Coronary Angioplasty Catheter Research Articles

Five French (5 Fr) guiding catheters for percutaneous coronary angioplasty and stent placement: An initial feasibility study.

Thirty patients were treated with percutaneous coronary intervention (PCI) using a 5 Fr guiding catheter. A recently developed, mechanically advantaged hand injector was used to deliver contrast and achieved excellent visualization through the 5 Fr system. Stent sizes ranged from 2.25 to 4.00 mm in diameter and from 8 to 24 mm in length. All primary lesions were successfully treated. The average contrast use was 70 cc per case. There were no major complications and only one minor femoral hematoma. In selected patients, a balloon angioplasty and stent placement can be performed safely and successfully with 5 Fr guiding catheters using currently available products. This technique creates a smaller arterial puncture site, which may obviate the need for a closure device and allow early and safe ambulation. With 5 Fr systems, it appears that contrast usage is reduced, thereby potentially decreasing cost and morbidity. Cathet. Cardiovasc. Intervent. 51:352-357, 2000.

Coronary stenting using a 6 F. diagnostic catheter: a report of two cases.

Standard guiding catheters for coronary interventions may not selectively engage the coronary ostium despite a successful cannulation with a diagnostic catheter of the same curve. This discrepancy is explained by a slight difference in shape between the two catheters (shorter tip of the guiding, absence of tip tapering, etc.). The authors report on the use of 6 F. coronary diagnostic catheters as guiding catheters for coronary angioplasty and stent implantation in two patients with critical stenoses: in the right coronary artery distal to a right internal mammary artery anastomosis in one and in the ostial right coronary artery in the other. In both cases, the use of diagnostic catheters was the key to success despite the vessel orifice being unfavourable for the use of different types of guiding catheters.

The Vessel Wall Remodelling Technique Using a Coronary Angioplasty Balloon and a Single Guide Catheter

The vessel wall remodelling technique was created by Moret to enable endovascular therapy of relatively wide-necked cerebral aneurysms. As originally described, two guide catheters are placed in the relevant vertebral or carotid artery, and a Solstice balloon (Micro Interventional Systems, Ca, USA) inflated across the neck of the aneurysm while coils are placed inside. I describe a modification of this technique, using a single guide catheter, and a "monorail" coronary artery angioplasty catheter.

Reuse of catheters for percutaneous transluminal coronary angioplasty: Effects on procedure time and clinical outcomes

Reuse of catheters for percutaneous transluminal coronary angioplasty: Effects on procedure time and clinical outcomes

Lower expression of neutrophil adhesion molecule indicates less vessel wall injury and might explain lower restenosis rate after cutting balloon angioplasty.

The Cutting Balloon is a novel dilatation catheter for coronary angioplasty (InterVentional Technologies Inc). It produces longitudinal, microsurgical incisions in the vessel wall before the actual dilatation. It is assumed that these controlled surgical incisions relieve hoop stress and reduce vessel wall injury and eventually restenosis. However, no clinical indicator to support the theory of reduced injury has been described. Certain clusters of differentiation (eg, CD11, CD18 on the leukocytes) are implicated in leukocyte adhesion, increased permeability, and opsonization. Therefore, they might serve as clinical indicators of the injury level of the vessels after angioplasty. We randomly selected 64 patients with isolated left anterior descending coronary artery disease for either Cutting Balloon angioplasty or conventional balloon angioplasty. The expression of CD18 and CD11b on the surface of neutrophils was determined by flow cytometric analysis. Serum levels of soluble intercellular adhesion molecule-1 (sICAM-1) were also measured. The expression of both the CD18 and CD11b in the coronary sinus blood gradually increased and reached its maximum at 48 hours after angioplasty. The sICAM-1 levels in the coronary sinus serum also increased after angioplasty. Percentage increases of CD18 and CD11b expression and the increase of the sICAM-1 levels at 48 hours after angioplasty (as ratios to baseline values before angioplasty) were less in the Cutting Balloon angioplasty group than in the conventional balloon angioplasty group (CD18, 1.10+/-0.05 versus 1.31+/-0.05, P<0.05; CD11b, 1.23+/-0.06 versus 1.72+/-0.10, P<0.001; sICAM-1, 1.12+/-0.05 versus 1.25+/-0.02, P<0.05). In all patients, the late lumen loss at follow-up angiogram positively correlated with the increased levels of CD11b (R=0.59, P<0.001) and sICAM-1 (R=0.38, P<0.05) at 48 hours after angioplasty. Balloon angioplasty upregulated Mac-1 (CD11b/CD18) on the surface of the neutrophils and increased sICAM-1 levels in association with late loss increase. These changes were significantly smaller in the Cutting Balloon angioplasty group than in the conventional balloon angioplasty group. This suggests that Cutting Balloon angioplasty may produce less vessel wall injury and, consequently, less neutrophil activation, which may account for the lower rate of restenosis.

