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Objective: This feasibility study examined safety and effectiveness of the new EXOSEAL™ Vascular Closure Device (VCD) designed to promote hemostasis and early ambulation after percutaneous procedures. Background: Most VCDs currently approved by the United States FDA have been associated with significantly shorter time-to-hemostasis (TTH) and time-to-ambulation (TTA) compared to standard manual or mechanical compression, but their ease of use, patient comfort during deployment, and safety profiles are variable. Methods: Patients underwent diagnostic or interventional procedures using 7F introducer sheaths. Primary safety endpoint was the 30-day combined rate of access-related complications and primary effectiveness endpoints were TTH and TTA. Results: Sixty patients were enrolled prospectively (mean age 63.3 ± 11.3 year, 17% diabetics). Device and procedural success was achieved in 92% and 93%, respectively. Mean TTH and TTA was 3.2 ± 3.0 minutes and 3.0 ± 6.2 hours, respectively. No deaths or serious access-related adverse events occurred. A ≥6 cm access-site hematoma was the only adverse event, observed in 3 patients. Conclusions: Use of the 7F EXOSEAL™ VCD was associated with short TTH and TTA, as well as low rates of procedural and 30-day access-related complications. [ABSTRACT FROM AUTHOR]

Objective: This feasibility study examined safety and effectiveness of the new EXOSEAL™ Vascular Closure Device (VCD) designed to promote hemostasis and early ambulation after percutaneous procedures. Background: Most VCDs currently approved by the United States FDA have been associated with significantly shorter time-to-hemostasis (TTH) and time-to-ambulation (TTA) compared to standard manual or mechanical compression, but their ease of use, patient comfort during deployment, and safety profiles are variable. Methods: Patients underwent diagnostic or interventional procedures using 7F introducer sheaths. Primary safety endpoint was the 30-day combined rate of access-related complications and primary effectiveness endpoints were TTH and TTA. Results: Sixty patients were enrolled prospectively (mean age 63.3 ± 11.3 year, 17% diabetics). Device and procedural success was achieved in 92% and 93%, respectively. Mean TTH and TTA was 3.2 ± 3.0 minutes and 3.0 ± 6.2 hours, respectively. No deaths or serious access-related adverse events occurred. A ≥6 cm access-site hematoma was the only adverse event, observed in 3 patients. Conclusions: Use of the 7F EXOSEAL™ VCD was associated with short TTH and TTA, as well as low rates of procedural and 30-day access-related complications. (J Interven Cardiol 2012;25:518-525) [ABSTRACT FROM AUTHOR]

The purpose of the present study was to investigate systemic and local levels of platelet-activating factor (PAF), a potent proinflammatory mediator implicated in cardiovascular pathophysiology in adult nonsmoking patients with periodontitis with or without coronary heart disease (CHD). Eighty-seven volunteers, 25 periodontitis patients, 19 periodontitis with CHD patients, 19 CHD patients, and 24 healthy controls were included, and periodontal conditions were assessed. Gingival crevicular fluid (GCF) and venous blood were collected, and PAF levels were measured by enzyme-linked immunosorbent assay. PAF levels in serum (303.3 ± 204 pg/ml) and in GCF (26.3 ± 6 pg/μl) of the periodontitis group with CHD, the periodontitis group (serum, 302.4 ± 241 pg/ml and GCF, 26.3 ± 8 pg/μl) and the CHD group (serum, 284.7 ± 192 pg/ml and GCF, 20.8 ± 6 pg/μl) were significantly higher than the healthy control group (serum, 65.4 ± 35 pg/ml and GCF, 7.7 ± 3 pg/μl; p < 0.05). In summary, the present study could demonstrate that in patients with periodontitis, the inflammatory mediator PAF is released into serum at least in the same range as for patients with coronary heart disease. However, no additive effects were seen when both conditions were present. [ABSTRACT FROM AUTHOR]

