Pulmonary embolism in patients with intermediate probability lung scans: diagnosis with Doppler venous US and D-dimer measurement

PURPOSE: To test the usefulness of lower limb Doppler venous compression ultrasound (US) and serum D-dimer measurements in diagnosis of pulmonary embolism in patients in whom ventilation-perfusion (V-P) scans indicate intermediate probability of pulmonary embolism. MATERIALS AND METHODS: V-P scanning, pulmonary angiography, US, and D-dimer measurements were performed in 36 patients without known deep venous thrombosis but with intermediate probability of having a pulmonary embolism. RESULTS: Pulmonary angiography demonstrated pulmonary embolism in 15 (41%) of 36 patients. US demonstrated deep venous thrombosis in only two patients, both with pulmonary embolism. Sensitivity of US was only 13%, but specificity was 100%. Five (14%) of the 36 patients had normal (< 220 micrograms/L) D-dimer levels; none of the five had pulmonary embolism. Sensitivity and specificity of D-dimer values were 100% and 16%, respectively, with a negative predictive value of 100%. CONCLUSION: Combined D-dimer measurement and US were helpful in correctly diagnosing pulmonary embolism in only seven (20%) of 36 patients. Pulmonary angiography is still required to diagnose pulmonary embolism in the majority of patients.     

Value of perfusion lung scan in the diagnosis of pulmonary embolism: results of the Prospective Investigative Study of Acute Pulmonary Embolism Diagnosis (PISA-PED)

To assess the value of perfusion lung scan in the diagnosis of pulmonary embolism, we prospectively evaluated 890 consecutive patients with suspected pulmonary embolism. Prior to lung scanning, each patient was assigned a clinical probability of pulmonary embolism (very likely, possible, unlikely). Perfusion scans were independently classified as follows: (1) normal, (2) near-normal, (3) abnormal compatible with pulmonary embolism (PE+: single or multiple wedge-shaped perfusion defects), or (4) abnormal not compatible with pulmonary embolism (PE-: perfusion defects other than wedge-shaped). The study design required pulmonary angiography and clinical and scintigraphic follow-up in all patients with abnormal scans. Of 890 scans, 220 were classified as normal/or near-normal and 670 as abnormal. A definitive diagnosis was established in 563 (84%) patients with abnormal scans. The overall prevalence of pulmonary embolism was 39%. Most patients with angiographically proven pulmonary embolism had PE+ scans (sensitivity: 92%). Conversely, most patients without emboli on angiography had PE- scans (specificity: 87%). A PE+ scan associated with a very likely or possible clinical presentation of pulmonary embolism had positive predictive values of 99 and 92%, respectively. A PE- scan paired with an unlikely clinical presentation had a negative predictive value of 97%. Clinical assessment combined with perfusion-scan evaluation established or excluded pulmonary embolism in the majority of patients with abnormal scans. Our data indicate that accurate diagnosis of pulmonary embolism is possible by perfusion scanning alone, without ventilation imaging. Combining perfusion scanning with clinical assessment helps to restrict the need for angiography to a minority of patients with suspected pulmonary embolism.     

The role of venous ultrasonography in the diagnosis of suspected deep venous thrombosis and pulmonary embolism

This paper describes the role of venous ultrasonography in the diagnosis of suspected deep venous thrombosis and pulmonary embolism. Inability to compress the common femoral or popliteal vein is usually diagnostic of a first episode of deep venous thrombosis in symptomatic patients (positive predictive value of about 97%). Full compressibility of both of these sites excludes proximal deep venous thrombosis in symptomatic patients (negative predictive value of about 98%). In patients with suspected deep venous thrombosis or in those who present with suspected pulmonary embolism but have a nondiagnostic lung scan, the subsequent risk for symptomatic venous thromboembolism is very low (<2% during 6 months of follow-up) provided that ultrasonography of the proximal veins remains normal in the course of 1 week (suspected deep venous thrombosis) or 2 weeks (suspected pulmonary embolism). Anticoagulation and further diagnostic testing can usually be safely withheld in these situations. Venous ultrasonography is much less reliable for the diagnosis of asymptomatic, isolated distal, and recurrent deep venous thrombosis than for the diagnosis of a first episode of proximal deep venous thrombosis in symptomatic patients. Clinical evaluation of the probability of deep venous thrombosis or pulmonary embolism, preferably by using a validated clinical model, complements venous ultrasonographic findings and helps to identify patients who would benefit from additional (often invasive) diagnostic testing. Thus, venous ultrasonography is thought to be a very valuable test for the diagnosis and management of patients with suspected deep venous thrombosis or pulmonary embolism.     

