Comparison of angioplasty with infusion of tirofiban or abciximab and with implantation of sirolimus-eluting or uncoated stents for acute myocardial infarction: the MULTISTRATEGY randomized trial

Context  Abciximab infusion and uncoated-stent implantation is a complementary treatment strategy to reduce major adverse cardiac events in patients undergoing angioplasty for ST-segment elevation myocardial infarction (STEMI). It is uncertain whether there may be similar benefits in replacing abciximab with high-dose bolus tirofiban. Similarly, the use of drug-eluting stents in this patient population is currently discouraged because of conflicting results on efficacy reported in randomized trials and safety concerns reported by registries. Objective  To evaluate the effect of high-dose bolus tirofiban and of sirolimus-eluting stents as compared with abciximab infusion and uncoated-stent implantation in patients with STEMI undergoing percutaneous coronary intervention. Design, Setting, and Patients  An open-label, 2 x 2 factorial trial of 745 patients presenting with STEMI or new left bundle-branch block at 16 referral centers in Italy, Spain, and Argentina between October 2004 and April 2007. Interventions  High-dose bolus tirofiban vs abciximab infusion and sirolimus-eluting stent vs uncoated stent implantation. Main Outcome Measures  For drug comparison, at least 50% ST-segment elevation resolution at 90 minutes postintervention with a prespecified noninferiority margin of 9% difference (relative risk, 0.89); for stent comparison, the rate of major adverse cardiac events, defined as the composite of death from any cause, reinfarction, and clinically driven target-vessel revascularization within 8 months. Results  ST-segment resolution occurred in 302 of 361 patients (83.6%) who had received abciximab infusion and 308 of 361 (85.3%) who had received tirofiban infusion (relative risk, 1.020; 97.5% confidence interval, 0.958-1.086; P < .001 for noninferiority). Ischemic and hemorrhagic outcomes were similar in the tirofiban and abciximab groups. At 8 months, major adverse cardiac events occurred in 54 patients (14.5%) with uncoated stents and 29 (7.8%) with sirolimus stents (P = .004), predominantly reflecting a reduction of revascularization rates (10.2% vs 3.2%). The incidence of stent thrombosis was similar in the 2 stent groups. Conclusions  In patients with STEMI undergoing percutaneous coronary intervention, compared with abciximab, tirofiban therapy was associated with noninferior resolution of ST-segment elevation at 90 minutes following coronary intervention, whereas sirolimus-eluting stent implantation was associated with a significantly lower risk of major adverse cardiac events than uncoated stents within 8 months after intervention. Trial Registration  clinicaltrials.gov Identifier: NCT00229515      

Follicular lymphoma international prognostic index

The prognosis of follicular lymphomas (FL) is heterogeneous and numerous treatments may be proposed. A validated prognostic index (PI) would help in evaluating and choosing these treatments. Characteristics at diagnosis were collected from 4167 patients with FL diagnosed between 1985 and 1992. Univariate and multivariate analyses were used to propose a PI. This index was then tested on 919 patients. Five adverse prognostic factors were selected: age (> 60 years vs 60 years), Ann Arbor stage (III-IV vs I-II), hemoglobin level (< 120 g/L vs 120 g/L), number of nodal areas (> 4 vs 4), and serum LDH level (above normal vs normal or below). Three risk groups were defined: low risk (0-1 adverse factor, 36% of patients), intermediate risk (2 factors, 37% of patients, hazard ratio [HR] of 2.3), and poor risk ( 3 adverse factors, 27% of patients, HR = 4.3). This Follicular Lymphoma International Prognostic Index (FLIPI) appeared more discriminant than the International Prognostic Index proposed for aggressive non-Hodgkin lymphomas. Results were very similar in the confirmation group. The FLIPI may be used for improving treatment choices, comparing clinical trials, and designing studies to evaluate new treatments.      

Treatment of inferior turbinate hypertrophy: a randomized clinical trial

In the past 130 years, many surgical procedures for turbinate reduction have been developed. We analyzed the long-term efficacy of 6 of these surgical techniques (turbinectomy, laser cautery, electrocautery, cryotherapy, submucosal resection, and submucosal resection with lateral displacement) over a 6-year follow-up period. We randomly divided 382 patients into 6 therapeutic groups and surgically treated them at the Department of Otorhinolaryngology of the University of Siena. After 6 years, only submucosal resection resulted in optimal long-term normalization of nasal patency and in restoration of mucociliary clearance and local secretory IgA production to a physiological level with few postoperative complications (p < .001). The addition of lateral displacement of the inferior turbinate improved the long-term results. We recommend, in spite of the greater surgical skill required, submucosal resection combined with lateral displacement as the first-choice technique for the treatment of nasal obstruction due to hypertrophy of the inferior turbinates.     

