Proportion Of Patients In Group Research Articles

Routine ganglionic plexi ablation during Maze procedure improves hospital and early follow-up results of mitral surgery

Ganglionic plexi are claimed to be potentially responsible for atrial fibrillation. We evaluated whether ganglionic plexi isolation improves the results of the Maze procedure during mitral valve surgery. A total of 75 patients with atrial fibrillation underwent radiofrequency ablation during mitral valve surgery without (group A) or with (group B) ganglionic plexi ablation with bipolar radiofrequency plus fat pad resection along the Waterston groove, left pulmonary veins, and Marshall's ligament. Ganglionic plexi were intraoperatively mapped, and fat pad specimens were sectioned and analyzed. Hospital and follow-up results were recorded. Amiodarone was discontinued at the sixth month. Active ganglionic plexi were mainly located in the upper parts of fat pads. Active specimens demonstrated more ganglionic plexi than inactive specimens (P <or= .015 at different levels) but did not correlate with atrial fibrillation recurrence (P = not significant). Atrial fibrillation was higher in group A at aortic declamping (P = .03) and discharge (P = .03). Early events were comparable (P = .565). At 16.7 +/- 0.95 (standard error) months, the cumulative freedom from atrial fibrillation, atrial flutter, and atrial tachycardia with antiarrhythmic therapy was 63.2% +/- 7.3% and proved higher in group B (83.9% +/- 7.9% vs group A 52.8% +/- 8.7%; P = .035). However, after the sixth month, at 12.8 +/- 0.80 months, freedom from atrial fibrillation, atrial flutter, and atrial tachycardia without antiarrhythmic therapy was 72.5% +/- 7.7% and proved higher in group B (92.9% +/- 6.9% vs 62.5% +/- 9.4%; P = .023). A higher proportion of patients in group B showed normalized E/A ratio (61.3% vs group A 36.4%; P = .029). No differences were detected in follow-up freedom from congestive heart failure (group A: 83.4% +/- 7.0% vs group B: 93.5% +/- 4.4%; P = .978) and hospital readmission (group A: 84.2% +/- 5.9% vs group B: 92.6% +/- 5.1%; P = .376). Ganglionic plexi isolation can improve hospital and follow-up results during mitral valve surgery and possibly ameliorate echocardiographic recovery of atrial function during follow-up.

Randomized Multicenter Trial of More Intense and Standard Early Verteporfin Treatment of Neovascular Age-Related Macular Degeneration

To compare efficacy and safety of a more intense regimen versus a standard one for retreatment of neovascular age-related macular degeneration (AMD) during the early period of verteporfin therapy (VT). Prospective, randomized, multicenter clinical trial. Two hundred three patients with predominantly classic choroidal neovascularization (CNV) secondary to AMD. During the first 6 months of VT, patients underwent retreatment every 2 (group A) or 3 (group B) months. After 6 months, both groups underwent retreatment every 3 months for as long as CNV activity was documented. Best-corrected visual acuity (BCVA) measured every 6 months, mean number of treatments per patient during 24 months' follow-up, proportions of patients in each group losing at least 3 lines of vision or gaining at least 1 line, greatest linear dimension (GLD) of the lesion as documented by fluorescein angiography every 6 months, and relationship between initial lesion size and BCVA. At all follow-up times, mean BCVAs were similar for groups A and B. Mean numbers of photodynamic therapy treatments were similar for both groups (4.07 vs. 4.36; P = 0.451, paired t test). A lower proportion (51.9% vs. 56.7%) of patients in group A had lost at least 3 lines of vision at 24 months. Groups A and B had similar increases in mean lesion size from baseline to 24 months (2104-3056 microm and 2179-3020 microm). At 24 months, patients in group A with a baseline lesion GLD of < or =2000 microm had significantly less mean loss of vision than patients in group A with a GLD of >2000 microm (P = 0.032); differences also were significant for group A with GLD of < or =2000 microm versus group B with GLD of < or =2000 microm (P = 0.041) or GLD of >2000 microm (P = 0.045); and mean vision losses from baseline were 8, 17, 15, and 14 letters, respectively. Overall outcomes regarding visual benefit, lesion anatomic features, and number of retreatments after 6 months were similar for patients receiving more intense or standard early therapy. An unplanned retrospective analysis showed that there was significantly less vision loss when the more intense regimen was used to treat smaller lesions.

