Magnum system for routine coronary angioplasty: a randomized study.

The Magnum system, initially designed for coronary angioplasty (PTCA) of chronic total occlusion, consists of a balloon catheter and a solid steel 0.021 inch (0.53 mm) steerable and removable wire with a soft and moldable distal portion, tipped with a 1 mm olive. To evaluate its performance in routine PTCA, 200 unselected consecutive patients were randomized to two equal groups, i.e., group Magnum (100 patients, 115 vessels) and group Standard (100 patients, 118 vessels) including 18 and 21 patients with chronic total occlusions, respectively. Randomization was performed by the sealed envelope system in the catheterization laboratory and crossover of system was imposed if it was not possible to place a balloon correctly within 20 min of fluoroscopy time. There were no significant differences between groups concerning clinical and angiographic baseline characteristics, size of initial balloons (3.0 +/- 0.3 mm in both groups), fluoroscopy time to cross the lesion with the wire (Magnum: 4 +/- 5, Standard: 5 +/- 6 min), total fluoroscopy time (Magnum: 11 +/- 9, Standard: 12 +/- 12 min), and need for crossover (Magnum: 10%, Standard: 16%). Success rates per lesion were comparable with 90% in group Magnum and 84% in group Standard, as were the complications with one inhospital death in group Standard, occurring three weeks after PTCA and stent implantation. There was no emergency operation. Six patients per group had myocardial infarction of whom two in group Magnum and one in group Standard developed a Q-wave. The following variables were significantly in favor of the Magnum system compared with the Standard system: success rate in nontotal lesions (97% versus 90%) crossover success in total occlusions (0 vs. 33%), fluoroscopy time to cross the lesion with the balloon once the wire was in place (1 +/- 2 vs. 2 +/- 4 min), and use of a single versus 1.2 +/- 0.5 wires per lesion. The only advantage of the Standard systems was the more common use of 7 French guiding catheters (Magnum: 40%, Standard: 53%, p = 0.09). The Magnum system compares favorably with standard systems for routine PTCA. The robust design of the Magnum wire does not impair ease of placement and safety but saves material and facilitates balloon advancement across the lesion.     

Magnum/Magnarail versus conventional systems for recanalization of chronic total coronary occlusions: a randomized comparison.

The Magnum/Magnarail system consists of "over-the-wire" balloon catheters and a 0.021 inch (0.53 mm) guide wire with a 1 mm olive-shaped tip. To compare it to conventional systems, 100 consecutive unselected patients with chronic total coronary occlusions were randomly assigned to one of two groups. If the balloon could not be placed within 20 minutes of fluoroscopy time with the allocated system, a crossover to the other system was imposed. The Magnum group comprised 50 patients and 52 occlusions, and the conventional group included 50 patients and 51 occlusions. There were no significant differences with regard to the length of the occlusions (Magnum 1.4 +/- 1.3 mm, conventional 1.6 +/- 1.7 mm) or the duration (Magnum 1.4 +/- 1.9 months, conventional 1.4 +/- 1.8 months). The primary success rate before crossover with the Magnum/Magnarail system was 67% versus 45% with conventional systems (p less than 0.05). The Magnum/Magnarail system as a second tool after crossover was successful in 11 of 28 patients (39%) versus 2 of 16 patient (12%) in whom success was achieved with a conventional system as a second tool (p less than 0.05). An increase in the creatine kinase level (more than twice normal) was seen in one patient (2%) in the Magnum/Magnarail group and none in the conventional group. Q wave infarctions were not seen. There was one in-hospital death (2%) in the conventional group. There were no significant differences with regard to the number of guiding and balloon catheters or fluoroscopy time. The Magnum/Magnarail system proved superior to conventional systems for balloon recanalization of chronic total coronary occlusions in terms of higher success rates.     

