Probe™, a balloon wire: Initial experience

Coronary angioplasty is unsuccessful in <3–5% of cases because the balloon catheter fails to follow a guidewire that has traversed a lesion. Between June 1986 and August 1987, 31 lesions were unable to be crossed with at least two standard angioplasty catheters. Finally, a 2.0-mm-diameter Hartzler LPS (ACS) was utilized and successfully crossed and dilated 16 out of 31 lesions (52%). In the remaining 15 lesions, the Probe^TM (USCI) 2.0 mm diameter × 1.5 cm long balloon wire was able to cross the lesions in 13 (82%) and successfully dilated 12. In one case, lesion rigidity prevented the balloon from expanding at 14 atm. A right coronary artery lesion was attempted in 11 cases, and a left anterior descending and circumflex artery lesion in two patients each. No complications were encountered. In seven out of 12 successful Probe^TM cases, a larger balloon catheter was used to further dilate the artery. This new balloon wire has increased our success rate in severe stenoses and in tortuous vessels with severe distal lesions, in which presently available angioplasty equipment has failed.     

Coronary balloon angioplasty through diagnostic 6 French catheters

We investigated the use of ultralow profile balloon catheters (Scimed ACE, USCI Probe, Cordis, Orion) for coronary angioplasty through 6 French diagnostic catheters (Schneider, Cordis). Contrast injection was assisted with a Hercules pump (Cordis) in all cases. During 21 procedures, angioplasty of 27 lesions in 20 selected patients was attempted (1.3 lesion/procedure). Twelve lesions were in the right, 10 in the left anterior descending, and 5 in the left circumflex coronary artery. Balloon size varied between 2.5 and 3.5 mm. Twenty lesions could be successfully dilated (74%) through the 6 French catheter and 7 lesions required an exchange to a 7 French angioplasty guiding catheter. For 5 cases, another balloon was also necessary to complete the procedure. The final overall success rate was 100% per patient and per lesion and there were no major complications. Despite the small internal catheter lumen (1.22 mm) coronary visualization was adequate, and mechanical support was good. Failures of 6 French catheters were attributed to insufficient torque control and excessive friction when the balloon crossed the tapered end of the diagnostic catheter. Coronary angioplasty through a diagnostic 6 French catheter is feasible and may represent a reasonable alternative for simple cases that are done during the same session as the diagnostic angiography. Once available, 6 French high flow angioplasty guiding catheters without a tapered tip should improve success while retaining the advantage of a small femoral puncture site.     

Multicenter evaluation of a new fixed-wire coronary angioplasty catheter system: Clinical and angiographic characteristics and results

Coronary angioplasty is increasingly used as an attempt to revascularize patients with severe coronary artery disease. To determine the efficacy of such treatment, a new fixed wire angioplasty catheter was evaluated by a multicenter group in a non-randomized fashion in 50 patients, average 58 ± 11 years (± 1SD), 58% men. Forty-four percent had a prior revascularization procedure (28% angioplasty, 16% coronary bypass surgery), 38% had a prior Q-wave myocardial infarction, 43% had grade 4 angina, and 60% multiple vessel disease. Angioplasty was attempted in 63 lesions which were located in a mid to distal location in 69%, with a proximal tortuosity score of 1.8 (2 = 45–60° entrance angle), and lesion angulation of 1.4 (1 = 45° lesion bend). In 88%, the device was the primary catheter used and in 6%, it was chosen when another system failed. The balloon was able to successfully cross 94% of all lesions attempted. Six lesions were crossed and dilated but significant residual stenoses remained. There were no significant device malfunctions, or angiographic or clinical complications. This feasibility evaluation of this new fixed wire system yielded excellent angiographic results. Although not a comparative study, this analysis suggests that this new generation of angioplasty catheter may improve the safety and efficacy of complex coronary angioplasty.     