Initial Experience With Reuse of Coronary Angioplasty Catheters in the United States

Objectives. We sought to evaluate the performance of angioplasty catheters, restored under a strict manufacturing process, in patients with coronary artery disease.Background. Most countries outside the United States routinely reuse disposable medical equipment, resulting in significant cost savings. Because of quality and legal concerns, reuse in the United States has been limited. We investigated the reuse of percutaneous transluminal coronary angioplasty (PTCA) balloon catheters, restored by a process strictly controlled for bioburden and sterility, in patients undergoing PTCA.Methods. Used PTCA balloon catheters were shipped to a central facility and were decontaminated, cleaned and tested for endotoxin using the limulus amebocyte lystate (LAL) gel clot method. Physical testing and quality assurance were performed. The products were packaged and sterilized with ethylene oxide. Catheter performance was assessed in a pilot study powered to detect a 5% difference in the angiographic failure rates of new and reused balloons (beta 0.8).Results. The study enrolled 107 patients. The indication for PTCA was stable angina pectoris in 69 patients, unstable angina in 22 and acute myocardial infarction in 16. Of the 107 patients enrolled, 106 had a successful laboratory outcome, and 1 required coronary artery bypass graft surgery after failed rescue stenting. There were 122 lesions attempted (American College of Cardiology/American Heart Association classification A, n = 32; B1, n = 43; ≥B2, n = 35; C, n = 12). Of the 110 lesions initially approached with restored PTCA catheters, 108 were crossed and dilated. Sixty-four required no further procedures. Stenting was performed in 37 patients (29 planned, 8 rescue). Thus, the angiographic failure rate was 7% (10 of 108, 95% confidence interval 2% to 12%), comparable to the 10% rate seen with new balloons in other studies.Conclusions. Restoration of disposable coronary angioplasty catheters using a highly controlled process appears to be safe and effective, with success rates similar to those of new products and no detectable sacrifice in performance. Cost analysis suggests that implementation of reuse technology for expensive disposable equipment may offer cost savings for U.S. hospitals, without sacrifice of quality.

Comparison of 6F with 7F and 8F guiding catheters for elective coronary angioplasty: Results of a prospective, multicenter, randomized trial

