Outcome comparison of different approaches to self-intermittent catheterization in neurogenic patients: a systematic review.

STUDY DESIGN: Systematic review (Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA); http://www.prisma-statement.org). OBJECTIVES: Different types of catheters and techniques have been described in the past three decades to identify the best self-intermittent catheterization method. Our aim is to review systematically the literature on the most appropriate material and technique to perform self-intermittent catheterization in the adult neurogenic population. METHODS: A systematic review search was performed through PubMed/Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases to study all types of self-intermittent catheters, and analyzing their impact on urinary tract infections (UTIs), urethral trauma, cost-effectiveness, quality of life and patient's satisfaction. We used the following keywords: 'intermittent catheterization/catheterisation', 'neurogenic', 'urinary catheters for intermittent use' and 'urethral catheterization/catheterisation' published by November 2015. RESULTS: After screening 3768 articles, 31 were included in the final synthesis (level of evidence 1b to 2b). The 2188 trial participants were mainly spinal cord injury adults and women with multiple sclerosis. Hydrophilic-coated catheters tended to decrease the incidence of UTI as well as urethral trauma and improve patient's satisfaction when compared with non-hydrophilic-coated catheters. Similarly, prelubricated catheters were associated with better results in terms of patient satisfaction. Sterile technique seemed to decrease the incidence of recurrent UTI; however, these results are counter-balanced by significantly increasing cost compared with clean catheterization. CONCLUSIONS: The present review demonstrated advantages of hydrophilic-coated catheters in decreasing risk of UTI and urethral trauma as well as improving patient's satisfaction. Prelubricated catheters has been shown to be superior to conventional polyvinyl chloride catheters. Randomized controlled trials comparing hydrophilic and prelubricated catheters must be conducted to assess possible superiority and cost-effectiveness.

Artificial Urinary Sphincter: Report of the 2015 Consensus Conference.

PURPOSE: The AMS800™ device, by far the most frequently implanted artificial urinary sphincter (AUS) worldwide, is considered to be the "gold-standard" when male incontinence surgical treatment is contemplated. Despite 40 years of experience, it is still a specialized procedure with a number of challenges. Here, we present the recommendations issued from the AUS Consensus Group, regarding indications, management, and follow-up AMS800™ implantation or revision. MATERIALS AND METHODS: Under ICS auspices, an expert panel met on July 10, 2015 in Chicago, IL, USA in an attempt to reach a consensus on diverse issues related to the AMS800™ device. Participants were selected by the two co-chairs on the basis of their practice in a University hospital and their experience: number of implanted AUSs according to AMS (American Medical System Holdings Inc., Minnetonka, MN) records and/or major published articles. Topics listed were the result of a pre-meeting email brainstorming by all participants. The co-chairs distributed topics randomly to all participants, who then had to propose a statement on each topic for approval by the conference after a short evidence-based presentation, when possible. RESULTS: A total of 25 urologists were invited to participate, 19 able to attend the conference. The present recommendations, based on the most recent and relevant data available in literature as well as expert opinions, successively address multiple specific and problematic issues associated with the AMS800™ trough a eight-chapter structure: pre-operative assessment, pre operative challenges, implantation technique, post-operative care, trouble-shooting, outcomes, special populations, and the future of AUSs. CONCLUSION: These guidelines undoubtedly constitute a reference document, which will help urologists to carefully select patients and apply the most adapted management to implantation, follow-up and trouble-shooting of the AMS800™.

Overview of the 2015 ICS Consensus Conference.

PURPOSE: The AMS800™ device is considered to be the "gold-standard" when male incontinence surgical treatment is contemplated. Despite 40 years of experience, it is still a specialized procedure with a number of challenges. Here, we present the recommendations issued from the AUS Consensus Group, regarding indications, management and follow-up AMS800™ implantation or revision. MATERIALS AND METHODS: Under ICS auspices, an expert panel met on July 10, 2015 in Chicago, IL, USA in an attempt to reach a consensus on diverse issues related to the AMS800™ device. Participants were selected by the two co-chairs on the basis of their practice in a University hospital and their experience: number of implanted AUSs according to AMS (American Medical System Holdings Inc., Minnetonka, MN) records and/or major published articles. Topics listed were the result of a pre-meeting email brainstorming by all participants. The co-chairs distributed topics randomly to all participants, who then had to propose a statement on each topic for approval by the conference after a short evidence-based presentation, when possible. RESULTS: The present recommendations, based on the most recent and relevant data available in literature as well as expert opinions, successively address multiple specific and problematic issues associated with the AMS800™ trough a 6-chapter structure: pre-operative assessment, pre operative challenges, implantation technique, post-operative care, trouble-shooting, and special populations. CONCLUSION: These guidelines undoubtedly constitute a reference document, which will help urologists to carefully select patients and apply the most adapted management to implantation, follow-up and trouble-shooting of the AMS800™. Neurourol. Urodynam. 35:437-443, 2016. © 2016 Wiley Periodicals, Inc.

