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Biomedical subjects

G Reeder

Publications and source records attributed to G Reeder.

13 recordsLinked to original sources

Percutaneous transmyocardial laser revascularisation for severe angina: the PACIFIC randomised trial. Potential Class Improvement From Intramyocardial Channels.

BACKGROUND: Percutaneous transmyocardial laser revascularisation (PTMR) is a proposed catheter-based therapy for refractory angina pectoris when bypass surgery or angioplasty is not possible. We undertook a randomised trial to assess the safety and efficacy of this technique. METHODS: 221 patients with reversible ischaemia of Canadian Cardiovascular Society angina class III (61%) or IV (39%) and incomplete response to other therapies were recruited from 13 centres. Patients were randomly assigned PTMR with a holmium:YAG laser plus continued medical treatment (n=110) or continued medical treatment only (n=111). The primary endpoint was the exercise tolerance at 12 months. Analyses were by intention to treat. FINDINGS: 11 patients died and 19 withdrew; 92 PTMR-group and 99 medical-treatment-group patients completed the study. Exercise tolerance at 12 months had increased by a median of 89.0 s (IQR -15 to 183) with PTMR compared with 12.5 s (-67 to 125) with medical treatment only (p=0.008). On masked assessment, angina class was II or lower in 34.1% of PTMR patients compared with 13.0% of those medically treated. All indices of the Seattle angina questionnaire improved more with PTMR than with medical care only. By 12 months there had been eight deaths in the PTMR group and three in the medical treatment group, with similar survival in the two groups. INTERPRETATION: PTMR was associated with increased exercise tolerance time, low morbidity, lower angina scores assessed by masked reviewers, and improved quality of life. Although there is controversy about the mechanism of action, and the contribution of the placebo effect cannot be quantified, this unmasked study suggests that this palliative procedure provides some clinical benefits in the defined population of patients.

Adult↗

Modern adjunctive pharmacotherapy of myocardial infarction.

During acute myocardial infarction (MI), aspirin, beta-adrenergic antagonists and oral angiotensin converting enzyme (ACE) inhibitors should be used as an adjunct to reperfusion therapy. Medications upon discharge from the hospital should include aspirin and a beta-blocker. An ACE inhibitor should also be prescribed unless the ejection fraction is > 45%. Particular indications for an ACE inhibitor are an anterior MI, congestive heart failure, ejection fraction < 45% and mitral regurgitation. beta-blockers, when given to patients treated with ACE inhibitors, appear to produce an additional benefit compared with an ACE inhibitor alone. Based on the Scandinavian Simvastatin Survival Study (4S), Cholesterol and Recurrent Events (CARE) and Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) trials, a statin should also be given to subjects with low density lipoprotein (LDL)-cholesterol levels above 125 mg/dl, independent of total cholesterol levels. Therapy should be administered in an attempt to reduce the LDL-cholesterol level to 90-100 mg/dl (2.3-2.6 mM/l). In patients with normal or low levels on initial evaluation, screening for lipid abnormalities should be deferred for 2 months since acute phase responses and passive hepatic congestion can cause spuriously normal levels. Calcium channel blockers, nitrates, lidocaine, anti-arrhythmic drugs and i.v. magnesium should not be administered routinely after acute MI and their use should be restricted to selected settings.

Adrenergic beta-Antagonists↗

Employment after coronary angioplasty or coronary bypass surgery in patients employed at the time of revascularization.

BACKGROUND: Patients who undergo coronary angioplasty have a shorter convalescence than those who undergo coronary bypass surgery. This may improve subsequent employment. OBJECTIVE: To compare employment patterns after coronary angioplasty or surgery. DESIGN: Multicenter, randomized clinical trial. SETTING: Seven tertiary care hospitals. PATIENTS: 409 employed patients with multivessel coronary artery disease. INTERVENTION: Coronary bypass surgery or balloon angioplasty. MEASUREMENTS: Time to return to work and time spent working during 4 years of follow-up. RESULTS: Patients who underwent angioplasty returned to work 6 weeks sooner than patients who underwent coronary bypass surgery (P < 0.001), but long-term employment did not differ significantly (P > 0.2). Long-term employment was significantly lower among patients who were 60 to 64 years of age (P < 0.001), those who worked less than full-time at study entry (P < 0.001), and those who had less formal education (P = 0.005). Patients with only one source of health insurance were more likely to continue working (P = 0.005). CONCLUSIONS: Faster recovery after angioplasty speeds return to work but does not improve long-term employment, which is primarily associated with nonmedical factors.

Age Factors↗

Medical care costs and quality of life after randomization to coronary angioplasty or coronary bypass surgery. Bypass Angioplasty Revascularization Investigation (BARI) Investigators.