Angioplasty of coronary bifurcation stenoses: Immediate and long-term results of the protecting branch technique

Percutaneous transluminal angioplasty (PTCA) of coronary stenoses involving major bifurcations carries a small but significant risk of side branch occlusion which can be avoided by simultaneously using multiple dilatation systems. Among 1,275 PTCA procedures performed between 1984 and 1988 in 1,035 consecutive patients, 42 double wire procedures were applied (4%) to protect and/or dilate major coronary side branches. A total of 80 coronary stenoses were attempted of which 76 were located on a bifurcation and 4 on other segments. In the first 11 patients (group A), 2 guiding catheters were used and PTCA of each vessel was successfully performed by means of separate double lumen over-the-wire balloon catheters. In the next 31 patients (group B), 2 guidewires were advanced through a single guiding catheter and PTCA was attempted using “Monorail” balloon catheters sequentially advanced over the wires. In group B, a successful PTCA was obtained in 29 patients (93%) but twisting of the wires hampered balloon progression in 5 cases, such that dilatation could only be performed by stepping back to a single wire technique. The procedure time in group B was significantly shorter than in group A: 144 ± 30 versus 230 ± 52 minutes (p = .01). Repeat angiography was performed in 35 out of 40 patients (87%) after a mean of 180 ± 46 days following successful PTCA. Angiographic restenosis was present in 37% (24/65) of bifurcation segments which, in our experience, is not significantly different from the angiographic restenosis rate in less complex lesions (248/740; 34%; NS). It is concluded that 1) the need for using a protecting branch technique in PTCA practice is uncommon (4%); 2) among other approaches, the use of a “Monorail” system allows successful dilatation in 93% of cases with a shortened procedure time; 3) the restenosis rate at repeat angiography is similar to that of non-bifurcated lesions.     

Initial experiences with a miniaturized pressure transducer during coronary angioplasty

A newly constructed pressure sensor with a diameter of 0.45 mm was evaluated in 15 patients undergoing balloon coronary angioplasty (PTCA). The sensor and an optic fiber were mounted on a 0.018″ guide wire, which was used in the balloon catheter. Pressure gradients were recorded before and after PTCA, respectively. The pressure tracings were of satisfactory quality in all cases. The mean systolic and diastolic gradients before PTCA were 32 ± 20mm Hg and 44 ± 26mm Hg, respectively. Pressure gradients were also obtained with the balloon placed in the lesion in order to simulate the conventional way of pressure measurement through the balloon catheter. In this setting, the systolic and diastolic gradients were 77 ± 32mm Hg and 59 ± 25mm Hg, respectively. Following balloon dilatation, the systolic pressure gradient decreased to 14 ± 12mm Hg, and the diastolic gradient to 13 ± 11 mm Hg. In conclusion, this new pressure sensor delivers recordings of good quality and may be especially of interest during angioplasty due to its small diameter.     

Coronary artery angioplasty with a helical autoperfusion balloon catheter

The initial in-hospital and long-term clinical experience with a helical autoperfusion balloon catheter in the treatment of coronary artery disease is reported. This new catheter design allows blood to flow passively around the inflated balloon through a protected helical channel molded into the balloon surface. Twelve consecutive patients underwent PTCA. Continuous ST monitoring, heart rate, average peak distal coronary blood flow velocity (APV), coronary blood flow (CBF), dP/dt and systemic and pulmonary arterial pressures were determined during PTCA. During balloon inflation there were no hemodynamic changes, TIMI flow was 1.7 ± 0.8, and APV was 39% of baseline. Luminal diameter stenosis improved from 61 ± 17 to 29 ± 13% (P < 0.05) following PTCA. Mean continuous inflation duration was 385 ± 215 sec and 6/12 patients had ≥ 7.5-min inflations. There were no in-hospital adverse cardiac events. One patient developed recurrent angina during 8 mo of follow-up and underwent successful PTCA of a restenotic lesion. We conclude that human plaques can be successfully dilated with a helical balloon catheter that provides autoperfusion and the ability to perform prolonged inflations with hemodynamic stability. A comparison of this PTCA catheter with standard balloon catheters is warranted. Cathet. Cardiovasc. Diagn. 40:179–185, 1997. © 1997 Wiley-Liss, Inc.     

