Treatment of drug-eluting stents in-stent restenosis with paclitaxel-coated balloon angioplasty: Insights from the French "real-world" prospective GARO Registry.

BACKGROUND: Data about paclitaxel-eluting balloon (PCB) angioplasty to treat drug-eluting stents (DES) in-stent restenosis (ISR) were mainly collected in selected patient populations in the setting of randomized trials. The main goal of this prospective registry was to confirm the positive findings of these studies in an unselected population in clinical practice. METHODS: Consecutive patients with DES-ISR treated by PCB angioplasty were recruited in this prospective real-world registry. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9 months. Secondary endpoints included acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) a composite of death, myocardial infarction (MI) and TLR and the occurrence of target vessel revascularization. RESULTS: A total of 206 patients (67.7 ± 10.2 years, 80.6% male, 41.3% diabetics) with 210 lesions were recruited. Unstable coronary artery disease was present in 55.3% of patients. The time from DES implantation to DES-ISR was 3.0 ± 2.4 years. Quantitative analyses revealed that patterns of treated DES-ISR were focal in 55.7% and diffuse in 44.3%. The reference diameter was 2.76 ± 0.64 mm. The 9-month follow-up rate was 90.8% (187/206). At 9 months, the TLR rate was 7.0% (13/187) whereas the rates for MACE, MI and cardiac death were 10.7% (20/187), 4.8% (9/187) and 2.1% (4/187) respectively. Results were consistent in patients with paclitaxel and non-paclitaxel-eluting stents (PES) ISR. CONCLUSION: This large prospective registry demonstrated acceptable rates of TLR and MACE at 9 months after treatment of DES-ISR by PCB angioplasty. PCB angioplasty was equally effective in patients with PES-ISR and non PES-ISR.

Stepwise implementation of a new diagnostic algorithm for multidrug-resistant tuberculosis in Haiti.

SETTING: The uptake of tests endorsed by the World Health Organization to detect and appropriately confirm multidrug-resistant tuberculosis (MDR-TB) in low-income countries remains insufficient. OBJECTIVE: To validate the implementation of line-probe assays (LPA) and liquid culture to develop an algorithm to detect MDR-TB in the challenging setting of Haiti. METHODS: Through an EXPAND-TB (Expanding Access to New Diagnostics for TB) partnership, proficiency testing and validation of 221 acid-fast bacilli positive specimens were performed. Sensitivity, cost and processing time were analysed. RESULTS: Using liquid vs. solid culture shortened the turnaround time from 54 to 19 days, with a sensitivity of 100% vs. 98.6% and a total cost reduction of 13%. LPA detected all TB and MDR-TB cases at a lower cost than culture, in a mean time of 7.5 days. CONCLUSION: The combined use of molecular and liquid culture techniques accelerates the accurate diagnosis of TB and susceptibility testing against first-line drugs in a significantly shorter time, and is less expensive. The implementation of this new algorithm could significantly and accurately improve the screening and treatment follow-up of patients affected with TB and MDR-TB.

Bleach treatment of sputum samples aids pulmonary tuberculosis screening among HIV-infected patients in Laos.

BACKGROUND: Laos has a high prevalence of tuberculosis (TB) and a slowly increasing prevalence of human immunodeficiency virus/acquired immunedeficiency syndrome (HIV/AIDS). Sputum smear microscopy is the only method currently available for routine screening of pulmonary TB, although it only detects one in three cases among persons living with HIV (PLWH). Bleach treatment of sputum samples (bleach method) has been shown to significantly improve the sensitivity of the test; however, its effectiveness in PLWH remains to be determined in Laos. OBJECTIVES: To determine the performance of the bleach method as a diagnostic tool for pulmonary TB in PLWH and to assess its cost-effectiveness in Laos. RESULTS: Of 174 sputum samples collected from 92 patients, 29 were culture-positive for Mycobacterium tuberculosis in 17 patients. The sensitivity of the direct method and the bleach method was respectively 59% and 93%, and specificity was 100% for both methods. The incremental cost-effectiveness ratio for screening an additional case was US$17.40. CONCLUSION: The bleach method is simple, cheap, easy to perform and cost-effective in PLWH. Its implementation in laboratories involved in routine screening of pulmonary TB among PLWH would allow practitioners to start the treatment of this life-threatening co-infection earlier.