BACKGROUND: Randomized trials comparing coronary angioplasty with bypass surgery in patients with multivessel coronary disease have shown no significant differences in overall rates of death and myocardial infarction. We compared quality of life, employment, and medical care costs during five years of follow-up among patients treated with angioplasty or bypass surgery. METHODS: A total of 934 of the 1829 patients enrolled in the randomized Bypass Angioplasty Revascularization Investigation participated in this study. Detailed data on quality of life were collected annually, and economic data were collected quarterly. RESULTS: During the first three years of follow-up, functional-status scores on the Duke Activity Status Index, which measures the ability to perform common activities of daily living, improved more in patients assigned to surgery than in those assigned to angioplasty (P<0.05). Other measures of quality of life improved equally in both groups throughout the follow-up period. Patients in the angioplasty group returned to work five weeks sooner than did patients in the surgery group (P<0.001). The initial mean cost of angioplasty was 65 percent that of surgery ($21,113 vs. $32,347, P<0.001), but after five years the total medical cost of angioplasty was 95 percent that of surgery ($56,225 vs. $58,889), a difference of $2,664 (P = 0.047). The five-year cost of angioplasty was significantly lower than that of surgery among patients with two-vessel disease ($52,930 vs. $58,498, P<0.05), but not among patients with three-vessel disease ($60,918 vs. $59,430). After five years of follow-up, surgery had an overall cost-effectiveness ratio of $26,117 per year of life added, but unacceptable ratios of $100,000 or more per year of life added could not be excluded (P=0.13). Surgery appeared particularly cost effective in treating diabetic patients because of their significantly improved survival. CONCLUSIONS: In patients with multivessel coronary disease, coronary-artery bypass surgery is associated with a better quality of life for three years than coronary angioplasty, after the initial morbidity caused by the procedure. Coronary angioplasty has a lower five-year cost than bypass surgery only in patients with two-vessel coronary disease.

Angioplasty, Balloon, Coronary↗

Influence of procedural success on immediate and long-term clinical outcome of patients undergoing percutaneous revascularization of occluded coronary artery bypass vein grafts.

OBJECTIVES: This study sought to determine whether successful recanalization of an occluded vein graft is associated with improvement in long-term clinical outcome. BACKGROUND: Coronary angioplasty of occluded vein grafts is associated with a lower initial success rate and a higher complication rate than angioplasty of vein grafts with subtotal stenoses and native coronary arteries. Whether successful angioplasty improves clinical outcome is unknown. METHODS: We analyzed 77 consecutive patients who underwent angioplasty of an occluded saphenous vein coronary artery bypass graft between August 1983 and June 1994. Patients with a myocardial infarction in the previous 24 h were excluded from the study. RESULTS: The mean age of the study cohort was 65 years; the mean (+/- SD) age of the treated grafts was 7.5 +/- 3.9 years. As an adjunct to balloon angioplasty, stents were used in 9% of procedures, laser in 30%, and atherectomy in 16%, and thrombolytic therapy was administered in 23% of patients. The angioplasty success rate was 71%. Major complications within 30 days of the procedure included death in 5.2% of patients, Q wave myocardial infarction in 1.3% and repeat bypass surgery in 7.8%; these events occurred with similar frequency in patients in whom angiographic success was and was not achieved. Kaplan-meier analysis comparing patients in whom angioplasty was successful (n = 55) and not successful (n = 22) revealed no differences in survival or occurrence of myocardial infarction or recurrent severe angina between the two groups in the 3 years after the procedure. Univariate analysis identified the age of the graft and use of newer interventional devices as predictors of death or myocardial infarction during this time period; procedural success was not associated with freedom from these adverse events after adjusting for these variables. CONCLUSIONS: Angioplasty of occluded vein grafts is associated with a low initial success rate and a high complication rate. Successful angioplasty does not appear to reduce the occurrence of adverse events in the 3 years after the procedure.

Aged↗

Development of a stable freeze-dried formulation of recombinant human interleukin-1 receptor antagonist.

PURPOSE: A formulation of recombinant human interleukin-1 receptor antagonist (rhIL-1ra) was developed that provided both acute protection during lyophilization and storage stability in the dried solid. METHODS: The formulation was optimized by monitoring the impact of excipients on protein degradation which was analyzed by turbidimetry and cation-exchange HPLC. RESULTS: The most appropriate pH was 6.5. Sodium citrate buffer provided better stability than sodium phosphate buffer. Glycine was selected as a bulking agent because the greatest protein stability was noted when this bulking agent was used in combination with an amorphous protein stabilizer. Among the amorphous stabilizers tested, sucrose protected rhIL-1ra best in the presence of glycine. When the protein was freeze-dried in the presence of an inadequate mass ratio of sucrose/protein (< 0.3), the rate of degradation of rhIL-1ra increased. For a formulation containing 100 mg/ml of rhIL-1ra, increasing the sucrose/protein mass ratio to > or = 0.3 greatly increased storage stability. The moisture content of the dried solid affected the storage stability to a minor degree. Three different stoppers obtained from the WEST Company did not affect the stability of rhIL-1ra. CONCLUSIONS: An optimized formulation could be reconstituted without precipitation after 14 months at 30 or 50 degrees C. At 30 degrees C, there was no loss of native protein due to deamidation, and only a 4% loss at 50 degrees C. These results indicated that the optimized formulation could be stored at ambient temperatures for long periods, without damage to the protein.

