Outpatient nursing case management for cardiovascular disease.

Case management has been an effective treatment model for maintaining costs while preserving quality of care for vulnerable populations who are frequent care users. Nursing case management has been effective in improving health outcomes in chronically ill populations. Specifically, nurse practitioner care has been as effective, and in some areas, more effective in managing chronic health problems of patients than care provided by physicians. Cardiovascular disease is a chronic condition, often accompanied by long-term symptoms and disability, that is prevalent in the United States population. Outpatient nursing case management for chronic health problems associated with cardiovascular disease is posited as a model for a heavily used system that maintains quality of care in this group.

Selective uptake of radiolabeled annexin V on acute porcine left atrial thrombi.

BACKGROUND: Annexin V is a human phospholipid binding protein that binds to activated platelets in vitro. We sought to determine the potential of this agent for imaging intracardiac thrombi in swine. METHODS AND RESULTS: Left atrial thrombi were formed by crush injury. In initial nonimaging experiments using intravenous 125I-labeled human annexin V, the mean thrombus/whole blood ratio was 13.4 +/- 4.8 for the entire thrombus using well counting of resected specimens (n = 8). Using intravenously injected 99mTc-labeled human annexin V, the left atrial thrombus/blood ratio by well counting was similar (14.2 +/- 10.6 for the entire thrombus and 26.2 +/- 14.9 for the peak section) (n = 12). The ratio for a control protein, 125I-ovalbumin, was only 1.0 +/- 0.2. 99mTc tomographic imaging was positive (n = 10) or equivocal (n = 2) in all experiments with but negative in 10 controls without left atrial thrombi. By region-of-interest analysis of the tomographic images, the mean left atrial appendage/blood ratio at 2 hours in animals with a thrombus was 3.90 +/- 1.12 compared with 0.84 +/- 0.10 in closed chest controls and 1.01 +/- 0.23 in open chest controls (P < .001). CONCLUSIONS: We conclude that 99mTc-labeled human annexin V detects acute left atrial thrombi in vivo in swine. The combination of a new thrombus detection agent, annexin V, with a 99mTc label may allow in vivo imaging of thrombi in humans.

Development and evaluation of the Seattle Angina Questionnaire: a new functional status measure for coronary artery disease.

OBJECTIVES: This study sought to establish the validity, reproducibility and responsiveness of the Seattle Angina Questionnaire, a 19-item self-administered questionnaire measuring five dimensions of coronary artery disease: physical limitation, anginal stability, anginal frequency, treatment satisfaction and disease perception. BACKGROUND: Assessing the functional status of patients is becoming increasingly important in both clinical research and quality assurance programs. No current functional status measure quantifies all of the important domains affected by coronary artery disease. METHODS: Cross-sectional or serial administration of the Seattle Angina Questionnaire was carried out in four groups of patients: 70 undergoing exercise treadmill testing, 58 undergoing coronary angioplasty, 160 with initially stable coronary artery disease and an additional 84 with coronary artery disease. Evidence of validity was sought by comparing the questionnaire's five scales with the duration of exercise treadmill tests, physician diagnoses, nitroglycerin refills and other validated instruments. Reproducibility and responsiveness were assessed by comparing serial responses over a 3-month interval. RESULTS: All five scales correlated significantly with other measures of diagnosis and patient function (r = 0.31 to 0.70, p < or = 0.001). Questionnaire responses of patients with stable coronary artery disease did not change over 3 months. The questionnaire was sensitive to both dramatic clinical change, as seen after successful coronary angioplasty, and to more subtle clinical change, as seen among outpatients with initially stable coronary artery disease. CONCLUSIONS: The Seattle Angina Questionnaire is a valid and reliable instrument that measures five clinically important dimensions of health in patients with coronary artery disease. It is sensitive to clinical change and should be a valuable measure of outcome in cardiovascular research.

Monitoring the quality of life in patients with coronary artery disease.

