angioplasty of de novo coronary stenoses and should be limited to stent procedures until data is available for other indications.
Unverdorben
Martin
M
Institute for Clinical Research, Center for Cardiovascular Diseases, Rotenburg an der Fulda, Germany.
Degenhardt
Ralf
R
Erny
Dominique
D
Scholz
Manfred
M
Wagner
Eberhard
E
Köhler
Henning
H
Berthold
Heiner K
HK
Vallbracht
Christian
C
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D002404:Catheterization / Q000295:instrumentation*; D017023:Coronary Angiography; D023921:Coronary Stenosis / Q000000981:diagnostic imaging / Q000473:pathology / Q000628:therapy*; D017743:Equipment Reuse; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012720:Severity of Illness Index; D016896:Treatment Outcome