Simplified hybrid algorithms for pressure wire interrogation exploiting advantages of a baseline and contrast Pd/Pa ratio indexes to predict stenosis significance: Insight from the SPARE multicenter prospective study.

BACKGROUND: Simplification of functional stenosis assessment with pressure guidewires may facilitate adoption of physiology-guided revascularization. An important step in this regard is the avoidance of hyperemic agents, required for fractional flow reserve (FFR) calculation. We evaluate the merits of a hybrid algorithms that combines the translesional pressure ratio (Pd/Pa) obtained at rest, after contrast medium injection (cFFR) and after adenosine administration (FFR). METHODS AND RESULTS: Eighty-six patients with 108 de novo intermediate coronary stenoses were included in this prospective, multicenter study. Using prespecified cut-off values that correctly identified stenosis with a 95% of agreement (<0.89 and >0.96 for Pd/Pa; <0.84 and > 0.87 for cFFR) we tested the efficiency of three different multi-step strategies combining the three indices to classify stenosis severity, using FFR-only measurement as reference. All three different hybrid algorithms (Pd/Pa-FFR; cFFR-FFR; Pd/Pa-cFFR-FFR) have more than 95% of agreement with FFR. Yet, the novel Pd/Pa-cFFR-FFR hybrid strategy demonstrated the best performance, avoiding the need of adenosine and medium contrast in 90% and 48% of cases, respectively. CONCLUSIONS: A hybrid Pd/Pa-cFFR-FFR decision-making algorithm could be an alternative and valuable strategy to increase the adoption of a physiology-guided PCI using conventional pressure guidewires and consoles.

Appraising failure of surgical and percutaneous revascularization: long term outcomes from an observational registry.

AIM: Many randomized trials have compared coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) in terms of efficacy, but data comparing outcomes of patients in which these two techniques have failed are lacking. METHODS: We included patients undergoing PCI at our center between July 2002 and December 2004. Subjects were distinguished in 2 groups: those with at least one occluded or stenotic saphenous vein graft (CABG failure), and those with at least one stent with angiographically documented restenosis (PCI failure). The primary endpoint was the long-term rate of major adverse clinical events. RESULTS: Two hundred and thirthy four patients were included, with a medium follow up of 61±13 months; 134 were assigned to the CABG failure group, and 104 to the PCI failure group, sharing high rates of baseline risk factors. At long term rates of death were higher in post CABG group (22.1% vs. 9.9%; P=0.015, RR 2.24 C.I. 95% 1.14-4.40) while death rates in patients with diagnosis of diabetes mellitus (24.0% vs. 23.5%; P=0.969, RR 1.020 C.I. 95% 0.38-2.74) were not different CONCLUSION: PCI can be safely offered to both these kinds of patients: as recently demonstrated post CABG outcomes seem to be more favorable in patients with diabetes mellitus.

Percutaneous drug-eluting stent implantation in diabetic patients: short and long term outcomes from an observational study.

AIM: The introduction of drug-eluting stents (DES) has markedly improved mid-term results of percutaneous coronary intervention (PCI) in diabetics. However, it is unclear whether the risk-benefit balance of DES in diabetics is maintained also at long-term and in insulin-requiring patients. We thus aimed to appraise long-term outcomes of diabetic patients treated with PCI with DES, stratifying according to insulin therapy. METHODS: We retrospectively collected baseline, procedural and outcome data from all patients undergoing PCI with DES from July 2002 to June 2004 at our center. We distinguished three groups: insulin-requiring diabetics, non-insulin-requiring diabetics and patients without diabetes. The primary end-point was the long-term rate of major adverse cardiac events (MACE, i.e. the composite of death, myocardial infarction, or target vessel revascularization). We also considered stent thrombosis according to the Academic Research Consortium Definition. RESULTS: We included a total of 1266 patients, with 3% of insulin-requiring diabetes, 22% with non-insulin-requiring diabetes, and 75% without diabetes. There were significant differences across groups in prevalence of male gender (respectively, 32.4%, 74.6% and 81%, P<0.001), and DES usage (54.1%, 34%, and 30.4%, P=0.007). Thirty-day MACE occurred with similar frequency in the three groups (8.1%, 7.3% and 6.3%, P=0.78), with death in 3%, 2%, and 1.4% (P=0.71) and myocardial infarction in 5.4%, 1.8% and 0.8% (P=0.02). After a median follow-up period of 58 months, MACE occurred in 59.5% of patients with insulin-requiring diabetes, in 50.6% of non-insulin-requiring diabetics and in 38.9% of non-diabetics (P<0.001). Death occurred in 24.3%, 17.5% and 8.5%, (P<0.001), myocardial infarction in 10.8%, 6.6%, and 5.1% (P=0.25), repeat revascularization in 46%, 31.6%, and 30% (P=0.11), and definite stent thrombosis in 0%, 1.1%, and 1.3% (P=0.78). CONCLUSION: Our study confirms the high risk profile of diabetic patients, especially when ischemic disease it is known. In this setting, diabetic and comorbidities fix the price not only in term of need of further revascularization, but mainly in survival decrease. It can be concluded that not only revascularization but also ­ and especially ­ comorbidities treatment plays a determinant role reducing follow-up events. Further research on additional pharmacologic treatments or hybrid revascularization strategies may mitigate the burden of morbidity and mortality.