Diagnosis of deep venous thrombosis and pulmonary embolism

Diagnostic evaluation in the patient with suspected deep vein thrombosis (DVT) and pulmonary embolism (PE) includes a clear correlation between clinical probability, test selection and test interpretation. Real-time B-mode ultrasound with color Doppler remains the imaging technique of choice in suspected DVT. The ventilation/perfusion (V/Q) lung scan is the preferred diagnostic modality in suspected PE. The D-dimer assay may be useful in excluding PA. New diagnostic techniques, including spiral computerized tomography may further modify the diagnostic algorithm.     

Rat gonadotropin-releasing hormone receptor expressed in insect cells induces activation of adenylyl cyclase

The diagnostic usefulness of measuring plasma D-dimers using the ELISA method and the latex agglutination test has been prospectively evaluated in 117 patients hospitalized for suspicion of acute venous thrombo-embolism (AVTE): pulmonary embolism was suspected in 80 patients and the remaining 37 had a suspicion of deep vein thrombosis of the lower limbs. The diagnosis of AVTE was confirmed in 50% of the patients, all of whom underwent gold standard invasive investigation i.e. pulmonary angiography and/or contrast venography. The sensitivity, specificity, negative predictive value and positive predictive value of a D-dimers plasma concentration exceeding 500 ng/ml for the diagnosis of AVTE were respectively 98, 58, 97 and 70% when using the ELISA method, and 86, 71, 84 and 75% when using the latex assay. In 47 patients whose lung scans yielded abnormalities of indeterminate probability of pulmonary embolism, the sensitivity of the ELISA method was very high (94%), but that of latex assay was low (67%). Our results demonstrate that measuring the plasma D-dimers by the latex assay should not be used in the diagnosis of AVTE. On the other hand, the ELISA method might be of great interest in the diagnostic strategy of AVTE, as a normal concentration of D-dimers rules out almost definitely the diagnosis of AVTE, and hence, spares from performing invasive investigations.     

DTPA aerosol in ventilation/perfusion scintigraphy for diagnosing pulmonary embolism

The use of lung scintigraphy in evaluating suspected pulmonary embolism (PE) is controversial. Several diagnostic methods have been described for lung scans, of which the most widely applied uses 99mTc-MAA for perfusion, 133Xe for ventilation and PIOPED diagnostic criteria. This study evaluates the accuracy of lung scintigraphy using an alternative ventilation agent, 99mTc-diethylenetriamine pentacetic acid (DTPA) aerosol, and specific criteria. METHODS: Diagnostic criteria for DTPA aerosol ventilation were prospectively applied to 5017 patients over a 9-yr period. Lung scan interpretations were analyzed for frequency of occurrence, and results were compared to those of angiography in 455 patients. RESULTS: Scans were interpreted as normal, low or high probability in 79% of patients and as either indeterminate or medium probability in 21% of patients. Three patients had normal scans and negative angiography. In patients with low-probability scans, 111 angiograms were performed: 103 (93%) were negative, and 8 (7%) were positive. In patients with indeterminate scans, 114 angiograms were performed: 85 (75%) were negative, and 29 (25%) were positive. In patients with medium-probability scans, 149 angiograms were performed: 86 (58%) were negative, and 63 (42%) were positive. In patients with high-probability scans, 78 angiograms were performed: 6 (8%) were negative, and 72 (92%) were positive. CONCLUSION: These results indicate that lung scintigraphy using DTPA aerosol and our criteria is accurate in diagnosing and stratifying risk of pulmonary embolic disease. Compared with 133Xe and PIOPED criteria, DTPA ventilation and our criteria reduced the false-negative rate in low-probability scans (7% versus 16%, p < 0.005) and decreased the fraction of intermediate-probability scans (21 % versus 39%, p < 0.01).     