A group of 460 patients was considered in our prospective study of assessment of the efficiency and safety of 6F (internal diameter 0.062 inches) guiding catheters to perform elective percutaneous coronary angioplasty by the femoral approach by using conventional balloon systems. The patients were randomly assigned either a 6F guiding catheter (first group, n = 231; 247 coronary lesions), or a 7F or 8F guiding catheter (second group, n = 229; 252 coronary lesions). The exclusion criteria were the ongoing myocardial infarction, the marked reduction of left ventricular function, and the decision to treat the lesion with a device not fitting the 6F guiding catheter. The angioplasty success rates (87% in the 6F group vs 88% in the 7F or 8F group) and the stent implantation rates (21% vs 25%) were similar in both groups. The ischemic complication rates (death, 2 vs 1) were also similar. The incidence of the femoral complications was significantly less important in the 6F group than in the 7/8F group (13.8% vs 23.5% p < 0.01). Significant differences also were noted for the procedural time (36 ± 22 vs 41 ± 28 min; p < 0.01), the fluoroscopy time (11 ± 10 vs 14 ± 4 min; p < 0.05), the volume of contrast injected (136 ± 68 ml vs 168 ± 95 ml; p < 0.0001), and the time of femoral compression after the introducer sheath removal (11.7 ± 9 vs 14.1 ± 12 min; p < 0.01). Our data suggest that 6F guiding catheters for elective coronary angioplasty are more effective than are the larger diameter catheters. Besides a significant decrease of vascular complications, angioplasty with a 6F guiding catheter reduces the procedural time and the amount of contrast. (Am Heart J 1997;134:131-137.)

Evaluation of the Cathetron system for recycling angioplasty catheters

The Cathetron (Minntech Corporation, Minneapolis, MN) peracetic acid-based reprocessing method for percutaneous transluminal coronary angioplasty (PTCA) catheters was evaluated for ability to sterilize and maintain catheter integrity. The balloons and lumens of 42 catheters (140 reprocessing cycles) were inoculated with suspensions of Staphylococcus epidermidis, S. aureus, Pseudomonas aeruginosa, and Bacillus circulans. Five catheters failed the initial evaluation of mechanical integrity and were discarded. Cultures from 37 catheter lumens, balloons, and hubs (n = 349) were negative following reprocessing. The Cathetron system reliably sterilized PTCA catheter; however, further studies using different brands of catheters and evaluating catheter sterility over time under storage conditions are required. Cathet. Cardiovasc. Diagn. 41:132–135, 1997. © 1997 Wiley-Liss, Inc.

Evaluation of the cathetron system for recycling angioplasty catheters.

The Cathetron (Minntech Corporation, Minneapolis, MN) peracetic acid-based reprocessing method for percutaneous transluminal coronary angioplasty (PTCA) catheters was evaluated for ability to sterilize and maintain catheter integrity. The balloons and lumens of 42 catheters (140 reprocessing cycles) were inoculated with suspensions of Staphylococcus epidermidis, S. aureus, Pseudomonas aeruginosa, and Bacillus circulans. Five catheters failed the initial evaluation of mechanical integrity and were discarded. Cultures from 37 catheter lumens, balloons, and hubs (n = 349) were negative following reprocessing. The Cathetron system reliably sterilized PTCA catheter, however, further studies using different brands of catheters and evaluating catheter sterility over time under storage conditions are required.

New concept in coronary angioplasty: Dilatation with a helical balloon that allows simultaneous autoperfusion

