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.     

Double perfusion system for coronary angioplasty at the origin of the main vessel

For the treatment of stenosis near the origin of either the left anterior descending artery or the left circumflex artery, one autoperfusion catheter was used to dilate the lesion while another was used to maintain perfusion of the nonstenosed vessel, which would normally suffer from a decrease in blood flow. This technique was applied to nine procedures in six patients. The balloon could be inflated for more than 60 sec in all cases. Satisfactory dilation was achieved without a significant decrease of systemic blood pressure during the procedure. © 1994 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.     

Distal coronary hemoperfusion during percutaneous transluminal coronary angioplasty

Distal coronary hemoperfusion during percutaneous transluminal coronary angioplasty (PTCA)—with an autoperfusion balloon or active system—facilitates prolonged balloon inflation. Prolonged inflations may tack up intimal dissections and improve the primary angioplasty result in complex lesions. Additionally, distal perfusion may reduce the likelihood of cardiogenic shock during high-risk PTCA. Autoperfusion balloons are most frequently used to treat acute or threatened closure. There currently is no prospective clinical study showing that stent implantation for this complication is more successful and more cost-effective. The blood flow rates through autoperfusion balloons may not abolish myocardial ischemia, and higher flow rates can often be achieved with pumps. Therefore, during high-risk PTCA, pumps may be preferred to prevent hemodynamic collapse. Clinical application of perfusion pumps is hampered by the risk for mechanical hemolysis during prolonged perfusion and the high velocity of the bloodstream that exits the PTCA catheter, causing distal vessel wall trauma. © 1996 Wiley-Liss, Inc.     

Sequential vs. kissing balloon angioplasty for stenting of bifurcation coronary lesions.

Coronary angioplasty of bifurcation lesions remains a technical challenge and is believed to result in low procedural success associated with the risk of side-branch occlusion. Furthermore, long-term results are associated with a high rate of reintervention. The aim of the study was to evaluate the immediate and long-term clinical and angiographic results of sequential vs. simultaneous balloon angioplasty (kissing balloon technique) for stenting of bifurcation coronary lesions. Between December 1999 and January 2001, 59 patients underwent coronary angioplasty because of symptomatic bifurcation lesions type III (i.e., side branch originates from within the target lesion of the main vessel, and both main and side branch are angiographically narrowed more than 50%). Twenty-six patients were treated with simultaneous and 33 patients with sequential balloon angioplasty. Main-vessel stent placement was mandatory; side-branch stenting and platelet IIb/IIIa antagonists were allowed at the discretion of the operator. Kissing balloon technique offered no advantage in terms of procedural success or need for repeat target vessel revascularization due to restenosis at 6-month follow-up. Using sequential balloon angioplasty, permanent or transient side-branch compromise rate (TIMI flow < 3) was significantly higher than after kissing balloon technique (33% vs. 0%, respectively; P = 0.003). Major clinical events in-hospital or at 6-month follow-up, however, showed no significant differences. Kissing balloon angioplasty reduces the rate of transient side-branch occlusion compared to sequential PTCA but does not improve immediate or long-term outcome compared to sequential PTCA for stenting of bifurcation lesions.     

Hugging balloon angioplasty of right coronary artery

We report a case of “hugging balloon” dilatation of a giant right coronary artery using two dilatation catheters, a balloon “on a wire” and a balloon “rapid exchange” systems via a single guiding catheter. The necessity of larger PTCA balloon catheter (>4.0 mm) was stressed.     

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.     

Hugging perfusion balloon salvage of a right coronary artery angioplasty

A case is described in which hugging balloons, one a perfusion and the other a non-perfusion balloon, were used to salvage a failed coronary angioplasty. A discussion concerning balloon combinations, techniques, and therapeutic options is included. (This article is a U.S. Government work and, as such, is in the public domain in the United States of America.) © 1996 Wiley-Liss, Inc.     

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.     