Non-invasive diagnosis of venous thromboembolism in outpatients

BACKGROUND: We designed a simple and integrated diagnostic algorithm for acute venous thromboembolism based on clinical probability assessment of deep-vein thrombosis (DVT) or pulmonary embolism (PE), plasma D-dimer measurement, lower-limb venous compression ultrasonography, and lung scan to reduce the need for phlebography and pulmonary angiography. METHODS: 918 consecutive patients presenting at the emergency ward of the Geneva University Hospital, Geneva, Switzerland, and H?pital Saint-Luc, Montreal, Canada, with clinically suspected venous thromboembolism were entered into a sequential diagnostic protocol. Patients in whom venous thromboembolism was deemed absent were not given anticoagulants and were followed up for 3 months. FINDINGS: A normal D-dimer concentration (<500 microg/L by a rapid ELISA) ruled out venous thromboembolism in 286 (31%) members of the study cohort, whereas DVT by ultrasonography established the diagnosis in 157 (17%). Lung scan was diagnostic in 80 (9%) of the remaining patients. Venous thromboembolism was also deemed absent in patients with low to intermediate clinical probability of DVT and a normal venous ultrasonography (236 [26%] patients), and in patients with a low clinical probability of PE and a non-diagnostic result on lung scan (107 [12%] patients). Pulmonary angiography and phlebography were done in only 50 (5%) and 2 (<1%) of the patients, respectively. Hence, a non-invasive diagnosis was possible in 866 (94%) members of the entire cohort. The 3-month thromboembolic risk in patients not given anticoagulants, based on the results of the diagnostic protocol, was 1.8% (95% CI 0.9-3.1). INTERPRETATION: A diagnostic strategy combining clinical assessment, D-dimer, ultrasonography, and lung scan gave a non-invasive diagnosis in the vast majority of outpatients with suspected venous thromboembolism, and appeared to be safe.     

Study on antifertility effect of a novel LHRH antagonist in male rats

The diagnosis of pulmonary embolism is even in contemporary clinical practice problematical. Pulmonary angiography is used in our departments very little due to its invasive character. The method of choice for diagnosis remains therefore perfusion scintigraphy of the lungs, in this country frequently without ventilation scintigraphy as it is not available in the majority of our departments of nuclear medicine. In recent years in the diagnostic algorithms also assessment of D-dimers was started, i.e. assessment of products of fibrinolysis assessed by monoclonal antibodies. The authors tried to find out how many patients admitted to the medical department for diagnosis of pulmonary embolization may have a false positive diagnosis on the basis of pulmonary scintigraphy. During the period III/96 to V/96 a total of 18 patients from the medical clinic with suspected pulmonary embolism were examined where the value of D-dimers(latex test) was assessed and at the same time perfusion scintigraphy was performed. With regard to the highly negative predictive value of D-dimer assessment the authors focused their attention on patients with a suspect or positive lung scan (i.e. treated on account of pulmonary embolism) while D-dimers were negative. Of 13 patients with suspect or possible pulmonary embolism, as assessed by scintigraphy, four had negative dimers(30%). With regard to the 90% reported negative predictive value, based on the literature, thus three of these patients were unnecessarily admitted to hospital and treated. The authors assume that assessment of D-dimers should be part of the examination protocol due to its non-pretentious character and low price as compared with costs of hospitalization.     