These preclinical studies investigate a new concept in coronary angioplasty and balloon catheter technology (the P100 catheter). The study sought to evaluate the morphology of experimental coronary arterial plaques dilated with the P100 in comparison to standard balloons, to determine the in vitro flow rates occurring during the inflation of the P100 in comparison to available perfusion catheters, and to assess the in vivo coronary flow velocity and the presence of ischemia during prolonged inflations with the P100. The development of myocardial ischemia is a major limitation of standard balloon angioplasty. To limit ischemia, autoperfusion catheters have been developed, in which blood flows through the balloon in the central catheter shaft. However, as the flow lumen profile is reduced to enhance the performance of these devices, so is the accompanying flow. An angioplasty catheter was designed to evaluate the feasibility of continuous autoperfusion around the dilatation balloon. The balloon surface was engineered to develop a helical trough for blood flow to occur during inflation. Arterial plaque morphology following angioplasty with the P100 (n = 8) and with standard balloons (n = 8) was evaluated in a swine model. In vitro flow rates during inflation of the P100 and available perfusion catheters were determined using 33% glycerol solution. In vivo coronary flow velocity was determined with a Doppler-tipped wire during 60-min continuous inflations with the P100, and 15-sec inflations with a standard balloon in 12 vessel segments in 7 dogs; using 3.0–3.5-mm-diameter balloons. All lesions were successfully dilated (<50% luminal diameter stenosis) with the P100 and standard balloons. There were no morphologic differences in plaques dilated with P100 compared to standard balloons. In vitro flow rates with conventional 3.0-mm balloon perfusion catheters ranged from 27.1 ± 2.1 ml/min (RX Flowtrack™) to 38.7 ± 0.9 ml/min (Stack Perfusion™), P < .05. Flow with the P100 ranged from 54.8 ± 4.3 ml/min (2.5-mm balloon) to 103.2 ± 4.5 ml/min (3.5-mm balloon), P <.05. Distal average peak coronary flow velocity during prolonged P100 inflations varied from 69 ± 7% of baseline at 5 min to 83 ± 8% of baseline at 40 min, with an upward trend in velocity the longer the balloon was inflated. Hemodynamics remained stable. Experimental plaques are successfully dilated with a helical balloon by a mechanism that appears similar to the dilatation mechanism of standard balloons. These preclinical studies show that angioplasty and autoperfusion can be accomplished by a balloon that does not have complete surface area contact with the vessel wall. A gap created by the helix can thus provide a conduit for blood flow. Clinical studies will determine whether this innovation, which alters the tubular geometry of current angioplasty balloons, will provide autoperfusion and equivalent dilatation effects in humans. Cathet Cardiovasc Diagn 40:109–116, 1997. © 1997 Wiley-Liss, Inc.

New concept in coronary angioplasty: dilatation with a helical balloon that allows simultaneous autoperfusion.

These preclinical studies investigate a new concept in coronary angioplasty and balloon catheter technology (the P100 catheter). The study sought to evaluate the morphology of experimental coronary arterial plaques dilated with the P100 in comparison to standard balloons, to determine the in vitro flow rates occurring during the inflation of the P100 in comparison to available perfusion catheters, and to assess the in vivo coronary flow velocity and the presence of ischemia during prolonged inflations with the P100. The development of myocardial ischemia is a major limitation of standard balloon angioplasty. To limit ischemia, autoperfusion catheters have been developed, in which blood flows through the balloon in the central catheter shaft. However, as the flow lumen profile is reduced to enhance the performance of these devices, so is the accompanying flow. An angioplasty catheter was designed to evaluate the feasibility of continuous autoperfusion around the dilatation balloon. The balloon surface was engineered to develop a helical trough for blood flow to occur during inflation. Arterial plaque morphology following angioplasty with the P100 (n = 8) and with standard balloons (n = 8) was evaluated in a swine model. In vitro flow rates during inflation of the P100 and available perfusion catheters were determined using 33% glycerol solution. In vivo coronary flow velocity was determined with a Doppler-tipped wire during 60-min continuous inflations with the P100, and 15-sec inflations with a standard balloon in 12 vessel segments in 7 dogs; using 3.0-3.5-mm-diameter balloons. All lesions were successfully dilated (< 50% luminal diameter stenosis) with the P100 and standard balloons. There were no morphologic differences in plaques dilated with P100 compared to standard balloons. In vitro flow rates with conventional 3.0-mm balloon perfusion catheters ranged from 27.1 +/- 2.1 ml/min (RX Flowtrack) to 38.7 +/- 0.9 ml/min (Stack Perfusion), P < .05. Flow with the P100 ranged from 54.8 +/- 4.3 ml/min (2.5-mm balloon) to 103.2 +/- 4.5 ml/min (3.5-mm balloon), P < .05. Distal average peak coronary flow velocity during prolonged P100 inflations varied from 69 +/- 7% of baseline at 5 min to 83 +/- 8% of baseline at 40 min, with an upward trend in velocity the longer the balloon was inflated. Hemodynamics remained stable. Experimental plaques are successfully dilated with a helical balloon by a mechanism that appears similar to the dilatation mechanism of standard balloons. These preclinical studies show that angioplasty and autoperfusion can be accomplished by a balloon that does not have complete surface area contact with the vessel wall. A gap created by the helix can thus provide a conduit for blood flow. Clinical studies will determine whether this innovation, which alters the tubular geometry of current angioplasty balloons, will provide autoperfusion and equivalent dilatation effects in human.

