Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate aNd discharge (STAND I and STAND II) trials

Despite advances in other aspects of cardiac catheterization, manual or mechanical compression followed by 4 to 8 hours of bed rest remains the mainstay of postprocedural femoral access site management. Suture-mediated closure may prove to be an effective alternative, offering earlier sheath removal and ambulation, and potentially a reduction in hemorrhagic complications. The Suture To Ambulate aNd Discharge trial (STAND I) evaluated the 6Fr Techstar device in 200 patients undergoing diagnostic procedures, with successful hemostasis achieved in 99% of patients (94% with suture closure only) in a median of 13 minutes, and 1% major complications. STAND II randomized 515 patients undergoing diagnostic or interventional procedures to use of the 8Fr or 10Fr Prostar-Plus device versus traditional compression. Successful suture-mediated hemostasis was achieved in 97.6% of patients (91.2% by the device alone) compared with 98.9% of patients with compression (p = NS). Major complication rates were 2.4% and 1.1%, and met the Blackwelder's test for equivalency (p <0.05). Median time to hemostasis (19 vs 243 minutes, p <0.01) and time to ambulation (3.9 vs 14.8 hours, p <0.01) were significantly shorter for suture-mediated closure. Suture-mediated closure of the arterial puncture site thus affords reliable immediate hemostasis and shortens the time to ambulation without significantly increasing the risk of local complications.     

Randomized controlled trial of topical hemostasis pad use for achieving vascular hemostasis following percutaneous coronary intervention.

OBJECTIVES: We conducted a randomized trial to determine the efficacy of two topical hemostasis pads in promoting vascular hemostasis following PCI, and to assess the appropriate level of anticoagulation for sheath removal. BACKGROUND: Pads coated with procoagulant materials are widely marketed and used to augment vascular hemostasis following PCI, yet clinical effectiveness and safety data are lacking. METHODS: 184 patients who underwent PCI using the femoral approach were randomized to one of four methods of sheath removal: (1) at ACT < 250 using the Chito-Seal pad; (2) at ACT < 250 using the Clo-Sur PAD; (3) at ACT < 250 using manual compression alone; (4) at ACT < 170 using manual compression alone. RESULTS: Time to hemostasis was significantly shorter in the hemostasis pad groups compared to the conventional compression groups (16.2 +/- 4.9, 16.0 +/- 5.3, 19.3 +/- 7.8, and 18.3 +/- 5.7 min, respectively, P = 0.027), however overall bed rest times following intervention were not reduced by use of either hemostasis pad. The incidence of major or minor bleeding complications did not differ among groups. Irrespective of hemostasis pad use, removal of sheaths at higher ACT levels allowed shorter time to ambulation following PCI without an increase in bleeding events. CONCLUSIONS: The hemostasis pads tested shortened time to hemostasis compared to standard manual compression, although the absolute reduction in time to hemostasis was relatively small and did not translate into a reduction in overall bed rest time. Independent of hemostasis pad use, removal of arterial sheaths at higher than conventional activated clotting times was safe and resulted in significant reductions in time to ambulation.     

Safety and efficacy of staple-mediated femoral arteriotomy closure: results from a randomized multicenter study.

BACKGROUND: Mechanical closure of percutaneous femoral arteriotomies following catheter based procedures remains problematic. METHODS: The EVS closure device is the first to utilize a staple to effect arteriotomy closure and was compared to manual compression following sheath removal in a 362 patient randomized (2:1 to device) multicenter trial. As pre-specified, one half of the patients underwent coronary intervention. RESULTS: Time to hemostasis was significantly reduced in the EVS group for both diagnostic (3.3 +/- 2.6 vs. 19.3 +/- 5.7 minutes; p < 0.001) and interventional procedures (5.5 +/- 5.1 vs. 22.3 +/- 9.9 minutes; p < 0.0001). Time to ambulation was similarly reduced in the EVS group following diagnostic (2.4 +/- 3.3 vs. 6.0 +/- 5.2 hours; p < 0.001) and interventional procedures (3.4 +/- 4.5 vs. 7.6 +/- 7.0 hours; p < 0.001). The incidence of major complications was similar between the EVS and manual compression groups at discharge (0.4% vs. 1.7%; p = NS) and at 30 day follow-up (0.4% vs. 2.5%; p = NS). CONCLUSION: Compared to manual compression, the EVS device provides a safe and effective method of femoral artery closure.     