A multicenter, prospective, randomized clinical trial comparing tension-free vaginal tape surgery and no treatment for the management of stress urinary incontinence in elderly women.

AIMS: The aim of our study was to test the hypothesis that elderly women undergoing tension-free vaginal tape surgery (TVT) will have a better quality of life (QOL) and satisfaction compared to non-treated women despite age- and technique-related potential morbidity. METHODS: This multicenter, prospective, randomized, controlled trial enrolled a total of 69 women aged over 70 years who initially consented to be randomized to either undergo immediate TVT surgery or to wait for 6 months before submitting to the same surgery (control group). The main outcomes measured at every visit (pre-randomization, 8-12 weeks and 6 months) consisted of the Incontinence-Quality of Life (I-QOL) Questionnaire, the Patient Satisfaction Questionnaire and the Urinary Problems Self-assessment Questionnaire, among others. RESULTS: The analysis included 31 patients in the immediate surgery group and 27 subjects in the control group. Peri-operative complications in the immediate surgery group were bladder perforation (22.6%), urinary retention (12.9%), urinary tract infection (3.2%) and de novo urgency (3.2%). At 6 months, the mean I-QOL scores for the TVT and control groups were respectively 96.5 +/- 15.5 and 61.6 +/- 19.8 (P < 0.0001); mean Patient Satisfaction scores were respectively 8.0 +/- 2.7 and 2.0 +/- 2.4 (P < 0.0001); and mean Urinary Problems scores were respectively 4.5 +/- 4.3 and 11.6 +/- 3.5 (P < 0.0001). CONCLUSION: At 6 months post-randomization, the group of elderly women who underwent immediate TVT surgery showed a significant improvement in QOL, patient satisfaction and less urinary problems compared to the group of women waiting for the same surgery.

A summary of the findings from the Post-CABG trial.

The Post-CABG trial was designed to assess the effects of 2 different lipid lowering strategies and low dose warfarin vs placebo (2 x 2 factorial) design on the progression of atherosclerosis in saphenous vein grafts. Atherosclerotic progression was determined by comparing baseline and follow-up angiograms (mean interval: 4.3 years) using quantitative angiography. Significant progression of disease in SVG's was reduced with the aggressive lipid lowering strategy compared to the moderate strategy; significant progression in SVG's was not altered by low dose warfarin. The beneficial effects on angiographic changes were demonstrated in multiple subgroups of participants in the trial. The composite clinical end point of death, MI, stroke, PTCA or repeat CABG was analyzed at the end of the trial and 3 years (extended follow-up) after closure of the angiographic trial. At the time of the extended follow-up the aggressive lipid strategy was associated with reduced clinical events; low dose warfarin was also associated with reduced clinical events.

Effect of an aggressive lipid-lowering strategy on progression of atherosclerosis in the left main coronary artery from patients in the post coronary artery bypass graft trial.

BACKGROUND: The Post Coronary Artery Bypass Graft Trial, designed to compare the effects of two lipid-lowering regimens and low-dose anticoagulation versus placebo on progression of atherosclerosis in saphenous vein grafts of patients who had had CABG surgery, demonstrated that aggressive lowering of LDL cholesterol levels to a mean yearly cholesterol level from 93 to 97 mg/dL compared with a moderate reduction to a level of 132 to 136 mg/dL decreased the progression of atherosclerosis in saphenous vein grafts. Low-dose anticoagulation did not affect progression. This secondary analysis tested the hypothesis that a similar decrease in progression of atherosclerosis would also be present in native coronary arteries as measured in the left main coronary artery (LMCA). METHODS AND RESULTS: A sample of 402 patients was randomly selected from 1102 patients who had baseline and follow-up views of the LMCA suitable for analysis. Patients treated with the aggressive lipid-lowering strategy had less progression of atherosclerosis in the LMCA as measured by changes in minimum (P=0.0003) lumen diameter or the maximum percent stenosis (P=0.001), or the presence of substantial progression (P=0.008), or vascular occlusion (P=0.005) when compared with the moderate strategy. CONCLUSIONS: A strategy of aggressive lipid lowering results in significantly less atherosclerosis progression than a moderate approach in LMCAs.