Atrial flutter termination by overdrive transesophageal pacing and the facilitating effect of oral propafenone

Transesophageal overdrive atrial pacing is effective and safe for atrial flutter termination. The influence of antiarrhythmic drug therapy on this procedure is controversial. In this study, we investigated whether oral propafenone may facilitate this procedure. Thirty patients with type I atrial flutter were randomized into 2 groups in which transesophageal pacing was attempted: group A, without treatment; and group B, after oral administration of propafenone 600 mg. Transesophageal pacing was effective in interrupting atrial flutter in 53% of patients (8 of 15) in group A and in 87% of patients (13 of 15) in group B. A significant lengthening of the flutter cycle was observed with respect to the baseline in patients given propafenone (261 ± 23 vs 217 ± 25, p < 0.01). Sinus rhythm resumed at a shorter paced cycle in group A patients (166 ± 13 vs 187 ± 14 ms, p < 0.01). The transesophageal threshold for stable atrial capture was significantly lower in group A (20.5 ± 0.2 vs 23.3 ± 1.2, p < 0.01). In no patient was the threshold for atrial capture higher than the pain threshold. We did not observe abrupt enhancement of atrioventricular conduction. We conclude that propafenone is effective and safe when used with transesophageal pacing in the termination of atrial flutter. The slowing effect of the drug on intraatrial conduction and the possible stabilizing effect on the reentry circuit appear to be outweighed by the positive effect of propafenone on the excitable gap of the circuit, facilitating its capture and accounting for the beneficial effect of the drug on arrhythmia termination.     

Transnasal transesophageal echocardiography: A new approach for the PFO occlusion in awake patients

Objectives : To reduce risks, discomfort, cost, and operative time for percutaneous patent foramen ovale (PFO) closure, we propose to perform this procedure under transesophageal echo‐guidance using a 10 Fr. catheter introduced through nasal way (TEENW). Background : Transesophageal or intracardiac echocardiography is commonly used to guide percutaneous PFO closure. Sedation needed quite frequently during transesophageal echocardiography, increased patients' discomfort, procedure prolongation, costs, use of both femoral veins, and additional intracardiac manipulations are the main limitations of standard techniques. Methods : We enrolled 20 consecutive patients with a history of cerebral ischemia and PFO with right‐to‐left shunt. In 15 patients Amplatzer® PFO occluder was used, whereas in five patients with longer PFO tunnel (>10 mm) Cardia Intrasept® was selected. Without sedation, a multifrequency monoplane probe, developed for intracardiac echocardiography, was introduced into the nostril and advanced forward the esophagus. Then under echo guidance, the closing device was presented, opened and released. Results : Procedure lasted for an average of 33.3 min, and no complications were seen. At procedure's completion, six patients showed persistence of reduced shunt during Valsalva manoeuvre. At six‐month follow‐up, shunts disappeared in all patients. Conclusion : TEENW is safe and well tolerated, and images' quality is high enough to deserve widespread adoption of this technique for PFO closure. © 2008 Wiley‐Liss, Inc.     

Short-term venous stasis influences routine coagulation testing.

Preanalytical variability is a common source of errors in coagulation testing, as clotting assays are particularly susceptible to poor standardization of the whole analytical process. To investigate the effect of a short-term venous stasis on routine coagulation testing, we measured activated partial thromboplastin time, prothrombin time, fibrinogen and D-dimer in plasma specimens collected either without venous stasis or following the application of a 60 mmHg constant, standardized external pressure by a sphygmomanometer, for 1 (1-min stasis) and 3 min (3-min stasis). When compared with blood specimens collected without stasis, the Pearson's correlation coefficients and the corresponding slopes of the Passing and Bablok regression line of samples collected following 1 and 3-min stasis were acceptable. However, statistically significant differences by paired Student's t-test could be observed for all parameters tests following 3-min stasis, and for all but the activated partial thromboplastin time after 1-min stasis. Significant difference between specimens collected after 1- and 3-min stasis was also achieved for prothrombin time (P < 0.01), fibrinogen (P < 0.01) and D-dimer (P < 0.05). The agreement between measurements was yet acceptable after 1-min stasis, but achieved clinical significance for prothrombin time, fibrinogen and D-dimer after 3-min stasis. Taken together, results of the present investigation confirm that the effects of venous stasis during venipuncture are clinically meaningful. As hematocrit values and activities of clotting factors VII, VIII and XII significantly increased, whereas that of activated factor VII remained unchanged, we hypothesize that a short-term venous stasis, as induced by up to 3-min tourniquet placing, might not be sufficient to produce additional procoagulant responses besides hemoconcentration.     

Reflections on methodical approaches to hematopoietic stem cell collection in children

Pediatric peripheral blood stem cell collection (PBSC) is challenging because it has potentially more side effects than in adults due to the small body mass and unique physiology of children. The extracorporeal volume of the cell separator device, poor venous access and metabolic complications due to citrate toxicity are the main problems to face during PBSC collection. These aspects are more relevant in very low body weight (BW) children of 20?kg or lower. An efficient, experienced and well-prepared team of pediatricians, apheresis physicians and nurses, and physicians involved in CVC positioning is crucial to performing a safe PBSC collection. Despite the growing demand for PBSC collection in the pediatric setting, there is not an actual unique standardized detailed practice approach to be employed, therefore, on reflection, we believe that it is timely to draw up useful evidence-based recommendations on which guidelines can be developed for use by those groups with limited or no experience.