Cost-efficacy modeling of catheter reuse for percutaneous transluminal coronary angioplasty

Objectives. Our goal was to provide the range of cost savings associated with various catheter reuse strategies.Background. Percutaneous transluminal coronary angioplasty catheters are commonly reused in several countries outside the United States. However, the cost-effectiveness of such reuse strategies has not been evaluated.Methods. Three theoretical models of catheter reuse were constructed using the actual costs for treating patients with coronary angioplasty at the Cleveland Clinic. Costs were calculated based on the number of balloon catheters, the amount of contrast agent used and the rates for urgent revascularization that were observed in a prospective Canadian study on catheter reuse.Results. The median cost to treat a lesion by means of coronary angioplasty using new catheters was $8,800 per patient. In reuse models, the potential to reduce cost depended on the number of balloon catheters used and the rates of urgent revascularization. The “best case” scenario offered a potential savings of $480 (5.5% of total in-hospital cost), whereas the “worst case” scenario resulted in an increased cost of $1,075 (12.2% of total in-hospital cost) compared with the single-use strategy. Cost of the “likely case” scenario was similar to that of the single-use strategy. Sensitivity analyses identified the different rates of revascularization and cost of balloon catheters required to offset potential savings in each strategy.Conclusions. Although reusing coronary angioplasty catheters may reduce total in-hospital costs, even a modest increase in complications requiring urgent revascularization may offset any potential savings. However, if an increase in complications and procedure time can be avoided, the reuse strategy has significant economic potential and, ultimately, may be extended to other percutaneous coronary interventional equipment.

Usefulness of a prototype directional catheter for excimer laser coronary angioplasty in narrowings unfavorable for conventional excimer or balloon angioplasty: E. Rechavia, J. Federman, A. Shefer, G. Macko, N.L. Eigler, F. Litvack. Cardiovascular Intervention Center, Cedars-Sinai Medical Center, Los Angeles, CA. Am J Cardiol 1995; 76:1144–6

Usefulness of a prototype directional catheter for excimer laser coronary angioplasty in narrowings unfavorable for conventional excimer or balloon angioplasty: E. Rechavia, J. Federman, A. Shefer, G. Macko, N.L. Eigler, F. Litvack. Cardiovascular Intervention Center, Cedars-Sinai Medical Center, Los Angeles, CA. Am J Cardiol 1995; 76:1144–6

Editorial comment: Reuse of coronary angioplasty catheters

Editorial comment: Reuse of coronary angioplasty catheters

Editorial comment: Reuse of coronary angioplasty catheters

Editorial comment: Reuse of coronary angioplasty catheters

Usefulness of a prototype directional catheter for excimer laser coronary angioplasty in narrowings unfavorable for conventional excimer or balloon angioplasty

We report clinical and angiographic results in 53 patients with 57 significant coronary or saphenous vein graft narrowings treated with directional excimer laser angioplasty. The target vessels were the left main (1%), anterior descending (32%), circumflex (19%), right coronary artery (39%), and vein grafts (9%). Lesions were morphologic class B1 (18%), B2 (79%), or C (3%), with 40 de novo and 17 restenotic lesions. Adjunctive balloon angioplasty was used in 53 lesions (93%). Mean pre- and postprocedural minimal lumen diameters were 0.6 ± 0.3 and 1.9 ± 0.7 mm (p < 0.001), corresponding to a mean diameter stenosis of 72 ± 20% and 27 ± 16%. Procedural success rate was 91%. Cumulative risk of death, Q-wave myocardial infarction, or emergency bypass operation was 9% (5 patients). Of patients who had a successful laser procedure, 28 (60%) with 30 lesions underwent angiographic follow-up at 6 ± 3 months after the procedure. Restenosis rates (>50% diameter restenosis or acute gain loss) were 37% and 23%, respectively. Four patients underwent bypass, 3 angioplasty, and 1 patient died from cancer. This study demonstrates the feasibility of directional application of laser energy to selected unfavorable narrowings for conventional excimer laser or balloon angioplasty. Further evaluation of this device using the now standard saline infusion technique is necessary to establish its ultimate role as a primary interventional device.