The effect of topical tetracaine eye drops on emergence behavior and pain relief after strabismus surgery

Pediatric strabismus surgery may be associated with postoperative nausea, vomiting, and emergence agitation (restlessness, thrashing, crying, moaning, disorientation). We hypothesize that emergence agitation after strabismus surgery is in part related to pain and that topical tetracaine ophthalmic drops can decrease the intensity and incidence of postoperative pain and emergence agitation. Eighty-eight subjects aged 1 to 12 years scheduled for strabismus surgery were enrolled in a double-masked randomized control trial. The patients were randomized to one of three groups: Group A received normal saline drops before and after surgery; Group B received normal saline drops before and tetracaine 1% drops after surgery; Group C received tetracaine 1% drops before and after surgery. An observer masked to group assignment assessed each patient in the postanesthesia care unit (PACU) using both a behavior scale and a modified behavioral pain scale. Patients in Group A were found to be in significantly more pain than Groups B or C at 5 minutes after arrival to the PACU (p < 0.013). Using the behavior scale, a significantly greater proportion of patients in Group A were crying or crying and thrashing at 5, 15, and 30 minutes after arrival to the PACU (5 minutes, p < 0.019; 15 minutes, p < 0.041; 30 minutes, p < 0.021). There was no significant difference between groups in total PACU time, PACU vomiting, PACU morphine use, or pain at home. Postoperative strabismus surgery pain was improved by the use of preoperative, and pre- and postoperative, tetracaine drops. Emergence agitation was not fully evaluated by the behavioral scale, and therefore, the effect of tetracaine drops on emergence agitation was not clarified. This study suggests that tetracaine drops can lead to a less stressful early postoperative experience for the patient.

Diagnosis of pulmonary emboli and image quality at CT pulmonary angiography: Influence of imaging direction with multidetector CT

To determine whether there was a significant difference in the prevalence of emboli detected when patients underwent computed tomography pulmonary angiography (CTPA) in a craniocaudal direction versus a caudocranial direction. This was a prospective study of 203 consecutive patients attending for CTPA for suspected pulmonary embolus. Imaging was performed on a multisection Siemens Volume Zoom CT machine, with bolus tracking centred on the main pulmonary artery after intravenous administration of contrast at 3 ml/s. Patients were examined in a single breath-hold, from the top of the aortic arch to the highest point of the diaphragm, in a randomly assigned cranio-caudal (group A), or caudo-cranial (group B) direction. Images were reviewed on a workstation in a cranio-caudal direction jointly by two radiologists unaware of the original imaging direction. The presence, number and position of arterial emboli were noted, and a subjective assessment of overall image quality and opacification of upper and lower lobe vessels (grade 1, 2, 3, or 4) was made. Emboli were detected in 46 patients. There was no significant difference in the prevalence of emboli detected in the two groups [group A craniocaudal direction n=22, group B caudocranial direction n=24 (p=0.76)]. Imaging direction did not significantly influence overall image quality (p=0.07), however, there was a significantly greater proportion of patients in group A with grade 1 opacification of the upper lobe arteries (p=0.02). Imaging direction does not significantly influence the diagnosis of pulmonary emboli but it does significantly improve the upper lobe pulmonary arterial enhancement with fewer non-diagnostic images, and on that basis we recommend that craniocaudal direction be used for CTPA studies.

Laparoscopic nerve-sparing complete excision of deep endometriosis: is it feasible?

Little is known about the morbidity associated with laparoscopic complete excision of endometriosis in terms of urinary, digestive and sexual function. We performed a prospective non-randomized study in 45 patients with laparoscopic complete excision of all detectable foci of endometriosis with segmental bowel resection using a non nerve-sparing technique (control group-group A n=20) and a nerve-sparing technique (case group-group B n=25). At initial gynaecological evaluation, and at follow-up details on dysmenorrhoea, pelvic pain, dyspareunia and dyschezia were evaluated using an interview-based questionnaire (10-point analogue rating scale: 0=absent, 10=unbearable). The mean (+/-SD) follow-up period was 15.3+/-10 months (range, 8.8-23 months) for group A and 3.5+/-2.1 months (range, 0.3-5.2 months) for group B. In the immediate postoperative course, in group A three women required blood transfusion vs seven women in group B (P=0.003). The median time to resume the voiding function was significantly shorter in group B (12.5 vs 3.0 days; P<0.01). At the time of follow-up a higher proportion of patients in group B were 'very satisfied' than those in group A (87.7% vs 59.0%, P=0.013). Laparoscopic nerve-sparing complete excision of endometriosis seems to be feasible and offers good results in terms of bladder morbidity reduction with apparently higher satisfaction than classical technique. Larger series with longer follow-up are needed to confirm our results.

Allograft T Cell Content Influences Early Engraftment after Reduced-Intensity Stem Cell Transplantation (RIST).