Monitoring the outcomes of treatment and quantifying patients' functional status have assumed a prominent role in both clinical trials and quality assurance programs. Because patients with coronary artery disease (CAD) may have comorbid illnesses, and because generic health status questionnaires may not focus on symptoms and impairments unique to coronary disease, a generic measure of health status may not be sufficient to detect important changes in patients' CAD. The responsiveness to clinical change of the Seattle Angina Questionnaire (SAQ), a disease-specific measure for CAD, was compared with that of the Short Form-36, a generic measure of health status. Both questionnaires were serially administered, 3 months apart, to 45 patients undergoing coronary angioplasty and to 130 patients with stable CAD. Most scales of both questionnaires improved significantly after coronary angioplasty. The responsiveness statistics of the SAQ exceeded those of the Short Form-36. Among 130 patients with initially stable angina, 33 deteriorated, 79 remained stable, and 18 improved over 3 months of observation. Mean SAQ scores changed significantly and appropriately in each of these groups. In contrast, none of the Short Form-36 scales detected these more subtle changes. Although useful in assessing overall function, a generic health status measure, such as the Short Form-36, may not be responsive enough to detect important clinical changes in patients' CAD. A disease-specific instrument, such as the SAQ, can be an important and relevant outcome measure in clinical trials or quality assurance programs.

Imaging arterial thrombosis: comparison of technetium-99m-labeled monoclonal antifibrin antibodies and indium-111-platelets.

UNLABELLED: Imaging with the 99mTc-T2G1s monoclonal antifibrin antibody fragment (Fab') has demonstrated promise in the noninvasive detection of venous thrombi in humans. The purpose of this study was to determine whether chronic arterial thrombi can also be detected by antifibrin antibody imaging. METHODS: Eighteen subjects with chronic arterial thrombi were studied with planar and tomographic imaging at 0 to 24 hr postinjection of 99mTc-labeled T2G1s monoclonal antifibrin antibody fragment. Imaging with 111In-labeled platelets was also performed. Images were visually graded by two observers as 0, 1, 2 or 3 (no, faint, moderate or marked) uptake, and quantitative analysis of tomographic images was done in 13 subjects. RESULTS: On visual analysis of planar images, 44% (8 of 18) of antifibrin patient studies were 1.0 or more and 66% (10 of 18) were judged negative compared with 94% (15 of 16) of platelet patient studies judged 1.0 or more and 6% (1 of 16) judged as negative (p < 0.01). Visual analysis of tomographic images was similar, with 61% (11 of 18) of antifibrin studies graded 1.0 or more compared with 100% (17 of 17) of platelet studies (p < 0.01). The tomographic target-to-background ratio was higher with platelets than with antifibrin antibody (2.5 +/- 1.4 versus 1.8 +/- 1.0, p < 0.05). CONCLUSION: In the large-vessel chronic arterial thrombi studied, the results of 99mTc-labeled monoclonal T2G1s antifibrin Fab' imaging were positive in only one-half of the patients studied, significantly less than the findings with platelet imaging, which were positive in all subjects. The higher rate of positive images with labeled platelets than with labeled antifibrin antibodies may be largely due to thrombus age, with continued platelet deposition but little active fibrin deposition.

Evaluation of annexin V as a platelet-directed thrombus targeting agent.

Annexin V is a human phospholipid binding protein (M(r) 36,000) that binds with high affinity to activated platelets in vitro. We studied the biodistribution and thrombus binding of annexin V in rabbit and swine models of fully occlusive arterial thrombi formed 1-2 h prior to injection of annexin V. Iodinated annexin V was cleared from blood in a rapid early phase (t1/2 = 6.4 min, 76% of radioactivity) and a slower late phase (t1/2 = 71 min, 24% of radioactivity). Organ uptake was highest in the kidney and spleen and lowest in heart and skeletal muscle. Thrombus/blood uptake ratios were (mean +/- SEM): 6.39 +/- 1.80 for rabbit iliac artery, 6.97 +/- 1.45 for swine carotid artery, and 7.68 +/- 1.70 for swine femoral artery (all p values < 0.01 versus control artery); a control protein, ovalbumin, showed an uptake ratio of 0.59 +/- 0.08 in swine femoral artery thrombi. These results indicate that annexin V is useful as an agent for selective targeting of platelet-containing thrombi.

Hospital mortality in acute myocardial infarction in the era of reperfusion therapy (the Myocardial Infarction Triage and Intervention Project).

