Shaping ability of ProTaper NEXT and BT-RaCe nickel-titanium instruments in severely curved root canals.

AIM: To compare the shaping ability of four different nickel-titanium rotary instruments during the preparation of curved root canals in extracted teeth. METHODOLOGY: A total of 80 root canals with curvatures ranging between 25° and 39° were divided into four groups of 20 canals. Based on radiographs taken prior to instrumentation, the groups were balanced with respect to the angle and the radius of canal curvature. Canals were prepared to a final apical size of 40 using Mtwo, ProTaper Universal, ProTaper NEXT and BT-RaCe. Using pre- and post-instrumentation radiographs, straightening of the canal curvatures and canal transportation were determined with a computer image analysis programme. Preparation time and instrument failures were also recorded. The data were analysed statistically using anova and Student-Newman-Keuls test. RESULTS: The use of BT-RaCe files resulted in significantly more straightening during instrumentation compared to Mtwo (P < 0.05), whilst the differences between all other instruments were not significant (P > 0.05). No significant differences were obtained between all four instruments regarding canal transportation (P = 0.429). Instrumentation with ProTaper NEXT files was significantly faster than with all other instruments (P < 0.05). During the preparation of the curved canals, one BT2 instrument fractured, whilst no fracture occurred when using the other instruments (P > 0.05). CONCLUSIONS: Within the parameters of this study, all instruments maintained root canal curvature well and were safe. However, care should be taken when using the BT2 instrument due to its unique cylindrical design.

Total occlusion trial with angioplasty by using laser guidewire. The TOTAL trial.

AIMS: A randomized trial was performed to assess the safety and efficacy of a laser guidewire, in the treatment of chronic coronary occlusions. METHODS AND RESULTS: In 18 European centres, 303 patients with a chronic coronary occlusion were randomized to treatment with either the laser guidewire (n=144) or conventional guidewires (mechanical guidewire, n=159). The primary end-point of the study was treatment success, defined as reaching the true lumen distal to the occlusion by the allocated wire within 30 min of fluoroscopic time: laser guidewire vs mechanical guidewire; 52.8% (n=76) vs 47.2% (n=75), P=0.33. Serious adverse events following the initial guidewire attempt were 0% (laser guidewire) and 0.6% (mechanical guidewire), respectively. Angioplasty (performed following successful guidewire crossing) was successful in 179 patients (91%, laser guidewire n=79, mechanical guidewire n=100), followed by stent implantation in 149 (79%). At the 6-month angiographic follow-up, the difference in binary restenosis rate (laser guidewire vs mechanical guidewire; 45.5% vs 38.3 %, P=0.72) or reocclusion rate (25.8% vs 16.1%, P=0.15) did not reach statistical significance. At 1, 6 and 12 months, angina and event-free survival were 69%, 35% and 24% (laser guidewire) vs 74%, 40% and 31% (mechanical guidewire). CONCLUSION: Although laser guidewire technology was safe, the increase in crossing success did not reach statistical significance.

Influence of treatment modality on angiographic outcome after coronary stenting in diabetic patients: a controlled study.