Allogeneic hematopoietic stem cells (HSC) generally engraft rapidly and completely after myeloablative conditioning. However, with reduced-intensity conditioning (RIC), mixed chimerism and graft failure are more common. Host immune status and HSC number are factors known to affect engraftment after reduced-intensity stem cell transplantation (RIST). In addition, donor T cells within the allograft may also influencethe kinetics of donor engraftment after RIST. To evaluate this, we performed a controlled comparison of engraftment outcomes among 3 groups undergoing RIST, varying by ex vivo T cell depletion (TCD) or in vivo depletion of activated T cells with methotrexate (MTX) to prevent graft-versus-host disease (GVHD). Group I (n = 50) received T cell replete (TCR) peripheral blood stem cells (PBSC) with cyclosporine (CSA) alone for GVHD prophylaxis. Group II (n = 17) received ex vivo TCD PBSC (positive/negative selection with T cell add-back to uniform dose of 1 x 105 CD3+ cells/kg) with CSA alone for GVHD prophylaxis. Group III (n = 31) received TCR PBSC with CSA plus MTX (5 mg/m2 IV x 4 doses) for GVHD prophylaxis. The 3 groups were similarly immunosuppressed from prior therapy before RIST (median absolute lymphocyte counts 330/μL, 260/μL, and 307/μL for Groups I, II, and III, respectively), and received an identical RIC regimen (fludarabine/cyclophosphamide) plus comparable numbers of filgrastim-mobilized PBSC from HLA-matched sibling donors (median 7.9 x 106, 7.6 x 106, and 6.8 x 106 CD34+ cells/kg, respectively; median 3.6 x 108, 1.0 x 105, and 3.2 x 108 CD3+ cells/kg, respectively). Hematopoietic recovery was slowest in Group III, consistent with the myelosuppressive effects of MTX (Table). A greater proportion of patients in Group I achieved complete donor chimerism (≥ 95%) by day +28 than in Groups II or III (P < 0.025), and at day +100, mixed donor chimerism persisted more often in Groups II and III than in Group I patients (P < 0.01). Correspondingly, early (< day +42) occurrence of grade 3–4 acute GVHD, before initiation of planned sequential donor lymphocyte infusions (DLI) in Group II, was more frequent in Group I than in either Groups II or III (p=0.08).Table:Hematopoietic Recovery, Engraftment, and GVHDGroupDays to ANC > 500, median (range)Days to plt > 100, median (range)Donor chimerism ≥ 95%Early acute GVHD, grades 3–4Day +28Day +100I9 (7–13)15.5 (12-42)37/44 (84%)36/38 (95%)9/50 (18%)II9 (7–10)17.5 (11–40)8/17 (47%)9/14 (65%)0/17 (0%)III14 (7–21)21.5 (12–85)23/31 (74%)21/31 (68%)2/31 (6%)Thus, the deletion of T cells by either ex vivo TCD or in vivo MTX administration measurably alters the kinetics and degree of donor T cell engraftment after RIST. These observations provide evidence that donor T cells are an independent factor affecting engraftment of allogeneic HSC after RIST by compensating for incomplete host immune ablation. These data also support the hypothesis that a graft-versus-host effect plays a significant role in engraftment after RIST. Manipulation of donor T cells through graft engineering techniques may be a useful strategy to enhance engraftment in the setting of RIST.

Velcade (V)-Thalidomide (T)-Dexamethasone (D) for Advanced and Refractory Multiple Myeloma (MM): Long-Term Follow-Up of Phase I–II Trial UARK 2001-37: Superior Outcome in Patients with Normal Cytogenetics and No Prior T.