Laboratory evaluation in the diagnosis of Lyme disease

PURPOSE: To provide a qualitative evaluation of the predictive value of the laboratory diagnosis of Lyme disease and to use the resultant data to formulate guidelines for clinical diagnosis. DATA SOURCES: A MEDLINE search of English-language articles or articles with English-language abstracts published from 1982 to 1996. DATA EXTRACTION: Sensitivity, specificity, and likelihood ratios were calculated, and a random-effects model was used to combine the proportions from the eligible studies. Prespecified criteria were used to determine which studies were eligible for analysis. DATA SYNTHESIS: Laboratory testing in general is not clinically useful if the pretest probability of Lyme disease is less than 0.20 or greater than 0.80. When the pretest probability is 0.20 to 0.80, sequential testing with enzyme-linked immunosorbent assay and Western blot is the most accurate method for ruling in or ruling out the possibility of Lyme disease. CONCLUSIONS: Laboratory testing is recommended only in patients whose pretest probability of Lyme disease is 0.20 to 0.80. If the pretest probability is less than 0.20, testing will result in more false-positive results than true-positive results; a negative test result in this situation effectively rules out the disease.     

Derivation of a clinical prediction model for the emergency department diagnosis of ectopic pregnancy

OBJECTIVE: To derive a clinical prediction model for estimating the pretest probability of ectopic pregnancy in ED patients with first-trimester abdominal pain or vaginal bleeding. METHODS: All hemodynamically stable first-trimester patients presenting to the ED of a tertiary care military teaching hospital over a 14-month period with a chief complaint of abdominal pain and/or vaginal bleeding had clinical data coded prior to determining outcome. They were then followed longitudinally until a criterion standard pregnancy outcome was established. RESULTS: Of the 486 patients enrolled, 280 (58%) had viable intrauterine pregnancies, 167 (34%) had nonviable intrauterine pregnancies, and 39 (8%) had ectopic pregnancies. Using a recursive partitioning model, a high-risk group was derived (that was separated from intermediate and low-risk groups), consisting of patients with abdominal peritoneal signs or definite cervical motion tenderness, with a sensitivity of 31% (95% CI: 17-48%), a specificity of 93% (95% CI: 90-95%), a positive likelihood ratio of 4.3, and a negative likelihood ratio of 0.74. A low-risk group, consisting of patients with either fetal heart tones or tissue at the cervical os, or the absence of pain other than midline menstrual-like cramping and lacking any pelvic tenderness, was differentiated from an intermediate-risk group, with a sensitivity of 96% (95% CI: 81-100%), a specificity of 22% (95% CI: 18-26%), a positive likelihood ratio of 1.2, and a negative likelihood ratio of 0.17. CONCLUSION: A clinical prediction model for estimating the probability of ectopic pregnancy in ED patients has been derived. It may prove to have practical clinical application for estimating pretest probability of ectopic pregnancy as well as assisting in medical decision making when laboratory and ultrasonographic findings are nondiagnostic. Clinical application should await prospective validation in an independent sample.     

Effects of insulin therapy on non-insulin-dependent diabetics with secondary oral hypoglycemic agent failure

A recent trend among physicians is the categorisation of lung scans as normal [excludes pulmonary embolism (PE)], high probability (confirms PE) and non-diagnostic (no judgement on PE risk). The low probability scan is therefore being eliminated as a functional category. This occasional survey contends that such an approach is misguided. Correction of the original PIOPED data with certain assumptions provides a more reproducible, albeit restricted, low probability scan category which excludes PE in 97% of cases in the low pre-test clinical category. Patients with a low probability scan with risk factors for PE (i.e. medium clinical risk) will require further investigation. More important, the very low probability scan category excludes PE in 98% of patients with low and more than 92% of patients with medium pre-test clinical likelihood. The demise of "low probability" is premature.     