A prospective, randomized trial of topical hemostasis patch use following percutaneous coronary and peripheral intervention

The use of topical hemostasis patches has grown rapidly despite a paucity of evidence supporting their clinical utility. We performed a randomized, controlled trial to assess the efficacy of a topical hemostasis patch as a means to accelerate vascular hemostasis following percutaneous intervention. One hundred fifty (150) patients undergoing coronary or peripheral intervention through a 6 Fr femoral arterial sheath were randomized to sheath removal with either: (1) manual pressure and adjunctive use of a patch incorporating a polysaccharide based procoagulant material (SafeSeal Patch, Possis Medical Inc.); or (2) conventional manual pressure alone. Sheaths were removed when the activated clotting time (ACT) fell to < or = 250 seconds. Patients ambulated 2 hours after hemostasis was achieved. Time to hemostasis (duration of compression required until cessation of bleeding following sheath removal) was significantly lower in the hemostasis patch arm (11.8 +/- 3.6 vs. 13.8 +/- 5.8 minutes; p = 0.02). Attainment of hemostasis in < 15 minutes was also more likely among patients randomized to the hemostasis patch rather than manual compression alone (odds ratio = 2.5; 95% confidence intervals 1.2, 5.1; p = 0.014). The median time to ambulation (total duration from the end of the interventional procedure to ambulation) was significantly reduced among patients in the hemostasis patch arm (2.8 vs. 3.8 hours; p = 0.03). Bleeding complications were uncommon and did not differ between the study arms. In conclusion, this trial supports the concept that the polysaccharide-based SafeSeal Patch enhances access site hemostasis following endovascular intervention.     

Vasoseal hemostasis following coronary interventions with Abciximab

Femoral arteriotomy management using a collagen vascular hemostasis device (VasoSeal) was studied in 50 consecutive patients following interventional coronary procedures performed with Abciximab (ReoPro). Low dose weight adjusted or no heparin was employed. The first 25 patients were permitted to sit up after 6 hours with ambulation the following day. The second 25 patients were allowed to sit up after 1 hour and ambulate after 6 hours. Despite early activity and ambulation, there were no hemorrhagic complications including hematoma, pseudoaneurysm, blood transfusion, or surgical repair. Hemoglobin and platelet counts remained stable overnight prior to discharge. This pilot study demonstrates the potential efficacy of VasoSeal in achieving early sheath removal and ambulation in patients undergoing interventional procedures using ReoPro. Cathet. Cardiovasc. Diagn. 44:405–406, 1998. © 1998 Wiley-Liss, Inc.     

A randomized controlled trial on the hemostasis of femoral artery using topical hemostatic agent

Objective: Evaluation of the effect of using a topical hemostatic agent named "ChitoHem(?)" on different factors on patients undergoing diagnostic coronary angiography. Methods: The present blind, randomized, controlled study included 124 patients randomly divided into 2 groups. In the treatment group following femoral sheath removal, ChitoHem(?) powder and in the control group conventional hemostatic procedure was applied. Results: In the treatment group, time to hemostasis, ambulation, and the use of sandbag were significantly shorter compared with the control group, respectively (4.6 ± 1.3 vs 12.4 ± 4.4 minutes, 3.5 ± 2.7 vs 23.0 ± 1.73 hours and 1.6 vs 98.4%; P < .05). There were no significant differences in hematoma formation and re-bleeding between the 2 groups. Conclusion: It was exhibited ChitoHem(?) topical hemostatic powder used on treatment patients undergoing diagnostic coronary angiography was statistically superior at reducing the time to hemostasis and ambulation as well as the use of sandbags compared with manual compression in control group.     

Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device

To overcome the challenge associated with achievement in hemostasis after a catheterization procedure, a suture-based closure device was compared with manual compression in a 600-patient randomized trial. The major study end points included the incidence of vascular complications and the time to ambulation after the procedure. The study included diagnostic or interventional procedures. The suture-mediated closure was performed immediately after the procedure independent of the anticoagulation level, whereas manual compression was performed per hospital protocol with sheath removal relying on normalization of patient’s anticoagulation status. A significant reduction in time to achieve hemostasis (7.8 ± 4.8 vs 19.6 ± 13.2 minutes, p <0001) and time to ambulation (4.5 ± 6.5 vs 17.8 ± 5 hours, p <0001) was associated with use of the suture-mediated closure device. The incidence of vascular complications was similar in the overall population (5.7% for suturing device vs 11.3% for compression) or in the interventional patient subset (8.4% for suturing device vs 9.6% for compression). There was a significant reduction in the incidence of vascular complications in the diagnostic procedure subset (4.4% for suturing device vs 12.1% for compression, p <0.05). Thus, the use of a suture-mediated closure device represents a safe alternative to manual compression. Hemostasis and ambulation can be achieved faster with the suturing device than with manual compression, with a potential reduction in access site complications.     

Multicenter, dose-ranging study of efegatran sulfate versus heparin with thrombolysis for acute myocardial infarction: The Promotion of Reperfusion in Myocardial Infarction Evolution (PRIME) trial

Background Adjunctive therapies that increase the incidence of normal reperfusion after thrombolysis for acute myocardial infarction (MI) could enhance clinical outcomes. Direct thrombin inhibitors may offer an advantage over standard adjunctive therapies. Methods We randomized 336 patients with acute MI at 33 sites to receive 1 of 5 doses of efegatran sulfate, a direct thrombin inhibitor, or heparin for 72 to 96 hours, both with accelerated alteplase and aspirin. The primary end point was the incidence of thrombolytic failure (death, reinfarction, or TIMI grade 0-2 flow in the infarct artery from 90 minutes to discharge or 30 days, whichever occurred earlier). Results Significantly more patients randomized to efegatran had evidence of heart failure at admission. The lowest-dose efegatran arm was terminated at 15 patients because of unacceptably increased thrombolytic failure. The primary end point occurred in 53.0% of patients treated with heparin, in 53.8% of patients treated with efegatran overall (P = .90), and in 55.4% of patients given intermediate-dose efegatran (P = .74). These findings were unaffected after adjustment was done for baseline differences. Most bleeding was minor; major bleeding and the use of blood transfusions did not differ significantly by treatment. Three patients in the high-dose efegatran group had intracranial hemorrhage, as did 1 patient in the heparin group. Continuous ST monitoring showed a shorter time to recovery for the efegatran group (median 107 minutes) compared with the heparin group (154 minutes; P = .025). Conclusions Efegatran sulfate appeared to offer no clear advantage over heparin as an adjunct to thrombolysis for acute myocardial infarction, although there may be a modest improvement in time to reperfusion. (Am Heart J 2002;143:95-105.)     

Serum glucose and lipid levels in adult congenital heart disease patients

Atherosclerosis has been correlated with known cardiovascular risk factors such as serum glucose or lipid levels. Because congenital heart disease patients tend to survive until adulthood, atherosclerosis has also become a matter of concern in these patients. One hundred fifty-eight congenital heart disease patients and 152 patients selected at random from the population were studied and compared to determine serum glucose, total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein cholesterol, and triglycerides levels. Both groups had similar socioeconomic status levels and the same environmental influences. Significant differences were seen between congenital heart disease patients and the control group, after sex, age, and body mass index adjustment, in fasting plasma glucose (97.7 [94.2-101.2] vs 86.9 [83.2-90.7], P < .001), total cholesterol (171.5 [165.7-177.3] vs 199.8 [90.7-206.0], P < .001), LDL cholesterol (103.9 [98.8-108.8] vs 123.8 [118.5-129.1], P < .001), and high-density lipoprotein cholesterol (48.1 [46.2-50.0] vs 54.2 [52.1-56.2], P < .001) levels. Nonsignificant differences were seen in triglycerides concentrations. Those patients with ventricular septal defect, coarctation of the aorta, and cyanosis had the lowest total cholesterol and LDL cholesterol concentrations. Congenital heart disease patients have lower plasma cholesterol concentrations and higher serum glucose levels than noncongenital ones.     