Magnum Meier wires with Crag Fx wire catheter for total occlusive coronary arteries

Magnum Meier wire was used with Crag Fx wire catheter instead of Magnum balloon catheter to facilitate wire crossing through total occlusion by improving flexibility of the system without losing wire pushability. Of 372 coronary angioplasty procedures performed between January 1994 and April 1995, there were 12 subacute occlusions with an interval of 3 wk or less and 30 chronic occlusions with an interval of >3 wk. Regular over-the-wire-type balloon catheters failed to dilate four subacute occlusions and nine chronic total occlusions. Magnum Meier wire with Crag Fx wire catheter was tried for one subacute occlusion and four chronic occlusions that were undilatable with a regular balloon system and successfully dilated the subacute occlusion and three of the chronic occlusions. The lesions successfully dilated by this new approach were either long or tandem lesions in vessels that were excessively tortuous or showed an acute angle at the orifice. Thus the Magnum Meier wire with Crag Fx wire catheter can be a useful tool for dilating totally occluded lesions in tortuous coronary arteries. Cathet. Cardiovasc. Diagn. 40:198–201, 1997. © 1997 Wiley-Liss, Inc.     

Angioscopic evaluation of prolonged vs standard balloon inflations during coronary angioplasty: A randomized study

To study the immediate effects of prolonged total balloon inflationduring PTCA, 41 patients (44 lesions) with chronic-stable anginawere randomized for prolonged sequential inflations (three tofive inflations of 3 to 5 min each, for a total duration of 12 min, group 1, n=20 lesions) or ‘standard’ sequentialinflations (three to five inflations of 1 min each, for a totalduration of 3 min, group 2, n-24 lesions). The mean durationof total balloon inflation time was 958 ± 129 s in group1 vs 205 ±46 s in group 2. Results of angioplasty wereassessed on both angiography and percutaneous transluminal coronaryangioscopy performed immediately after the procedure. High qualityimaging of the coronary lumen and lesion morphology was possibleon angioscopy in all patients without any complications. Post-PTCAangiographic percent diameter stenosis was significantly lessin group 1 compared to group 2: 26 ± 10% vs 36 ±8% (P<0.05). On angioscopy, flaps were seen in 16 patientsin group 2, but in only six in group 1 (P<0.02). There wasno difference in the incidence of thrombi on angioscopy betweenthe two groups (group 1: nine cases, group 2: 10 cases). Sensitivityof angiographic detection of flaps and thrombi was poor: 10%and 12% respectively. One patient in each group developed alongitudinal dissection, detected on both angiography and angioscopy. Conclusions: (1) prolonged sequential balloon inflations leadto less residual luminal stenosis after PTCA, with a decreasedincidence of intimal flaps in comparison with standard inflations.(2) Post-PTCA transluminal coronary angioscopy is safe and offersbetter assessment of luminal effects of PTCA than angiography.     

Immediate and chronic results of cutting balloon angioplasty: A matched comparison with conventional angioplasty

Background: At the initial stages of percutaneous transluminal coronary angioplasty (PTCA), several studies reported on the feasibility of coronary artery incision and dilatation leading to the extension of the PTCA technique. Hypothesis: This study was designed to determine the immediate and chronic results of cutting balloon (CB) angioplasty. Methods: This procedure was performed on 127 lesions in 110 patients (male 83%, age 61.8 ± 9.3 years). Results: The overall procedural success rates for the CB were 93.7% (119 lesions) and 92.7% (102 patients), while solitary CB without pre- and/or postdilatation was 76.4% (91 lesions). There was one major in-hospital complication (Q-wave myocardial infarction, 0.9%), but there were no deaths or emergency coronary artery bypass graftings. Significant angiographic dissections (≥ grade C) occurred in four patients, and coronary perforation occurred in one. The successfully treated CB group (95 lesions) was matched with the successful conventional angioplasty group (PTCA group) for chronic result assessment in regard to reference vessel size and lesion characteristics. In the CB group, postprocedural minimal luminal diameters were significantly larger and the percentage of stenosis at the stenotic site was significantly lower compared with the PTCA group. Restenosis occurred in 22 lesions (23.1%). This showed a significantly lower restenosis rate compared with the PTCA group (42.1%). In addition, the restenosis rate of the CB without inclusion of the pre- and/or postdilatation-treated lesions was 19.7%. Conclusions: (1) Cutting balloon angioplasty procedures can be performed with high success rates with few major in-hospital events. (2) The restenosis rate in the CB group was significantly lower compared with the PTCA group.     

