Appropriate use criteria of transesophageal echocardiography in Greece: A single center experience

Appropriate use criteria of transesophageal echocardiography in Greece A single center experience Accepted Manuscript Appropriate use criteria of transesophageal echocardiography in Greece A single ce[.]

Accepted Manuscript

Appropriate use criteria of transesophageal echocardiography in Greece: A single

center experience

Dr G Georgiopoulos, MD, MSc, PhD, C Aggeli, A Laina, M Deligianni, D.

Oikonomou, S Lampridou, G Vogiatzi, D Tousoulis

PII: S1109-9666(16)30181-6

DOI: 10.1016/j.hjc.2016.12.005

Reference: HJC 103

To appear in: Hellenic Journal of Cardiology

Received Date: 10 September 2016

Accepted Date: 5 December 2016

Please cite this article as: Georgiopoulos G, Aggeli C, Laina A, Deligianni M, Oikonomou D, Lampridou

S, Vogiatzi G, Tousoulis D, Appropriate use criteria of transesophageal echocardiography in Greece: A

single center experience, Hellenic Journal of Cardiology (2017), doi: 10.1016/j.hjc.2016.12.005.

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APPROPRIATE USE CRITERIA OF TRANSESOPHAGEAL

ECHOCARDIOGRAPHY ΙΝ GREECE: A SINGLE CENTER EXPERIENCE

G.Georgiopoulos1, C Aggeli1, A.Laina1, M.Deligianni1, D.Oikonomou1, S Lampridou1,

Vasilissis Sofias 114, CODE 115 28

Hippokration Hospital, Athens

GREECE

Tel: +30-213-2088099 & Fax +30-213-2088676

e-mail:georgiopoulosgeorgios@gmail.com

APPROPRIATE USE CRITERIA OF TRANSESOPHAGEAL ECHOCARDIOGRAPHY ΙΝ

GREECE: A SINGLE CENTER EXPERIENCE

ABSTRACT

Introduction: The American College of Cardiology Foundation (A.C.C.F) along with the American

Society of Echocardiography (A.S.E.) have enabled an accurate and clinically oriented evaluation

of echocardiography indications by introducing Appropriate Use Criteria (AUC)

Aim: This study was designed to evaluate the degree of implementation of AUC for

transesophageal echo (TEE) in daily clinical practice in a tertiary university hospital of Greece

during the era of economic recession

Materials and Methods: From November 2014 to May 2014 we enrolled prospectively 300

patients, who were examined in the Echocardiography Laboratory of the 1st University

Cardiology We recorded participants’ demographic and clinical characteristics using

questionnaires and followed a scoring process according to ACCF guidelines to classify patients

into appropriate, inappropriate or uncertain category Primary endpoint was to assess the

association between class of appropriateness and abnormal results in TEE

Results: In 89.4% of patients labelled as appropriate, TEE was abnormal, significantly higher as

compared to patients of uncertain eligibility (50%) and those to whom TEE was considered to be

inappropriate (35%) (p<0.001) Subgroup analysis revealed a positive association between AUC

and increased possibility for abnormal TEE in female subjects (p=0.001) as well as patients

younger than 50 years old (p<0.001) Significant association was finally established between AUC

than 3 (p=0.013)

Conclusion: TEE constitutes a medical practice with an optimal cost/effectiveness ratio and should

be further encouraged in our country in accordance to austerity policy as long as the AUC are

generally applied

Keywords: Transesophageal echocardiography;appropriate use criteria;appropriateness

Word count: 2194 (main text)

Number of Tables: 2

Number of figures: 4

Considerable improvements in cardiovascular (CV) imaging may have rendered diagnosis easier

and more successful but have also led to the concomitant inflation of the work up process of the

patient and at the same time to a significant increase in health care costs Healthy technology

assessment provides significant aid in decision-making and in the evaluation of the benefits, risks

and costs of diagnostic tests Physicians besides clinical experience need evidence-based

information in order to choose the best diagnostic technique for each patient among existing

technologies and to best incorporate them into daily clinical practice (1, 2)

The American College of Cardiology Foundation (A.C.C.F) along with the American Society of

Echocardiography (A.S.E.) have enabled a more accurate and clinically oriented evaluation of

echocardiography indications in cardiology patients by introducing Appropriate Use Criteria