OBJECTIVES: This retrospective study was designed to determine the six-month angiographic outcome after stenting of native coronary arteries in insulin-treated (ITDM) and non-ITDM patients with diabetes mellitus (DM) and compare the results with those in non-DM patients. BACKGROUND: The influence of the treatment modality for DM on restenosis in patients undergoing coronary artery stenting has not been elucidated sufficiently. METHODS: A total of 1,439 (70%) of 2,061 patients underwent repeated angiography within six months of coronary stenting. The ITDM and non-ITDM (oral hypoglycemic drugs or diet) were documented in 48 (3.3%) and 177 patients (12.3%), respectively, leaving 1,214 non-DM patients. RESULTS: Baseline reference vessel diameter tended to be smaller in ITDM patients (mean, 2.73 mm) than in non-DM and non-ITDM patients (2.88 mm and 2.85 mm, respectively). However, percent diameter stenosis was not different. The median number of stents deployed was 1; median stent length was 15 mm. Statistically significant differences were present after stenting for the means of minimal lumen diameter (MLD) and acute gain between ITDM patients (MLD: 2.67 mm, acute gain: 1.98 mm) and non-DM patients (MLD: 2.81 mm, acute gain: 2.16 mm). At follow-up, percent diameter stenosis, late lumen loss and loss index were significantly higher in both non-ITDM lesions (42%, 1.14 mm and 0.56, respectively) and ITDM lesions (48%, 1.26 mm and 0.65, respectively) than in non-DM lesions (35%, 0.96 mm and 0.45, respectively). The corresponding differences between non-ITDM and ITDM lesions did not reach statistical significance. Restenosis rates in non-DM, non-ITDM and ITDM lesions were 23.8%, 32.8% (p = 0.013 vs. non-DM) and 39.6% (p = 0.02 vs. non-DM, p = 0.477 vs. non-ITDM), respectively. CONCLUSIONS: This study showed that compared with stenting in non-DM patients, stenting of native coronary arteries in DM patients is associated with significantly increased lumen renarrowing, regardless of the treatment modality for DM.

Restenosis after stenting of matched occluded and non-occluded coronary arteries. Should there be a difference?

AIMS: It is not known whether the higher restenosis rates reported after balloon angioplasty of occluded as opposed to non-occluded coronary arteries are still found after placement of coronary stents in lesions matched for factors known to affect late angiographic outcome. METHODS AND RESULTS: In a retrospective analysis of 1276 patients who had undergone coronary stent placement and in whom 6-month angiographic follow-up was available, we identified 144 patients with a total coronary occlusion which matched a non-occluded coronary lesion in another 144 patients. Matching lesion pairs were of the same type (de novo or restenotic), were supplied with the same type of stent, had reference vessel diameters identical within 0.3 mm and stented vessel segment lengths identical within 8 mm, and were located in corresponding target vessels. After stenting, statistically identical minimal lumen diameters had been achieved in both groups (occluded: 2.74+/-0.35 mm, non-occluded: 2. 77+/-0.32 mm, P = 0.45). At follow-up, minimal lumen diameters were not different (occluded: 1.65+/-0.77 mm, non-occluded: 1.76+/-0.76 mm, P = 0.24), reflecting an identical late lumen loss for occlusions (1.09+/-0.76 mm) and non-occluded lesions (1.01+/-0.70 mm, P = 0.38). Because of the significantly larger acute gain, the loss index was significantly lower for occluded vessels (0.40+/-0.27 vs 0. 51+/-0.35, P = 0.003). Corresponding restenosis rates were 33% (occluded) and 28% (non-occluded;P = 0.44). For stented vessel segment lengths >18 mm, restenosis rates were markedly higher (occluded: 42%, non-occluded: 36%) than for stented vessel segment lengths

Beating heart operations including hybrid revascularization: initial experiences.

BACKGROUND: The outcome of patients (n = 45) with coronary one- to three-vessel disease undergoing beating heart operations using a recently developed stabilizing device was investigated. METHODS: Left internal mammary artery-to-left anterior descending coronary artery (LIMA-to-LAD) revascularization was carried out alone (n = 31) or as hybrid procedure in combination with a balloon angioplasty (n = 14). RESULTS: All 45 patients underwent a successful LIMA-to-LAD procedure without intraoperative complication during a 21 +/- 8-minute (range, 10 to 53 minutes) LAD occlusion time. In 14 hybrid procedures a total of 19 stenoses including 3 left main stenoses were treated successfully by percutaneous transluminal coronary angioplasty and stenting. The postoperative courses were uneventful with the exception of two surgical reexplorations necessitated by bleeding. No worsening of renal, neurologic, or respiratory functions occurred in any patient. In the group having a single LIMA-to-LAD procedure, early postoperative coronary angiograms (22 of 31) showed a patent LIMA graft and excellent anastomosis; this was also true in 4 patients 12 months after operation as shown in angiograms. All patients undergoing hybrid revascularization demonstrated a patent LIMA-to-LAD anastomosis; in 1 patient there was a dissection in the midlevel of the LIMA, which was stented successfully. The 6-month follow-up angiograms in 7 of 14 patients revealed open LIMA bypass grafts in all patients except 1, who was stented because of dissection. CONCLUSIONS: These data indicate that a beating heart operation including hybrid revascularization is safe and effective in selected patients with coronary one- to three-vessel disease including left main stenosis. This approach may be especially advantageous in comparison with conventional coronary artery bypass grafting in patients with severe concomitant disease.

