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K K Haase

Publications and source records attributed to K K Haase.

At least 37 records · Page 2Linked to original sources

Reduction of restenosis by vessel size adapted percutaneous transluminal coronary angioplasty using intravascular ultrasound.

Restenosis following percutaneous transluminal coronary angioplasty (PTCA) remains a serious problem in interventional cardiology. Recent trials using stent implantation have proposed a reduction in restenosis, presumably due to a higher initial luminal gain. This study was conducted to evaluate if the short- and long-term results following conventional PTCA may be favorable, if balloon dilation was performed according to measurements gained by intravascular ultrasound (IVUS) (vessel size adapted PTCA). The use of intracoronary stents might be omitted if comparable long-term results could be achieved by this modified technique of balloon angioplasty. This unicenter and nonrandomized pilot trial was initiated in January 1995 with 252 patients who had 271 lesions. IVUS was performed before and after intervention to determine the external elastic membrane (EEM) diameter at the lesion site. The balloon catheter was sized according to the EEM diameter measured by IVUS (EEM 10%). The mean balloon diameter was 4.1 +/- 0.5 mm, the dilation time 130 +/- 60 seconds with a balloon pressure of 7.0 +/- 2.0 atm. Clinical acute and 1-year long-term follow-up were obtained for all patients and follow-up angiography in 71% of patients. Acute events occurred postinterventionally in 5 patients (2%). The cumulative event rate during long-term follow-up was 14%. The angiographic restenosis rate (diameter stenosis >50%) after 1 year was 19%. Vessel size adapted PTCA using IVUS led to favorable acute and long-term results with a low restenosis rate and a low 1-year clinical event rate. Despite dissections that occur frequently using large balloon sizes, an increased rate of major complications did not occur, indicating a safe procedure and substantiating the philosophy of "therapeutic dissections." The results need to be verified in a randomized trial.

Angioplasty, Balloon, Coronary↗

Local drug delivery: impact of pressure, substance characteristics, and stenting on drug transfer into the arterial wall.

Injection parameters for local drug delivery are frequently determined by studies with marker substances. However, the pharmacologic properties of the actual drug may influence delivery efficiency and lead to different results. Aim of this study was to assess the delivery capacities of two device-drug combinations in order to verify this approach for further in vivo studies. Tritiated (3H) preparations (5 ml) of the hydrophylic low-molecular-weight heparin reviparin and the lipophilic taxane paclitaxel were injected into the left anterior descending artery of freshly explanted porcine hearts with the Infusasleeve II catheter system. A balloon support pressure of 6 atm and infusion pressures of 40, 60, 80, or 100 psi were used. In three additional groups, reviparin was injected following stent implantation and paclitaxel was injected prior to or following stent implantation. Arteries along with surrounding myocardium were harvested. The artery was carefully dissected, and artery and myocardium were separately homogenized, and activity was measured. Of the totally delivered activity, 0.09%+/-0.03% (40 psi) to 0.17%+/-0.13% (100 psi) of reviparin and 2.03%+/-0.67% (60 psi) to 2.68%+/-1.57% (100 psi) of paclitaxel were found in the vessel wall. The results for different injection pressures were not significantly different for either drug. The percentage activity delivered to the vessel wall was substantially larger in the paclitaxel group as compared to reviparin delivery (P < 0.01 at 60, 80, and 100 psi). The mean concentration of reviparin in the artery was 20 to 33 times higher than in the myocardium. For paclitaxel the factors were 110 to 243. Stent implantation prior to or following local delivery did not result in a different delivery efficiency. The results demonstrate that the characteristics of the delivered drug contribute largely to the delivery efficiency. Using identical injection parameters, drug concentrations in the arterial wall were significantly higher for the lipophilic paclitaxel as compared to the hydrophilic reviparin. Stenting of the artery did not influence delivery efficiency.