The hemostatic effects of warfarin titration in post CABG patients in comparison to placebo treatment.

BACKGROUND: Since coronary artery bypass graft patients remain at risk of coronary artery and bypass graft occlusion after successful surgery, adjunct treatment regimens are under investigation. In a study of the patients of the multicenter Post Coronary Artery Bypass Graft (Post CABG) Trial, 1 mg warfarin was found to have no important effect on coagulation parameters. STUDY DESIGN: The effects of 1, 2 and 3 mg warfarin were evaluated at six-week intervals in 20 Post CABG Trial patients receiving titrated dose increases in comparison to 20 patients of similar age, gender and time from CABG treated with placebo. RESULTS: International normalized ratio (INR) values increased with warfarin dose increments for 1, 2, and 3 mg, respectively (0.95+/-0.16, 1.08+/-0.19, and 1.34+/-0.39) and in comparison to placebo treated patients (dosextreatment p<0.001). Factor VII coagulant activity decreased with warfarin titration (1 mg, 119.0+/-18.3 %; 2 mg, 100.6+/-32.8 %; 3 mg, 95.0+/-27.8 %) and in comparison to placebo (dosextreatment p=0.008). Levels of prothrombin fragment F1.2, tissue plasminogen activator, fibrinogen and von Willebrand factor were unchanged with warfarin dose increments and in comparison to placebo. CONCLUSIONS: At doses up to 3 mg, warfarin acts on the INR through a reduction of factor VII with no effect on the fibrinolytic system, fibrinogen or von Willebrand factor. At these doses F1.2 did not document reduced coagulation activity. The observations of this study were consistent with the decision in the Post CABG Trial to increase the warfarin dose above 1 mg to achieve a distinct effect of warfarin that was less than full anticoagulation.

Entry sites for coronary angiography and therapeutic interventions: from the proximal to the distal radial artery.

When coronary angiography was introduced at the Montreal Heart Institute, Montreal, Quebec, in 1964, a cutdown arteriotomy of the proximal radial artery 2 to 3 cm distal to its origin was selected as the standard access site used instead of the brachial artery approach described by Mason Sones Jr. The risk of symptomatic local thrombosis requiring surgical care appeared less at that site on the basis of collateral circulation to the hand by the ulnar and palmar arches. Attempts to replace the time-consuming cutdown arteriotomy by a percutaneous transarterial approach led successively to the axillary, femoral and brachial arteries and finally, over 20 years later, to the radial artery. The transradial approach for diagnostic angiography, first reported in 1989 and adapted by others several years later for angioplasty, is now used in over 44 countries. The only contraindication for this approach is the rare, inadequate ulnar artery collateral circulation to the hand, clinically recognized by an abnormal Allen test. The transradial approach is advantageous in that there is an easier and safer postprocedural hemostasis at the entry site, it is preferred by patients and ambulation within hours is compatible with an outpatient procedure.

Lessons from the post coronary artery bypass graft study in evaluating and controlling technical variability in angiographic trials. Post CABG Investigators.

Although many investigators have evaluated the technical variability of quantitative angiographic techniques used to study atherosclerosis regression in native coronary arteries, few have studied the variability inherent in repeated studies of atherosclerotic saphenous vein grafts. This study describes 2 studies performed during the course of the Post Coronary Artery Bypass Graft (CABG) Clinical Trial that were designed to assess the reproducibility of: (1) repeated angiographic views within a short time period; and (2) reproducibility of the total process of quantitative analysis of saphenous vein graft angiograms. Statistical methods are described that provide a more meaningful assessment of the impact of measurement variability in the analytic process versus the variability related to changes induced by pharmacologic interventions. One such method, the increase in standard deviation (SD) among patients (ISDP), showed that repeated angiographic views increased the variability of calculation of lesion minimal diameter by 1.5%, whereas the ISDP for repetition of the entire process of quantitative angiographic readings increased variability 6.4%. These data from the Post CABG trial reveal that technical variability is small and has negligible impact on the conclusions of the study.