Bacterial DNA has been found in coronary plaques and it has therefore been concluded that bacteria may play a role as trigger factors in the chronic inflammatory process underlying coronary atherosclerosis. However, the microbial spectrum is complex and it is not known whether microorganisms other than bacteria are involved in coronary disease. Fungal 18S rDNA signatures were systematically investigated in atherosclerotic tissue obtained through catheter-based atherectomy of 38 patients and controls (unaffected coronary arteries) using clone libraries, denaturating gradient gel analysis (DGGE), in situ hybridization and fluorescence in situ hybridization (FISH). Fungal DNA was found in 35 of 38 (92.11%) coronary heart disease patients by either polymerase chain reaction (PCR) with universal primers or in situ hybridization analysis ( n = 5), but not in any control sample. In a clone library with more than 350 sequenced clones from pooled patient DNA, an overall richness of 19 different fungal phylotypes could be observed. Fungal profiles of coronary heart disease patients obtained by DGGE analysis showed a median richness of fungal species of 5 (range from 2 to 9) with a high interindividual variability (mean similarity 18.83%). For the first time, the presence of fungal components in atherosclerotic plaques has been demonstrated. Coronary atheromatous plaques harbour diverse and variable fungal communities suggesting a polymicrobial contribution to the chronic inflammatory aetiology. [ABSTRACT FROM AUTHOR]

Interventions in aorto-coronary venous bypass grafts (CABG) can cause acute procedural complications due to distal embolization of debris. In the FIRST ( First European Investigation Regarding the Systematic use of the TriActiv device) multicenter trial the distal endovascular protection system TriActiv (Kensey Nash) was evaluated during intervention of CABG. 195 patients in 17 centers in Germany with significant disease of a vein graft were enrolled. Inclusion and exclusion criteria were comparable to the SAFER trial. Acute procedural success was achieved in 98% of cases. Aspirated debris was found in 96.5% of patients. Primary endpoints (MACE at 30 days) occurred in 8.7% of all pts. (ITT). No patient died and 7.2% of patients suffered from MI. The rate of early revascularization was 1.5%. Secondary endpoints (MACCE at 30 days) were found in 9.2% and at hospital discharge in 8.7% of patients. The TriActiv system is safe and effective. Normal post procedural flow can be preserved and the MACE rate is with 8.7% considerably low. The FIRST trial supports the growing belief that PCI of CABG should be performed with protection systems. [ABSTRACT FROM AUTHOR]

The concept of initiating fibrinolytic therapy in patients who cannot undergo immediate percutaneous coronary intervention (PCI) in the setting of acute ST-segmentelevation myocardial infarction (STEMI) has been proposed as a strategy to improve outcomes. However, evidence supporting the use of this strategy is not conclusive, and the results of recent randomized controlled trials are apparently contradictory. Probably, the time points of administration of the adjunctive thrombolytics and antiplatelet agents and the time loss until coronary intervention have a major influence on the discrepancy of outcomes in different trials. Therefore, the relationship between therapeutic time intervals and outcome in patients treated with facilitated PCI has been analyzed. In this single center retrospective study, 131 patients with STEMI were treated with a combined pharmaco-mechanical reperfusion strategy using half-dose r-tPA combined with a glycoprotein (GP) IIb/IIIa antagonist prior to PCI. Specific time points were recorded for each patient, including the time of symptom onset, the time of first medical contact, the start of intravenous thrombolysis, the time of administration of the GP IIb/IIIa antagonist and the start of coronary intervention. We then examined the relationship between the time delay from symptom onset to the initiation of various steps of treatment and the residual myocardial damage as expressed by the severity of both global and regional myocardial dysfunction calculated from a left ventriculography study performed 3 months later. The median time from symptom onset to the first medical contact, with 25th and 75th percentiles in parentheses, was 1.25 h (0.75, 3), from symptom onset to initiation of thrombolytic therapy 2.25 h (1.25, 3), to initiation of GP IIb/ IIIa inhibitor therapy 3.5 h (2, 5.69), and to the start of coronary intervention 4.81 h (2.85, 7.91). The time between symptom onset and initiation of both thrombolytic therapy and coronary intervention was significantly related to the global ejection fraction and to the extent of regional hypokinesia at the 3-month follow-up (p<0.05). The time to the initiation of GP IIb/IIIa inhibitors was only significantly related to the global ejection fraction (p<0.05), while the time to the first medical contact did not show a similar relationship (p>0.05). Furthermore, we observed a significant relationship between the infarct-related artery (IRA) patency at the initial angiogram and the residual regional myocardial damage at follow-up; normokinesia at follow- up was found in 61.3% of patients with an initially patent IRA and in 41.2% of patients with an initially occluded IRA, whereas severe hypokinesia was found in 13.8% and 37.3%, respectively (p<0.05). In patients with STEMI treated with a facili tated PCI strategy using half dose r-tPA in combination with a glycoprotein IIb/IIIa receptor blocker, the 3-month global and regional residual myocardial dysfunction is significantly related to the time elapsed between the onset of symptoms and the start of both fibrinolytic therapy and coronary intervention. [ABSTRACT FROM AUTHOR]