Successful excimer laser angioplasty following unsuccessful primary balloon angioplasty

We report five patients where excimer laser coronary angioplasty facilitated successful balloon dilatation of heavily calcified lesions that could not be dilated by conventional angioplasty techniques alone. In each case, the lesion was crossed successfully with a guide wire. Conventional angioplasty failed because of inability to cross the lesion with a balloon (four lesions) or inability to dilate the lesion with balloon inflation (two lesions). These cases illustrate an indication for excimer laser coronary angioplasty as an adjunctive procedure in heavily calcified coronary stenoses. © 1993 Wiley-Liss, Inc.     

Efficacy of a new angioplasty catheter for severely narrowed coronary lesions

Conventional over the wire dilation catheters may be unsuccessful in crossing coronary lesions that are severely narrowed. Hence, a new, extremely low profile coronary angioplasty catheter specifically designed to dilate such lesions was investigated. The catheter features a 2.0, 2.5 or 3.0 mm (inflated diameter) balloon mounted on a guide wire. The deflated profile of the 2.0 mm balloon measures 0.020 +/- 0.001 in. (0.51 +/- 0.03 mm). The catheter can be used in conjunction with 7F angiographic or 8F guide catheters. The catheter was used in 61 patients, aged 43 to 86 years, with predominantly Canadian Cardiovascular Society class III-IV angina. Dilation was attempted in 77 lesions. Lesion length averaged 5.7 +/- 3.1 mm (mean +/- 1 SD), minimal diameter 0.51 +/- 0.25 mm and internal vessel diameter 2.27 +/- 0.43 mm. Sixty lesions (78%) were successfully dilated to less than 50% residual stenosis with this catheter alone; nine lesions were further dilated with a larger balloon catheter. The new catheter was unable to cross 13 lesions (17%); only 2 of these lesions were subsequently crossed with a conventional over the wire system. On the other hand, the catheter was used after failure of conventional dilating catheters in 21 lesions and was successful in 16. The new catheter was particularly valuable for distal lesions and those demonstrating 90 to 99% diameter reduction. For all lesions crossed, stenosis decreased from 76 +/- 11 to 29 +/- 12% after 2.9 +/- 2.7 inflations and peak inflation pressure of 8.0 +/- 2.9 bar. Complications were rare; coronary occlusion occurred in two lesions (3%) and dissection in three lesions (4%).(ABSTRACT TRUNCATED AT 250 WORDS)     

Preliminary experience with 5 and 6 French diagnostic catheters as guiding catheters for coronary angioplasty

With the reduction in profile of balloon dilation catheters, until recently, it has been the internal dimensions and performance of the guiding catheter that has mandated the use of 7, 8 or 9 French (F) systems for the performance of percutaneous transluminal coronary angioplasty (PTCA). A new 5F catheter design (Sherwood Medical Co., St. Louis, MO) provided a large inner lumen (0.4") permitting use of 0.20-0.22" fixed-wire PTCA balloon catheters with good coronary visualization. Potential advantages include reduced coronary artery ostial trauma and catheter induced damping and enhanced patient comfort. We report our initial experience in 14 patients undergoing PTCA with a 5 and 6F guide/fixed-wire system. Mean age was 63 +/- 10 (43-78 years). PTCA indications: Cardiogenic shock (1), post-myocardial infarction angina pectoris (2), grade III angina (5) and unstable angina pectoris (6). Vessel attempted: Left anterior descending (3), circumflex (4), obtuse marginal (2), diagonal (1), right coronary artery (3), and internal thoracic artery (1). Twelve patients had femoral approach; two brachial approach. The USCI Probe (USCI Division, Billerica, MA) was used in 8 lesions and SCIMED ACE (SCIMED Life Systems, Maplegrove, MN) catheter in 7 lesions. Successful 5 or 6F guide/fixed-wire dilations reduced the stenosis (77 +/- 14 to 37 +/- 30%) and were successfully performed in 79% (11/14). One 5F patient required 8F guiding catheter and was dilated with 2.0 fixed-wire balloon. A second failed 5F PTCA could not be dilated with any larger conventional system. A third total occlusion could not be crossed with a guidewire or fixed wire balloon. No patient had a complication.(ABSTRACT TRUNCATED AT 250 WORDS)     