Pulmonary embolism: prospective comparison of spiral CT with ventilation-perfusion scintigraphy

PURPOSE: To compare prospectively the accuracy of spiral computed tomography (CT) with that of ventilation-perfusion scintigraphy for diagnosing pulmonary embolism. MATERIALS AND METHODS: Within 48 hours of presentation, 142 patients suspected of having pulmonary embolism underwent spiral CT, scintigraphy, and (when indicated) pulmonary angiography. Pulmonary angiography was attempted if interpretations of spiral CT scans and of scintigrams were discordant or indeterminate and intermediate-probability, respectively. RESULTS: In the 139 patients who completed the study, interpretations of spiral CT scans and of scintigrams were concordant in 103 patients (29 with embolism, 74 without). In 20 patients, intermediate-probability scintigrams were interpreted (six with embolism at angiography, 14 without); diagnosis with spiral CT was correct in 16. Interpretations of spiral CT scans and those of scintigrams were discordant in 12 cases; diagnosis with spiral CT was correct in 11 cases and that with scintigraphy was correct in one. Spiral CT and scintigraphic scans of four patients with embolism did not show embolism. Sensitivities, specificities, and kappa values with spiral CT and scintigraphy were 87%, 95%, and 0.85 and 65%, 94%, and 0.61, respectively. CONCLUSION: In cases of pulmonary embolism, sensitivity of spiral CT is greater than that of scintigraphy. Interobserver agreement is better with spiral CT.     

Noninvasive diagnosis of pulmonary embolism

With the development of new methods for detecting pulmonary embolism, the need for angiography has been greatly reduced. Plasma D-dimer assays, lower-limb ultrasonography, and ventilation/perfusion lung scans in combination with the clinical assessment enable safe, cost-effective diagnoses.     

Comparison of immunofiltration assay of plasma D-dimer with diagnostic imaging in deep vein thrombosis

This prospective study was designed to assess the diagnostic sensitivity, specificity and negative predictive value of the NycoCard D-dimer plasma immunofiltration assay in patients with suspected deep vein thrombosis (DVT) confirmed by ultrasonography/venography. 84 medical patients were recruited: 43 patients (51%) had proven venous thrombosis, 33 by venography and 10 by ultrasonography. The sensitivity of NycoCard D-dimer in patients with DVT was 95.3%, the specificity was 22.0% and the negative predictive value was 81.8%. An algorithm including the NycoCard D-dimer test for the acute management of DVT is proposed. This would enable low-risk patients to be discharged early from hospital, without imaging or anticoagulant therapy.     

Enhanced expression of bcl-2 inhibits apoptosis in cultured human keratinocytes

Intravenous heparin followed by oral warfarin sodium is effective for preventing recurrent thromboembolism in patients who have pulmonary embolism or proximal vein thrombosis. The effectiveness of intravenous heparin depends on obtaining an adequate anticoagulant response early during therapy. A validated heparin protocol should be used to ensure that an adequate anticoagulant response is obtained as soon as possible. Low molecular weight heparin has the practical advantage that it does not require monitoring and dose finding. If thrombolytic therapy is indicated, it is safer for many patients to base management on the noninvasive diagnosis rather than performing pulmonary angiography. In patients suspected to have pulmonary embolism who have nondiagnostic lung scan and adequate cardiorespiratory reserve, serial noninvasive leg testing is a practical approach that avoids pulmonary angiography, identifies patients who have proximal vein thrombosis requiring treatment, and avoids the risks of anticoagulant treatment in the majority of patients.     

Ventilation-perfusion lung scanning and spiral computed tomography of the lungs: competing or complementary modalities?