Animals↗

Occurrence of a saccular pseudoaneurysm formation two weeks after perforation of the left anterior descending coronary artery during balloon angioplasty in acute myocardial infarction.

We describe the occurrence of a localized saccular pseudoaneurysm in a 69-year-old patient 2 weeks after perforation of the left anterior descending coronary artery during balloon angioplasty in acute myocardial infarction. The therapy of perforations requires prolonged balloon inflations, perfusion balloons, covered stents, or surgery. Coronary peudoaneurysm formations are rare; their therapy requires covered stents or surgery. Cathet. Cardiovasc. Intervent. 47:341-346, 1999.

Aged↗

[Risk of invasive diagnosis with retrograde catheterization of the left ventricle in patients with acquired aortic valve stenosis].

In patients with aortic valve stenosis, the determination of the transstenotic pressure gradient is usually performed by cardiac catheterization with retrograde passage of the aortic valve. The aim of this study was to determine retrospectively the risk of the invasive examination with retrograde catheterization of the left ventricle and predictors for an increased risk. From 1984 to 1995, 457 patients (63 +/- 11 years) with aortic stenosis were investigated in the Medizinische Klinik Tübingen. In 435 patients (95.2%), the retrograde catheterization of the left ventricle was successful; in 19 cases a transseptal left heart catheterization was performed, and in 3 patients an invasive determination of the pressure gradient was not assessed. Complications occurred in 39 patients (8.5%). 5 patients died due to the catherization procedure (mortality rate 1.1%), 2 of them as a consequence of perforation of the left ventricle, one patient of heart failure, one of myocardial infarction, and another of fulminant pulmonary embolism. Four procedures (0.9%) were complicated by cerebral embolism, in 3 patients a pericard tamponade occurred, and in one case caused by transseptal punction of the interatrial septum. The most complications were peripheral vascular problems in 19 patients (4.2%). Predictors for increased risk dur to retrograde catheterization were age > 70 years (p = 0.008) and aortic valve area < or = 0.7 cm2 (p = 0.02). patients with a doppler echocardiographic instantaneous pressure gradient > or = 70 mm Hg were more likely to sustain a complication (p = 0.04). The retrograde catheterization of a stenotic aortic valve was successful in most cases. In approximately 2% of patients, complications occurred which can be attributed directly to retrograde catheterization and with significant higher frequency in patients over 70 years and with severe stenosis. Especially in these cases, invasive determination of the gradient should not be performed if reliable doppler echocardiographic information is available.

Adult↗

Visualization and comparison of drug effects after local paclitaxel delivery with different catheter types.

BACKGROUND: The microtubule stabilizing compound paclitaxel has proved to have potent antiproliferative effects on smooth muscle cells both in vitro and in vivo. It induces cellular modifications that result in reduced proliferation, migration and signal transduction by shifting the cellular microtubule equilibrium towards assembly. We therefore reasoned that a visualization of the altered cytoskeleton could enable an evaluation of the drug effects following local drug delivery. METHODS AND RESULTS: 3 catheters - the porous balloon, the microporous balloon and the double balloon catheter - were chosen for this study representing the spectrum from passive to active, pressure-driven delivery. After the induction of a defined plaque in the right carotid arteries of 40 New Zealand rabbits by electrical stimulation, 32 animals underwent balloon dilatation and 8 animals served as pre-interventional control group with electrostimulation only. In 24 animals (n = 8 in each group) subsequent local paclitaxel delivery (10 micromol/L) was performed. 8 animals served as control with angioplasty only. Vessels were excised 1 week following intervention. Immunohistochemistry with antibodies against bromodeoxyuridine, alpha-actin, macrophages, von Willebrand factor and alpha-tubulin was performed. Cytoskeletal changes were analyzed by electron microscopy. Tubulin staining and electron microscopy revealed changes with distinct staining patterns for the different catheters. Specific catheter-induced injuries could be identified for the porous and double balloon catheter. Intimal proliferation, percentage of macrophages and extent of injury favor the double balloon catheter for local paclitaxel delivery. CONCLUSIONS: The alterations of the cytoskeleton induced by paclitaxel allowed for the detection of drug action by staining of tubulin and electron microscopy. This enables an evaluation of transfer, distribution and drug effects directly in the vasculature without marker substances. The double balloon catheter appears to be best suited for local paclitaxel therapy.