Efficacy and safety of using perfusion dilatation catheter as initial balloon in coronary angioplasty

The efficacy and safety in using a new low-profile perfusion balloon catheter (PBC) as the initial balloon in percutaneous coronary angioplasty (PTCA) was assessed retrospectively in 61 patients: 43 males, mean age 62 ± 12 years. Thirty-three patients (54%) had unstable angina. PTCA was performed using an improved PBC in the following vessels: LAD 40%; CX 21%; RCA 24%. Lesion morphology was: Type A 21%; Type B1 18%; Type B2 40%; Type C 21%. Mean artery size was 3.01 ± 0.53 mm. Mean PBC size was 3.14 ± 0.45 mm. The mean number of inflations used was 2.85 ± 2.0. The mean longest inflation was 415 ± 213 sec and the total inflation time was 663 ± 342 sec to a mean maximum pressure atmosphere of 7.85 ± 2.0 bars. The number of balloons used per procedure was 1.2 ± 0.44. In 50 patients (82%) only one balloon was used during the PTCA. PTCA was successful (<50% diameter stenosis without major complications) in 60 patients (98.4%). Mean diameter stenosis at baseline was 82 ± 9.5% and post-angioplasty 13 ± 10.6%. A mild intimal tear occurred in 6 patients (9.8%). A stent was implanted in 3 patients (4.9%) due to severe dissection. In hospital reocclusion occurred in one patient (1.6%). There were no deaths or emergency bypass surgery. A low profile PBC is safe and effective as an initial balloon in PTCA. It may reduce the number of balloons used and inflations per procedure. © 1994 Wiley-Liss,Inc     

Excimer laser angioplasty vs. balloon angioplasty in saphenous vein bypass grafts: Quantitative angiographic comparison of matched lesions

Technologies which ablate or debulk tissue may result in better angiographic outcomes by altering the elastic properties of the vessel wall. Accordingly, the procedural outcomes of 88 vein graft lesions treated by either excimer laser angioplasty with adjunct balloon angioplasty (PELCA + PTCA, n = 44) (Spectranetics CVX-300, 1.4-, 1.7-, or 2.0-mm catheters) or balloon angioplasty alone (PTCA, n = 44) were analyzed by quantitative angiography (Cardiac Measurement System). Lesions were individually matched for vessel position, reference diameter (RD), and minimal luminal diameter (MLD). Matching was deemed adequate as the preprocedure MLD (PELCA + PTCA, 1.14 ± 0.48 mm; PTCA, 1.20 ± 0.47 mm) and RD (PELCA + PTCA, 3.23 ± 0.56 mm; PTCA, 3.25 ± 0.57 mm) were not significantly different. There were also no significant differences between PELCA + PTCA- and PTCA-treated lesions with respect to patient age, graft age, lesion length, symmetry, and plaque area. Balloon diameter at maximal inflation was 2.77 ± 0.55 mm (PELCA + PTCA group) and 2.84 ± 0.59 mm (PTCA group), P = NS. Final MLD postprocedure was 2.17 ± 0.54 mm and 2.19 ± 0.55 mm for PELCA + PTCA- and PTCA-treated lesions (P = NS), respectively. Vessel stretch [(balloon diameter − MLD pre)/RD], elastic recoil [(balloon diameter − MLD post)/RD], and acute gain [(MLD post − MLD pre)/RD] were calculated and normalized for vessel size (RD). Vessel stretch (PELCA + PTCA, 0.60 ± 0.22; PTCA, 0.59 ± 0.24; P = NS), elastic recoil (PELCA + PTCA, 0.28 ± 0.18; PTCA, 0.26 ± 0.16), and acute gain (PELCA + PTCA, 0.34 ± 0.24; PTCA, 0.31 ± 0.23; P = NS) were not significantly different between the two treatment groups. In a matched population of successfully treated vein graft lesions, PELCA + PTCA did not reduce elastic recoil or improve immediate angiographic outcome, as compared with PTCA alone. © 1996 Wiley-Liss, Inc.     