INTRODUCTION: A 2-arm Phase I/II trial was initiated to determine activity and toxicities of the VTD combination in patients with advanced and refractory MM.METHODOLOGY: Of 85 patients enrolled, 63 (74%) had abnormal cytogenetics (CA) including 40 patients with deletion of chromosome 13; 71 (84%) had received 1 prior autotransplant, including 56 (66%) with 2 prior autotransplants; 73% had previously received T; none had received prior V. V was given at a starting dose of 1.0 mg/m2 (group A) on days 1, 4, 8, and 11 every 21 days; T was added with the 2nd cycle at dose increments of 50, 100, 150, and 200 mg daily in cohorts of at least 10 patients. In the absence of grade > 2 peripheral neuropathy (PN) with V at 1.0 mg/m2 plus T 200mg, V was then increased to 1.3 mg/m2 (group B); T was added in the same incremental dosing schedule as in group A. D was added (20 mg on days 1, 2, 4, 5, 8, 9, 11, and 12 every 21 days) with cycle #4 if partial response (PR) or better was not achieved; 34 patients received D, 19 in group A and 15 in group B. PR was defined as ≥ 50% reduction in serum M-protein and/or ≥ 75% reduction of urine M-protein. Responses were computed on an intent-to-treat basis.RESULTS: Median numbers of cycles in group A were 6, 10, 7, 2 per T cohort and 12, 6, 11, 3, respectively, in group B. PR was obtained in 55% of patients, including 16% who achieved ≥ n-CR; an additional 15% had ≥ 25% M-protein reduction. Median EFS/OS for all 85 patients were 9/22 mos. Compared to group A, group B had a superior 12-mo EFS (47% vs. 26%) and OS (79% vs. 57%) (p=0.008/p=0.06); however, the 2 groups were not well balanced with regard to recognized prognostic factors (group A contained more patients with a low albumin level, high B2M, abnormal cytogenetics [CA] and high bone marrow plasmacytosis). No T dose effect on EFS or OS was apparent (≤ 100 mg/d, n=42; > 100 mg/d, n=43). Both EFS (p=0.01) and OS (p=0.03) were shorter in the presence of CA. EFS was also inferior in case of prior T (26% vs. 63%, p=0.03). The most common grade 3 or 4 toxicity was myelosuppression (thrombocytopenia and neutropenia). The proportion of patients in group A with PN grade > 1 was 41% at study entry and only slightly increased to 50% after cycle 5, with no T dose effect; the corresponding values for group B were 51% at study entry and 56% after cycle 5, with PN reaching grade 3 in 2/6 patients in the T=200 mg cohort. Syncope was observed in 2/6 patients receiving T=200mg in group B. Thus, in group A no T-MTD was reached, whereas it was 150mg in group B.CONCLUSION: VTD is well tolerated at V 1.0 + T 200mg and V 1.3 + T 150mg. Its overall remarkable activity in a high-risk patient population yielded superior EFS/OS in the absence of either CA or prior T. The imbalance of prognostically relevant features, however, precludes a final dose recommendation for V. VTD (V=1.0, T=200mg, D=40mg) has since been combined with PACE combination chemotherapy (VTD-PACE) in Total Therapy 3 (TT3), raising >=n-CR rates beyond 80% compared to 65% with TT2+T (ASCO 2005), permitting robust PBSC collection >20 million CD34 cells/kg in >90% of >150 patients enrolled, when performed after the first cycle of VDT-PACE.

Clinical benefits of hepatocellular carcinoma surveillance: A single-center, hospital-based study

Although there is no definitive evidence that hepatocellular carcinoma (HCC) screening in high-risk groups improves survival, many physicians screen high-risk populations with various tools such as alpha-fetoprotein (AFP) and ultrasonography (USG). The aim of this study was to clarify clinical differences between HCC patients diagnosed by surveillance and those with incidentally detected HCC. Two hundred and seventy-one Japanese patients with HCC diagnosed between January 1991 and December 2001 were recruited. They were categorized into two groups: 178 patients (group 1) had subclinical HCC diagnosed by surveillance and 93 patients (group 2) presented with incidentally detected HCC. The tumor size was significantly smaller in group 1 compared to that of group 2 (2.8 vs. 5.6 cm; P<0.0001). A significantly higher proportion of patients in group 2 had multiple HCC and portal vein infiltration when compared to group 1. Eighty-six (48.3%) group 1 patients and 16 (17.2%) group 2 patients underwent local ablation treatment, which is a curative treatment available for small HCCs (P<0.0001). The cumulative actuarial survival rate was significantly higher in group 1 than in group 2 (P=0.0091). Early detection of HCC by surveillance may contribute to a greater chance of receiving effective treatment and prolonged survival, although a further prospective, randomized study is needed.

A randomized controlled trial of pegylated interferon α‐2a (40 KD) or interferon α‐2a plus ribavirin and amantadine vs interferon α‐2a and ribavirin in treatment‐naïve patients with chronic hepatitis C