Clinical experience with low profile fixed wire balloon catheter system for percutaneous transluminal coronary angioplasty

Clinical records of the first 45 consecutive patients (66 lesions) in whom the Probe TM a balloon on the wire, was used for percutaneous transluminal coronary angioplasty have been reviewed. The aim of this analysis was to establish the efficacy and safety of this device. Majority of the lesions taken up were considered severe and difficult to cross. The probe was the 1st catheter used in 51 lesions (77%) and in 15 lesions (23%) it was used after other balloon catheters. In 88% (58/66) of lesions treated the Probe reduced the stenosis to less than 50% of the luminal diameter. Of the 45 patients treated 39 (87%) had a successful result. Of the 19 patients with multiple lesions 74% (14/19) had complete revascularisation and in 16% (3/29) had the most significant vessel dilated. Two patients (3%) required urgent coronary artery bypass surgery for acute occlusions. There was no hospital death. Of 50 probe devices used 5 (10%) malfunctioned: the balloon ruptured (at 5 Bars pressure) in 2 instances, balloon twisted causing "Volvulous" in 1 and balloon failed to deflate in 2 cases. The probe has significant advantages over other balloon systems for treating severe coronary lesions because of its low profile. It is however a delicate catheter system and prone to malfunction if not handled with care. Our results show that it is an excellent system for opening difficult and tight coronary lesions.     

Early clinical experience with a hot tip laser wire in patients with chronic coronary artery occlusions

Chronic coronary artery occlusions remain one of the problems limiting the use of percutaneous transluminal coronary angioplasty (PTCA). We have studied the use of an 0.018 inch laser hot tip wire. It was coupled either to a continuous wave argon or Nd-YAG laser generator and introduced through a balloon catheter to try and cross and dilate a series of chronic coronary artery occlusions in which initial conventional attempts had failed. Four LAD and 6 RCA occlusions were attempted; we successfully crossed and dilated 6 (60%) lesions, 4 (40%) using the laser wire alone to recanalize the occlusion and in 2 a combination of laser wire and conventional means.     

Pressure wire guide provisional coronary stent implantation

OBJECTIVES: Whether coronary artery lesion successfully dilated by balloon angioplasty should be stented or not is unclear. The purpose of this study is to evaluate the provisional stent implantation method assessing residual ischemia by pressure wire. METHODS: Thirty-one patients with de-novo lesions suitable for stenting were enrolled in a pressure wire guided provisional stent study. The pressure wire was used to assess the fractional flow reserve(FFR) before and after balloon angioplasty. When the FFR after angioplasty was less than 0.75, stent implantation was planned. Patients with lesions consisting of an intermediate stenosis proximal to the target lesion, chronic total occlusion, bypass graft and left main lesion were excluded from the study. Stent implantation was permitted even if the FFR was more than 0.75 when the operator thought stenting was necessary. Medical treatment was given with aspirin 162 mg/day, cilostazol 200 mg/day for 6 months and additional ticlopidine 200 mg/day for a month after stenting the lesion. RESULTS: Target vessel was the left anterior descending coronary artery in 19 lesions, the right coronary artery in 3, and the circumflex coronary artery in 9. Stent implantation was performed in seven (23%) of 31 lesions and the other 24(77%) lesions were treated with only balloon angioplasty. The FFR before intervention was 0.58 +/- 0.16, and improved to 0.87 +/- 0.07 (p < 0.0001). Percentage diameter stenosis before intervention was 70.7 +/- 12.6% and improved to 20.1 +/- 13.3% (p < 0.0001) after intervention. There was no major cardiac event (death, coronary artery bypass grafting, myocardial infarction, stent thrombosis). Six months follow-up angiography was performed in 27 patients (87%). Angiographic restenosis (percentage diameter stenosis > or = 50%) was found in four patients (15%). A new lesion was found in two patients. Target vessel revascularization was performed in six patients (21%). CONCLUSIONS: Lesions successfully dilated by balloon angioplasty with FFR > or = 0.75 do not require stenting.     

