The probe, a balloon-on-the-wire: clinical experience with a new low-profile, fixed-wire balloon catheter system

We reviewed the clinical records of the 1st 144 consecutive patients in whom the Probe trade mark, a balloon-on-the-wire, was used for percutaneous transluminal coronary angioplasty at the Texas Heart Institute. The goal of our retrospective study was to establish the efficacy and safety of this new balloon catheter. The Probe was used in 227 lesions, most of which were considered severe and difficult to pass. The Probe was the 1st catheter used in 160 lesions (70%), and in 67 lesions (30%) the Probe was used after other balloon catheters. In 70.9% (161/227) of lesions treated, the Probe reduced the stenosis to less than 50% of the luminal diameter. Of 144 patients treated, 116 (81%) had a successful result: 98 of these had adequate recanalization of all vessels treated, while 17 had adequate recanalization of the most significant vessels. A relatively high number of lesions (17 lesions, 7.5%) became totally occluded during the procedure. Eight patients (6%) required emergency surgery because of impending infarction. No hospital deaths occurred, and there were only 2 patients who suffered transmural myocardial infarction. Of the 160 Probe devices used, 23 (14%) malfunctioned: the balloon ruptured in 11 procedures; the balloon twisted, causing "balloon volvulus," in 5; the balloon failed to deflate in 4; and the tip detached in 3. The Probe has significant advantages over other balloon systems for treating severe coronary lesions because of its low profile, but it is also less reliable and safe. Our results show that the Probe should be used with great care, and only in treating lesions not amenable to treatment with removable-guidewire catheters.