We determined whether triple therapy comprising amantadine (AMA), ribavirin (RBV) and either peginterferon (PEG-IFN) alpha-2a or conventional IFN alpha-2a would improve sustained virological response (SVR) rates over dual therapy with IFN alpha-2a and RBV in patients with chronic HCV infection. A total of 362 treatment-naïve patients were randomized to 48 weeks of treatment with: PEG-IFN alpha-2a 180 microg/week (group A) or IFN alpha-2a 3 MU tiw (groups B and C). All patients received RBV 1000 or 1200 mg/day and those in groups A and B received AMA 200 mg/day. SVR was defined as an undetectable HCV RNA after 24 weeks of untreated follow-up. At the end of therapy, 74.4% (95% CI 0.66-0.82) of patients in group A were HCV RNA-negative compared with 42.5% (95% CI 0.33-0.50) of those in group B (P = 0.0001) and 48.8% (95% CI 0.40-0.56) of those in group C. SVR was achieved in a significantly greater proportion of patients in group A compared with groups B and C: 65.3% (95% CI 0.53-0.56), 33.3% (95% CI 0.25-0.41) and 44.6% (95% CI 0.36-0.53; P = 0.0001) respectively. In patients with genotype 1, SVR rates were 55.2, 22.8 and 28.8% with the three regimens respectively. Factors independently associated with SVR were HCV genotype 2 or 3, therapy with PEG-IFN, female gender and age. In treatment-naive patients with chronic hepatitis C, triple therapy with PEG-IFN alpha-2a, RBV and AMA produces higher SVR than dual or triple therapy with conventional IFN alpha-2a.

Are Autoimmune Diseases or Glomerulonephritis Affecting the Development of Panel-Reactive Antibodies in Candidates for Renal Transplantation?

Panel-reactive antibodies (PRA) are a major obstacle to kidney transplantation (KTx). It is not completely clear why only some patients develop PRA, whereas others do not. We hypothesized that other factors, such as autoimmune diseases involving the kidney, might be a trigger for PRA development. We reviewed the original diseases that led to renal failure and their possible role in PRA development. Charts of 270 patients on the active waiting list for KTx were reviewed for complete demographics, presence of PRA, peak PRA level, first KTx or retransplantation, original disease, blood transfusions, pregnancy and rejection. Patients were divided into group 1 (PRA >10%) and group 2 (PRA <10%). There was a significantly higher proportion of patients in group 1 with autoimmune diseases than in group 2. The same proportion was found significant for all of the patients as well as for the patients listed for the first KTx (new patients). Previous KTx has significant impact on both class I and II peak PRA levels when compared with new patients who are already sensitized. A subanalysis of retransplantation showed patients with autoimmune disease (54%) have more graft loss due to rejection compared with nonautoimmune disease (43%). There is an association between high PRA level and autoimmune diseases causing renal failure regardless of the previous KTx status. Besides the risk of recurrence, autoimmune disease seems to affect the risk of graft loss due to rejection.

Neurologic consequence of delaying glatiramer acetate therapy for multiple sclerosis: 8-year data

To assess the long-term effectiveness of continuous glatiramer acetate (GA) therapy in relapsing-remitting multiple sclerosis (RRMS). This open-label extension followed a randomized, placebo-controlled, double-blind study of GA of approximately 30 months duration. Patients originally randomized to GA continued on it (group A) and those randomized to placebo switched to GA (group B). Of 251 original patients, 142 (56.6%) remained in the study after 8 years. Annual relapse rate for both groups declined to approximately 0.2 (approximately one relapse every 5 years). However, a significantly larger proportion of patients in group A had stable or improved Expanded Disability Status Scale scores compared with group B (65.3% vs 50.4%, respectively; P = 0.0263), possibly attributable to the delay of GA treatment for approximately 30 months in group B. GA was well tolerated and no drug-related laboratory changes were observed. These data support early initiation of GA therapy as an efficacious and well-tolerated long-term treatment for RRMS patients.

Prospective Evaluation of Patients with Increasing Opiate Needs: Prescription Opiate Abuse and Illicit Drug Use

Multiple aberrant behaviors have been described to identify patients abusing opioids and using illicit drugs. However, patient behavior encompassing aggressive seeking or complaining about the need for higher doses of opioids has not yet been evaluated with regards to misuse or abuse patterns of prescription drugs and illicit drug usage. The objective of this study was to evaluate and identify the prevalence of illicit drug use and prescription drug abuse or misuse in patients seeking higher doses of opioids and compare to a group of patients not seeking higher doses of opioids. A prospective, non-randomized, consecutive, observational study. A total of 200 patients from an interventional pain management setting with 100 consecutive patients in each group either not seeking additional opioids (Group I) or seeking higher doses of opioids (Group II) were evaluated with urine testing for illicit drug use, and/or misuse or abuse of opioids. Drug testing was carried out by Rapid Drug Screen. Results of this study showed a significantly greater proportion of patients in Group II using illicit drugs (15% vs 32% P = 0.005). Combined use of illicit drugs and abuse of non-prescribed opioids was also present in a significantly greater proportion of patients in Group II (15% vs 39% P = 0.000). A significant number of patients in Group I (32%) and Group II (30%) failed to show the prescribed drug in their urine. A significant proportion of patients, whether they were seeking additional opioids or not, used illicit drugs. Further, a greater proportion of patients in Group II used illicit drugs and non-prescribed opioids.

