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How Well Do Laboratories Adhere to Recommended Clinical Guidelines for the Management of Myocardial Infarction? The Italian Experience.

To the Editor:

The Cardiac Marker Guidelines Uptake in Europe (CARMAGUE) [1] study (1) pointed out the current use of evidence-based guidelines for the utilization of cardiac biomarkers in Europe (EU) and North America (NA). However, the Southern European countries (Italy, Spain, Portugal, and France) are noticeably underrepresented in the survey. The 2013 Third Italian Survey on the use of cardiac biomarkers (2) by the Working Group on Myocardial Markers (GdS MM) of the Italian Society for Clinical Pathology and Laboratory Medicine (SIPMeL) could usefully integrate the CARMAGUE results for a more comprehensive picture of the worldwide penetration of evidence-based guidelines in this field.

The Italian survey, based on a 47-item questionnaire compiled via the Web or during societal educational meetings, produced 126 valid responses from laboratories serving intensive care units (72%) and local laboratories (28%). The composition of responders was sufficiently similar to the CARMAGUE sample (central/teaching hospitals 50%; district/community hospitals 39%) to allow a comparison. It was focused on myocardial markers measured, cardiac troponin (cTn) analytical and preanalytical factors (including internal quality control and external quality assessment, turnaround time, specimen of choice, sampling times, methods, and instruments), cTn decision limits and the way they were chosen, guideline-based protocols, and cTn point-of-care testing use. In addition, preanalytical and analytical factors, as well as the interpretation of the results for the cardiac natriuretic peptides, were surveyed.

Results of the Italian survey (2) were as follows: 64% of responders used cardiac troponin I (cTnI), 10.2% high-sensitivity cardiac troponin T (hs-cTnT), and 38% cTn point-of-care testing in combination with central laboratory; cTn was the preferred marker for acute coronary syndromes in approximately 100% of responders (EU 99.5%; NA 98.7%) and the sole marker in 50% of laboratories (35.8% EU; 50.7% NA), a substantial increase compared to previous data, 3% from the 2005 survey by GdS MM SIPMeL (3). Use of other cardiac markers in Italy was somewhat different from the CARMAGUE study: creatine kinase MB isoenzyme (CK-MB) mass was used by 20.2%; myoglobin by 9% (7% together with CK-MB mass); obsolete markers, such as aspartate transaminase, lactate dehydrogenase, CK-MB activity, and CK, by 8% of responders, mainly in local laboratories but with a substantial decrease compared to previous 40% in the 2005 survey (3). Comparisons with CARMAGUE data for cardiac markers other than cTn are presented in Table 1.

For cTn, the 99th percentile decision limit was used in 78% of laboratories (42% alone and 36% in combination with a 10% CV concentration), a 10% CV concentration in 12%, and other local limits in 10% (EU 52.3%, 16.2%, 29.5% and NA 45.2%, 24.2%, 22.6%, respectively). The derivation of the decision limit was the package insert (56%), scientific literature including specific guidelines (13%), and local validation (18%), similar to

CARMAGUE (EU 61.9%, 17.1%, 21% and NA 40%, 15%, 45%, respectively). In Italy, there was a great variability of decision limits for the same cTn method; for example, only 72% of laboratories using hs-cTnT used the manufacturer-recommended 14 ng/L limit (50.3% in CARMAGUE), and the contemporary Abbott cTnI decision limits varied from 30-400 ng/L (25-500 ng/L in CARMAGUE). Ninety percent of responders did not use an absolute or relative S (EU 65.2%; NA 81.9%). The sampling times were very dispersed (2-h 2.7%; 3-h 13.9%; 4-h 2.7%; 6-h 33.3%; 8-h 2.7%; 9-h 33.3%; 12-h 5.5%; 24-h 2.7%) with emphasis at 6-h and 9-h, and very different as compared to the CARMAGUE data that showed emphasis at 3-h (EU 37.6%; NA 50.0%) and 6-h (EU 48.1%; NA 41.7%). In Italy, 72.2% (69.9% in 2005) (3) of responders used protocols shared with clinicians (EU 67.6%; NA 65.8%) and 55% reported the use ofwritten agreed protocols (EU 35.2%; NA 36.0%).

The global picture from this comparison shows both similarities and differences between NA, EU (representative of Northern Europe), and Italy (representative of Southern Europe). In Italy, there was a higher percentage of laboratories that have abandoned obsolete biomarkers, the presence of shared and written protocols, and better use of the 99th percentile for cTn. A slightly lower interest in the laboratory validation of the industrial kits can be seen, as well as a preference for sampling times related to the 6-9 h suggested by the 2007 Universal Definition of Myocardial Infarction (4) rather than to the 3-6 h of the Third Universal Definition of Myocardial Infarction (5).