Secretory immunoglobulin A (sIgA) is the most important Ig on mucosal surfaces. In bronchoalveolar lavage (BAL) fluid, sIgA is mainly produced by bronchus-associated lymphoid tissue (BALT). The presence of pre-formed antibodies against donor tissue in kidney transplantation is associated with hyperacute rejection, indicating a humoral (antibody-mediated) reaction. In heart and liver transplantation, humoral rejection has also been documented. The goal of this study was to evaluate the role of IgA in patients after lung transplantation. An enzyme-linked immunosorbent assay was established to determine the levels of sIgA, IgA, and total protein in the lavage. IgA and sIgA were both detectable in BAL from transplanted lungs. IgA and sIgA levels were both higher during episodes of infection than during episodes of rejection or during the control episodes. The level of IgA during episodes of rejection equaled the level of IgA during the control episodes. The level of sIgA was significantly decreased during episodes of acute rejection (1.8±1.0 μg/mL) when compared with the control (7.2±1.0 μg/mL; p=0.013). This study demonstrates that BALT retains the ability to produce Ig even after lung transplantation. The levels of IgA and sIgA and their ratio do not contribute to the differentiation between rejection and infection in lung-transplanted patients. [ABSTRACT FROM AUTHOR]

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Remarkable symptoms of angina pectoris during exercise in a young girl were first treated with diltiazem 60 mg t.i.d. The history of the patient showed an operation on coarctatcio aortae 11 months after birth. Seven years later, she underwent a second operation for a re‐implantation of the left main track (LMT) into the aortic root in the presence of Bland‐White‐Garland‐Syndrome. In order to elucidate morphological aspects a heart catheterization was performed because of persistent and increasing symptoms. Figure 1 illustrates an unusual high re‐implantation site of the LMT and in accordance with this; a LMT‐bending of nearly 90° could be demonstrated. Intravascular ultrasound (IVUS) clearly visualized an additional compression of the LMT during every heart cycle at the bended site (Figures 2 and 3). After implantation of a paclitaxel eluting stent (DES; 3.0/8 mm), a normal angiographic aspect occurred (Figure 4). Three months later the patient was free of symptoms at rest and under stress echo conditions. A six months angiographic follow‐up confirmed a perfect long‐term result (Figure 5).We suggest that the longitudinal growing of our patient was the main reason for the development of the bending at the origin of LMT. Those patients with symptoms of angina pectoris and with re‐implanted coronary arteries should undergo angiographic evaluation along with IVUS. In the era of DES, a satisfying option for treatment is available with very promising long‐term results. [ABSTRACT FROM AUTHOR]