A prospective, randomized, double-blinded comparison of ropivacaine 0.5%, 0.75%, and 1% ropivacaine for peribulbar block

Study objective To evaluate the efficacy of three different concentrations of ropivacaine (0.5%, 0.75%, and 1%) together with a single concentration of hyaluronidase administered for peribulbar block. Design Prospective, randomized, double-blind study. Setting Anesthesia department of a university teaching hospital. Patients 68 ASA physical status I, II, and III patients undergoing elective cataract surgery. Interventions Patients were randomly allocated to receive peribulbar block with 6.5 mL of either 0.5% (Group Ropi-5; n = 22), 0.75% (Group Ropi-7.5; n = 22), or 1% ropivacaine (Group Ropi-10; n = 24). In all patients, 0.5 mL of hyaluronidase was added to the local anesthetic solution. Measurements and main results A larger proportion of patients in Groups Ropi-7.5 (82%) and Ropi-10 (83%) showed complete motor block 15 minutes after injection compared with Group Ropi-5 (55%; p = 0.05, and p = 0.03, respectively). Hypotension (reduction of systolic blood pressure by 30% or more from baseline) was observed in two Group Ropi-5 patients (9%), and two Group Ropi-7.5 patients (9%; p = 0.31), whereas bradycardia (reduction in heart rate ≤ 50 bpm) was observed in one Group Ropi-5 patient (4%), and three Group Ropi-10 patients (12%; p = 0.18). Seven hours after surgery, a smaller proportion of Group Ropi-10 patients (64%) showed complete recovery of sensory function as compared with both Group Ropi-5 (94%) and Group Ropi-7.5 (90%; p = 0.03 and p = 0.03, respectively). Complete recovery of motor function 1 hour after surgery was more frequent in Group Ropi-5 (37%) than in Group Ropi-7.5 (5%) or Group Ropi-10 (9%; p = 0.05 and p = 0.05, respectively); however, no other differences in recovery of motor function were observed at any other observation times, with complete recovery in all patients 7 hours after surgery. Conclusions While confirming that ropivacaine is a good option for peribulbar anesthesia, this study demonstrated that the use of 0.75% or 1% concentrations are preferred in that they produce quick and deep sensory and motor block of the operated eye. If recovery of normal motor function is important after surgery, the 0.75% concentration probably represents the best compromise.

Differences in Clinical Profile and Outcome in Patients With Decompensated Heart Failure and Systolic Dysfunction or Preserved Systolic Function

To compare the clinical characteristics and short- and long-term prognosis for chronic heart failure with left ventricular systolic dysfunction or preserved systolic function. Three-hundred twenty-eight consecutive patients with decompensated chronic heart failure were studied prospectively. Depending on ejection fraction, participants were classified as having systolic dysfunction (group 1, ejection fraction < or = 40%,) or preserved systolic function (group 2, ejection fraction >40%). Systolic dysfunction was detected in 192 patients (58.5%) and preserved systolic function in 41.5%. Mean age was 62.7 (12.5 years) in group 1 and 65.2 (16.2 years) in group 2 (P=.03), with a male prevalence of 73.3% and 49.3%, respectively (P<.001). Ischemic cardiomyopathy was more frequent in group 1 (44.8% vs 25%; P<.001). Physical examination and electrocardiogram findings were similar in both groups, except for a higher proportion of patients in group 1 with a heart third sound (43.2% vs 25%; P=.001) and left bundle branch block (40.6% vs 15.4%; P<.001) and abnomal Q waves (31.3% vs 20.6%; P=.04). In-hospital mortality was similar in patients with systolic dysfunction and preserved systolic function (2.9% vs 1%; P=NS). Twenty-four-month cumulative survival was 61% for patients with systolic dysfunction and 76% for patients with preserved systolic function (log rank test P=NS). In the Cox proportional hazards model, which included age, sex, functional class, hepatomegaly, peripheral hypoperfusion, BUN, sodium level, ejection fraction > 40%, and biventricular heart failure, preserved systolic function was not associated with late mortality. The variables that were independent predictors of late mortality were peripheral hypoperfusion (OR = 3.7; P<.0001), low sodium level (OR=0.9; P=.009) and male sex (OR=1.9; P=.041). Decompensated chronic heart failure with preserved systolic function was more frequent in women and older patients. Patients with preserved systolic function had a lower prevalence of coronary heart disease. However, these differences had no impact on the short- and long-term prognosis.