Limitations of current risk-adjustment models in the era of coronary stenting

Background Several risk-adjustment models have been developed to compare outcomes of conventional coronary angioplasty across physicians and institutions. Yet the accuracy of these models in contemporary interventional practice—characterized by the widespread use of stents and novel adjuvant pharmacotherapies—has not been sufficiently studied. Methods The principal published predictive models for inhospital mortality after angioplasty were validated in 11,681 patients undergoing coronary stenting and 6475 patients undergoing balloon-only procedures in the Society for Cardiac Angiography and Interventions registry from July 1996 to December 1998. We examined the 2 components of model accuracy: discrimination, as determined by the c-index; and calibration, as measured by the Hosmer-Lemeshow statistic and predicted-versus-observed probability plots. Results The discriminative properties of the models were preserved in the validation cohort and did not differ statistically from one another (c-indexes 0.85-0.89). Hosmer-Lemeshow statistics, however, showed poor fit (P < .001), with all 3 models substantially overestimating the risk of adverse outcomes. Although recalibration of the models achieved satisfactory goodness of fit, laboratory-specific ratings differed depending on the model applied. Conclusions Predictive models developed in the era of conventional angioplasty cannot be applied directly to current interventional practice. Although recalibration restores model fit, application of different recalibrated models yields inconsistent assessment of laboratory performance. Development of new, widely generalizable models is warranted, but such models will require continued reassessment as medical technology evolves and practice patterns change. (Am Heart J 2003;145:683-92.)     

Comparison of percutaneous transmitral commissurotomy with Inoue balloon technique and metallic commissurotomy: immediate and short-term follow-up results of a randomized study

Background The Inoue balloon technique for mitral commissurotomy is well established and carried out worldwide. Metallic commissurotomy is reported to be a cheaper and effective alternative to balloon mitral commissurotomy. Methods One hundred patients were randomized into 2 groups to undergo percutaneous transmitral commissurotomy (PTMC) by means of the Inoue balloon technique (IBMC, n = 49) or metallic commissurotomy (PMMC, n = 51). Patients were crossed over to the other technique when the initial technique was a failure. Success of valvotomy, procedure-related complications, and follow-up events of the 2 techniques were compared. Results Basal echocardiographic and hemodynamic data were similar in both groups. Procedural success was similar in both groups: 45 of 49 procedures (91.8%) in the IBMC group, compared with 46 of 51 procedures (90.18%) in the PMMC group (P = 1.0). Crossover was also comparable, with 1 occurring in the IBMC group, compared with 3 in the PMMC group. Complications such as cardiac tamponade and mitral regurgitation (requiring or not requiring mitral valve replacement) were similar in both groups, with 3 complications in the IBMC group, compared with 4 complications in the PMMC group (P = .29). After a follow-up period of approximately 4 months, both groups had similar event rates and comparable hemodynamic parameters (P = not significant). Conclusions Both IBMC and PMMC are successful means of providing relief from severe mitral stenosis with a gain in valve area and reduction in transmitral gradient. Both techniques have similar procedural success, complication rates, and follow-up events. (Am Heart J 2002;144:1074-80.)     

Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices

BACKGROUND: Vascular access site management is crucial to safe, efficient and comfortable diagnostic or interventional transfemoral percutaneous coronary procedures. Two new femoral access site closure devices, Perclose and Angio-Seal , have been proposed as alternative methods to manual compression (MC). We compared these two devices and tested them in reference to standard MC for safety, effectiveness and patient preference. METHODS: Prospective demographic, peri-procedural, and late follow-up data for 1,500 patients undergoing percutaneous coronary procedures were collected from patients receiving femoral artery closure by MC (n = 469), Perclose (n = 492), or Angio-Seal (n = 539). Peri-procedural, post-procedural, and post-hospitalization endpoints were: 1) safety of closure method; 2) efficacy of closure method; and 3) patient satisfaction. RESULTS: Patients treated with Angio-Seal experienced shorter times to hemostasis (p < 0.0001, diagnostic and interventional) and ambulation (diagnostic, p = 0.05; interventional, p < 0.0001) than those treated with Perclose. Those treated with Perclose experienced greater access site complications (Perclose vs. Angio-Seal, p = 0.008; Perclose vs. MC, p = 0.06). Patients treated with Angio-Seal reported greater overall satisfaction, better wound healing and lower discomfort (each vs. Perclose or vs. MC, all p < or = 0.0001). For diagnostic cath only, median post-procedural length of stay was reduced by Angio-Seal (Angio-Seal vs. MC, p < 0.0001; Angio-Seal vs. Perclose, p = 0.009). No difference was seen in length of stay for interventional cases. CONCLUSIONS: Overall, Angio-Seal performed better than Perclose or MC in reducing time to ambulation and length of stay among patients undergoing diagnostic procedures. There was a higher rate of successful deployment and shorter time to hemostasis for Angio-Seal, and this was accomplished with no increase in bleeding complications throughout the follow-up. Additionally, Angio-Seal performed better than Perclose in exhibiting a superior 30-day patient satisfaction and patient assessment of wound healing with less discomfort.     

Comparison of Angioseal and Manual Compression in Patients Undergoing Transfemoral Coronary and Peripheral Vascular Interventional Procedures

Vascular closure devices (VCDs) were introduced in the early 1990s with the goal of limiting the time, labor, bed rest, and patient discomfort associated with manual compression (MC) for hemostasis after cardiovascular interventions. However, its advantage over MC has not been extensively studied after interventional procedures. The aim of this study was to do prospective, randomized study comparing the safety and efficacy of the Angio-Seal (AS) to that of MC in patients undergoing transfemoral coronary and peripheral vascular interventional procedure.A prospective, randomized trial was undertaken on consecutive series of patients admitted to King Fahd Hospital of the University for transfemoral coronary and peripheral vascular interventional procedures over 1 year. The study was designed to compare the hemostasis time in minutes and the incidence of vascular complications in patients receiving AS with those undergoing MC. All patients were on antiplatelets and received heparin during the procedure.During the study period, 160 patients were included, 80 in each group. There was a significant difference in mean time to hemostasis in minutes (15.83 ± 1.63 minutes for MC and 0.42 ± 0.04 minutes for the AS; p < 0.001), time to ambulation in minutes (280 ± 15 for MC and 120 for AS; p = 0.04) and in minor complications (33.8% in MC vs. AS 5%; p < 0.001). However, the major complication rate did not significantly differ between the two groups (0% in AS vs. 2.5% in MC; p = 0.15).AS was found to achieve rapid closure of the femoral access site safely in patients undergoing coronary and peripheral vascular interventional procedures under antiplatelets and systemic heparinization.     

Validity of the reduced-sample insulin modified frequently-sampled intravenous glucose tolerance test using the nonlinear regression approach