Animals↗

Extent, determinants and clinical importance of pressure recovery in patients with aortic valve stenosis.

AIMS: In experimental studies the recovery of pressure distal to stenotic valve orifices has been well described. We evaluated the extent, determinants, and clinical importance of pressure recovery in patients with aortic valve stenosis. METHODS AND RESULTS: The study was performed in 37 patients with aortic valve stenosis, in whom cardiac catheterization was performed and left ventricular and aortic pressures were determined using a high-fidelity multi-tip micromanometer catheter. To register the pressure waveforms accurately the catheter was positioned so that the proximal micromanometer was in the left ventricle, the second at the site of minimal pressure in the vena contracta, and the third (the most distal) in the ascending aorta 16 cm further downstream. The amount of pressure recovery within the ascending aorta was up to 44% of the maximal pressure drop. The index pressure recovery was directly correlated to the Gorlin-derived aortic valve area (r=0.80) and indirectly correlated to the ratio of aortic valve area and the cross-sectional area of the ascending aorta. CONCLUSIONS: This clinical study confirmed experimental data, that index pressure recovery is dependent on the ratio of the effective valve area and the cross-sectional area of the ascending aorta. Pressure recovery may need to be considered in patients with mild to moderate aortic stenosis and with a small cross-sectional area of the ascending aorta.

Adult↗

Angiotensin I-converting enzyme gene polymorphism, coronary artery disease and myocardial infarction. An angiographically controlled study.

OBJECTIVES: We investigated the association between insertion/deletion polymorphism of the angiotensin I-converting enzyme (ACE) gene, the presence and extent of coronary artery disease, and myocardial infarction. BACKGROUND: The D allele of the ACE gene has been associated with coronary artery disease and myocardial infarction, but this association has been challenged in epidemiological studies. METHODS: Nine hundred and sixty-nine men and 341 women undergoing coronary angiography were studied. The ACE genotypes were assessed by polymerase chain reaction from genomic deoxyribonucleic acid, homozygosity for the D allele was controlled using an insertion-specific primer. Coronary artery disease was defined by angiographic criteria, the extent of coronary artery disease by the number of coronary arteries with >/=50% lumen narrowing. RESULTS: The ACE genotypes did not differ in terms of age, sex, body mass index, blood pressure, plasma lipids or lipoproteins. We found no association between the ACE genotypes and coronary artery disease (odds ratio, 95% confidence interval in DD genotypes for coronary artery disease in men 0.97, 0.70-1.36; in women 1.56, 0.95-2.57), extent of coronary artery disease (men 1.17, 0.85-1.61; women 1.24, 0.65-2.34), or myocardial infarction among the patients with coronary artery disease (men 1.07, 0.78-1.48; women 0.95, 0.50-1.76). The ACE genotype was not associated with coronary artery disease or myocardial infarction in hypertensives (n=771; odds ratio for coronary artery disease 0.93, 0.65-1.34; odds ratio for myocardial infarction 0.94, 0.66-1.33), or in patients </=60 years (n=649; odds ratio for coronary artery disease 1.05, 0.72-1.52; odds ratio for myocardial infarction 0.96, 0.63-1.47). CONCLUSION: ACE insertion/deletion gene polymorphism is associated neither with the prevalence nor the extent of coronary artery disease, nor with myocardial infarction in this relatively large sample of Caucasian men and women. Genotyping for ACE insertion/deletion polymorphism is not useful in assessing the individual risk of coronary artery disease or myocardial infarction.