Complex coronary bifurcation lesions treated with the novelpolymer-free dedicated bifurcation paclitaxel-eluting stent (Nilepax): clinical and angiographic clinical results of theprospective, multicentre bipax clinical trial

Aims: We report the angiographic and clinical outcomes of patients with de novocoronary bifurcation lesions treated with the Nile PAX dedicated device.Methods and results: From Dec/08 to Mar/09, a total of 102 pts with singlebifurcation lesion were prospectively enrolled in this non-randomised, multicenter(10 sites in Europe/South America) study. Lesion criteria were vessel size 2.5-3.5mm in the parent vessel (PV) and 2.0-3.0 mm in the SB, and lesion length <14 mmin the PV. Clinical follow-up (FU) was scheduled at 1, 3, 6, 9 and 12 months, andyearly up to 5 years. Angiographic FU was scheduled at 9 months (primaryendpoint). Angiographic analysis was performed by an independent angiographiccore laboratory. Data analysis and management was performed by an independentdata coordinating center; also, all clinical events were independently adjudicatedby a clinical events committee. Mean age was 63 years, 29% had diabetes, 16previous MI, and 40% previous intervention. The LAD/Dg was the most prevalentlocation (75%), and 60% had significant involvement of both branches. In theprocedure, PV was predilated in 97%; the study stent was successfully attemptedand implanted in 99%. Overall, 25% of SB received an additional stent; and 94%of lesions had final kissing-balloon inflation. By quantitative coronary angiography,baseline mean lesion length, vessel diameter and% diameter stenosis were: 10.9mm, 2.99 mm and 72% in the PV, and 4.1 mm, 2.28 mm, and 38% in the SB, respectively. Angiographic success (residual stenosis <50%, final TIMI 3 flow, andabsence of dissection) was achieved in 98%. There was only 1 major adversecardiac event (MACE) during hospitalisation, which was adjudicated as a non-Qmyocardial infarction during hospitalisation, and no additional adverse events werereported up to 30 days...

[Why I don't give up the femoral approach!]. / Pourquoi je n'abandonne pas la voie fémorale!

Since its introduction in 1989, the safety of transradial approach compared to the femoral approach is mainly due to reducing entry site complications, allowing early ambulation, but at the price of a higher rate of procedural failure, arterial occlusion and radiation for operators and patients. Nevertheless, these advantages can be minimized with a modern femoral approach requiring a 4-French catheter for diagnostic angiography and a low dose heparin, new antithrombotic drugs and a reasonable use of glycoprotein (GB)IIb-IIIa for angioplasty. The radial approach is the best way to go in hemorrhagic high-risk patients and the femoral approach is safer in complex procedures. The operator has to hold the two accesses and to know when to switch to another approach to minimize complications, procedure time, radiation and contrast use.

[The best of interventional cardiology in 2006]. / L'essentiel de l'année 2006 en cardiologie interventionnelle.

The year 2006 was a landmark in interventional cardiology. Confirmations of results of large-scale trials and meta analyses, the commercialisation of new drug-elution stents, discussions about well established methods, questions about long-term outcomes of dilated patients, have made 2006 a particularly rich year in controversy, especially during its last three months.

[The best of interventional cardiology in 2005]. / L'essentiel de l'année 2005 en cardiologie interventionnelle.

During 2005, the evolution of interventional cardiology has largely been dominated by the trial of active endoprostheses, whose advantage has been consistently shown by various studies, mete-analyses and surveys. Extending their use to new indications and evaluating new drugs have also been studied. In parallel, clinical trials have been performed in the promising field of percutaneous treatment of valvular heart disease, particularly mitral insufficiency and calcified aortic stenosis in the adult.

Characterization of low- and very-low-density hepatitis C virus RNA-containing particles.

The presence of hepatitis C virus (HCV) RNA-containing particles in the low-density fractions of plasma has been associated with high infectivity. However, the nature of circulating HCV particles and their association with immunoglobulins or lipoproteins as well as the characterization of cell entry have all been subject to conflicting reports. For a better analysis of HCV RNA-containing particles, we quantified HCV RNA in the low-density fractions of plasma corresponding to the very-low-density lipoprotein (VLDL), intermediate-density lipoprotein, and low-density lipoprotein (LDL) fractions from untreated chronically HCV-infected patients. HCV RNA was always found in at least one of these fractions and represented 8 to 95% of the total plasma HCV RNA. Surprisingly, immunoglobulins G and M were also found in the low-density fractions and could be used to purify the HCV RNA-containing particles (lipo-viro-particles [LVP]). Purified LVP were rich in triglycerides; contained at least apolipoprotein B, HCV RNA, and core protein; and appeared as large spherical particles with a diameter of more than 100 nm and with internal structures. Delipidation of these particles resulted in capsid-like structures recognized by anti-HCV core protein antibody. Purified LVP efficiently bind and enter hepatocyte cell lines, while serum or whole-density fractions do not. Binding of these particles was competed out by VLDL and LDL from noninfected donors and was blocked by anti-apolipoprotein B and E antibodies, whereas upregulation of the LDL receptor increased their internalization. These results suggest that the infectivity of LVP is mediated by endogenous proteins rather than by viral components providing a mechanism of escape from the humoral immune response.