Fresh organic matter of municipal solid waste enhances phytoextraction of heavy metals from contaminated soil.

In this study, the ability of the organic fraction of municipal solid wastes (OFMSW) to enhance heavy metal uptake of maize shoots compared with ethylenediamine disuccinic acid (EDDS) was tested on soil contaminated with heavy metals. Soils treated with OFMSW and EDDS significantly increased the concentration of heavy metals in maize shoots (increments of 302%, 66%, 184%, 169%, and 23% for Cr, Cu, Ni, Zn, and Pb with respect to the control and increments of 933%, 482%, 928%, 428%, and 5551% for soils treated with OFMSW and EDDS, respectively). In soil treated with OFMSW, metal uptake was favored because of the high presence of dissolved organic matter (DOM) (41.6x than soil control) that exhibited ligand properties because of the high presence of carboxylic acids. Because of the toxic effect of EDDS on maize plants, soil treated with OFMSW achieved the highest extraction of total heavy metals.

Efficacy of a new antidandruff thermophobic foam: a randomized, controlled, investigator-blinded trial vs. ketoconazole 2% scalp fluid.

BACKGROUND: Ketoconazole (K), zinc pyrithione (ZP), and salicylic acid (SA) are compounds active in the treatment of dandruff. A thermophobic foam formulation containing K 1%, ZP 0.5%, and SA 2% is now available. STUDY AIM: To compare the efficacy of thermo phobic foam with K 2% scalp fluid in the treatment of moderate to severe dandruff. Patients and methods In a randomized, prospective, parallel-group, investigator-blinded, 4-week treatment trial, a total of 54 patients (mean age 43 +/- 8 years) were enrolled. Foam (F group) (n = 37) or K 2% scalp fluid (SF group) (n = 17) was applied daily for 7 days and twice weekly for 3 weeks thereafter. Clinical assessment of the total dandruff severity score (TDSS) was performed at baseline, after 2 and 4 weeks. The TDSS was calculated using a four-grade quantitative score (0 = no dandruff; 3 = severe dandruff) dividing the scalp area into four zones and adding the single score for each area. RESULTS: At baseline, TDSS was 7.1 +/- 2 and 5.1 +/- 1 in the F and SF groups, respectively. At the end of treatment period, beneficial effects were observed in both groups. The TDSS was reduced to 2.5 +/- 1 in the F group and to 3.7 +/- 1.2 in the SF group (mean difference in favor of F group: -1.2; 95% CI: -0.57 to -1.8) (P = 0.0003). A complete or nearly complete resolution of dandruff was observed in 24 out of 37 (64%: 95%CI: 48-77%) in the F group and in 7 out of 17 (41%: 95% CI: 21-64%) in the SF group (P = 0.06 between groups). CONCLUSIONS: This new antidandruff thermophobic foam has shown to be more effective than ketoconazole 2% scalp fluid in the treatment of severe dandruff.

Evaluation of the efficacy and tolerability of oral terbinafine (Daskil) in patients with seborrhoeic dermatitis. A multicentre, randomized, investigator-blinded, placebo-controlled trial.

BACKGROUND: Previous uncontrolled trials have suggested that oral terbinafine, an antimycotic allylamine compound, could be useful in the treatment of seborrhoeic dermatitis. OBJECTIVES: To investigate in a placebo-controlled trial the clinical efficacy of oral terbinafine (Daskil(R), Mipharm, Milan, Italy) in patients with moderate to severe seborrhoeic dermatitis. METHODS: Sixty outpatients (mean +/- SD age 37 +/- 11 years; 32 men and 28 women) with moderate to severe seborrhoeic dermatitis were enrolled in a multicentre, randomized, placebo-controlled, investigator-blinded, parallel-group, 12-week study. After a 2-week wash-out period, enrolled patients were randomized to treatment with oral terbinafine 250 mg daily (n = 30) or placebo (moisturizing ointment) (n = 30) applied twice daily for 4 weeks (weeks 0-4). Patients were followed up for an additional 8 weeks after completion of treatment and were clinically evaluated at weeks 0, 2, 4 and 12 by an investigator unaware of the patient's type of treatment. The primary end-point of the study was clinical evaluation of erythema, scaling and itching, each scored on a 0-3 scale. A global clinical score, representing the sum of each evaluated symptom, was also calculated. RESULTS: Demographic and clinical data were equally balanced between the placebo and terbinafine groups. All enrolled patients concluded the study. At baseline, the mean +/- SD global clinical score was 7.4 +/- 1.3 in the placebo group and 7.7 +/- 1.0 in the terbinafine-treated group. At weeks 4 and 12 the mean +/- SD global clinical score in the placebo group was 5.9 +/- 1.7 and 6.3 +/- 1.2, respectively, which was not significantly different from baseline. As compared with baseline values and the placebo group, terbinafine treatment significantly (P < 0.0001, Tukey-Kramer test) reduced the mean +/- SD global clinical score (to 1.0 +/- 1.1 at week 4, and 1.2 +/- 1.4 at week 12), as well as the individual erythema, scaling and itching scores. No serious adverse events were recorded during the study in either group. CONCLUSIONS: This is the first controlled trial that has shown oral terbinafine to be effective in the treatment of moderate to severe seborrhoeic dermatitis. Clinical improvement following 4 weeks treatment with terbinafine was maintained 8 weeks after completing treatment.