[First annual report of practitioners of interventional cardiology in private practice in Germany. Results of procedures of left heart catheterization and coronary interventions in the year 1996]. / Erster Jahresbericht niedergelassener Invasivkardiologen in Deutschland. Ergebnisse für diagnostische Linksherzkatheteruntersuchungen und Koronarinterventionen 1996.

The German Society for Cardiac Angiography and Interventions in Private Practice has started a registry of cardiac procedures since 1996 in order to establish a standard for performance. Although quality management for the cath lab makes sense and is also legally required, there is no generally recommended infrastructure for quality assurance existing in Germany at this time. Therefore, the German Society of Cardiologists in Private Practice (BNK) initiated a project in 1994 to develop a computer program for paperless documentation of diagnostic cardiac catheterizations and coronary interventions (PTCA) using a minimal data set. In 1996, 8 private associated groups participated in this project. The (anonymous) analysis of 10,316 diagnostic cardiac catheterizations and 2597 PTCA yielded the following results: In 95% of the patients, diagnostic cardiac catheterization was performed using the femoral and in 5% the brachial/radial approach. The mean volume of administered contrast medium was 164 +/- 138 ml/patient. The mean LV-EF was greater than 50% in 58.4% of the patients and between 30% and 50% in 10.1%. Coronary artery disease was diagnosed in 69.6% of the patients and valvular/congenital heart disease in 8.5%. In 18.4% of the patients undergoing diagnostic cardiac catheterizations no significant heart disease was identified. Mortality in the cath lab as well as the rate of cerebral insults was 0.05%. In 22.9% and 19% of the patients PTCA and cardiac surgery respectively was recommended. In patients undergoing PTCA, stable angina was present in 74.4% and unstable angina in 13.1%. Of the total number of PTCA procedures, 5.8% were performed in the setting of acute myocardial infarction. The PTCA lesion success rate was 96%, the mean diameter stenosis was 81% pre and 6% post-intervention. The mortality rate at 1 month post-PTCA was 0.4%, and myocardial infarction 1.0%. An acute occlusion occurred in 1.3% of the PTCA patients; 0.6% had to be transferred for emergency bypass surgery. None of the cath labs had on-site surgery. In comparison to other registries, our data show some similarities but also some different trends. Thus, our newly developed software proved to be reliable, fast and easy to use. Participating centers receive immediate feedback regarding their position within the whole group.

Stenting of nonacute total coronary occlusions: predictors of late angiographic outcome.

