Report from the 94th Cardiovascular and Renal Drugs Advisory Committee Meeting, October 11, 2001.
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Adrenergic beta-Antagonists↗
Biomedical subjects
J Borer
Publications and source records attributed to J Borer.
Management of posterior urethral valves on the basis of urodynamic findings.
PURPOSE: Abnormal urodynamic findings are common in boys with a history of posterior urethral valves. However, to our knowledge there are few reports on the results of treating these abnormal findings. We analyzed the treatment of abnormal urodynamic parameters and its outcome in 21 boys who underwent valve ablation. MATERIALS AND METHODS: After valve ablation multichannel urodynamic studies were performed in 31 boys, including 21 in whom studies were done before and after therapy was started for abnormal parameters. Detrusor instability and impaired bladder compliance were treated with anticholinergics or augmentation cystoplasty, and impaired detrusor contractility was managed with clean intermittent catheterization. RESULTS: Before therapy 17 of 21 boys had impaired compliance and detrusor instability, 2 had impaired compliance without instability and 2 had instability alone. After treatment 8 boys had impaired compliance and 4 had detrusor instability. After anticholinergics were initiated new onset myogenic failure in 2 boys necessitated clean intermittent catheterization. Of the 13 patients who presented with urinary incontinence 10 became dry and 3 had improvement with therapy. Vesicoureteral reflux in 10 boys at the time of the initial urodynamic study resolved in 7 with anticholinergic medication and in 1 after clean intermittent catheterization was begun for severely impaired compliance. All 21 boys were treated with anticholinergics and 2 were ultimately treated with augmentation cystoplasty. Clean intermittent catheterization was also instituted in 5 patients, including the 2 who required clean intermittent catheterization after myogenic failure developed. Five boys with high voiding pressures were found to have outlet obstruction due to residual valve tissue in 2, bladder neck obstruction in 2 and urethral stricture in 1 despite normal flow rates in 2. CONCLUSIONS: Urodynamic studies are helpful in guiding therapy in boys after valve ablation. Anticholinergic therapy can improve compliance, decrease detrusor instability, improve continence and eliminate vesicoureteral reflux in the majority of boys, although there is an associated risk of myogenic failure. Flow rates and fluoroscopic voiding studies are often unable to detect outlet obstruction and must be obtained in conjunction with voiding pressure measurements to make this diagnosis.
Follow-Up Studies↗
Applied stapling technique in radical retropubic prostatectomy: efficient, effective and efficacious.
PURPOSE: We demonstrated the efficiency, efficacy and effectiveness of the endoscopic gastrointestinal anastomosis (GIA) stapler in radical retropubic prostatectomy. MATERIALS AND METHODS: A total of 21 patients with organ confined prostate cancer on preoperative staging underwent radical retropubic prostatectomy. During these procedures we analyzed the applicability and efficacy of the endoscopic GIA vascular stapler to effect ligation, division and stapling of the dorsal vein complex and lateral pedicles of the prostate. This group was compared to 7 controls in whom we performed surgery for organ confined disease, using the stapler solely for the lateral prostatic pedicles or not at all depending on availability. One patient with localized muscle invasive transitional cell carcinoma of the bladder underwent radical cystectomy using the endoscopic GIA stapler in a sequential fashion to ligate and divide all pedicles of the specimen. RESULTS: Mean total operative time was 2 hours (range 1 hour 40 minutes to 2 hours 50 minutes) and average estimated blood loss was 400 cc. All patients were discharged from the hospital on postoperative day 3. To date 17 of the 21 patients are continent and 6 are potent. CONCLUSIONS: Although not designed to replace the standard approach to radical retropubic prostatectomy, we believe that this technique makes the procedure easier and more approachable in the hands of the less experienced surgeon.
Humans↗
Relationship between determinants of oxygen delivery and respiratory abnormalities in preterm infants with anemia.
To study the relationship between anemia and breathing abnormalities in preterm infants, we measured oxygen supply and demand in two groups of anemic infants less than or equal to 32 weeks of gestational age. Six-second apnea density was less than 1% in one group and greater than or equal to 5% in the other. There were no differences in hemoglobin concentration, available oxygen, oxygen consumption, or Doppler-determined cardiac output between the two groups of infants. Furthermore, in anemic preterm infants with apnea density greater than or equal to 5%, reductions in 6-second apnea density were similar after erythrocyte transfusion (mean +/- SEM: from 8.6% +/- 1.1% to 4.7% +/- 0.7%) or after an isovolemic infusion of 5% albumin (from 9.0% +/- 1.4% to 4.7% +/- 0.7%). These results show no relationship between measures of oxygen delivery and respiratory irregularities, and indicate that volume expansion may play a role in ameliorating the pneumocardiogram abnormalities.
Anemia↗
Six- and twelve-month follow-up of the phase I Thrombolysis in Myocardial Infarction (TIMI) trial.
The Thrombolysis in Myocardial Infarction (TIMI) trial Phase I was designed to compare the efficacy and side effects of intravenous recombinant tissue-type plasminogen activator (rt-PA) and intravenous streptokinase (SK) in patients with acute myocardial infarction (AMI). As previously reported, rt-PA led to a reperfusion rate of 62% of totally occluded coronary arteries compared with 31% for SK (p less than 0.001). This study was not designed to determine if intravenous thrombolytic therapy decreases the mortality of AMI; however, the findings in these patients after 1 year of follow-up do permit certain insights into the impact of early reperfusion and reocclusion on the clinical course of patients with AMI. The mortality rate at 6 and 12 months was not significantly different in patients treated with rt-PA compared with SK (7.7% and 10.5% rt-PA vs 9.5% and 11.6% for SK). The frequency of recurrent AMI, coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA) was similar in the 2 treatment groups. There was no significant difference in 6- and 12-month mortality or in the rate of recurrent AMI in patients who received thrombolytic therapy before compared with after 4 hours of the onset of AMI symptoms. When the results were analyzed on the basis of the patency of the infarct-related artery, irrespective of thrombolytic agent used, for those patients with patent arteries 90 minutes after the initiation of therapy, there was a trend toward a lower 6-month (5.6% vs 12.5%) and 12-month mortality (8.1% vs 14.8%) (p = 0.07).(ABSTRACT TRUNCATED AT 250 WORDS)
Actuarial Analysis↗
Thrombolysis in Myocardial Infarction (TIMI) Trial, Phase I: A comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge.