Marshall-Marchetti-Krantz urethropexy and Burch colposuspension for stress urinary incontinence in women with low pressure and hypermobility of the urethra: early results of a prospective randomized clinical trial.

OBJECTIVE: The aim of the study was to compare the effects of Burch colposuspension and Marshall-Marchetti-Krantz urethropexy with videourethroscopic control in the correction of stress urinary incontinence in patients with low pressure and hypermobility of the urethra. STUDY DESIGN: Thirty women were randomly assigned to undergo 1 of the 2 surgical procedures from November 1993 to May 1996 (15 Burch colposuspensions and 15 Marshall-Marchetti-Krantz urethropexies) and were evaluated subjectively and objectively for stress urinary incontinence at 2 and 12 months. Data obtained were analyzed with the Student t test, the Fisher exact test, and the Wilcoxon signed rank test. RESULTS: At 1 year of follow-up 15 women in the Marshall-Marchetti-Krantz urethropexy group (100%) and 10 women in the Burch colposuspension group (66%) were subjectively considered cured (P =.02, 2-tailed Fisher exact test), and stress test results were negative in 14 women (93%) and 8 women (53%), respectively (P =.017, 2-tailed Fisher exact test). The resumption of spontaneous voiding was attained after 6.5 +/- 3.3 days in the Burch colposuspension group and in 20.5 +/- 13.4 days in the Marshall-Marchetti-Krantz urethropexy group (P <.001, 2-tailed Wilcoxon rank sum test). CONCLUSION: The high cure rate and low associated morbidity mark the Marshall-Marchetti-Krantz procedure with videourethroscopic control as more effective than Burch colposuspension in repairing stress urinary incontinence associated with low pressure and hypermobility of the urethra.

Transabdominal repair of cystocele by wedge colpectomy during combined abdominal-vaginal surgery.

The aim of the study was to evaluate the effectiveness of transabdominal wedge colpectomy as surgical treatment for cystocele. One hundred and sixty-three women with either first or second-degree cystocele (Beecham classification), rectocele and concomitant stress urinary incontinence or benign pelvic masses were submitted for a combined operation. Transabdominal repair of the cystocele was performed by wedge colpectomy employing two different absorbable sutures, Vicryl and PDS. The choice of suture was not random but depended on the period at which surgery was performed. Data obtained were analyzed with Student's t-test and Fisher's exact test. The cystocele cure rate was 90.2% (110 out of 122) at 3-year follow-up and was significantly associated with the preoperative degree, being 95.5% and 76.5% in first and in second degree, respectively (P = 0.003). At 1-year follow-up the cure rate was significantly associated with the type of the suture employed (P = 0.01). At 2-year follow-up rectocele cure rate was 97.2% and vaginal vault prolapse appeared in 3.5% of cases. Stress urinary incontinence relapsed in 10% of patients after Burch colposuspension. After the operation 94.1% of the women declared normal coitus. In the present series wedge colpectomy was found to be effective in repairing first-degree cystocele, whereas a high incidence of relapse was observed when second-degree cystocele was present preoperatively. The suture material employed influenced the cure rate.

Marshall-Marchetti-Krantz procedure and Burch colposuspension in the surgical treatment of female urinary incontinence.

Urinary stress incontinence was treated by the Marshall-Marchetti-Kranz (MMK) procedure in 42 and by Burch coloposuspension in 44 women. All were assessed preoperatively and for greater than 1 year postoperatively, both clinically and by urodynamic tests. Cure of incontinence was achieved to a similar extent by both procedures, in 71% after the MMK and 79% after the Burch operation. Results were better than average if there was no prolapse and if the bladder was stable preoperatively.