Randomised comparison of coronary stenting with and without balloon predilatation in selected patients.

BACKGROUND: The SWIBAP (stent without balloon predilatation) prospective randomised trial was designed to compare direct coronary stenting with stenting preceded by lesion predilatation with an angioplasty balloon. OBJECTIVE: To determine the feasibility and safety of direct stenting in non-complex coronary lesions in a prospective study. PATIENTS AND DESIGN: All patients < 76 years of age scheduled to undergo angioplasty of a non-complex, non-calcified lesion in a coronary artery of > 3.0 mm, who granted their informed consent, were randomised into the trial. In group I, the stent was placed without balloon predilatation, while in group II stent implantation was preceded by balloon predilatation. The primary end point was the angiographic result according to procedure assigned by randomisation. An intravascular ultrasound substudy was performed in 60 patients. RESULTS: Stent implantation was successful without predilatation in 192 of the 197 group I patients (97.5%), and with predilatation in 197 of the 199 group II patients (99%) (NS). No in-hospital stent thrombosis or death occurred. Overall procedural times, fluoroscopy times, and volumes of contrast agent given (mean (SD)) in group I v group II were 23.50 (13.54) min v 27.96 (15.23) min (p = 0.002), 6.04 (4.13) min v 6.67 (3.65) min (NS), and 135 (65) ml v 157 (62) ml (p < 0.001), respectively. No major adverse cardiovascular events had occurred by 30 days. CONCLUSIONS: The feasibility and safety of direct stenting of selected and non-complex coronary lesions is confirmed. This technique was as successful as the conventional approach and was associated with a minor reduction in fluoroscopic exposure and procedure time and the administration of less contrast agent.

Non-ophthalmologist screening for retinopathy of prematurity.

AIM: To determine if a non-ophthalmologist can accurately screen for retinopathy of prematurity (ROP) by evaluating the posterior pole blood vessels of the retina. ROP is a common ocular disorder of premature infants and may require multiple screening examinations by an ophthalmologist to allow for timely intervention. Since there is a strong correlation between posterior pole vascular abnormalities and vision threatening ROP, screening examinations performed by non-ophthalmologist may yield useful clinical information in high risk infants. METHODS: Infants born at the Medical University of South Carolina who met screening criteria (n = 142) were examined by a single non-ophthalmologist using a direct ophthalmoscope to evaluate the posterior pole blood vessels for abnormalities of the venules and/or arterioles. To determine the accuracy of the non-ophthalmologist's clinical observations, infants were also examined by an ophthalmologist, using an indirect ophthalmoscope, who graded the posterior pole vessels as normal, dilated venules, or dilated and tortuous venules and arterioles (including "plus disease"). RESULTS: There was significant correlation (p <0.001) between the non-ophthalmologist's and ophthalmologist's diagnoses of posterior pole vascular abnormalities. 47 infants had normal posterior pole blood vessels by the non-ophthalmologist examination. Of these, 31 (66%) were considered to have normal vessels and 16 (34%) to have dilated venules by the ophthalmologist. The non-ophthalmologist correctly identified abnormal posterior pole vessels in all 21 infants diagnosed with abnormal arterioles and venules by the ophthalmologist. No infants with clinically important ROP ("prethreshold" or worse) would have failed detection by this screening method. CONCLUSION: Using a direct ophthalmoscope, a non-ophthalmologist can screen premature infants at risk for ROP by evaluating the posterior pole blood vessels of the retina. While not necessarily recommended for routine clinical practice, this technique may nevertheless be of value to those situations where ophthalmological consultation is unavailable or difficult to obtain.

Results of large (8-9 mm) bilateral lateral rectus muscle recessions for exotropia.