Age Factors↗

Frequency and efficacy of glycoprotein IIb/IIIa therapy for treatment of threatened or acute vessel closure in 1332 patients undergoing percutaneous transluminal coronary angioplasty.

BACKGROUND: Glycoprotein (GP) IIb/IIIa antagonists are potent inhibitors of thrombocyte aggregation and thrombus formation. Several large-scale randomized studies for prevention of thrombotic complications have shown their potential to reduce these complications in patients undergoing percutaneous transluminal coronary angioplasty (PTCA). It was the purpose of this observational trial to assess the frequency and efficacy of primary GP IIb/IIIa antagonist therapy as a bailout procedure for the prevention of threatened or abrupt vessel closure in patients after conventional balloon angioplasty. METHODS AND RESULTS: From January 1995 to December 1996, PTCA was performed in 1332 consecutive patients with coronary artery disease. Overall, threatened or abrupt vessel closure was observed in 63 (4.7%) patients of the patient population. In these patients, abciximab was administered (0.25 mg/kg body weight intravenous bolus, followed by a 12-hour infusion at 10 mg/min). Repeat PTCA was performed shortly after the administration of the abciximab bolus to achieve an optimal flow at the time of active GP IIb/IIIa therapy. One day after intervention, early follow-up angiography was performed. Follow-up after 1 year included the clinical status of all patients and, if possible, control angiography. Overall, the preintervention minimum lumen diameter (MLD) measured 0.74 +/- 0.27 mm and the diameter stenosis was 75% +/- 24%. The postintervention MLD increased to 2.60 +/- 0.55 mm, and the diameter stenosis decreased to 24% +/- 22%. At 24-hour angiographic follow-up, the MLD decreased to 2.47 +/- 0.49 mm and the diameter stenosis increased to 28% +/- 24%, correspondingly. The thrombus score decreased from 2.8 +/- 1.5 before abciximab treatment to 0.88 +/- 0.81 after abciximab treatment, and Thrombolysis In Myocardial Infarction flow grade increased from 2.1 +/- 1.1 to 2.9 +/- 0.3. In-hospital events occurred in 2 patients. Both patients had to undergo emergency coronary artery bypass grafting (1 of these patients died). During long-term follow-up, there were 10 clinical events (1 death, 3 repeat PTCA, and 6 coronary artery bypass graft operations for restenosis at the target lesion site). The cumulative event rate after 1 year (including acute and follow-up events) for both the total group and for the target vessel was 19%. CONCLUSIONS: The results of this study demonstrate that GP IIb/IIIa antagonists are able to prevent vessel occlusion after PTCA complicated by subsequent threatened or abrupt vessel closure. In these situations, GP IIb/IIIa antagonists provide effective treatment for the reduction of thrombus at the target lesion site, which constitutes a second key element for threatened or abrupt vessel occlusion.

Abciximab↗

Accuracy of computer-based quantification of aortic valve stenosis.

In patients with aortic valve stenosis, the quantification of stenosis is usually performed using fluid-filled catheters and a computerized calculation program. The aim of this study was to determine the accuracy of this technique in comparison to the manual planimetry of the area between the curves of a simultaneous registration, using a multitip micromanometer catheter. The study was performed in 19 patients, in whom left and right heart catheterization was warranted. Systolic left ventricular and aortic peak pressures were significantly overestimated using a fluid-filled catheter (206 +/- 35 vs. 199 +/- 37 mm Hg, P = 0.0003, and 148 +/- 18 vs. 143 +/- 21 mm Hg, P = 0.0052). However, peak-to-peak pressure gradients were identical comparing both techniques (58 +/- 31 vs. 56 +/- 32 mm Hg, r = 0.983). The mean pressure gradients and aortic valve areas based on simultaneous measurements of left ventricular and aortic pressures by micromanometer catheters were identical to the values determined by a computer-based program using fluid-filled catheters (54 +/- 21 vs. 52 +/- 21 mm Hg, r = 0.923, P < 0.05, and 0.75 +/- 0.25 vs. 0.77 +/- 0.25 cm2, r = 0.935). Thus, the conventional use of fluid-filled catheters and of a computerized calculation of aortic valve area is valid for quantification of aortic stenosis in patients with sinus rhythm and without significant aortic regurgitation.