(AUC) This initiative represents an organized effort to respond to the need for the rational use of

emerging imaging techniques while retaining high-quality care services (3-5) In detail, ACCF/ASE

reviewed clinical scenarios where echocardiography is indicated or considered and published in

2011 the revised guidelines for transthoracic and transesophageal (TEE) echocardiography use (1,

3, 6-8)

Under economic recession settings, AUC have become increasingly important helping healthcare

community to identify cost-restraining policy options (9) Greece among other countries has

profoundly been affected by the global financial crisis with a wide range of socioeconomic and

political consequences Austerity measures have been applied throughout the public sector and

National Health System could not be an exception (10, 11)

The purpose of the present study was to evaluate the degree of implementation of the

appropriate use criteria towards TEE in a tertiary University Hospital (1st University Cardiology

Clinic, University of Athens, General Hospital “Hippocration”, Athens, Greece) Under this prism,

we sought to assess the association between class of appropriateness and abnormal results in TEE

in all examined patients, as well as in pre-specified subgroups of interest (i.e male versus female

subjects, younger versus elderly subjects and patients with CV risk factors versus apparently

healthy subjects)

Materials and Methods

Population

Three-hundred consecutive patients, hospitalized or outpatients who were referred at the

Echocardiography Laboratory of the 1st University Cardiology with TEE were included in the study

The study was conducted from November 2014 to May 2014

Study sample selection

All recruited patients were eligible for transesophageal echocardiography according to ACCF

guidelines 2011 Written informed consent was obtained from each participant Patients with

difficulty in swallowing or patients suffering from esophageal varices or esophageal achalasia

were excluded

Methods

by using appropriate questionnaires In addition to, CV related treatment as well as the

prevalence of the main CV risk factors (i.e hypertension, dyslipidemia, diabetes mellitus, smoking

and family history of CV disease) were assessed

The TEE ultrasound was performed with Philips® iE33 machine equipped with a multiplane x7-2t

matrix probe Patients were asked to abstain from food consumption for at least four hours

previous to their examination Detailed medical history was recorded and a venous catheter was

inserted in a peripheral vein of the arm Anesthesia was induced by local administration of

xylocaine in the oropharynx followed by intravenous (IV) infusion of midazolam TEE was then

conducted and at the end of the procedure IV flumazenil (imidazobenzodiazepine) was given as

antidote to anesthesia The patient remained at the Laboratory for approximately 20 minutes

after the end of the TEE under medical surveillance until full recovery

2011 Appropriate Use Criteria for transesophageal ultrasound by the American College of

Cardiology Foundation, 2011

The AUC were conceived and released in order to provide physicians with guidelines concerning

TEE based on a wide spectrum of the most frequently met clinical scenarios in daily clinical

practice The experts in echocardiography and in relative cardiology fields who evolved the

guidelines used a scoring process to classify these clinical scenarios into 3 categories of

appropriateness: appropriate, inappropriate or uncertain In a total score of 7 to 9 the test is

generally acceptable and considered to be a reasonable approach for a specific indication The

test is rated as uncertain or inappropriate when the median score is 4 to 6 or 1 to 3 respectively

strength of corresponding indication (3)

Statistical analysis

Continuous variables are expressed as mean ± standard deviation while nominal/ordinal variables

in absolute or percentage value (%) Normal distribution of variables of interest was assessed

graphically by histograms and P-P plots Correlations between continuous variables were

evaluated using Pearson’s coefficient Associations between nominal variables were examined

with Chi square test (x2 test) Statistical analysis was performed using SPSS software 18.0 (SPSS

Inc, Chicago IL, USA) We deemed statistical significance at 0.05 (p≤0.05) Software G * Power 3

(University of Dusseldorf) was used for power considerations (12) Type I error was predefined at

0.05 The recruited sample size of 300 subjects provided >95% power to detect a significant

association between nominal variables (i.e occurrence of abnormal findings in TEE and subgroup

of population according to AUC) for differences in the possibility of positive TEE greater than 5%

For subgroup analysis, our study yielded 85% power to establish significant associations between

abnormal findings and AUC for proportion differences in positive TEE greater than 10% and

sample size equal to 100 per subgroup

Ethics

The study was performed in accordance with the principles of the Declaration of Helsinki and was

approved by the local ethics committee, the Scientific Council of “Hippocration” General Hospital