Intravenous administration of 80 mg of recombinant tissue plasminogen activator (rt-PA, 40, 20, and 20 mg in successive hours) and streptokinase (SK, 1.5 million units over 1 hr) was compared in a double-blind, randomized trial in 290 patients with evolving acute myocardial infarction. These patients entered the trial within 7 hr of the onset of symptoms and underwent baseline coronary arteriography before thrombolytic therapy was instituted. Ninety minutes after the start of thrombolytic therapy, occluded infarct-related arteries had opened in 62% of 113 patients in the rt-PA and 31% of 119 patients in the SK group (p less than .001). Twice as many occluded infarct-related arteries opened after rt-PA compared with SK at the time of each of seven angiograms obtained during the first 90 min after commencing thrombolytic therapy. Regardless of the time from onset of symptoms to treatment, more arteries were opened after rt-PA than SK. The reduction in circulating fibrinogen and plasminogen and the increase in circulating fibrin split products at 3 and 24 hr were significantly less in patients treated with rt-PA than in those treated with SK (p less than .001). The occurrence of bleeding events, administration of blood transfusions, and reocclusion of the infarct-related artery was comparable in the two groups. Thus, in patients with acute myocardial infarction, rt-PA elicited reperfusion in twice as many occluded infarct-related arteries as compared with SK at each of seven serial observations during the first 90 min after onset of treatment.
Blood Coagulation↗
Intravenous recombinant tissue-type plasminogen activator in patients with acute myocardial infarction: a report from the NHLBI thrombolysis in myocardial infarction trial.
The efficacy and safety of a 3 hr, 80 mg intravenous infusion of recombinant tissue-type plasminogen activator (rt-PA) were investigated in 47 patients with acute myocardial infarction. Coronary angiography, performed before the administration of rt-PA and for 90 min thereafter, demonstrated that 37 patients had total coronary occlusion before therapy. After 90 min of rt-PA (50 mg), reperfusion of the infarct-related artery was observed in 25 patients (68%). Continuous infusions of heparin for anticoagulation were administered for 8 to 10 days. Of 36 patients who underwent follow-up coronary cineangiography, 21 had initially presented with total occlusion and had experienced reperfusion at 90 min. Sustained perfusion of the infarct-related artery was observed in 14 (67%) of these 21 initially reperfused patients. Late angiography was performed in nine patients who initially demonstrated subtotal occlusion of the infarct-related artery; sustained perfusion was observed in eight (89%). Significant bleeding was observed in 15 patients (32%). A hematoma at the site of the acute catheterization accounted for most instances of significant bleeding (11/15, 73%). Administration of rt-PA resulted in a significant decline in fibrinogen and plasminogen while amounts of fibrin(ogen) degradation products rose. In no patient, however, did fibrinogen levels decline to less than 140 mg/dl. Thus, rt-PA, administered as a brief 80 mg intravenous infusion, is capable of restoring blood flow in a high proportion of patients with acute myocardial infarction due to total coronary obstruction. Declines in plasma fibrinogen and plasminogen are observed. If combined with heparin anticoagulation and invasive vascular procedures, significant bleeding is a common complication.(ABSTRACT TRUNCATED AT 250 WORDS)
Adult↗
High dose intravenous streptokinase for acute myocardial infarction: preliminary results of a multicenter trial.
To assess the efficacy of intravenous streptokinase in patients with acute myocardial infarction, 40 patients (30 men and 10 women, mean age 54 years) with acute myocardial infarction were given 1.5 million U of streptokinase intravenously in 1 hour, and coronary arteriography was performed repeatedly to assess reperfusion. Streptokinase treatment was begun 270 +/- 86 (mean +/- SD) minutes after the onset of chest pain. Of the 40 patients, 34 had total or near total coronary occlusion before streptokinase administration. In 14 (41%) of these 34 patients, some reperfusion occurred during the 90 minutes after the administration of streptokinase, but in only 11 of the 14 was reperfusion present at 90 minutes. After streptokinase administration, all patients received heparin for 8 to 10 days; they were subsequently administered aspirin and dipyridamole. Clinical evidence of reocclusion during the first 24 hours of heparin therapy occurred in one patient. Thus, when given to patients with acute myocardial infarction and total coronary occlusion an average of 4 1/2 hours after the onset of chest pain, high dose intravenous streptokinase achieves reperfusion in only about 40% and results in sustained reperfusion in only about 30%.
Adult↗
[Significance of radionuclide ventriculography (RNV) for the social medicine evaluation of myocardial infarct patients].
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Adult↗
Evaluation of cardiac function in patients with thalassemia major.
The application of noninvasive techniques to the evaluation of cardiac function in iron overload has identified a high incidence of abnormalities in asymptomatic patients prior to the onset of overt cardiac deterioration. Of the tests we have used, radionuclide cineangiography appears to be the most sensitive because it can be conveniently applied during the physiological stress of exercise. Other tests of cardiac function that include stress are also likely to be more sensitive than resting measurements of cardiac function. Systematic application of these techniques to the study of patients on iron chelation therapy should results in an early determination of the efficacy of such treatment.
Adolescent↗