OBJECTIVES: This study was designed to determine and assess factors predictive of the intermediate-term outcome of stenting of nonacute total coronary occlusions. BACKGROUND: Balloon angioplasty of recanalized coronary occlusions is associated with a combined restenosis/reocclusion rate of up to 65%. Adjunctive stenting holds the potential to reduce this rate significantly. However, variables affecting the late angiographic outcome of coronary stenting in the setting of a total occlusion have not been elucidated sufficiently. METHODS: Coronary stenting was performed in 143 consecutive patients with a nonacute total occlusion; 120 of these patients (84%), with a total of 121 occlusions, underwent repeat angiography within 6 months and comprised the study group. High pressure stent implantation aimed to cover the site of the occlusion as well as adjacent diameter stenoses > or = 70% and all possibly induced dissections. Pertinent angiographic and procedural variables obtained at the time of the intervention were entered into a multivariate logistic regression analysis model to assess their influence on the angiographic outcome at follow-up. RESULTS: Mean preinterventional reference lumen diameter for the 121 vessels was 2.99 +/- 0.53 mm (mean +/- SD); occlusion length ranged from 4 to 44 mm (median of 7.7). After balloon angioplasty, dissections were found in 80% of patients. Lesions were covered with stents a median of 16 mm in length (range 8 to 53). The minimal lumen diameter (MLD) achieved after stenting was 2.89 +/- 0.48 mm. After a median follow-up period of 4.5 months, mean MLD was assessed at 1.91 +/- 0.90 mm, corresponding to a loss index of 0.34 +/- 0.31. There were 27 vessels with a nonocclusive restenosis > or = 50% and 8 with a reocclusion, for a combined restenosis/reocclusion rate of 29%. Factors found to adversely influence angiographic outcome were a post-stenting MLD < or = 2.54 mm, a stented vessel segment length > 16 mm, a balloon/vessel diameter ratio for final stent expansion < or = 1.00 and the presence of a dissection after balloon angioplasty. CONCLUSIONS: Compared with previous reports on stand-alone balloon angioplasty, stenting of nonacute total coronary occlusions lowers the 6-month restenosis/reocclusion rate to approximately 30%. The late procedural outcome is independently and statistically significantly influenced by the MLD after stenting, the length of the stented vessel segment, the balloon/vessel diameter ratio for final stent expansion and the incidence of dissections after balloon angioplasty.

Recanalization of total coronary occlusions using a laser guidewire (the European TOTAL Surveillance Study).

The success rates of coronary angioplasty for the treatment of chronic total occlusions are less favorable than for coronary stenosis. Therefore, a new laser guidewire (LW) was designed to facilitate the crossing of chronic total occlusions. We report on the results of a European multicenter surveillance study, evaluating the laser guidewire performance. Between May 1994 and July 1996, 345 patients (age 59 +/- 10 years, 291 men) with chronic total occlusions were enrolled in 28 European centers. The median age of occlusion was 29 weeks (range 2 to 884), the occlusion length 19 +/- 10 mm. LW recanalization was successful in 205 patients (59%/). LW perforation occurred in 73 patients (21%), with hemodynamic consequences in 4 (1%). There were no deaths, emergency coronary artery bypass graft surgery, or Q-wave myocardial infarctions. In a multivariate regression analysis an occlusion age of <40 weeks (p = 0.001, RR = 1.34) and an occlusion length <30 mm (p = 0.01, RR = 1.59) were independent predictors of success. Results indicate that the LW is an effective and safe tool in the treatment of chronic total occlusion refractory to conventional guidewires.

Short-term results and intermediate-term follow-up of laser wire recanalization of chronic coronary artery occlusions: a single-center experience.