Adult↗

Local and systemic delivery of low molecular weight heparin following PTCA: acute results and 6-month follow-up of the initial clinical experience with the porous balloon (PILOT-study). Preliminary Investigation of Local Therapy Using Porous PTCA Balloons.

The purpose of this study was to assess safety and feasibility of intracoronary delivery of reviparin using a porous balloon following percutaneous transluminal coronary angioplasty. The 2.7 mm porous balloon used in this study had 35 holes arranged in a spiral pattern. Eighteen patients (male n = 10, female n = 8, age 63 +/- 9 years) undergoing successful PTCA in coronary arteries with a vessel diameter of 2.5 to 3.0 mm determined by online QCA (LAD = 11, RCX = 3, RCA = 4) were included. They received a bolus of 7,000 anti-Xa-IU reviparin followed by local delivery of 1,500 anti-Xa-IU in 4 ml with an injection pressure of 2 atm. The patients received additionally 10500 anti-Xa-units intravenously during the following 24 hours and a daily dose of 7000 anti-Xa-units reviparin subcutaneously for the following 28 days. Angiograms were obtained before and after PTCA, directly after local delivery, at 24 hours postintervention and after 6 months. The primary success rate was 100%. Quantitative coronary angiography showed a minimum luminal diameter of 0.42 +/- 0.14 mm before PTCA, 1.87 +/- 0.45 after PTCA, 1.67 +/- 0.43 after LDD, 1.63 +/- 0.46 after 24 hours, and 1.06 +/- 0.6 after 6 months. Angiographic follow-up was obtained in all patients. No major complications occurred during the 6-month follow-up period. The angiographic restenosis rate was 28% (5/18) at follow-up. This study demonstrates safety and feasibility of local intracoronary delivery of reviparin with a porous balloon following PTCA even in smaller diameter coronary arteries.

Aged↗

[Advantages in using intravascular ultrasound in percutaneous transluminal coronary angiography].

UNLABELLED: Recent randomized clinical trials reported a reduction of restenosis using intracoronary stents and suggested that this restenosis reduction is a result of the higher immediate luminal gain in comparison to conventional percutaneous transluminal coronary angioplasty (PTCA). The hypothesis of this study is based on the assumption that IVUS guided PTCA leads to equivalent long term PTCA results as compared to PTCA and the additional placement of a stent. Thus, the purpose of this non-randomized single center study was to evaluate (1) the safety and efficacy and (2) the long term outcome of vessel size adapted PTCA in patients with native coronary lesions. From April 1995 to March 1996 the morphological dimensions of the target lesions were determined in 107 patients with 108 lesions by intravascular ultrasound prior to conventional balloon angioplasty. Quantitative parameters of the vascular dimensions were assessed on-line and the diameter of the balloon catheter was adapted to the external elastic membrane (EEM) at the lesion site minus 10%. Using this strategy, mean balloon diameter was 4.1 +/- 0.5 mm. Acute and one year clinical follow-up results were obtained in all 107 patients. Angiographic success was defined as a final percent diameter stenosis of < 30%. The following criteria determined by postinterventional IVUS were also used to define a successful PTCA: luminal CSA gain of > 30% with an angiographically patent flow (TIMI 3). Acute events occurred in two patients (one death and one successful acute surgical revascularisation). During one year follow-up, 11 patients had a clinical event including death, Q-wave MI, surgical revascularisation, and repeat PTCA. In 83 patients (78%), control angiography was performed and revealed an angiographic restenosis rate of 21% using the NHLBI criterion of a diameter stenosis > 50% CONCLUSION: The use of balloon diameters following these measurements is safe in the acute setting with a low number of in hospital events and effective in reducing clinical events as well as angiographic restenosis rates during one year follow-up. These promising results warrant verification in larger scale randomized trials.

