The PESIT trial

Pulmonary Embolism in

Syncope Italian Trial PESIT Trial

Mohammed H. ElwanAssociate Researcher, Emergency Medicine Academic Group, University of Leicester, UK

Registrar in Emergency Medicine, University Hospitals of Leicester NHS Trust, UK

Assistant Lecturer of Emergency Medicine, Alexandria University, Egypt

UHL Journal Club – 7th Feb 2017

Today’s business• Background• Question• Methods• Strengths• Limitations• Conclusion

Background What is syncope?- Transient LOC- Spontaneous resolutionCan PE cause syncope?Possibly,

Proximal obstruction ↓CO Syncope

BackgroundWhat is the problem?

- PE is on the differential, but could it be paid little attention?

- Prevalence has not been rigorously studied, yet!

QuestionWhat is the

prevalence of PEin patients hospitalized for

a first episode of syncope?

MethodsDesign

• Prospective cross-sectional study

Setting• Multicentre - 11 Italian hospitals

Sampling• Consecutive patients

MethodsInclusion

• > 18• Admitted after a first episode of syncope (LOC < 1min, complete resolution)

Exclusion• Obvious causes for syncope (seizures, head trauma, stroke)• Previous syncope• On anticoagulant therapy• Pregnancy

Sample size• estimated a sample size of 550 patients

MethodsStudy

procedure

•Patients interviewed within 48h•CXR•ECG•ABG, routine bloods•D Dimer

Diagnosing PEModified Well’s score

D Dimer

CT-PA/ VQ

scan

PE criterionIntraluminal filling defect on CT-PA

Or a perfusion defect of at least 75% on VQ scan

Thrombotic burdenIdentification of the most proximal location of the

embolus on the CT-PA or measurement of the severity of the perfusion defect on the VQ scan

Results

Results

Results2584

ED patients

717Admitted

1867Discharged

from ED

Results717

Admitted

560Included

157Excluded

Results560

Included

330Low probability

+ negative D Dimer

PE Ruled out

230high

probability and/or positive

D Dimer

97PE

Confirmed

Results

42.2%97/ 230

High probability patients

17.3%97/560

Entire cohort

560Included

330Low probability

+ negative D Dimer

PE Ruled out

230high

probability and/or positive

D Dimer

97PE

Confirmed

Results

42.2%97/ 230

High probability patients

17.3%97/560

Entire cohort

25%52/205

undetermined origin of syncope

12.7%45/355

potential alternative explanation for

syncope

ResultsThrombotic burden

63% Involved main pulmonary artery/ lobar artery

Strengths- Multicentre- Consecutive patients- Validated guideline based work-up for PE

Limitations- Did not include patients discharged from ED- The subjectivity of the diagnosis of syncope- Workup was standardised but not mandated- CT was done only in high likelihood/ high D Dimer cohort- No objective confirmation of DVT- Other syncope causes were left to the discretion of treating physician- Excluded patients with multiple syncope/ on anticoagulants

Authors’ conclusion

Pulmonary embolism was identified in nearly

one of every six patients hospitalized for a first episode of syncope

So,

What’s in this study for us?

First,Let’s look at the numbers again

17.3%97/560 (study cohort)

97/2584 patients presenting to ED with syncope

First,Let’s look at the numbers again

3.8%That is

One in 26

Second,

Association ≠ causation

This study does not tell us whether identified PE is the cause of syncope or an incidental finding

(Not a question a cross-sectional study would answer anyway)

Third,

Clinical significanceThis study does not tell us the significance of PE identification in

changing a “hard outcome”

Bottom-line

Thank you!