The disposition index, the product of the insulin sensitivity index (S_I) and the acute insulin response to glucose, is linked in African Americans to chromosome 11q. This link was determined with S_I calculated with the nonlinear regression approach to the minimal model and data from the reduced-sample insulin-modified frequently-sampled intravenous glucose tolerance test (Reduced-Sample-IM-FSIGT). However, the application of the nonlinear regression approach to calculate S_I using data from the Reduced-Sample-IM-FSIGT has been challenged as being not only inaccurate but also having a high failure rate in insulin-resistant subjects. Our goal was to determine the accuracy and failure rate of the Reduced-Sample-IM-FSIGT using the nonlinear regression approach to the minimal model. With S_I from the Full-Sample-IM-FSIGT considered the standard and using the nonlinear regression approach to the minimal model, we compared the agreement between S_I from the Full- and Reduced-Sample-IM-FSIGT protocols. One hundred African Americans (body mass index, 31.3 ± 7.6 kg/m² [mean ± SD]; range, 19.0-56.9 kg/m²) had FSIGTs. Glucose (0.3 g/kg) was given at baseline. Insulin was infused from 20 to 25 minutes (total insulin dose, 0.02 U/kg). For the Full-Sample-IM-FSIGT, S_I was calculated based on the glucose and insulin samples taken at −1, 1, 2, 3, 4, 5, 6, 7, 8,10, 12, 14, 16, 19, 22, 23, 24, 25, 27, 30, 40, 50, 60, 70, 80, 90, 100, 120, 150, and 180 minutes. For the Reduced-Sample-FSIGT, S_I was calculated based on the time points that appear in bold. Agreement was determined by Spearman correlation, concordance, and the Bland-Altman method. In addition, for both protocols, the population was divided into tertiles of S_I. Insulin resistance was defined by the lowest tertile of S_I from the Full-Sample-IM-FSIGT. The distribution of subjects across tertiles was compared by rank order and κ statistic. We found that the rate of failure of resolution of S_I by the Reduced-Sample-IM-FSIGT was 3% (3/100). For the remaining 97 subjects, S_I for the Full- and Reduced-Sample-IM-FSIGTs were as follows: 3.76 ± 2.41 L mU⁻¹ min⁻¹ (range, 0.58-14.50) and 4.29 ± 2.89 L mU⁻¹ min⁻¹ (range, 0.52-14.42); relative error, 21% ± 18%; Spearman r = 0.97; and concordance, 0.94 (both P < .001). After log transformation, the Bland-Altman limits of agreement were −0.29 and 0.53. The exact agreement for distribution of the population in the insulin-resistant tertile vs the insulin-sensitive tertiles was 92%, κ of 0.82 ± 0.06. Using the nonlinear regression approach and data from the Reduced-Sample-IM-FSIGT in subjects with a wide range of insulin sensitivity, failure to resolve S_I occurred in only 3% of subjects. The agreement and maintenance of rank order of S_I between protocols support the use of the nonlinear regression approach to the minimal model and the Reduced-Sample-IM-FSIGT in clinical studies.     

Perceptions of chest pain differ by race

Background African American patients are less likely to receive thrombolytic therapy and coronary revascularization than are white patients. Delay and clinical presentation may be keys to understanding differences in care. Objective To determine how symptom recognition and perception influence clinical presentation as a function of race, we characterized symptoms and care-seeking behavior in African American and white patients seen in the ED with chest pain. Methods The prospective study was conducted from April 1999 to September 1999 among patients who were seen in the ED and were admitted or observed in the ED Chest Pain Unit (n = 215). Interviews were conducted within 48 hours with a structured set of questions. Results Thirty-one percent of white patients and 8.9% of African American patients were admitted with a diagnosis of acute myocardial infarction (P = .001). African American patients were as likely as white patients to report “typical” objective symptoms but were more likely to attribute their symptoms to a gastrointestinal source rather than a cardiac source (P = .05). Of those patients with the final diagnosis of myocardial infarction (n = 45), 61% of African American patients attributed symptoms to a gastrointestinal source and 11% to a cardiac source, versus 26% and 33%, respectively, for white patients. The median prehospital delay for African American patients was 263 minutes (interquartile range, 120 to 756 minutes), similar to the 247 minutes for white patients (interquartile range, 101 to 825 minutes, P = .72), despite African American patients (80%) being more likely than white patients (66%) to perceive their symptoms as severe/life-threatening at onset (P = .05). Conclusion Racial differences in symptom perception exist. Although the proportion of objectively defined typical symptoms were similar, self-attribution was more often noncardiac in African American patients than in white patients. Self-attribution, in addition to objective clinical findings, is likely to influence caregiver diagnostic approaches and therefore therapeutic approaches, and merits further study. (Am Heart J 2002;144:51-9.)     