Excimer Laser Angioplasty with Adjunctive Balloon Dilatation Versus Balloon Dilatation Alone for the Treatment of In-Stent Restenosis: Results of a Randomized Single-Center Study

Background: Laser ablation of neointimal tissue prior to balloon dilatation has been shown to be a potential treatment modality for restenosis within previously implanted stents. It remains controversial whether this treatment provides superior acute and long-term results compared to conventional balloon dilatation. Methods and Results: Between November 1995 and November 1996, 96 patients with significant (≥ 50%) in-stent restenosis were randomized to receive excimer laser angioplasty with adjunctive balloon dilatation (ELCA + PTC A, n = 47) or PTCA alone (n = 49). Both groups did not differ with regard to gender, clinical history, location of the lesion, reference diameter, or lesion length. Angiographic success was achieved in 46 patients with ELCA + PTCA (98%) and in 48 patients with PTCA alone (98%). In-hospital complications included acute closure in one patient of each group, one CABG, one repeat PTCA, and one non-Q wave MI with ELCA + PTCA, versus two bleeding and one death with PTCA. Clinical follow-up was obtained in all patients, while angiographic follow-up was available in 35 of 47 (ELCA+PTCA) versus 35 of 49 (PTCA) patients with a mean follow-up time of 163 ± 81 days. With ELCA+PTCA, MLD increased from 0.82 ± 0.38 to 1.99 ± 0.33 mm versus 0.81 ± 0.39 mm to 2.07 ± 0.60 mm with PTCA (P = NS). At follow-up, MLD was 1.32 ± 0.60 mm with ELCA + PTCA versus 1.45 ± 0.75 mm with PTCA (P = NS). Late adverse events included nine repeat PTCA with ELCA +PTCA (19%) versus 12 with PTCA (24%), three CABG with ELCA +PTCA (6%) versus two with PTCA (4%), and one death (2%) with PTCA (P = NS). Angiographic restenosis rate was 52% with ELCA + PTCA versus 47% with PTCA alone (P = NS). Conclusion: Our data suggest that excimer laser angioplasty with adjunctive balloon dilatation for the treatment of in-stent restenosis provides similar acute results as plain balloon dilatation and may offer no advantage over PTCA alone with regard to intermediate-term outcomes.     

Exaggerated luminal loss a few minutes after successful percutaneous transluminal coronary angioplasty in patients with recent myocardial infarction compared with stable angina: An intracoronary ultrasound study

This study investigates the mechanisms of exaggerated acute luminal loss after successful coronary angioplasty in patients with recent myocardial infarction compared with stable angina by angiography and intracoronary ultrasound (ICUS). We studied 15 consecutive patients (group 1) who, after a successful thrombolysis for myocardial infarction, underwent delayed (8 ± 2 days after the myocardial infarction) successful balloon coronary angioplasty. Group 1 patients were individually matched with 15 stable angina patients (group 2). The percentage of stenosis and acute luminal loss were measured by quantitative coronary analysis. The ultrasound characteristics of lumen pathology were described as soft, hard, calcified, eccentric, concentric, thrombotic, and dissection lesions. Matching by stenosis location, reference diameter, sex, and age resulted in 2 comparable groups of 15 lesions with identical baseline characteristics. Immediately after percutaneous transluminal coronary angioplasty (PTCA), the minimal luminal diameter increased from 0.5 ± 0.3 mm to 2.4 ± 0.3 mm and from 0.5 ± 0.2 mm to 2.4 ± 0.3 mm in groups 1 and 2, respectively. Similar balloon sizes were used in both groups. The acute luminal loss (the difference between the maximal dilated balloon diameter and the minimal luminal diameter) immediately after PTCA was 0.4 ± 0.2 mm and 0.3 ± 0.3 mm (14 ± 8% and 10 ± 11% of balloon size) (P = not significant [NS]) in groups 1 and 2, respectively. After ICUS (mean 24 min after the last balloon deflation), the acute luminal loss was 0.9 ± 0.3 mm and 0.5 ± 0.4 mm (29 ± 11% and 17 ± 8% of balloon size) (P = 0.01) in groups 1 and 2, respectively. There was a significantly higher prevalence of intracoronary thrombus formation as detected by ICUS in group 1 compared with group 2 (80% vs. 20%; P < 0.001). In matched groups of successfully treated coronary angioplasty, patients with recent myocardial infarction had a similar magnitude of acute gained luminal loss immediately after the procedure. However, an exaggerated luminal loss a few minutes after the last balloon deflation in patients with recent myocardial infarction was noted because of mural thrombus formation compared with patients with stable angina. Cathet. Cardiovasc. Diagn. 41:32–39, 1997. © 1997 Wiley-Liss, Inc.     