Prognostic factors for atherosclerosis progression in saphenous vein grafts: the postcoronary artery bypass graft (Post-CABG) trial. Post-CABG Trial Investigators.

OBJECTIVES: The study was done to assess patients in the Post-Coronary Artery Bypass Graft (Post-CABG) trial to determine prognostic factors for atherosclerosis progression. BACKGROUND: Saphenous vein grafts (SVGs) are effective in relieving angina and, in certain patient subsets, in prolonging life. However, the progression of atherosclerosis in many of these grafts limits their usefulness. METHODS: The Post-CABG trial studied moderate versus aggressive lipid-lowering and low-dose warfarin versus placebo in patients with a history of coronary artery bypass surgery and found that more aggressive lipid lowering was effective in preventing progression of atherosclerosis in SVGs, but warfarin had no effect. Using variables measured at baseline, we sought the independent prognostic factors for atherosclerosis progression in SVGs, employing the statistical method of generalized estimating equations with a logit-link function. RESULTS: Twelve independent prognostic factors for atherosclerosis progression were found. In the order of their importance they were: maximum stenosis of the graft at baseline angiography, years post-SVG placement; the moderate low-density lipoprotein-cholesterol (LDL-C) lowering strategy; prior myocardial infarction; high triglyceride level; small minimum graft diameter; low high-density lipoprotein-cholesterol (HDL-C); high LDL-C; high mean arterial pressure; low ejection fraction; male gender; and current smoking. CONCLUSIONS: This study identified Post-CABG patient and SVG characteristics associated with saphenous vein graft atherosclerosis progression. These data provide a basis for rational risk factor management to prevent progression of SVG atherosclerosis.

Long-term effects on clinical outcomes of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation in the post coronary artery bypass graft trial. Post CABG Investigators.

BACKGROUND: The Post Coronary Artery Bypass Graft Trial, designed to compare the effects of 2 lipid-lowering regimens and low-dose anticoagulation versus placebo on progression of atherosclerosis in saphenous vein grafts of patients who had had CABG surgery, demonstrated that aggressive lowering of LDL cholesterol (LDL-C) levels to <100 mg/dL compared with a moderate reduction to 132 to 136 mg/dL decreased the progression of atherosclerosis in grafts. Low-dose anticoagulation did not significantly affect progression. METHODS AND RESULTS: Approximately 3 years after the last trial visit, Clinical Center Coordinators contacted each patient by telephone to ascertain the occurrence of cardiovascular events and procedures. The National Death Index was used to ascertain vital status for patients who could not be contacted. Vital status was established for all but 3 of 1351 patients. Information on nonfatal events was available for 95% of surviving patients. A 30% reduction in revascularization procedures and 24% reduction in a composite clinical end point were observed in patients assigned to aggressive strategy compared with patients assigned to moderate strategy during 7.5 years of follow-up, P=0. 0006 and 0.001, respectively. Reductions of 35% in deaths and 31% in deaths or myocardial infarctions with low-dose anticoagulation compared with placebo were also observed, P=0.008 and 0.003, respectively. CONCLUSIONS: -The long-term clinical benefit observed during extended follow-up in patients assigned to the aggressive strategy is consistent with the angiographic findings of delayed atherosclerosis progression in grafts observed during the trial. The apparent long-term benefit of low-dose warfarin remains unexplained.

Lipid lowering and coronary bypass graft surgery.

This article reviews the rationale for lipid lowering in patients who have coronary heart disease, and specifically for post-bypass patients. It has been well demonstrated that after coronary artery bypass graft surgery, atherosclerosis continues to progress in the native circulation and develops at an accelerated rate in saphenous vein bypass grafts. During the last decade, numerous clinical trials based on angiographic or clinical outcomes have clearly shown the beneficial effect of lipid lowering in coronary heart disease. Three trials (CLAS, post-CABG, and CARE) have demonstrated delayed progression of atherosclerosis in SVGs and/or a reduction of cardiac deaths, nonfatal MI, and the need for revascularization after lowering LDL-cholesterol. The recommended target of LDL cholesterol level of more than 100 mg/dl can be safely reached with diet and monotherapy using one of the statin drugs (HMG-CoA reductase inhibitors). Despite this widely-circulated information, there appears to be inadequate public and professional awareness of the importance of properly managing hyperlipidemia after coronary artery bypass graft surgery.