Written informed consent was obtained from all participants

Results

Participants’ demographic and clinical characteristics are summarized in Table 1 Increased

prevalence of CV risk factors was prominent in our study’s sample Almost one third of the

population had at least one risk factor while aggregation of more than one co-morbidities was

reported in most patients (Figure 1) Table 2 depicts patients’ classification into groups of

appropriateness for TEE

In terms of TEE findings, 49 (16.3 %) patients had a test without significant findings On the other

hand, 71 (23.7 %) and 16 (5.33 %) of the patients presented with mitral and aortic valve disease

respectively while 27 (9 %) patients were characterized by combined heart valvulopathy

Additionally, 20 (6.7 %) patients were diagnosed with endocarditis and 18 (6%) patients with left

atrium appendage thrombus In 36 (12 %) patients abnormal communication between left and

right heart chambers was detected and in 45 (15 %) patients an open foramen ovale was

diagnosed Finally, 18 (6%) patients were examined for more complexed congenital heart disease

(Figure 2)

Class of appropriateness and TEE findings

251 (83.7%) out of 300 patients demonstrated abnormal findings in the TEE Notably, this

percentage was significantly higher in eligible patients (89.4%) as compared to patients of

uncertain eligibility (50%) and those to whom TEE was considered to be inappropriate (35%) (p

<0.001) (Figure 3)

Subgroup analysis

further examined in predetermined (a priori) subgroups of biological interest

In detail, a positive association between AUC and increased possibility for abnormal TEE was

established in female subjects (p=0.001) of our study but not in male patients (p=0.351) (Figure

4A) A statistically significant association between AUC and clinical findings was detected in the

subgroup of younger subjects (p<0.001) but was not established in their older counterparts

(p>0.05 for both patients over 50 and 70 years old) (Figure 4B) Finally subgroup analysis was

performed according to the number of traditional CV risk factors (Group 1: 0 risk factors, Group 2:

0<risk factors≤2, Group 3: 3≥ risk factors) Interestingly, significant association between AUC and

abnormal findings in TEE was established only in the Group 1 (p=0.028) and Group 3 (p=0.013)

(Figure 4C)

Safety concerns

No acute major complications were reported across the study Six patients (2.0%) experienced

adverse symptoms immediately after completion of the examination Symptoms were usually

vagotonic reactions including pre-syncope episode, sweating, nausea and vomiting, or a

hypersensitivity reaction None of the outpatients included in the study needed further

hospitalization All study patients were monitored for at least 48 hours from the end of the

examination (in-hospital patients or outpatients who returned to obtain exam results or

performed additional diagnostic tests at the Hospital where the study was held) and no one

reported short term complications Moreover, hospitalized patients with multiple co-morbidities

undergoing TEE did not present subsequent respiratory infection after invasive TEE

Discussion

To the best of our knowledge, the present study constitutes the first report on the degree of

implementation of AUC for TEE in daily clinical practice in a tertiary university hospital from

Greece during the era of economic recession Taken into account the need for rationalization of

public health costs, we found intriguing to answer the question if Greek cardiologists adopt the

appropriate criteria for this procedure according to evidence based medicine

In fact, an appropriate use of TEE was established in our hospital since the majority (91.3%) of the

patients referred for this examination were eligible for TEE according to AUC reported by ACCF In

contrast, 6.7% of the recruited patients did not fulfill the criteria and the procedure was

considered inappropriate Most importantly, the TEEs determined as appropriate presented

statistically more abnormal findings compared to the uncertain or inappropriate, stressing out the

importance of the AUC into daily practice

However, the role and guidance of AUC should not be overestimated Indeed, most tests carried

out revealed abnormal findings regardless of appropriateness (83.7%) This underlines the

clinician’s important role in decision making As Marwick and Fonseca noted, the use of

appropriate criteria in echocardiography should be combined with the physician’s knowledge and

experience, the available techniques and the willingness to provide high quality medical care to

the patient in need (13)

Subgroup analysis revealed that AUC were strongly associated with TEE findings in patients

younger than 50 years old when compared to older subjects Young patients are more easily

classified into a category of appropriateness while multiple co-morbidities in older people seem to

attenuate the accuracy of classification and further blunt a priori possibilities of abnormal TEE

Under these settings, patients under 50 years of age exhibit clear benefit from the criteria