Significance of balloon imprint during coronary angioplasty.

Balloon imprint during angioplasty is often seen, but not at all inflations. We prospectively studied 235 consecutive patients undergoing 282 PTCAs during a 4-month period, who were divided into two groups: those with balloon imprint during inflation (159 patients, 190 lesions; 67%) and those without (76 patients, 92 lesions; 33%). Clinical and lesion characteristics and immediate outcome were compared. Patients undergoing urgent PTCA had less balloon imprint than those undergoing nonurgent PTCA (14.2% vs. 28.3%; P < 0.005). Although not reaching statistical significance, younger patients and diabetic patients tended toward less balloon imprint (P < 0.06). Patients with observed imprint had less visible thrombus at lesion site (31.1% vs. 42.4%; P < 0.05), and a tendency without statistical significance toward more dissections but less acute closure was observed (P < 0.07). In addition, more stents were implanted in the imprint group (79.5% vs. 66.3%; P < 0.02). Patients needing pressure > 6 atm to break the imprint had more eccentric lesions (68% vs. 27.1%; P < 0.000) and more dissections (13.9% vs. 5.1%; P < 0.03) than those needing lower pressure. Patient and lesion characteristics may determine the appearance of balloon imprint at PTCA, which in turn influences the procedure and its immediate outcome. Cathet Cardiovasc Intervent 2001;53:331-333.     

Direct coronary stenting without predilatation: A new therapeutic approach with a special balloon catheter design

Coronary stenting is the primary therapeutic option for many coronary lesions, after the risk of subacute stent thrombosis and bleeding complications has been reduced by antithrombotic regimens and improved stent expansion. It would be desirable to shorten the procedure and the duration of ischemia, and to reduce the risk of ischemic complications during balloon inflation by implanting the stent without previous dilatation of the lesion. This is not possible with the presently available stent delivery systems. This new therapeutic concept was tested with a specially designed balloon catheter, on which slotted-tube stents can be fixed between two conical radiopaque markers. Sixty-one patients elegible for angioplasty underwent direct stent implantation without predilatation. Four procedures were performed for acute myocardial infarction, and two as high-risk PTCA. Single slotted-tube stents (Palmaz-Schatz, NIR, or JOStent) of 14–16-mm length were mounted between the conical radiopaque markers of a special balloon which provided a fixation for the crimped stent. The direct implantation was successful in 80% of all patients, while in 10% the stent could be deployed after predilatation of the lesion. In 10% of lesions a stent could not be implanted with this and any other delivery system. When patients with successful direct stenting were compared with those with indirect (after predilatation) or unsuccessful stent deployment, the presence of angiographically visible calcification was higher in the unsuccessful cases (75% vs. 19%; P < 0.01), and the patients were older (72 ± 8 vs. 61 ± 12 years; P < 0.01). Radiation exposure time was only 8.7 ± 5.1 min as compared with 12.6 ± 7.6 min in conventional stent procedures with predilatation (P < 0.05). The number of balloons used per lesion was also lower than with conventional stenting. Stent dislocation was observed in 5%, and no embolization occurred. The new therapeutic approach of direct stenting without predilatation proved to be a safe and successful procedure in this initial series of coronary angioplasties. When calcified coronary lesions are avoided, it provides a way to rationalize stent implantation with shorter radiation exposure times, fewer balloons, and the potential advantage of fewer ischemic complications as no balloon predilatation is required. Cathet. Cardiovasc. Diagn. 43:245–252, 1998. © 1998 Wiley-Liss, Inc.     