The effect of aggressive and moderate lowering of LDL-cholesterol and low dose anticoagulation on plasma lipids, apolipoproteins and lipoprotein families in post coronary artery bypass graft trial.

The reported results (The Post Coronary Artery Bypass Graft Trial Investigators. The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation on obstructive changes in saphenous-vein coronary-artery bypass grafts. New Engl J Med 1997;336:153-162) of the Post Coronary Artery Bypass Graft (Post CABG) trial have shown that aggressive lowering was more effective than moderate lowering of low density lipoprotein (LDL) cholesterol in reducing the progression of atherosclerosis in saphenous-vein grafts (27 vs. 39%; P < 0.001); low dose warfarin had no effect on the progression of atherosclerosis. The present report describes the effect of long-term (an average of 4.3 years) aggressive treatment with high (40-80 mg/day) and moderate treatment with low (2.5-5 mg/day) doses of lovastatin on lipids, apolipoproteins (apo) and apoA- and apoB-containing lipoprotein families. To achieve the target LDL-cholesterol levels (60-85 mg/dl for aggressive group and 134-140 mg/dl for moderate group), cholestyramine (8 g/day) was given to 25% of subjects on aggressive and 5% of subjects on moderate treatment. Although with both treatment strategies there were significant decreases (P<0.001) in the levels of total cholesterol, LDL-cholesterol, apoB, LDL-apoB and cholesterol-rich Lp-B family, percent changes in the levels of these variables were greater in the aggressive- than in the moderate-treatment groups. These treatments had only marginal effects in increasing the levels of high density lipoprotein cholesterol, apoA-I and Lp-A-I and Lp-A-I:A-II families. The long-term aggressive treatment exerted no effect on the concentrations of triglycerides, apoC-IlI, apoC-III in VLDL + LDL and triglyceride-rich Lp-Bc families. Neither treatment affected the levels of Lp(a). The potentially modifying influence of warfarin and apoE phenotypes on lovastatin-induced changes in lipoprotein variables was found to be of little significance. It is likely that the beneficial effect of lovastatin in reducing the progression of atherosclerosis in grafts is mediated through its specific lowering effect on cholesterol-rich Lp-B particles.

Aggressive cholesterol lowering delays saphenous vein graft atherosclerosis in women, the elderly, and patients with associated risk factors. NHLBI post coronary artery bypass graft clinical trial. Post CABG Trial Investigators.

BACKGROUND: The NHLBI Post Coronary Artery Bypass Graft trial (Post CABG) showed that aggressive compared with moderate lowering of low-density lipoprotein-cholesterol (LDL-C) decreased obstructive changes in saphenous vein grafts (SVGs) by 31%.1 Using lovastatin and cholestyramine when necessary, the annually determined mean LDL-C level ranged from 93 to 97 mg/dL in aggressively treated patients and from 132 to 136 mg/dL in the others (P<0.001). METHODS AND RESULTS: The present study evaluated the treatment effect in subgroups defined by age, gender, and selected coronary heart disease (CHD) risk factors, ie, smoking, hypertension, diabetes mellitus, high-density lipoprotein cholesterol (HDL-C) <35 mg/dL, and triglyceride serum levels >/=200 mg/dL at baseline. As evidenced by similar odds ratio estimates of progression (lumen diameter decrease >/=0.6 mm) and lack of interactions with treatment, a similar beneficial effect of aggressive lowering was observed in elderly and young patients, in women and men, in patients with and without smoking, hypertension, or diabetes mellitus, and those with and without borderline high-risk triglyceride serum levels. The change in minimum lumen diameter was in the same direction for all subgroup categories, without significant interactions with treatment. CONCLUSIONS: Aggressive LDL-C lowering delays progression of atherosclerosis in SVGs irrespective of gender, age, and certain risk factors for CHD.