Buffers↗

Better functional status in American than Canadian patients with heart disease: an effect of medical care?

OBJECTIVES: This study compared functional status in Americans and Canadians with and without prior symptoms of heart disease to separate the effects of medical care from nonmedical factors. BACKGROUND: Coronary angiography and revascularization are used more often in the United States than in Canada, yet rates of mortality and myocardial infarction are similar in the two countries. Recent data suggest that functional status after myocardial infarction is better among Americans than Canadians, but it is uncertain whether this difference is due to medical care or nonmedical factors. METHODS: Quality of life was measured in patients enrolled in seven American and one Canadian site in the Bypass Angioplasty Revascularization Investigation. Prior symptoms of heart disease were defined as angina, myocardial infarction or congestive heart failure before the episode of illness leading to randomization. Functional status was measured with the Duke Activity Status Index and overall emotional and social health using Medical Outcome Study measures on the basis of patient status before the index episode of acute ischemic heart disease. RESULTS: Quality of life was generally better in the 934 Americans than in the 278 Canadians, with overall health rated as excellent or very good in 30% of Americans versus 20% of Canadians (p = 0.0001), higher median Duke Activity Status Index scores (16 vs. 13.5, p = 0.03) but equivalent emotional health (76 vs. 76, p = 0.74) and social health scores (100 vs. 80, p = 0.07). Among the 350 patients without prior symptoms of heart disease, Americans and Canadians had similar overall health, Duke Activity Status Index and emotional and social health scores. However, of the 860 patients with previous symptoms of heart disease, Americans had higher overall health (p = 0.0001) and Duke Activity Status Index scores (p = 0.0008) but similar emotional and social health scores. The results were essentially unchanged after statistical adjustment for potential confounding factors. CONCLUSIONS: The functional status of patients without prior symptoms of heart disease is similar in Americans and Canadians. However, among patients with previous symptomatic heart disease, functional status is higher in Americans than in Canadians. This difference may be due to different patterns of medical management of heart disease in the two countries.

Aged↗

Initial functional and economic status of patients with multivessel coronary artery disease randomized in the Bypass Angioplasty Revascularization Investigation (BARI).

Randomized trials of coronary angioplasty and bypass surgery have hypothesized that these procedures will have equivalent long-term rates of death and myocardial infarction. Functional status, quality of life, employment, and healthcare cost will therefore be critical measures of the efficacy of these alternative revascularization procedures. Patients at 7 sites in the Bypass Angioplasty Revascularization Investigation (BARI) were enrolled in an ancillary Study of Economics and Quality of Life (SEQOL). Physical function was assessed by the Duke Activity Status Index and emotional status by the Mental Health Inventory. Employment patterns and health care utilization were also measured at study entry and at 3-month intervals in follow-up. The 934 patients enrolled in SEQOL were similar to the 895 remaining BARI randomized patients. Most patients (63%) aged < or = 64 years were working, and almost all working patients (96%) intended to return to work. Patients aged > or = 65 years had lower household incomes but better health insurance coverage. Overall health ratings were significantly correlated with both physical and emotional status (p < 0.001). Patients enrolled in SEQOL are representative of the overall BARI population. Data collected in SEQOL will provide a detailed picture of the physical, emotional, and economic well-being after coronary angioplasty and bypass surgery.

Angioplasty, Balloon, Coronary↗

Age differences in perception of risk.

Age differences in perception of risk and the likelihood of disregarding warning signs were examined. A total of 358 adults, between 18 and 85 years old, were asked to rate 12 warning labels with respect to (a) how risky it would be to ignore the warning, (b) how likely it was that they would disregard the warning, and (c) how familiar they were with the labels. The older groups indicated higher risk in ignoring the signs than did the younger group. The older subjects were also less willing to disregard the signs than the younger subjects.

Adolescent↗

Recent progress in engineering the Pittsburgh intravenous membrane oxygenator.

The University of Pittsburgh intravenous membrane oxygenator (IMO) is undergoing additional engineering development and characterization. The focus of these efforts is an IMO device that can supply as much as one-half basal O2 consumption and CO2 elimination rates while residing within the inferior and superior vena cavae after peripheral venous insertion. The current IMO design consists of a bundle of hollow fiber membranes potted to manifolds at each end, with an intra-aortic type balloon integrally situated within the fiber bundle. Pulsation of the balloon using helium gas and a balloon pump console promotes fluid and fiber motion and enhances gas exchange. During the past year, more than 15 IMO prototypes have been fabricated and extensively bench tested to characterize O2 gas exchange capacity, balloon inflation/deflation over relevant frequency ranges, and the pneumatics of the sweep gas pathway through the device. The testing has led to several engineering changes, including redesign of the helium and sweep gas pathways within the IMO device. As a result, the maximum rate of balloon pulsation has increased substantially above the previous 70 bpm to 160 bpm, and the vacuum pressure required for sufficient sweep gas flow has been reduced. The recent IMO prototypes have demonstrated an O2 exchange capacity of as much as 90 ml/min/m2 in water, which appears within 70% of our design goal when extrapolated to scaled up devices in blood.

Biomedical Engineering↗