Angioplasty of total coronary occlusions using combination of intracoronary Probing Catheter and balloon on wire Probe.

We describe our experience with a technique for PTCA of total coronary occlusions using the ultra low profile balloon on wire Probe. An intracoronary Probing Catheter was used to facilitate crossing the stenosis with a guide wire. This was followed by exchanging the guide wire for the Probe into the obstruction for balloon dilatation. This technique was used in 22 consecutive patients undergoing PTCA for chronic total occlusion. The total obstruction could be crossed by guide wire (0.014 flex or 0.016 standard) passed through Probing Catheter in 19 patients (86%). The obstruction could be successfully dilated by the Probe, delivered through the probing catheter, in 17 of these patients. Of the remaining 2 patients, one could be dilated by sequential dilatation using over the wire low profile balloon system and the other one by dilatation with the Probe, respectively. The Probing Catheter technique offers a new method to apply balloon on wire technology to the dilatation of chronic total coronary occlusions with very promising results.     

Probe "balloon on a wire" ultra-low-profile coronary catheter: results of PTCA in 107 patients

A new low-profile "balloon-on-a-wire" angioplasty catheter, the Probe (USCI), was used in 107 patients over a 4-month period. Twenty-nine patients had stable angina, 59 had unstable angina, and 19 had had myocardial infarction (MI) 3 to 15 days prior to the procedure; 71 patients had single-vessel and 36 had multi-vessel disease. In this series, 57 lesions were defined as complex. Successful dilatation was defined as a residual stenosis of less than 30%. Of 132 non-total obstructions, 127 (97%) were successfully dilated. Two distal lesions could not be reached, two lesions could not be crossed by the balloon, and a distal lesion dilatation resulted in acute closure in one case. Of 19 total obstructions, 16 (84%) were successfully dilated (mean residual stenosis 23%). The wire tip was unable to cross the lesion in the three unsuccessful procedures. Seven complications occurred in the series, all involving non-total obstructions: closure of a distal vessel and a side branch caused no clinical symptoms or EKG changes; three local dissections were tacked back with repeat dilatation; and two longitudinal dissections caused no apparent reduction in luminal diameter. The Probe's low-profile and exceptional trackability enabled it to cross very tight lesions with minimal trauma to the vessel wall. The high degree of conformability of the PET balloon minimizes vessel straightening or sheer forces and appears to reduce the potential for dissection. The device may therefore extend the indications and ease of PTCA while reducing complications of the procedure.     

Probe “balloon on a wire” ultra-low-profile coronary catheter: Results of ptca in 107 patients

A new low-profile “balloon-on-a-wire” angioplasty catheter, the Probe? (USCI), was used in 107 patients over a 4-month period. Twenty-nine patients had stable angina, 59 had unstable angina, and 19 had had myocardial infarction (Ml) 3 to 15 days prior to the procedure; 71 patients had single-vessel and 36 had multi-vessel disease. In this series, 57 lesions were defined as complex. Successful dilatation was defined as a residual stenosis of <30%. Of 132 non-total obstructions, 127 (97%) were successfully dilated. Two distal lesions could not be reached, two lesions could not be crossed by the balloon, and a distal lesion dilatation resulted in acute closure in one case. Of 19 total obstructions, 16 (84%) were successfully dilated (mean residual stenosis 23%). The wire tip was unable to cross the lesion in the three unsuccessful procedures. Seven complications occurred in the series, all involving non-total obstructions: closure of a distal vessel and a side branch caused no clinical symptoms or EKG changes; three local dissections were tacked back with repeat dilatation; and two longitudinal dissections caused no apparent reduction in luminal diameter. The Probe's low-profile and exceptional trackability enabled it to cross very tight lesions with minimal trauma to the vessel wall. The high degree of conformability of the PET balloon minimizes vessel straightening or sheer forces and appears to reduce the potential for dissection. The device may therefore extend the indications and ease of PTCA while reducing complications of the procedure.     