Aged↗

Local and systemic delivery of low molecular weight heparin stimulates the reendothelialization after balloon angioplasty.

OBJECTIVE: Recent investigations revealed the importance of endothelial cell integrity and function in the pathogenesis of restenosis after angioplasty. Agents which stimulate reendothelialization may prevent restenosis after interventional procedures. The results of in vitro studies suggested that heparin and low molecular weight heparin administration may enhance the recovery of the endothelium. In this study the extent of endothelial denudation and the occurrence and time course of endothelial regeneration after experimental balloon angioplasty followed by subcutaneous or local delivery of low molecular weight heparin was investigated. METHODS: A total of 102 rabbits were included in the study. An atheromatous plaque was induced by electrical stimulation in the right carotid artery of the animals. All animals underwent balloon angioplasty. Thirty-two rabbits received no further medical treatment. Twenty-five rabbits received subcutaneous low molecular weight heparin reviparin (400 anti-Xa-units/day) during the following 7 days. In 25 animals the dilated arterial segments were treated locally with reviparin (1500 anti-Xa-units/4 ml, 2 atm) using a porous balloon (2.5 mm, 35 holes, diameter 75 microns). Twenty animals served as control group without intervention. The vessels were excised 3, 7, 14, 28 and 56 days following intervention. Sections were stained with an antibody against von Willebrand factor and PECAM 1 to confirm the endothelial origin of the lining cells. After bromodeoxyuridine labeling, the extent of proliferation was determined by using a monoclonal antibody. In addition, morphometric analysis of the intimal and medial area was performed. RESULTS: Three days after balloon angioplasty histomorphological analysis showed a reduction of about 60% of the preinterventional endothelial cell number in all three groups. Already one week after intervention there was a significantly higher number of endothelial cells in both groups of low molecular weight heparin treated animals compared to the untreated group (s.c. group 144 +/- 33, local group 142 +/- 32 versus untreated 79 +/- 17 endothelial cells, p < or = 0.05). This significant difference was maintained during the following four weeks and demonstrated a 2-fold increase in endothelial proliferation in the heparin treated animals compared with the untreated group. In addition, immunohistological examination showed a significant decrease in smooth muscle cell proliferation in the s.c. and local reviparin treated animals and a subsequent reduction of intimal thickening. CONCLUSION: Local delivery of low molecular weight heparin promotes reendothelialization and contributes to the inhibition of smooth muscle cell proliferation.

Administration, Cutaneous↗

Acute and one year follow-up results after vessel size adapted PTCA using intracoronary ultrasound.

AIMS: Recent randomized clinical trials have reported a reduction in restenosis with intracoronary stents and have suggested that this restenosis reduction is a result of the higher immediate luminal gain, in comparison to conventional percutaneous transluminal coronary angioplasty (PTCA). The hypothesis of this study is based on the assumption that PTCA results may be optimized by determining vessel dimensions before intervention, using intravascular ultrasound. This may lead to long-term PTCA results equivalent to PTCA and the additional placement of a stent. The purpose of this prospective non-randomized single-centre study was to evaluate (1) the safety and efficacy and (2) the long-term outcome of vessel-size adapted PTCA in patients with native coronary artery obstructions. METHODS AND RESULTS: From January 1995 to December 1995 the morphological dimensions of target lesions were determined in 144 patients with 152 lesions by intravascular ultrasound prior to conventional balloon angioplasty. Quantitative assessment of the vascular dimensions were assessed on-line and the diameter of the balloon catheter was adapted to the external elastic membrane diameter at the lesion site. Using this strategy, mean balloon diameter was 4.0 +/- 0.5 mm and mean pressure for complete balloon expansion was 7 +/- 2 atmospheres. Acute and one year follow-up results were obtained in all 144 patients. Acute events occurred in two patients (one death and one acute surgical revascularization). During one year follow-up, 16 patients (12%) had a clinical event including one cardiac death, two transmural myocardial infarctions, 10 repeat PTCAs within the target lesion and three elective coronary artery bypass grafts (CABG). In 75% (n:112) control angiography was performed and revealed an angiographic restenosis rate of 21% using the NHLBI criteria of a diameter stenosis > 50%. CONCLUSION: Intravascular ultrasound provides an accurate and precise description of vascular dimensions at the site of the stenotic lesion. The use of balloon diameters following these measurements appears to be (1) safe in the acute setting with a low number of in hospital events and (2) gives a low restenosis rate and number of clinical events at one year follow-up. These promising results warrant verification in larger-scale randomized trials.