A first‐in‐man study of the reitan catheter pump for circulatory support in patients undergoing high‐risk percutaneous coronary intervention

Objectives : To investigate the safety of a novel percutaneous circulatory support device during high‐risk percutaneous coronary intervention (PCI). Background : The Reitan catheter pump (RCP) consists of a catheter‐mounted pump‐head with a foldable propeller and surrounding cage. Positioned in the descending aorta the pump creates a pressure gradient, reducing afterload and enhancing organ perfusion. Methods : Ten consecutive patients requiring circulatory support underwent PCI; mean age 71 ± 9; LVEF 34% ± 11%; jeopardy score 8 ± 2.3. The RCP was inserted via the femoral artery. Hemostasis was achieved using Perclose? sutures. PCI was performed via the radial artery. Outcomes included in‐hospital death, MI, stroke, and vascular injury. Hemoglobin (Hb), free plasma Hb (fHb), platelets, and creatinine (cre) were measured pre PCI and post RCP removal. Results : The pump was inserted and operated successfully in 9/10 cases (median 79 min). Propeller rotation at 10,444 ± 1,424 rpm maintained an aortic gradient of 9.8 ± 2 mm Hg. Although fHb increased, there was no significant hemolysis (4.7 ± 2.4 mg/dl pre vs. 11.9 ± 10.5 post, P = 0.04, reference 20 mg/dl). Platelets were unchanged (pre 257 ± 74 × 10⁹ vs. 245 ± 63, P = NS). Renal function improved (cre pre 110 ± 27 μmol/l vs. 99 ± 28, P = 0.004). The RCP was not used in one patient following femoral introducer sheath related aortic dissection. All PCI procedures were successful with no deaths or strokes, one MI, and no vascular complications following pump removal. Conclusions : The RCP can be used safely in high‐risk PCI patients. This device may be an alternative to other percutaneous systems when substantial cardiac support is needed. © 2009 Wiley‐Liss, Inc.     

Intracoronary fracture and embolization of a coronary angioplasty balloon catheter: retrieval by a simple technique.

We report a technique for retrieval of a balloon along with a portion of its shaft from the coronary system using a simple technique that does not involve the use of snare or any other retrieval tool. An additional angioplasty wire and a balloon catheter were used to remove the balloon from the coronary system.     

Monorail™ Piccolino catheter: A new rapid exchagne/ultralow profile coronary angioplasty system

The Monorail^TM Piccolino coronary angioplasty balloon catheter (MBC) was evaluated on 118 patients at two centers. Technical success was achieved in 110 patients (93%). Time for catheter exchange and total fluoroscopy time were significantly lower for the Monorail catheter than with standard equipment (exchange time 97 vs. 170 seconds P <.05 and fluoroscopy time 17 vs. 88 seconds P < 0.001). The advantages of rapid exchange and the ability of utilize 2 Monorail balloon catheters through one 9F guiding catheter for simultaneous inflations allowed for maximal flexibility in treating patients with bifurcation lesions. The double wire approach utilizing one Monorail balloon catheter with a 7F guiding catheter was also technically successful. The Monorail^TM Piccolino balloon catheter has unique features that allow for greater ease of operator use, rapid catheter exchange, and optimal angiographic visualization. It is felt that this catheter design provides distinct advantages over standard angioplasty equipment.     

Early experience of transluminal coronary angioplasty (TCA) by the brachial artery (the sones technique in transluminal angioplasty)

Sixteen translumlnal coronary angioplasty procedures (TCA), eight right coronary artery (RCA) and eight left anterior descending coronary artery (LAD), by the brachial artery cut-down approach, were attempted with 9/16 (56%) immediate successes and 2/16 (12%) early recurrences. The procedure success rate for RCA obstructive lesions, 6/8 (75%) was greater than for LCA obstructions, 3/8 (38%). In six unsuccessful procedures the balloon catheter could not be advanced into the lesion, and in one unsuccessful procedure dissection of the coronary artery proximal to the lesion occurred. The brachial (Sones) technique for transluminal coronary angioplasty permits the use of softer guiding catheters for selective probing and approach to the coronary lesion but may be more likely to induce coronary spasm. Complete and high-resolution pre TCA anglograms with multiple views to disclose the exact anatomy of the coronary artery and Its lesion Is essential to ensure successful dilatation.     

Comparison of angioplasty and bypass surgery in multivessel coronary artery disease

The role of coronary angioplasty in the treatment of patient with multivessel coronary artery disease has not been fully established. We compared immediate and 1-year follow-up results in 60 patients undergoing coronary angioplasty for multivessel coronary disease in 1982 with 41 patients anatomically suitable for angioplasty but who underwent elective coronary bypass surgery during the same time period. Baseline variables were similar in both groups except for number of vessels diseased which was higher in the surgical group. Angioplasty was initially successful in 70% of cases. There were no deaths. Mean initial hospital days were lower in the angioplasty group. At follow-up there were no significant differences in survival, functional class, occurrence of subsequent myocardial infarction or use of cardiac medications. However, 33% of the successfully dilated patients required either repeat dilatation or subsequent bypass surgery because of restenosis or inadequate initial revascularization. The statistical power of the study was limited due to the small sample sizes. While demonstrating that angioplasty can be successfully performed in patients with multivessel disease, definitive conclusions about the comparability of the two treatments are hampered by possible selection bias and small patient numbers. This issue could be better addressed by a multicenter prospective randomized trial.     