Three-dimensional ultrasonography: an objective outcome tool to assess collagen distribution in women with stress urinary incontinence

Objectives To examine the distribution of periurethral collagen by three-dimensional ultrasonography (3D US) and to incorporate this technology into a practical treatment decision tree for women with stress urinary incontinence desiring collagen injection. Methods Forty-six women who received periurethral collagen injection were assessed with 3D US to document the position and volume of collagen around the urethra. Patients with a good clinical response were observed with serial 3D US scans. Women with no persistent improvement who showed a low volume or asymmetric distribution of collagen were offered repeat injections. When the patient had no improvement despite symmetric or circumferential distribution of collagen with good volume retention, another anti-incontinence treatment was recommended. Group 1 was composed of women who had a good clinical outcome and group 2 of those who did not. A statistical comparison between the two outcome groups was done to determine whether any particular distribution pattern was associated with an increased likelihood of clinical success. Results Of the 46 patients, 21 (46%) were satisfied with their continence after their last periurethral collagen injection, with a median follow-up of 14.0 months (range 2 months to 4.25 years). A significantly greater proportion of patients in group 1 had circumferentially distributed collagen on 3D US compared with those in group 2 (62% versus 20%, P = 0.006). Conclusions Circumferential distribution of collagen around the urethra is associated with a higher likelihood of clinical success. The assessment of periurethral collagen by 3D US provides an affordable, noninvasive, objective outcome measure that may aid in treatment planning.

Is 2-Week Duration Sufficient for Stenting in Endopyelotomy?

Internal stenting is an integral part of endopyelotomy. Studies in animals show good healing after 1 to 2 weeks of ureterotomy. Inherent stent related problems warrant a minimum possible duration of stenting without compromising the results of endopyelotomy. We performed a prospective randomized trial to evaluate the optimum duration of stenting after endopyelotomy. A total of 57 consecutive patients with primary ureteropelvic junction obstruction were randomized to undergo 7/14Fr internal endopyelotomy stent placement for 2 (group 1) and 4 (group 2) weeks. A symptom based questionnaire was administered to all patients at stent removal. Followup was done with diuretic scanning at 3, 6, 9 and 12 months and then yearly, and thereafter with diuretic renography. In each group 26 patients were available for evaluation. The 2 groups were comparable in terms of age, sex, symptoms and ipsilateral glomerular filtration rate. Mean followup was 22.3 (range 12 to 36) and 21.3 months (range 12 to 35) in groups 1 and 2, respectively. At the end of 1 year 24 group 1 (92.3%) and 23 group 2 (90.3%) patients had an improved drainage pattern. This difference was not significant. Stent related symptoms were present in a good proportion of patients in groups 1 and 2 but there was a significant difference in the incidence of urinary tract infections (11.5% versus 38.1%, p = 0.04). Of the group 2 patients 64% preferred 2 weeks of stenting. Two weeks seems to be a sufficient duration to allow functional restoration across the ureteropelvic junction after endopyelotomy and decrease stent related complications.

Can we predict which patients with implantable cardioverter defibrillators receive appropriate shock therapy? A study of 155 patients

Background: Appropriate shock therapy (AST) occurs in the minority of patients with implantable cardioverter defibrillators (ICDs). We assessed which patients received AST and whether there were any predictive factors. Methods: We retrospectively analysed data from 155 patients implanted with ICDs at our institution from a period from February 1984 to February 2001. Stored electrogram data were analysed. We sub-divided patients on the basis of underlying cardiac disease. Various clinical echocardiographic and electrophysiological variables were studied. Results: AST occurred in 53 (34%) of patients (Group 1) and no AST in 102 (64%) of patients (Group 2). Impaired LV function was significantly associated with AST. Group 1 patients had a lower ejection fraction (EF) compared to Group 2 (37.5±13% vs. 47.8±14%, P<0.0001). Seventy-two percent of patients with AST had an EF <40% vs. 35% of patients in Group 2 ( P<0.0001). NYHA Class was also associated with AST, 42% of Group 1 were in NYHA Class III/IV vs. 12% in Group 2 ( P<0.001). Programmed electrical stimulation (PES) was a predictor of AST. PES was positive in a greater proportion of patients in Group 1 vs. 2 (88% vs. 64%, P<0.0006). Sub-group analysis showed that patients with dilated cardiomyopathy (DCM) had a high incidence of AST (80%). In these patients PES was a poor predictor of AST being positive in only 25%. Conclusion: AST occurs in the minority of our patients. Certain pre-procedural variables predict AST. PES does not appear useful in predicting shock therapy in DCM patients and a negative PES should not preclude ICD implantation in this group.