PURPOSE: Commonly recommended maximum lateral rectus muscle recession for exotropia ranges from as little as 7 mm to as much as 11 mm. Published studies on recessions of 8 mm or more are scarce. Many ophthalmic surgeons still avoid recessions larger than 7 mm because of the fear of creating abduction deficits and surgical overcorrections. Therefore, we sought to determine the incidence of clinically detectable abduction deficits and their correlation with early surgical overcorrection in exotropic patients who had undergone large 8 to 9 mm lateral rectus muscle recessions. SUBJECTS AND METHODS: A retrospective chart review identified 30 patients with exotropia ranging from 35delta to 65delta who were treated with 8 to 9 mm recessions of both lateral rectus muscles. Patients with concurrent oblique muscle surgery were included. Mean followup time was 15 months (range 3-30 mos). RESULTS: Twenty-four patients (80%) required only one operation. The remaining 6 patients (20%) required a second operation, four for overcorrection and two for undercorrection. Nine patients (30%) had mild but persistent abduction deficits postoperatively. However, abduction deficits were not predictive of poor outcome (p=0.959). Other variables that did not significantly affect outcome included age (p=0.894), systemic anomalies (p=0.127), size of preoperative exotropia (p=0.987) and amount of rectus muscle recession (p=0.480). However, concurrent oblique muscle surgery was associated with a higher risk of a poor result. CONCLUSIONS: 8-9 mm lateral rectus recessions are not associated with a poor outcome, except in association with concurrent oblique muscle surgery.

[Effects of active synchronized prolonged coronary perfusion in the animal]. / Effets de la perfusion coronaire active synchronisée prolongée chez l'animal.

The efficacy of a system of active diastolic synchronised coronary perfusion was studied during prolonged balloon angioplasty in 8 sheep. In the first part of the study (group 1) including 5 animals, the aim was to study the effects of high and constant flow (48 ml/min) for 90 minutes perfusion on haemolysis, the arterial wall and the perfused myocardium. The second part of the study (group 2), including 3 animals, assessed whether flow adapted to the extent of the vascular bed perfused (24 to 40 ml/min) could protect the myocardium for an interval of 60 minutes. In group 1, after 90 minutes of perfusion (48 ml/min), there was no haemolysis, or jet lesion of the arterial wall distal to the catheter tip. On the other hand, the creatinine phosphokinase levels increased at the 60th minute (188 vs 119 i.u./l for controls) and at the 90th minute (238 vs 119 i.u./l; p < 0.05). Moreover, the perfused myocardium was the site of histological lesions. These observations showed myocardial changes due to the "overflow phenomenon". In group 2, the flow rate was adapted to each animal, increasing progressively until disappearance of electrocardiographic signs of ischaemia (ST elevation) and maintained for 60 minutes. No signs of haemolysis, jet lesions or myocardial changes were observed, with absence of creatinine phosphokinase elevation and histological abnormalities. These preliminary results show that the system investigated allowed myocardial protection after arterial occlusion for an interval of 60 minutes.

Thrombotic microangiopathy in a patient with chronic myelogenous leukemia on hydroxyurea.

We describe the case of a 57-year-old woman with chronic myelogenous leukemia who was on hydroxyurea and developed a fatal thrombotic microangiopathy with renal, retinal and central nervous system involvement. There was no evidence of medullary or extramedullary leukemia transformation. Repeated examinations of the peripheral blood film revealed only minimal morphological changes of microangiopathic hemolysis. The diagnosis was made by postmortem examination of the kidneys, brain, meninges and retina. The underlying etiology may have been a paraneoplastic phenomenon of the chronic phase of CML or may have indicated the beginning of transformation to an accelerated phase. A late side effect of hydroxyurea therapy cannot be excluded.

Pseudomonas aeruginosa coronary stent infection.

Stent infection is a rare complication of coronary angioplasty. We report a case of a coronary stent bacterial infection due to Pseudomonas aeruginosa, shortly after implantation of the stent in the left circumflex artery, which presented as an acute pericarditis. Surgical treatment consisted of stent removal and partial excision of the circumflex artery without coronary artery bypass grafting.

Concentration of teicoplanin in the serum of adults with end stage chronic renal failure undergoing treatment for infection.

We examined the adequacy of the following schedule for the administration of i.v. teicoplanin to patients with chronic renal failure: three doses of 6 mg/kg at 12 h intervals, a fourth dose 24 h later and then subsequent doses every 72 h. Eight infected patients undergoing dialysis were investigated, with serum antibiotic concentrations measured ten minutes before and one hour after administration. Mean trough concentrations were 6.9 +/- 3.1 mg/L on day two, 9.8 +/- 4.4 mg/L (day three), 9.2 +/- 4.8 mg/L (day six), 10.9 +/- 5.5 mg/L (day nine), 12.1 +/- 6.1 mg/L (day 12) and 14.8 +/- 8.0 mg/L (day 15). The proposed schedule achieved adequate trough serum teicoplanin concentrations by 48 h in six out of eight patients examined. The dosage regimen was well tolerated.

Can non-ophthalmologists screen for retinopathy of prematurity?