切割球囊血管成形术的作用机制及其在冠心病治疗中的应用

经皮腔内冠状动脉成形术后急性冠脉综合征和再狭窄等并发症是困扰冠心病介入治疗效果多年的难题 ,切割球囊血管扩张术是为解决这一难题出现的众多新技术中的一种。作者就切割球囊的结构、作用机制和临床应用等作一简要综述     

Emergency endoluminal stenting for abrupt vessel closure following coronary angioplasty: A randomized comparison of the wiktor and palmaz-schatz stents

In order to compare the efficacy of two different stent types in case of bailout stenting, 65 patients, with abrupt or threatened vessel closure following coronary angioplasty, were randomly assigned to either Wiktor (Medtronic Inc., Minneapolis, MN, 33 patients) or Palmaz-Schatz (Johnson & Johnson Interventional, Warren, NJ, 32 patients) stent implantation. Stenting was technically feasible in all except one patient and immediately successful in reverting ischemia and vessel closure in 60 patients (92%). At hospital discharge, complication rates were comparable: early vessel closure, 18% (Wiktor) versus 13% (Palmaz-Schatz) (P=0.53); any clinical event (such as death, myocardial infarction, and surgical revascularization): 18% (Wiktor) versus 22% (Palmaz-Schatz) (P=0.71). At 6 months follow-up, these complication rates remained equal: restenosis, 38% (Wiktor) versus 27% (Palmaz-Schatz) (P=0.42); any clinical and angiographic (vessel closure and restenosis) event: 45% (Wiktor) and 41% (Palmaz-Schatz) (P=0.69). Baseline, direct postprocedural, and follow-up quantitative coronary analysis data were similar, with, however, an exception for the postprocedural residual stenosis [28% (24-32%) (Wiktor) and 21% (18-23%) (Palmaz-Schatz] (means and 95% confidence intervals). In conclusion, despite a discrete postprocedural angiographic benefit observed with the Palmaz-Schatz stent, the long-term clinical and angiographic outcome is similar in both treatment groups. The choice whether to implant a Wiktor or Palmaz-Schatz stent may probably be left to the discretion of the operator and his experience with one particular device.     

经皮冠状动脉内切割球囊成形术的临床应用

目的评价经皮冠状动脉内切割球囊成形术的临床疗效.方法使用切割球囊导管对20例冠心病患者(男18例、女2例,年龄53.4±6.3岁)的24支冠状动脉进行扩张.结果手术成功率为90%(18例),病变成功率为91.7%(22支).未出现死亡、急性Q波型心肌梗死和急性心包填塞等并发症.病变部位狭窄程度由术前的(85.6±7.3)%降至术后的(28.5±9.4)%.术后随访1～10个月,有3例复发心绞痛,其中1例经血管造影证实为再狭窄.结论切割球囊成形术是一种安全、有效的介入性治疗技术,其成功率高、并发症少.     

切割球囊冠状动脉腔内成形术52例临床分析

目的　应用切割球囊行冠状动脉腔内成形术并对其疗效进行评价。方法　对 5 2例冠心病患者的 63处病变行切割球囊扩张治疗 ,对其进行分析 ,并短期随访。结果　 63处血管直接切割球囊扩张治疗 ,成功率92 1% ,其中 9例完全闭塞性病变中 7例获得成功。 2例支架内再狭窄均扩张成功。 63处病变切割球囊扩张后安放支架 43个 (支架安放率 68 3 % ) ,2 0例单纯行切割球囊扩张术者残余狭窄为 0～ 2 0 % [平均为 ( 7 2±5 6) % ]。 1例患者术后出现心包填塞 ,无严重内膜撕裂、急性闭塞、急诊冠脉架桥术及急性心肌梗死发生。随访6～ 12个月 ,1例单纯行切割球囊扩张术患者于术后 1月出现心绞痛 ,经冠脉造影证实为再狭窄。其他患者随访期间无心脏事件发生。结论　切割球囊行冠状动脉腔内成形术安全、有效 ,短期疗效良好