Probe angioplasty of total coronary occlusion using the Probing Catheter technique

Coronary angioplasty (PTCA) of total coronary occlusion is limited by the inability of guidewires and conventional dilating catheters to cross all such lesions. A new technique was therefore prospectively evaluated for PTCA of these lesions using the ultra-low-profile Probe "balloon on a wire" device. An intracoronary Probing Catheter was used to facilitate crossing the stenosis with a guidewire and then to deliver a Probe into the obstruction for balloon dilatation. This technique was utilized in 64 consecutive patients with "absolute" coronary occlusions demonstrating no angiographically detectable antegrade coronary flow. Successful dilatation was achieved in 47 (73%). Among 33 occlusions of less than 3 mo duration 31 (94%) were successfully dilated whereas only 16 of 31 more chronic occlusions were dilated (P less than .01). Chronic occlusions with a tapered morphology and those located more than 1 cm from a branch point were more frequently dilatable. There were no serious complications including no vessel perforations with this technique. The Probing Catheter technique offers a safe and effective method for the dilatation of recent coronary occlusions by using balloon on a wire technology.     

Sequential dilatation of septal and left anterior descending artery: single guiding catheter and double guide wire technique

A new technique was used to dilate sequentially a bifurcation lesion involving the left anterior descending artery and the origin of a large septal branch. Two steerable long guide wires (300 cm) were advanced through a single guiding catheter and placed across each lesion. The balloon catheters were introduced into the target arteries for angioplasty one at a time over the pre-positioned guide wires. After the septal branch had been successfully dilated, the balloon catheter was completely withdrawn from the manifold and a second balloon catheter positioned in the left anterior descending artery over the guide wire already placed across the stenosis. Such a technique is feasible and safe, and overcomes the potential risks of the conventional kissing balloon technique.     

Probe™ angioplasty of total coronary occlusion using the probing catheter™ technique

Coronary angioplasty (PTCA) of total coronary occlusion is limited by the inability of guidewires and conventional dilating catheters to cross all such lesions. A new technique was therefore prospectively evaluated for PTCA of these lesions using the ultra-low-profile Probe? “balloon on a wire” device. An intracoronary Probing Catheter? was used to facilitate crossing the stenosis with a guidewire and then to deliver a Probe? Into the obstruction for balloon dilatation. This technique was utilized in 64 consecutive patients with “absolute” coronary occlusions demonstrating no angiographically detectable antegrade coronary flow. Successful dilatation was achieved in 47 (73%). Among 33 occlusions of less than 3 mo duration 31 (94%) were successfully dilated whereas only 16 of 31 more chronic occlusions were dilated (P<.01). Chronic occlusions with a tapered morphology and those located more than 1 cm from a branch point were more frequently dilatable. There were no Serious complications including no vessel perforations with this technique. The Probing Catheter? technique offers a safe and effective method for the dilatation of recent coronary occlusions by using balloon on a wire technology.     

Use of a hollow wire to facilitate angioplasty of occluded vessels.

An USCI 0.038 inch (0.97 mm) floppy tipped hollow wire was used to facilitate the passage of angioplasty guide wires across severe stenoses or vessel occlusions before balloon angioplasty. The hollow wire was passed through a standard 7 or 8 French gauge Judkins coronary catheter to establish whether the obstruction could be breached. This reduced the cost of failure because angioplasty guiding systems were not committed to procedures that were unlikely to be successful. The hollow wire provides stability for the passage of the guide wire and can be used to measure distal pressure and inject contrast. To date it has been used in a total of 15 cases of occluded vessels; it failed to cross the lesion in four cases. Successful angioplasty followed in all patients in whom the lesion was crossed.     