Aged↗

Lesion morphology assessed by pre-interventional intravascular ultrasound does not predict the incidence of severe coronary artery dissections.

AIMS: Coronary artery dissections are common findings following percutaneous transluminal coronary angioplasty and occur with an incidence of approximately 20% to 40%. The purpose of this study was to evaluate the impact of intravascular ultrasound for the prediction of severe dissections by pre-interventional analysis of lesion morphology and plaque composition. METHODS AND RESULTS: Pre- and post-interventional intravascular ultrasound was performed in 197 patients with 205 lesions. Using intravascular ultrasound criteria, 24 lesions were classified as soft (hypo- or iso-echogenic), 73 as intermediate (hyper-echogenic) and 108 as calcified (calcific arc > 90 degree of the vessel circumference). Additionally, calcium localization was defined as subendothelial, central or deep. The incidence of dissections was 37.5% in patients with soft lesions, 24.7% in patients with intermediate and 36.1% in patients with calcified lesions. In calcified lesions, the occurrence of severe dissections was not dependent on the localization of calcium deposits. The procedural parameters were similar in all patients. The minimal inflation pressure, however, was significantly higher in calcified lesions (P < 0.01). CONCLUSION: Assessment of lesion morphology by intravascular ultrasound cannot predict the occurrence of severe dissections following percutaneous transluminal coronary angioplasty. Furthermore, despite significantly higher inflation pressures in heavily calcified lesions, the incidence of dissections was found to be comparable in all lesions.

Adult↗

Perspectives of coronary excimer laser angioplasty: multiplexing, saline flushing, and acoustic ablation control.

BACKGROUND AND OBJECTIVE: Bubble formation, pressure wave generation, and cavitations constitute major factors influencing the outcome of clinical Excimer laser angioplasty. Thus, the rationale of this study was to determine the extent of pressure waves occurring during excimer laser ablation and to discuss possibilities that allow a less traumatic plaque removal in the coronary circulation. STUDY DESIGN/MATERIALS AND METHODS: Conventional and experimental Xenon-Chlorid-Excimer lasers emitting light at a wave-length of 308 nm and a pulse duration of 115 ns were used for testing of signals. Whereas the conventional excimer laser light source transmits light through all fibers of a 1.7 mm laser catheter simultaneously, the prototype excimer laser divides the laser beam into several areas of uniform energy fluence by scanning the beam from one section to the other using the intermission between two laser discharges. Hydrophones consisting of piezoelectric films detected the acoustic signals, which were obtained on normal arterial wall and atherosclerotic plaque. RESULTS: Multiplexing decreases maximum pressures for both normal arterial wall and calcified plaque significantly, whereas pressure rise time remains comparable. During ablation of pure blood, a linear increase of peak pressures of 1 MPa at 10 mJ/mm2 to 7.5 MPa at 50 mJ/mm2 is found. Contrast media intensifies the extent of pressure wave formation. At 20 mJ/mm2, 60% contrast media added to blood results in an increase of maximum pressures from 1.5 MPa up to 5 MPa. Dilution with saline solution is effective; however, high concentrations of > 90% are required to achieve a significant pressure wave reduction. CONCLUSION: Peak pressures of several thousand kPa occur during excimer laser ablation of contrast media, blood, calcified plaque, and normal arterial wall in a decreasing order. Multiplexing and saline flushing are capable of reducing the intensity of the generated acoustic signals during tissue ablation. It has to be taken into consideration, however, that high concentrations of saline solution are necessary to achieve a significant reduction of peak pressures.