OBJECTIVES: This study sought to elucidate the short-term efficacy and intermediate-term outcome of excimer laser recanalization of chronic coronary artery occlusions in patients in whom attempts at mechanical revascularization had failed. BACKGROUND: Recanalization of chronic coronary occlusions with the use of a mechanical guide wire fails in 30% to 50% of cases, mostly because of inability to pass the wire through the lesion. The value of using excimer laser energy in this setting has not yet been determined. METHODS: The study group comprised 66 consecutive patients with 68 chronic coronary occlusions. Patients were eligible for inclusion in the study if a previous attempt at mechanical revascularization had failed and if their angiographic status was such that 1) the vessel segment distal to the occlusion could be visualized by way of collateral vessels, 2) the entry point of the occlusion was clearly outlined, and 3) not more than one anatomic bend was expected within the occlusion. Excimer laser energy was applied to the lesion through a 0.018-in. (0.046 cm) fiber-optic guide wire. Adjunctive balloon angioplasty and stenting were performed in all successfully treated patients but one. RESULTS: Thirty-four occlusions (50%) in 32 patients (48%) could be crossed with the laser wire. Location and age of the occlusion had no adverse influence on the outcome of laser wire recanalization, nor did the presence of bridging collateral vessels, a major side branch at the site of the lesion or a blunt stump of the occlusion. An inverse relation was found between the success rate and the length of the occlusion, such that a 19% reduction of the success rate accompanied each 10-mm increment of the mean occlusion length. Thus, the success rate was 68% for lesions < or = 10 mm but only 25% for lesions > 30 to < or = 40 mm. The presence of a bend in the lesion exceeding 60 degrees was strongly related to procedural failure. During a median angiographic follow-up period of 18 weeks, restenosis > 50% (n = 6) or reocclusion (n = 4) was found in 10 of the 32 successfully treated patients, for an intermediate-term success rate of 33% (22 of 66). Clinical follow-up revealed improved anginal status in 21 patients (66%) after a median of 24 weeks. Major complications (death, myocardial infarction, emergency operation) were not encountered. CONCLUSIONS: Successful recanalization of a chronic coronary occlusion by using currently available laser wires can be expected in 50% of selected patients in whom attempts at mechanical revascularization fail. Restenosis or reocclusion accounts for an overall 6-month success rate of 35%.

Comparison of immediate and intermediate-term results of intravascular ultrasound versus angiography-guided Palmaz-Schatz stent implantation in matched lesions.

BACKGROUND: Intravascular ultrasound (IVUS) provides more precise information than angiography about vascular dimensions. This information is used by some centers to optimize intracoronary stent implantation. There are no direct comparisons of the effects on restenosis of optimal IVUS-guided versus angiography-directed high-pressure stenting. METHODS AND RESULTS: Lesions of patients who had a 6-month angiographic follow-up study were eligible for matching. From 445 consecutive lesions treated by Palmaz-Schatz (P-S) stenting guided by IVUS (IVUS group) in Milan, 173 lesions were individually matched with 173 of 476 consecutive lesions treated by P-S stenting directed by angiography (Angio group) in Hamburg. Lesions were selected by a computerized program according to baseline clinical, angiographic, and procedural variables. Immediate and 6-month angiographic results were retrospectively compared, distinguishing an "early phase" from a "late phase." This distinction was based on the more aggressive dilation strategy with larger balloons and more demanding IVUS criteria for optimal stent expansion used in Milan in the early phase. In both phases, a larger minimum lumen diameter (MLD) immediately after stenting and after 6 months was achieved in the IVUS group than in the Angio group. In the early phase, the dichotomous restenosis rate was lower in the IVUS group than in the Angio group (9.2% versus 22.3%; P=.04). In the late phase, there was no difference in restenosis between the groups (22.7% versus 23.7%; P=1.0). CONCLUSIONS: In matched lesions treated with high-pressure stenting, IVUS guidance achieved a larger MLD than angiographic guidance. However, in the IVUS group, the restenosis rate was lower only in the early phase, when balloons larger than currently used were selected to maximize the stent lumen area.

Infarct size measurement by triphenyltetrazolium chloride staining versus in vivo injection of propidium iodide.