Predicting outcome after thrombolysis in acute myocardial infarction according to ST-segment resolution at 90 minutes: a substudy of the GUSTO-III trial. Global Use of Strategies To Open occluded coronary arteries

Background Resolution of ST-segment elevation after thrombolysis for acute myocardial infarction has been shown to have prognostic significance 3 hours (180 minutes) after the initiation of therapy. Whether prognostically useful information can be achieved as early as 90 minutes after thrombolysis is unknown. Methods An electrocardiographic substudy of 2352 patients from the Global Use of Strategies To Open occluded coronary arteries (GUSTO-III) trial was undertaken to compare outcomes according to ST-segment resolution at 90 minutes versus 180 minutes after administration of thrombolytic therapy. Results Of 2352 patients in the substudy, 2241 had a baseline and 90-minute electrocardiogram, and 2218 had a baseline and 180-minute ECG. Complete ST-segment resolution occurred in 44.2% of patients at 90 minutes and 56.5% of patients at 180 minutes. ST-segment resolution at both 90 and 180 minutes was associated with lower 30-day and 1-year mortality. Multivariate analysis revealed ST-segment resolution at 90 minutes to be an equally strong predictor of 30-day mortality as resolution at 180 minutes. Patients who were at particularly high risk for mortality were those aged >70 years, those who presented with Killip class >1, and those with anterior infarctions. Conclusions The presence of ST-segment resolution on standard 12-lead electrocardiographic monitoring 90 minutes after thrombolysis is a useful independent predictor of mortality at 30 days and 1 year. The potential for obtaining prognostic results as early as 90 minutes after thrombolysis sets a new precedent for optimum electrocardiographic monitoring times in these patients. (Am Heart J 2002;144:81-8.)     

Effectiveness of hemostasis with Foley catheter after vacuum-assisted breast biopsy

Background

Interventional bleeding and post-interventional hematoma are the most common complications following vacuum-assisted breast biopsy (VABB). The aim of the current study was to evaluate the effectiveness of Foley catheter-induced hemostasis in VABB.

Methods

A randomized prospective controlled trial was conducted using a total of 437 consecutive 8-gauge ultrasound-guided VABB procedures that were performed in 282 patients from June 2012 to October 2013. In each procedure, hemostasis was induced with either a Foley catheter or with external compression. Bleeding during intervention, hematoma post-intervention and the time of procedure were recorded. Statistical analysis included a Chi-Square test and an independent-samples t-test, and P value <0.05 was considered to be significant.

Results

Significantly less bleeding and post-interventional hematoma resulted when hemostasis was induced using a Foley catheter vs. compression (7.6% vs. 17.4%, P=0.002; 8.9% vs. 27.9%, P<0.001). The mean time of breast biopsy was significantly less when using a Foley catheter vs. compression (33.6 vs. 45.5 min, P<0.001). No post-procedural infectious was encountered. In stratification analysis, there were no significantly different bleeding rates between the Foley catheter and compression methods in cases of single lesions (6.7% vs. 14.1%, P=0.346). In cases of multiple lesions, the Foley catheter method produced less bleeding/hematoma than compression (10.4% vs. 47.4%, P=0.018; 16.7% vs. 52.6%, P=0.020). Whether using a Foley catheter or compression to induce hemostasis, no significant difference was found in the rate of bleeding or hematoma when lesions <15 mm were removed (3.8% vs. 6.1%, P=0.531; 6.1% vs. 11.4%, P=0.340). When lesions ≥15 mm were excised, the rates of interventional bleeding and post-interventional hematoma were significantly lower in the Foley catheter study group than the compression control group (12.5% vs. 32.2%, P=0.034; 12.5% vs. 49.4%, P<0.001). There was significantly less bleeding (P=0.004) and hematoma (P<0.001) in the upper external quadrant when using a Foley catheter compared with compression (4.5% vs. 15.7%, P=0.004; 9.8% vs. 40.2%, P<0.001), but no significant differences for other quadrants.

Conclusions

Inducing hemostasis with a Foley catheter after VABB is a very effective and safe alternative to hemostasis with compression.     