Acoustics↗

Efficacy of low-molecular-weight heparin delivery with the Dispatch catheter following balloon angioplasty in the rabbit iliac artery.

Local drug delivery can be achieved with active injection systems or passive contact of a compound with the arterial wall. The Dispatch catheter allows for passive diffusion of drugs from drug compartments while preserving blood flow through the central conduit. The aim of this study was to investigate whether a reduction in neointima formation can be achieved by local delivery of a limited amount of a highly concentrated solution of the low-molecular-weight heparin Reviparin. In 16 New Zealand white rabbits, successful balloon dilatation was performed in both iliac arteries, followed by local delivery of 4 ml Reviparin (1,000 IU/ml). The arteries were harvested at 7, 28, or 56 d following the procedure. The intimal cell layers increased substantially between 7 and 28 d following balloon dilatation with or without local drug delivery. The medial cell layers showed only a little increase. Proliferation of smooth muscle cells reached an early peak after 7 d, with a significantly higher proliferation index following local delivery. The maximum amount of macrophages in the intima and media was detected after 28 d. The lumen area decreased with time and was 0.6 +/- 0.7 mm2 in the local delivery group at 56 d compared with 0.5 +/- 0.5 mm2 in the control group. In conclusion, local delivery of Reviparin with the Dispatch catheter is safe and feasible. However, the infusion of highly concentrated low-molecular-weight heparin over a short period of time did not result in a reduction of neointima formation and restenosis following balloon dilatation in the rabbit iliac artery.

Angioplasty, Balloon, Coronary↗

Local drug delivery with porous balloons in the rabbit: assessment of vascular injury for an improvement of application parameters.

OBJECTIVES: Sufficient intramural drug concentrations with the use of porous balloon catheters can be achieved with additional vascular trauma only. However, effective delivery of a potent drug even in deeper layers of the vessel wall might outweigh these traumatic side effects. Given the porous balloon catheter, the parameters of injection pressure and applied fluid volume will influence the interventional result. METHODS: We tested a 2.5-mm porous balloon (35 75-micron pores) in the right carotid artery of New Zealand rabbits and used injection pressures of 1, 2, and 5 atm and fluid volumes of 2 and 4 ml of low-molecular-weight heparin solution in combination with the different parameters (n = 5 animals/group). In 50 rabbits, an intimal fibromuscular plaque was induced by using the electrostimulation model. Balloon dilatation and then application of the porous balloon was performed in 30 animals, 10 animals were only electrostimulated, and 10 animals served as a control group with balloon dilatation only. The vessels were excised 7 d after intervention, stained, and analyzed histomorpologically. Anti-Xa assays revealed the extent of systemically escaped drug, and serial cuts allowed for exact determination of vessel wall injuries. RESULTS: Effective local drug delivery could not be achieved with an injection pressure of less than 2 atm. Specific pressure-driven effects such as jet injuries could be identified. When the pressure was high enough for disruptive drug delivery (> or = 2 atm), fluid volumes of 4 ml led to loose elastic membranes and local thickening within the media. CONCLUSIONS: Sufficient intramural drug distribution using porous balloon catheters can be achieved with low injection pressures. Different fluid volumes strongly determine the extent of additional vascular injury.

Angioplasty, Balloon, Coronary↗