Infarct size delineation by triphenyltetrazolium chloride (TTC) staining is dependent on sufficient reperfusion. We therefore evaluated the possibility of using propidium iodide (PI), a reagent conventionally used in flow cytometry to fluorescently stain dead cells, for infarct size analysis after short periods of reperfusion. Forty-five rabbits were subjected to either 15 min, 2 h or 4.5 h of coronary artery occlusion without reperfusion, or to 15 min, 30 min and 2 h of coronary artery occlusion followed by 30 min, 1 h and 3 h of reperfusion. Fifteen min before terminating the experiment, PI was injected into the left atrium. Patent blue violet was used to delineate the area at risk. Following incubation in TTC, the area at risk was excised and cross sections obtained for microscopical infarct size quantification by PI fluorescence. PI fluorescence was absent after permanent occlusion and in control areas. Infarct sizes measured by TTC staining were significantly smaller after 1 h of reperfusion as compared to 3 h of reperfusion (30 min occlusion: 1+/-1 v 34+/-9%; P<0.05; 2 h occlusion: 9+/-6 v 47+/-8%; P<0.01). In contrast, infarct sizes determined by PI fluorescence reached values comparable to those measured by TTC staining or conventional histology after longer times of reperfusion already after 30 min of reperfusion (30 min occlusion: 35+/-16.5%; 2 h of occlusion: 61+/-8%). Therefore, after short times of reperfusion infarct size measurement by PI fluorescence is more reliable than by TTC staining.

Recanalization of chronic coronary artery occlusions using laser followed by balloon angioplasty.

Excimer laser angioplasty with adjunctive percutaneous transluminal coronary angioplasty of chronic coronary artery occlusions was performed using the Litvack 1.3 Z laser catheter in 80 patients in whom the occlusion could be passed by a guidewire; success rate was 89%. Angiographic follow-up revealed a restenosis rate of 33% and a reocclusion rate of 20%, and clinical follow-up showed a significant symptomatic improvement. It is concluded that laser angioplasty is a promising method for the treatment of chronic coronary artery occlusions.

Influence of the terminal complement-complex on reperfusion injury, no-reflow and arrhythmias: a comparison between C6-competent and C6-deficient rabbits.

OBJECTIVE: The complement system has been suggested to play a role in reperfusion injury which may result from an enhanced destruction of myocardial tissue or from an impairment of reflow. We investigated the influence of the C5b-9 complement complex on infarct size, reflow and arrhythmogenesis. METHODS: Twenty-eight C6-competent rabbits and 18 rabbits with congenital C6 deficiency were subjected to either 30 min or 2 h of coronary artery occlusion followed by reperfusion. C6 deficiency was confirmed by the complement titration test and immunohistology. The triphenyl tetrazolium chloride method was used to delineate infarct size. Reflow into infarcted areas was evaluated histologically after an in vivo injection of propidium iodide which served as an early fluorescence microscopic marker of damaged myocardium subjected to reflow. Continuous ECG monitoring allowed the recording of arrhythmias. RESULTS: After 30 min of coronary artery occlusion infarct size was significantly smaller in C6-deficient rabbits (5.0 +/- 2% of the risk region) as compared to C6-competent rabbits (28.4 +/- 8.5%, P = 0.0371). The extent of reflow into damaged myocardium was nearly the same in both animal groups at this time (38 +/- 9 vs. 39 +/- 7% of the risk region). After 2 h of coronary artery occlusion, infarct size was not different between both animal groups, but the extent of reflow into damaged myocardium was significantly smaller in C6-competent rabbits than in C6-deficient rabbits (25 +/- 4 vs. 40 +/- 4%; P = 0.0185). Two of the 18 C6-deficient rabbits had ventricular arrhythmias (Lown II-IV), none of which was fatal. Eleven of the 28 C6-competent animals had major ventricular arrhythmias which were fatal in 6 rabbits. CONCLUSIONS: These results suggest that the lytic C5b-9 complement complex leads to reperfusion injury in the early phase (30 min) of ischaemia, resulting in a larger infarct. After 2 h of ischaemia, complement activation enhances the no-reflow phenomenon but does not affect infarct size. Finally, the C6 status seems to influence the susceptibility to ventricular arrhythmias after coronary artery occlusion, independent of reperfusion.

Early accumulation of the terminal complement-complex in the ischaemic myocardium after reperfusion.