Use of a hollow wire to facilitate angioplasty of occluded vessels

An USCI 0.038 inch (0.97 mm) floppy tipped hollow wire was used to facilitate the passage of angioplasty guide wires across severe stenoses or vessel occlusions before balloon angioplasty. The hollow wire was passed through a standard 7 or 8 French gauge Judkins coronary catheter to establish whether the obstruction could be breached. This reduced the cost of failure because angioplasty guiding systems were not committed to procedures that were unlikely to be successful. The hollow wire provides stability for the passage of the guide wire and can be used to measure distal pressure and inject contrast. To date it has been used in a total of 15 cases of occluded vessels; it failed to cross the lesion in four cases. Successful angioplasty followed in all patients in whom the lesion was crossed.     

First clinical experience of a novel penetration catheter for patients with severe coronary artery stenosis.

The study aimed to evaluate the efficacy of a novel penetration catheter for severe coronary artery disease. Severe coronary artery diseases such as chronic total occlusions or severe calcified stenoses sometimes obstruct the subsequent crossing of balloon catheter after successful wire crossing. A novel penetration over-the-wire catheter has been developed for severe coronary artery disease. The main shaft is a coreless stainless coil that consists of eight stranded stainless wires to cross through a severe stenosis by manual rotation. This device was applied during percutaneous coronary intervention for patients with severe coronary artery disease obstructing the subsequent crossing of balloon or microcatheters after successful wire crossing. Initial results were examined. Fourteen eligible patients were enrolled consecutively. Among those, 10 patients had chronic total occlusion and 7 patients showed severe angiographical calcification. The device was successfully crossed through the lesion and enabled subsequent dilatation in all patients without any complication. This new device enables the crossing of severe coronary artery stenoses and therefore favors further dilatation in this lesion subset.     

The use of an exchange guide wire in coronary angioplasty

Of 84 consecutive patients referred for coronary angioplasty, an exchange length (260 cm) guide wire was used in 17 (20%) to allow serial passage of different sized dilatation catheters. Exchanges were performed for the following reasons: 1) inability to cross the stenotic segment with a full-sized dilatation catheter, with exchange for a smaller catheter to permit initial dilatation followed by a second exchange to reintroduce the full-sized balloon catheter; 2) premeditated initial use of a low-profile balloon catheter in severe stenosis, with subsequent exchange to a full-sized balloon catheter; 3) inability to achieve a satisfactory reduction of the transstenotic gradient or angiographic stenosis with the initial dilation catheter, requiring subsequent passage of a larger balloon catheter into the partially dilated segment. Eighteen of 19 attempted exchanges and 18 of 19 angioplasty procedures were completed successfully. The use of exchange guide wires permits multiple recrossings of a dilated segment, allows safe serial passage of different sized balloon catheters, and obviates the need for renegotiating difficult proximal coronary anatomy. The exchange guide wire techique can be applied safely and effectively to coronary angioplasty and provides an additional option in the successful completion of movable guide wire angioplasty procedures.     

Subselective Intracoronary Access Guide Catheters for use with the ProbeTM Balloon on a Wire Coronary Dilatation Device

Subselective coronary access guide catheters are described for use with the Probe^TM balloon on a wire coronary dilatation device. These access catheters provide the following advantages over the "naked" Probe^TM: (1) Guide catheter stabilization, (2) Lesion access, (3) Lesion visualization, (4) Lesion crossing, and (5) Lesion protection. The Probe/access catheter system was used in 51 patients on 132 lesions (average 2.6 lesions/patient; range 1–8 lesions/patient) of which 116 (88%) were dilated successfully. Failures tended to be in total occlusions or in eccentric subtotal occlusions that could not be crossed with the Probe^TM tip wire. No patient required emergency coronary bypass. One patient sustained a small myocardial infarction within 24 hours of the procedure. One patient developed hemopericardium after rupture of a small branch coronary artery. One patient died from intracerebral bleeding due to thrombolytic and anticoagulant therapy. The Probe^TM access catheter system has several advantages over the Probe^TM device alone, and future developments can be expected to extend these benefits. (J Inter-ven Cardiol 1989:2:1)