The recently developed technique of spiral computed tomographic angiography (CTA) is being used for the detection of pulmonary emboli (PE), and several studies have assessed its accuracy using pulmonary angiography as the gold standard. CTA shows a high level of accuracy in the detection of pulmonary emboli in segmental or larger central vessels. The specificity is high enough to eliminate the requirement for angiography if a positive CTA result is found. The main factor limiting the sensitivity of CTA is the frequency of peripheral emboli in the vessels outside the central chest field covered by CTA. The incidence of such peripheral emboli varies in different reports from 0% to 36%, and their significance remains arguable. Interpretative criteria for V./Q.- lung scintigraphy have been refined as a result of the lessons learned from the PIOPED study. Using these modified criteria, and taking into account the prior probability of PE based on the presence or absence of clinical risk factors, treatment decisions can be reasonably made in patients in the following categories: those with normal lung scans, those with high probability scans and high prior probability of PE, and those with low probability scans and low clinical suspicion. Patients with intermediate probability or indeterminate scans, and those in whom the scan results conflict with the clinical expectation, will need further tests. Ultrasound examination of the leg veins, if positive, will select a further subgroup of patients for active treatment. Patients with a negative or inconclusive ultrasound result, who previously have been candidates for pulmonary angiography, can now go on to CTA. The advantages in specificity which CTA offers will make it an important part of the diagnostic workup for selected patients, but in view of its increased cost and high radiation dose compared with V./Q. scintigraphy, the argument that CTA should completely replace lung scintigraphy is currently unsupportable.     

Accuracy of clinical assessment of deep-vein thrombosis

The clinical diagnosis of deep-vein thrombosis is generally thought to be unreliable. From experience, we hypothesised that this widely held view might be incorrect. We developed a clinical model and prospectively tested its ability in three tertiary care centres to stratify symptomatic outpatients with suspected deep-vein thrombosis into groups with high, moderate, or low probability groups of deep-vein thrombosis. We evaluated our clinical model in combination with venous ultrasonography to determine the potential for an improved and simplified diagnostic approach in patients with suspected deep-vein thrombosis. All patients were clinically assessed to determine the probability for deep-vein thrombosis before they had ultrasonography and venography. All tests were performed and interpreted by independent observers. In 529 patients, the clinical model predicted prevalence of deep-vein thrombosis in the three categories: 85% in the high pretest probability category, 33% in the moderate, and 5% in the low category. There was no statistical difference in the performance of the model in the three centres. The model demonstrated excellent interobserver reliability (Kappa = 0.85). There were important differences with ultrasonography between the high and low pretest probability groups for both positive predictive values (100% (95% CI, 94-100%) vs (63% [35-85%], respectively). Thus, use of the clinical model combined with ultrasonography would decrease the number of false positive and negative diagnosis if venography were done when the ultrasound result and pretest probability were discordant. The diagnostic process could be simplified by excluding those patients with low pretest probability and normal ultrasound results from serial testing.     

Stratification of patients according to prior cardiopulmonary disease and probability assessment based on the number of mismatched segmental equivalent perfusion defects. Approaches to strengthen the diagnostic value of ventilation/perfusion lung scans in acute pulmonary embolism

A categorical diagnosis of "high probability" or "intermediate probability" encompasses a spectrum of diagnostic probabilities of pulmonary embolism (PE) that is not communicated to the referring physician. The diagnostic value of ventilation/perfusion lung scans, in the present investigation, was strengthened by use of a table to determine the likelihood of PE in individual patients on the basis of the observed number of mismatched segmental equivalent perfusion defects. In addition, we tested the hypothesis that stratification of patients according to the presence or absence of prior cardiopulmonary disease may enhance the ventilation/perfusion scan assessment of the probability of PE among both of these clinical categories of patients. Data were derived from the collaborative study of the Prospective Investigation of Pulmonary Embolism Diagnosis (PIOPED). Ventilation/perfusion lung scans were evaluated in 378 patients with acute PE and 672 patients in whom suspected PE was excluded. Among patients with no prior cardiopulmonary disease, > or = 1.0 mismatched segmental equivalents was indicative of PE in 102 of 118 (86 percent) vs 113 of 155 (73 percent) among patients with prior cardiopulmonary disease (p < 0.02). Among patients with prior cardiopulmonary disease, > or = 2 mismatched segmental equivalents were required to indicate > or = 80 percent probability of PE. Stratification on the basis of the presence or absence of prior cardiopulmonary disease, therefore, enhanced the ability of ventilation/perfusion scan readers to assign an accurate positive predictive value and specificity to individual patients based on the observed number of mismatched segmental equivalent defects. Among patients with no prior cardiopulmonary disease, fewer mismatched segmental equivalent defects were required to indicate a high probability of PE than were required by PIOPED criteria. The findings from some of these patients, by PIOPED criteria, would have indicated intermediate probability. Some indeterminate probability readings, therefore, will be eliminated among patients stratified with no prior cardiopulmonary disease.     