The terminal, membrane-damaging complement complex C5b-9 accumulates in the infarcted myocardium. In experimental myocardial infarction, we investigated the time course of C5b-9 deposition and the influence of reperfusion. In a group of 17 rabbits (group 1), the circumflex coronary artery was occluded for different time periods ranging from 0.5 to 29 h without subsequent reperfusion. A second group of 23 rabbits (group 2) underwent coronary artery occlusion for periods ranging from 0.5 to 6 h followed by reperfusion. C5b-9 was determined in transmural myocardial biopsies by immunohistochemistry and by ELISA. In group 1, C5b-9 accumulation in the ischaemic myocardium was found only after 5 to 6 h of coronary artery occlusion. In group 2 (ischaemia and reperfusion), significant C5b-9 deposition was already observed after 30 min of myocardial ischaemia. We conclude that in the absence of reperfusion C5b-9 accumulation occurs as a late event when most of the jeopardized myocardium has probably already become necrotic. In the presence of reperfusion, however, the complement system is activated rapidly and this could play a role in the pathogenesis of reperfusion injury.

[Does rotablation of complex coronary artery stenosis lower the risk of subsequent PTCA?]. / Senkt die Rotablation komplexer Koronararterienstenosen das Risiko der anschliessenden PTCA?

To answer the question of whether pretreatment of complex coronary artery lesions via rotablation reduces the risk of subsequent PTCA, we compared the results of PTCA of 250 patients with Typ B- and C-lesions treated between April 1 and November 11 1991 (Group A) with a group of 437 patients treated between January 1 and May 1 1992 (Group B), for whom not only PTCA but also rotablation was available. Rotablation was successful in 102 of 119 procedures (85.7%), the rate of major complications was 1.8%. The primary success rate for treatment of all complex lesions was higher in group B (87.3%) in which 22.2% of the lesions were treated with the rotablator than in group A (83.1%). Dissection rate was similar in both groups (18.5% in group A, 17.5% in group B). In group B patients, however, dissections could be controlled more frequently by the use of a reperfusion catheter (21% vs 8.3% in group A). Serious complications caused by a dissection were not so often observed. In group B patients the rate of major complications due to dissection was lower (2.5% vs 4.4% in group A). In summary, pretreatment of complex coronary artery lesions via rotablation seems to increase the success rate of the following PTCA and to reduce its risks.

[Early hemostasis after coronary therapeutic interventions by using a collagen plug]. / Frühzeitige Blutstillung nach koronartherapeutischen Eingriffen durch Anwendung von Kollagenplugs.

Significant bleeding at the puncture site is one of the most important problems in the care of patients undergoing interventional coronary procedures like PTCA, rotablation, laser angioplasty or stent implantation. This is due to systemic application of heparin, acetylic salicic acid and, in stent patients, even additional coumadine. Furthermore, the interventional systems implement catheter systems with a large inner and outer lumen leading to increased vessel trauma. To decrease the risk of bleeding and to reduce the time of pressure dressing and bed rest, a bovine collagen plug (VasoSeal) was used in 600 consecutive patients undergoing one of the above-mentioned interventional procedures. In the majority of patients (pts.) (474/600 = 79%) either no (404 pts.) or minimal (70 pts.) bleeding occurred. Bed rest could be reduced from more than 24 h to 6-12 h. In 65/600 pts. (11%) significant bleeding developed which could be controlled by compression. Bed rest in these patients was 13-20 h. Larger bleedings or complications occurred in 61/600 pts. (10.2%) and could be controlled conservatively in all but eight patients. One patient (0.2%) had a narrowing of the artery at the puncture site after the procedure, probably due to intraarterial plug application. In another patient (0.2%) embolization of the plug into the popliteal artery occurred which could be treated by embolectomy using a Fogarty-catheter. Arteriovenous fistulae or aneurysms developed in 8/600 pts. (1.3%) but these are no specific complications of the hemostatic device. The plug could not be placed in 13/600 pts. (2%), mainly in the beginning of the study.(ABSTRACT TRUNCATED AT 250 WORDS)