Protection of ischemic/reperfused canine myocardium by CL18/6, a monoclonal antibody to adhesion molecule ICAM-1

A blocking monoclonal antibody to intercellular adhesion molecule-1 (ICAM-1), CL18/6, previously has been demonstrated to inhibit neutrophil attachment to isolated vascular endothelium and cardiomyocytes. Due to the well known participation of ICAM-1 in the inflammatory responses associated with myocardial ischemia/reperfusion injury, we investigated if CL18/6 could attenuate myocardial ischemia/reperfusion injury in vivo. Saline (3-5 ml, i.v., n = 6), non-blocking control MAb CL18/1D8 or CL18/6 (both 0.5 mg kg-1, i.v., n = 4) were administered prior to coronary occlusion (1 h) and subsequent reperfusion (5 h) produced by inflation of a coronary balloon angioplasty catheter in isoflurane-anesthetized, closed-chest dogs. Heart rate and arterial pressure were measured, and regional myocardial blood flow (rMBF), and myeloperoxidase activity (MPO) to index local neutrophil sequestration, were determined. Myocardial infarct size (IS) was evaluated using the tetrazolium staining technique and expressed as a percent of area at risk (AR). Changes in heart rate and arterial pressure were insignificant throughout the experiment. rMBF (mean +/- s.e.m.) in the ischemic subendocardium for each treatment group was: Saline (0.07 +/- 0.02 ml min-1 g-1); CL18/1D8 (0.04 +/- 0.02); CL18/6 (0.06 +/- 0.02). IS/AR% was: saline (37 +/- 3%); CL18/1D8 (39 +/- 9%); CL18/6 (15 +/- 4%*); * = significantly different from CL18/1D8 and saline, P < 0.05. MPO assayed from AR immediately adjacent to the infarct was significantly reduced below infarct MPO only in the CL18/6 treated group-36%). The results indicate that CL18/6 antagonism of ICAM-1 provided cardioprotection associated with reduced neutrophil activity in vulnerable myocardium, and suggest that ICAM-1 mediated neutrophil sequestration in endangered cardiac tissue is an important mechanism of myocardial ischemia/reperfusion injury.

Regional flow adjusted hemoperfusion during coronary angioplasty: circulatory support/myocardial protection.

Routine percutaneous transluminal coronary angioplasty catheters are adequate and demonstrate high success rates in balloon angioplasty with stable patients. Active hemoperfusion seems to offer an advantage in patients with hemodynamic instability. Active hemoperfusion provides myocardial protection during coronary interventions and can be applied in conjunction with routine angioplasty equipment. When compared with other devices demonstrating clinical utility in a supported angioplasty setting, this flow adjustable active antegrade hemoperfusion pump appears reliable, simple to use, cost-effective, and requires much less instrumentation than the more bulky CPS systems.

Is Reuse of Angioplasty Balloon Catheters Safe

Balloon catheters for percutaneous transluminal coronary angioplasty (PTCA) cost $750 or more, and are marked single use only. These catheters are not sterilized and reused in the U.S., but reuse is common in Canada and Europe. This 10-month study compared PTCA outcomes …

Reusing balloon catheters for coronary angioplasty?

Reusing balloon catheters for coronary angioplasty?