Single device approach to ultrasound-guided percutaneous transluminal coronary angioplasty and stenting: Initial experience with a combined intracoronary ultrasound/variable diameter balloon

We evaluated the use of both intracoronary ultrasound (ICUS) information and unique balloon characteristics provided by a combined ICUS/variable diameter balloon catheter during coronary interventions to achieve the maximal residual lumen using the least number of devices. In 47 patients, 64 coronary lesions were treated with either sequential percutaneous transluminal coronary angioplasty (PTCA) (n = 40) or stenting (primary [n = 17], secondary [n = 7]). The result after PTCA was judged satisfactory if the lumen cross sectional area (by ICUS) in the lesion exceeded 65% of the mean reference area. Stent implantation was judged according to revised MUSIC trial criteria. PTCA or stenting was successful in all 64 lesions using 47 combination devices and 10 conventional balloons (mean number of balloons per lesion: 0.90). PTCA group: diameter stenosis decreases from 78 ± 11 to 23 ± 13% following inflation at 10.3 ± 3.0 atm. ICUS lumen area was 4.6 ± 1.9 mm² (proximal reference: 7.4 ± 3.3 mm², distal reference: 5.7 ± 1.8 mm²) resulting in a residual area stenosis of 28 ± 15%. Stent group: diameter stenosis was reduced from 77 ± 14 to 10 ± 10% after stenting. ICUS defined minimal lumen area in the stent was 8.2 ± 2.2 mm² (proximal reference: 8.7 ± 2.6 mm², distal reference: 8.0 ± 2.2 mm²) resulting in a residual area stenosis of 7.2 ± 14.6%. No patient death, myocardial infarction, or emergency surgery occurred and only one target lesion required re-PTCA during hospitalization. In conclusion, use of a combined ICUS/variable diameter balloon catheter allows a single device strategy for ICUS-guided PTCA and stenting device strategy for ICUS-guided PTCA and stenting in the majority (84%) of unselected lesions. Cathet. Cardiovasc. Diagn. 40:393–399, 1997. © 1997 Wiley-Liss, Inc.     

One balloon,one stent: An effective cost-containment strategy for elective stent deployment

A cost-containment strategy to reduce stent procedure-related resources utilizing an integrated system comprised of a Stablizer™ guide wire, a Brite-Tip™ guiding catheter, and a single Titan™ balloon catheter for both lesion predilatation and poststent deployment was compared to a conventional strategy utilizing a nonintegrated guide wire, guiding catheter, and balloon components. Both groups were comparable with respect to demographics, number of lesions stented, and stents deployed per lesion. No differences in lesion length or pre- and poststent minimal luminal diameter were observed. Balloon use was significantly reduced using the integrated strategy when compared to the conventional strategy (1.3 ± 0.5 vs. 2.1 ± 1.1; P < 0.01); overall nonstent-related resource utilization was significantly reduced ($747 ± $401 vs. $1,093 ± $467; P < 0.01). Procedural success rates were identical in both groups (100%), and no patient sustained subacute stent thrombosis or required target vessel revascularization at 1 mo follow-up. We conclude that the use of a single Titan™ balloon catheter as part of an integrated cost-containment strategy for both lesion predilatation and poststent deployment results in considerable cost savings while maintaining high procedural and clinical success rates. Cathet Cardiovasc Diagn 40:17–20, 1997. © 1997 Wiley-Liss, Inc.     

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.     

Novel perfusion sleeve for use during balloon angioplasty: Initial clinical experience

The perfusion sleeve (PS) is an “over-the-balloon” catheter designed to add perfusion capability to standard PTCA catheters. To evaluate the clinical effectiveness of this device, eight patients underwent standard PTCA with the PS retracted in the guide (Inflation 1-Control) and after deployment of the PS (Inflation 3-Control). Between standard inflations the PS was advanced and aligned with the already positioned PTCA balloon which was inflated for up to 15 minutes (Inflation 2-Perfusion). TIMI III flow was present in 5/7 and TIMI II flow in 2/7 patients during Inflation 2-Perfusion. Absolute ST segment shift (mm) on the ECG was significantly less at 3 minutes and prior to balloon deflation with the PS in place (1.0 ± 1.4 and 1.1 ± 1.1 mm) compared to Inflation 1-Control and Inflation 3-Control (2.6 ± 1.3 and 2.3 ± 0.3 mm) respectively (P ≤ 0.05). Use of the PS in conjunction with standard PTCA is feasible, provides perfusion during prolonged balloon inflations and reduces the magnitude of ischemia. Cathet. Cardiovasc. Diagn. 44:358–362, 1998. © 1998 Wiley-Liss, Inc.