BACKGROUND: Dilation and tortuosity of the posterior pole vessels ("plus disease") is a poor prognostic sign and may indicate the presence of threshold or pre-threshold retinopathy of prematurity (ROP). Because stage 3 ROP appears rarely in the absence of posterior pole vascular abnormalities, we prospectively evaluated the ability of non-ophthalmologists (4th-year medical students, pediatric residents, and nurse practitioners) to identify abnormalities in the retinal blood vessels of infants undergoing examinations for ROP. METHODS: Fifty infants weighting less than 1600 g at birth were examined between 32 and 40 weeks after conception. Prior to ophthalmological examination, non-ophthalmologist examiners graded posterior pole vessels as normal or abnormal based on ophthalmoscopic appearance. One hundred twenty-one ocular examinations were performed using the teaching mirror of the indirect ophthalmoscope, 179 using the direct ophthalmoscope. The indirect ophthalmoscopy was performed simultaneously by an ophthalmologist who evaluated the posterior pole vessels for abnormalities prior to conducting a peripheral fundus examination on either eye. RESULTS: Testing sensitivity for the non-ophthalmologist examiners using direct and indirect ophthalmoscopy was 96% and 92%, respectively. Combining the results from direct and indirect ophthalmoscopy, the Clopper-Pearson 95% sensitivity confidence interval for identifying abnormal arterioles and venules was 82% to 99%, with a point estimate of 95%. CONCLUSION: These data suggest that non-ophthalmologist examiners can detect posterior pole vascular abnormalities in premature infants. If properly trained, they could possibly play a role in screening or follow-up examinations for ROP.

Dissociated horizontal deviation and accommodative esotropia: treatment options when an eso- and an exodeviation co-exist.

Dissociated strabismus includes movements in the vertical, horizontal, and torsional axes. Dissociated vertical deviation (DVD) is an oversimplified label because it implies a purely vertical deviation. When the abducting component of the dissociated strabismus complex is prominent, the term dissociated horizontal deviation (DHD) is used. We present six patients with accommodative esotropia who developed prominent DHD. Only two patients have a prior history of congenital esotropia. Latent nystagmus was observed in five of the patients. With the combination of DHD and esotropia, an esodeviation during active fixation may become an exodeviation when the patient is visually inattentive. Five patients required surgery for DHD. Four options are used and discussed. DHD can be treated alone with lateral rectus muscle recession. DHD can be treated as above, but combined with medial rectus muscle recessions or posterior fixation sutures to simultaneously treat the esotropia. The esotropia can be treated alone, possibly with a reduced surgical dosage. If the patient varies from an esodeviation to an exodeviation, but is straight much of the day, observation without surgical therapy may be advisable. Just as a hypotropia can have an overlying DVD, an esotropia can have an overlying DHD. This combination may masquerade as variable angle esotropia or may present as an esodeviation when the patient is visually attentive and an exodeviation when the patient is visually inattentive.

[Synchronized anterograde perfusion during percutaneous transluminal coronary angioplasty: preliminary clinical study]. / Perfusion antérograde synchronisée pendant l'angioplastie coronaire: étude clinique préliminaire.

A new circulatory system, "physiologic anteroperfusion system", has been developed and tested in 6 patients with significant proximal coronary artery stenosis. Prolonged and safe balloon inflation was possible without any ischemic signs. The system consists of an electronic cardiac synchroperfusor which, by activating a pulsatile unit, permits increased diastolic anteroperfusion of autologous blood under physiologic pressure through low-profile standard angioplasty catheters. This study reports the results obtained in 6 patients during proximal prolonged percutaneous transluminal coronary angioplasty. Four men and two women suffering from severe exertional angina pectoris, with normal resting left ventricular function, no collaterals and excellent apical two-dimensional four-chamber echocardiographic views were studied. After a 90 +/- 10 seconds of control occlusion under continuous monitoring of hemodynamics, electrocardiograms (3 to 4 leads), two-dimensional echo and chest pain grading, a second balloon inflation protected by the physiologic anteroperfusion system at a flow rate of 44 +/- 12 ml/min was performed for fifteen minutes. The ischemic signs present in the myocardium depending on the occluded artery were totally abolished during prolonged inflation protected by physiologic anteroperfusion system. All the patients were successfully dilated and were discharged from hospital the following morning without cardiac enzyme elevation or signs of central or peripheral hemolysis. Conclusion, in 6 patients with severe proximal coronary artery stenosis, safe prolonged proximal angioplasty without signs of ischemia was performed using a new simple physiologic anteroperfusion system, which allows active diastolic flow-pressure controlled autologous arterial blood perfusion, through standard low profile catheters.