We acknowledge that there is still a lot of room for the educational engagement of scientific societies focused on the adoption of evidence based guidelines, on renewed attention to the local evaluation of the analytical performance of laboratory methods, and on clearly defined, shared, and formal protocols, according to the accreditation requirements.

Author Contributions: AH authors confirmed they have contributed to the intellectual content of this paper and have met the following 3 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; and (c) final approval of the published article.

Authors' Disclosures or Potential Conflicts of Interest: No authors declared any potential conflicts of interest.

Acknowledgments: We thank Gianni Antonio Galli (Estote Misericordes, Fl), Daniela Rubin (Laboratorio Analisi Ulss7, Conegliano Veneto TV), Francesca Veneziani (Patologia Clinica, Ospedale S. Maria Nuova, Fl), Deborah Mazzei (Laboratorio Analisi Chimico-Cliniche AOUP, PI), and Matteo Cassin (Cardiologia, Ospedale di Pordenone, AAS5, PN) for their participation in designing the 2013 Third Italian Survey, processing the data, interpreting the results, and writing the final report.

References

(1.) Collinson P, Hammerer-Lercher A, Suvisaari J, Apple F, Christenson RH, Pulkki K, et al. On behalf of the Working Group for Cardiac Markers, European Federation of Clinical Chemistry and Laboratory Medicine. How well do laboratories adhere to recommended clinical guidelines for the management of myocardial infarction: The CARdiac MArker Guidelines Uptake in Europe study (CARMAGUE). Clin Chem 2016;62: 1264-71.

(2.) Cappelletti P, Galli GA, Malloggi L, Stenner E, Moretti M, Morandini M, et al. Stato dell'arte dei marcatori cardiaci in Italia: la III indagine del GdS MM SIMeL [in Italian]. Riv Ital Med Lab 2014;10:212-23.

(3.) Galli GA, Gambetta C, Caputo M, Cappelletti P. Indagine sull'utilizzo dei marcatori miocardici in Italia [in Italian]. RIMeL/IJLaM 2005;1:46-55.

(4.) Thygesen K, Alpert JS, White HD, Jaffe AS, Apple FS, Galvani M, et al. Universal definition of myocardial infarction. Circulation 2007;116:2634 -53.

(5.) Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD, et al. Third universal definition of myocardial infarction. Eur Heart J 2012;33:2551-67.

Piero Cappelletti [2] *

Margherita Morandini [3]

Marco Moretti [4]

Lucia Malloggi [5]

Elisabetta Stenner [6] on behalf of the Working Group on Myocardial Markers of Italian Society for Clinical Pathology and Laboratory Medicine (GdS MM SIPMeL)

[2] SIPMeL, Castelfranco Veneto TV, Italy

[3] Patologia Clinica, AAS5 Pordenone, Italy

[4] Laboratorio Analisi AOR Marche Nord, Pesaro, Italy

[5] Laboratorio Analisi Chimico-Cliniche AOUP, Pisa, Italy

[6] Patologia Clinica, ASUIT Trieste, Italy

* Address correspondence to this author at: Via Vespucci 4-33170 Pordenone, Italy

E-mail pie.cappelletti@gmail.com

Previously published online at DOI: 10.1373/clinchem.2016.266429

[1] Nonstandard abbreviations: CARMAGUE, CARdiac MArker Guidelines Uptake in Europe; EU, Europe; NA, North America; cTn, cardiac troponin; cTnI, cardiac troponin I; hs-cTnT, high-sensitivity cardiac troponin T; CK-MB, creatine kinase MB isoenzyme.
Table 1. Percentage of cardiac markers measured in combination with
cardiac troponin. (a)

                                  I     EU   NA

CK-MB mass                       20.2   25   25

Myoglobin                         9     13   4

Cardiac natriuretic peptides      10    ND   ND

CK                               11.9   40   14

Lactate dehydrogenase/           7.1    15   4
hydroxybutyrate dehydrogenase

Aspartate transaminase           6.3    1    1

CK-MB activity                   5.5    27   5

(a) I, Italian data from the GdS MM SIPMeL survey [Cappelletti et
al. (2)) EU, Northern European data from the CARMAGUE study
[Collinson et al. (1 ]; NA, North American data from the
CARMAGUE study [Collinson et al. (1)]

ND, not done.
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Author:Cappelletti, Piero; Morandini, Margherita; Moretti, Marco; Malloggi, Lucia; Stenner, Elisabetta
Publication:Clinical Chemistry
Article Type:Letter to the editor
Geographic Code:4EUIT
Date:Feb 1, 2017
Words:1345
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