Do Number of Pain Conditions Influence Emotional Status?

This study was designed to evaluate psychological status of 150 individuals; 50 without chronic pain and without psychotherapeutic drug therapy, Group I or control group; 50 patients with chronic pain, Group II, chronic pain group with involvement of one region; and 50 chronic pain patients with involvement of two or more regions, Group III. All the participants were tested utilizing Millon Clinical Multiaxial Inventory -III (MCMI-III). Results were analyzed and compared for various clinical personality patterns including personality traits and personality disorders; severe personality pathology for schizotypal, borderline and paranoid personality pathology; and multiple clinical syndromes including generalized anxiety disorder, somatization disorder, major depression, bipolar manic disorder and dysthymic disorder, etc. There were no significant differences noted in clinical personality patterns or severe personality pathology. In the analysis of clinical syndromes, generalized anxiety disorder, somatization disorder, and depressive disorders were seen in a progressively greater proportion of patients in Groups I to III. In conclusion, this evaluation showed that abnormal clinical personality patterns are present in both groups of patients. Psychological abnormalities with generalized anxiety disorder, somatization disorder, and depression are commonly seen in chronic pain patients.

Cold haemagglutinin disease: clinical significance of serum haemolysins.

Two hundred and twenty-one patients with cold haemagglutinins of thermal amplitude > or = 30 degrees C (considered to be a reasonable indicator of clinical significance) were classified by in vitro haemolysin activity into three groups. Group 1 contained 116 individuals in whom haemolysins were never detected; the 74 patients in Group 2 had monophasic haemolysins alone; whereas both monophasic and biphasic haemolysins were detected in the 31 Group 3 patients. There was a significantly higher proportion of patients in Groups 2 and 3 with haptoglobin levels < 0.1 g/l compared with Groups 1 and 2, respectively (P < 0.005 and P < 0.001). Direct antiglobulin test results showed that the autoimmune response became more complex and IgM predominant through Groups 1-3, resulting in an increasing ability to activate complement which was reflected in increasing haemolysin activity and number of patients with active haemolysis. The 31 patients in Group 3 were mostly elderly (median age 71 years at presentation) and the majority had chronic cold haemagglutinin disease (CHAD), several in association with lymphoid neoplasms or carcinomas; only four had acute CHAD. The natural history of idiopathic chronic CHAD was of mild, well compensated haemolysis, punctuated by severe acute episodes necessitating intensive therapy. The condition often remained active for long periods and did not appear to affect natural lifespan. In some cases, no treatment (or just warmth) was needed; in others continuous or intermittent prednisolone and/or chlorambucil were effective; yet others required a greater variety and more intense therapy, or treatment of associated conditions. Blood transfusion support was frequently required when haemolysis was severe.

Bradycardia is associated with development of coronary collateral vessels in humans.

The development of mature coronary collateral vessels in patients with obstructive coronary artery disease (CAD) decreases the ischemic myocardial burden. Chronic bradycardia has been shown to stimulate formation of collateral vessels in experimental models. To test our hypothesis that CAD patients with bradycardia would have better developed collateral circulation than would members of a control group. A retrospective study examining the relationship between bradycardia and the development of coronary collateral vessels in patients with obstructive CAD. Admission electrocardiograms and rhythm tracings obtained during angiography of all patients presenting to the cardiac catheterization laboratory were screened from January to October 1997. Angiograms for patients with heart rates < or = 50 beats/min were reviewed. An equivalent number of consecutive patients with heart rates > or = 60 beats/min served as controls. Patients with acute myocardial infarction, with rhythms other than sinus, and without high grade obstructive CAD (< 70% stenosis) were excluded from the study. The study population consisted of 61 patients, 30 having heart rates < or = 50 beats/min (group A), and 31 controls with heart rates > or = 60 beats/min (group B). A significantly greater proportion of patients in group A than of matched controls was demonstrated to have developed collaterals (97 versus 55% in group B, P < 0.005). The mean collateral grades were 1.66 and 0.95 for subjects in groups A and B, respectively (P < 0.001). CAD patients with bradycardia are more likely (odds ratio 24, 95% confidence interval 5-146) to have angiographic coronary collaterals than are those with higher heart rates. Results of this study demonstrate that there is an association between bradycardia and growth of collateral vessels in patients with obstructive CAD. Bradycardic agents may be useful for promoting development of coronary collaterals in patients with atherosclerotic disease.