This study was conducted in 19 hospitals in the metropolitan Seattle area and included 6,270 unselected patients who had acute myocardial infarction (AMI) between January 1988 and April 1991. Hospital mortality was determined and related to patient demographic and clinical characteristics, the use of reperfusion therapies, and to complications after AMI. Thrombolytic therapy or direct coronary angioplasty < 6 hours from symptom onset was used to treat 1,185 (19%) and 524 (9%) patients, respectively. There were 629 (10%) hospital deaths; most occurred during the first 3 days of hospitalization. Factors affecting mortality after admission included: recurrent chest pain, recurrent AMI, development of heart failure, and the occurrence of stroke. After adjustment for age, treatment with thrombolytic therapy or direct angioplasty had no independent effect on reducing the overall mortality rate. Hospital mortality rates for AMI have improved considerably since 1970, although recurrent myocardial ischemic events continue to have an adverse effect on outcome. The current use of reperfusion treatments has had minimal causal impact on overall mortality rates, principally because less than one third of patients, who are relatively "low risk," are eligible and receive these treatments.

Percutaneous rotational thrombectomy reduces acute reocclusion in an animal model of acute coronary thrombosis.

This study was designed to compare acute reocclusion rates after treatment of acute coronary thrombosis with a percutaneous thrombectomy device or standard balloon angioplasty. Our group has previously reported on the rationale and development of a mechanical device for the treatment of intra-arterial thrombosis. This device removes fibrin from thrombus, allowing for dissolution of the cellular elements of the thrombus. Theoretically, thrombus removal (as opposed to displacement) might result in a lower rate of acute rethrombosis. The present study utilizes the device percutaneously in the coronary arteries of closed chest swine and compares recanalization and reocclusion rates with standard balloon angioplasty. Twenty-six animals with total thrombotic coronary occlusions were treated; 13 with each device. Reocclusion rates with the thrombectomy device were significantly reduced at 60 min and 120 min after recanalization (p < 0.02), and the mean time to reocclusion was prolonged by 45 min (p = 0.07). Technical problems included poor handling characteristics in early prototypes and stress fractures secondary to improper use. Changes in catheter design and operator protocols have largely eliminated these problems. We conclude that this study demonstrates the feasibility of percutaneous mechanical thrombectomy in the coronary arteries and that reocclusion rates after recanalization of thrombotic occlusions compare favorably to standard angioplasty.

Thrombolysis by rotational thrombectomy followed by tissue plasminogen activator: evaluation by angioscopy.

Thrombus removal using percutaneous rotational thrombectomy (PRT), followed by tissue plasminogen activator (t-PA), was studied by contrast angiography and fiberoptic angioscopy in a canine femoral artery model of thrombosis. After thrombus induction and following each treatment, comparisons were made between angioscopy and angiography for the detection of thrombus and subintimal dissection. Angioscopic images were scored in a blinded fashion for lining, protruding, or occlusive thrombus (class 1,2, or 3) as well as estimated wall coverage by thrombus. Angiograms were studied for percent diameter stenosis and the presence of flaps. Following external forceps crush injury of 18 arteries, two hour occlusion, and injection of thrombin, mean angiographic stenosis was 66%, thrombus coverage by angioscopy was 81%, and mean angioscopy class was 2.5. Following PRT, stenosis decreased to 27% (p less than 0.008), thrombus coverage was reduced to 49% (p less than 0.02), and angioscopy class dropped to 2.0 (p less than 0.07). After t-PA treatment, these values were further reduced to 25% (p = NS), 26% (p less than 0.02), and 1.3 (p less than 0.008), respectively. In comparison to angiography, subintimal dissection (seen as flaps) and thrombus (lining, protruding, or occlusive) were present significantly more often by angioscopy (p less than 0.001). It is concluded that PRT results in significant thrombolysis, apparent by angiography and angioscopy. Follow-up t-PA can produce additional, incremental thrombolysis, apparent only by angioscopy. A beneficial role for t-PA following mechanical thrombolysis is suggested by this model. The superior sensitivity of angioscopy for detection of flaps and thrombus is underscored by this study.