Clinicians' interpretation of the indeterminate ventilation-perfusion scan report

Most patients with suspected pulmonary embolism are initially investigated by radio-nuclide ventilation-perfusion (VQ) scanning. Approximately 70% of VQ scans are "indeterminate". Further investigations should be considered in such patients in order to establish a definitive diagnosis. However, these investigations are rarely requested in patients with indeterminate scans in our institution. We therefore decided to review the casenotes of such patients to determine their subsequent management. Over a 9 month period, 131 (32%) out of a total of 413 consecutive VQ scans were reported as indeterminate. The casenotes of 111 of these patients (65 female, 46 male, mean age 65 years, range 17-91 years) were reviewed. 52 of the 111 patients (46%) were treated on clinical grounds without further investigation; 12 patients (11%) had further investigation; and in 39 of the cases (35%) the VQ scan report was misinterpreted. 20 (38%) of the 52 patients managed on clinical grounds were treated for pulmonary embolus with anticoagulation and 26 (50%) were not anticoagulated. Of the 12 patients who were investigated further, nine had lower limb Doppler ultrasound and three had contrast venography. No patients had pulmonary angiography. Of the 39 cases where the VQ report was misinterpreted, the result was misquoted in the casenotes of 37 (95%) as negative for PE and none of these patients were anticoagulated, and in two cases (5%) it was misquoted as positive for PE and anticoagulant therapy was instituted. The misunderstanding was observed in all clinical firms. Such misinterpretation may have significant implications, since 30-40% of patients with indeterminate scans may have had PE. Our findings suggest that clinicians need to be better informed of the significance of an indeterminate VQ scan result.     

Simultaneous laboratory-based comparison of ResMed Autoset with polysomnography in the diagnosis of sleep apnoea/hypopnoea syndrome

ResMed Autoset (AS) is a simplified diagnosis system for obstructive sleep apnoea/hypopnoea syndrome (OSAS) based on the respiratory flow/time relationship by pressure variation measured through simple nasal prongs. A multicentre prospective trial was used to compare AS and polysomnography (PSG) for diagnosing 95 patients, with suspected OSAS. Physicians gave a pretest probability of the patient having OSAS. The apnoea/hypopnoea index (AHI) was compared between the two methods of diagnosis for the whole population and for subgroups according to the pretest probability. Twenty-four patients had AHI < 15 events x h(-1) on PSG and 19 AHI 15-30, and 52 patients had AHI > or = 30. Correlation between AHI assessed by AS and PSG was r=0.87 for total sleep time (TST), p<0.0001. A Bland and Altman plot gave an agreement between the two methods of +/-40%. For a threshold of AHI > or = 15 events x h(-1) to diagnose OSAS, AS has a sensitivity of 92%, specificity of 79%, positive predictive value of 93% and negative predictive value of 76%. With a pretest probability > or = 80%, sensitivity and positive predictive value were 98 and 100% respectively. Of six false negative, four had a high pretest probability (> 80%) or Epworth score > or = 10. Using these parameters as a criterion for proceeding to PSG after a negative AS study would mean that two apnoeic patients (AHI 20 and 17 events x h(-1) by PSG) would escape detection. The Autoset is useful for the detection of obstructive sleep apnoea but with high pretest probability and a negative Autoset result polysomnography should be performed.