Impact of counterbalance between macrophage migration inhibitory factor and its inhibitor Gremlin-1 in patients with coronary artery disease

Objective: Monocyte infiltration is a critical step in the pathophysiology of plaque instability in coronary artery disease (CAD). Macrophage migration inhibitory factor (MIF) is involved in atherosclerotic plaque progression and instability leading to intracoronary thrombosis. Gremlin-1 (Grem1) has been recently identified as endogenous inhibitor of MIF. To date there are no data on the clinical impact of this interaction in cardiovascular patients. Methods and results: Plasma levels of MIF and Grem1 were determined by enzyme-linked immunoassay in patients with acute coronary syndromes (ACS, n = 120; stable CAD, n = 166 and healthy control subjects, n = 25). MIF levels were significantly increased in ACS compared to stable CAD and healthy control (ACS: median 2.85; IQR 3.52 ng/ml; versus SAP: median 1.22; IQR 2.99 ng/ml; versus healthy control: median 0.10; IQR 0.09 ng/ml, p < 0.001). Grem1 levels were significantly higher in ACS and stable CAD patients compared to healthy control (ACS: median 211.00; IQR 130.47 ng/ml; SAP: median 220.20; IQR 120.93 ng/ml, versus healthy control: median 90.57; IQR 97.68 ng/ml, p < 0.001). Grem1/MIF ratio was independently associated with ACS, whereas the single parameters were not associated with the presence of ACS. Furthermore, Grem1/MIF ratio was associated with angiographic signs of intracoronary thrombi and severity of thrombus burden. Conclusion: These novel findings suggest a potential role of Grem1/MIF ratio to indicate acuity of CAD and the grade of plaque stability. Prospective angiographic cohort studies involving plaque imaging techniques are warranted to further characterize the prognostic role of this novel risk marker in CAD patients.     

An updated meta-analysis of calcium-channel blockers in the prevention of restenosis after coronary angioplasty

Background In 1994, a meta-analysis of 5 small randomized trials reported a 30% reduction in the odds of angiographic restenosis when calcium-channel blockers (CCB) were given after percutaneous coronary intervention. Recently, the results of 2 large similar trials (Nisoldipine In Coronary Artery Disease in Leuven [NICOLE], and Coronary AngioPlasty Amlodipine in REstenosis Study [CAPARES]) were published. An extended meta-analysis including the results of the latter trials was performed. Methods A total of 2380 patients were analyzed. Statistical analysis included calculation of odds ratios for each trial, common odds ratio, and homogeneity for treatment effects across trials. Results The incidence of angiographic restenosis was 36% in the CCB-treated group and 42% in the placebo group. The odds ratio of restenosis with CCB therapy was 0.78 (95% CI 0.64-0.95) compared with control patients (P = .01). Treatment effects were homogeneous across the trials. For the combined end point of death, coronary artery bypass grafting, repeat percutaneous transluminal coronary angioplasty, and myocardial infarction, 126 of 626 events occurred in the CCB group and 191 of 655 in the placebo group (odds ratio 0.61 [95% CI 0.47-0.80], P < .001). Conclusions This extended meta-analysis confirmed a reduction in the odds of restenosis and clinical events when CCBs were added to standard therapy after percutaneous coronary intervention. (Am Heart J 2003; 145:404-8.)     

A randomized trial assessing the effect of coumarins started before coronary angioplasty on restenosis: results of the 6-month angiographic substudy of the Balloon Angioplasty and Anticoagulation Study (BAAS)

Background Thrombus formation during coronary angioplasty may play a role in the restenosis process.Methods The effect of pretreatment with coumarins on 6-month angiographic outcome was studied. In addition, the effect of “optimal” anticoagulation, defined as an international normalized ratio >70% of the follow-up time in the target range, was studied. A total of 261 patients were assigned to aspirin alone (ASA group) and 270 patients to aspirin plus coumarins started 1 week before the procedure (coumarin group).Results The mean international normalized ratio was 2.7 ± 1.2 at the start of the procedure and 3.1 ± 0.5 during follow up. Quantitative coronary analysis was performed on 301 lesions in the ASA group and of 297 lesions in the coumarin group. At 6 months, the minimal luminal diameter was similar in the ASA and coumarin groups. Optimal anticoagulation, however, was an independent predictor of a larger minimal luminal diameter at follow up (P = .01).Conclusion Overall, coumarins do not improve angiographic outcome 6 months after coronary angioplasty. (Am Heart J 2003;145:58-65.)