Eenduidige diagnostiek van longembolie: progress after YEARS

Transcription

1 Eenduidige diagnostiek van longembolie: progress after YEARS Menno Huisman Department of Thrombosis and Hemostasis Leiden University Medical Center, Leiden, the Netherlands

2 Disclosures MV Huisman None for this presentation The YEARS study was supported by unrestricted grants from participating hospitals

3 Standard diagnostic management Wells decision rule (<500 ng/ml) Konstantinides S et al ESC guideline on PE. Eur Heart J 2014

4 Wells beslisregel

5 Standard Management 20-30% no CTPA, majority of CTPA negative for PE 3-month VTE risk <1.5% Christopher study. JAMA 2006 Adherence in clinical practice variable Newnham. BMJ 2013

6 Standard Management Consequences: Unrequired CTPA Roy. Ann Intern Med 2006

7 The YEARS algorithm Simultaneous assessment of: D-dimer test in all patients Prediction rule of 3 items of the original Wells rule Variable D-dimer thresholds depending on clinical probability Van Es. J Thromb Haemost 2015

8 Used D-dimer tests Vidas D-dimer Exclusion, Biomerieux, Marcy- L Étoile, France Tinaquant, Roche Diagnostica, Mannheim, Germany STA-LIA DiagnosticaStago, Asnieres, France Innovance, Siemens, Marburg, Germany

9 The YEARS algorithm Suspected acute PE Order D-dimer test and score the 3 YEARS items: - Clinical signs of DVT? - Hemoptysis? - PE most likely diagnosis? 0 YEARS items D-dimer < YEARS items D-dimer YEARS items D-dimer <500 1 YEARS items D-dimer 500 PE excluded Order CTPA PE excluded Order CTPA

10 YEARS study: Aim Prospective validation of the YEARS algorithm Safety: 3-month VTE risk after normal tests After negative pulmonary angiography 1.7% ( ) Efficiency: van Beek. Clin Radiol 2001 Reduction in number of CTPA

11 Methods Prospective cohort clinical outcome study in 12 hospitals in the Netherlands Consecutive patients with suspected PE Management according to YEARS algorithm

12 Results 3616 patients between October 2013 and July patients excluded (4.2%) PE prevalence 13.2% Van der Hulle T et al. Lancet 2017; 390: Konstantinides S (editorial). Lancet 2017;390:

13 Baseline Characteristics (n=3465) Mean age 53 years (SD 18) Female 62% Duration of complaints (median) 3 days (IQR 1-8) Outpatient 88% COPD with treatment 12% Heart failure with treatment 4% Estrogen use 16% of women Immobilization or surgery in the previous 4 weeks 12% Previous history of PE or DVT 10% Malignancy 10% Van der Hulle T et al. Lancet 2017; 390:

14 Flow Chart

15 Flow Chart Suspected acute PE 0 YEARS items D-dimer <1000 N= YEARS items D-dimer 1000 Negative CTPA N=352 1 YEARS items D-dimer <500 N=327 1 YEARS items D-dimer 500 Negative CTPA N=964 2 Nonfatal events 1 PE 1 DVT 2 PE not excluded as cause of death 4 Lost to follow-up 3 Nonfatal events 2 PE 1 DVT 3 PE not excluded as cause of death 3 Nonfatal events 3 PE 4 Nonfatal events 4 DVT 1 PE not excluded as cause of death 1 Lost to follow-up Van der Hulle T et al. Lancet 2017; 390:

16 Primary outcome Category Complete algorithm N=2944 Managed without CTPA N=1629 Managed with CTPA N=1315 Total VTE (95%CI) 0.61% % % Fatal PE (95%CI) 0.20% % % Van der Hulle T et al. Lancet 2017; 390:

17 Efficiency No CTPA indicated in 48% of patients Compared to standard algorithm D-dimer threshold No CTPA Absolute Reduction <500 ng/ml 34% 14% <age adjusted Age*10 in patients >50 years old 37% 8.7% Van der Hulle T et al. Lancet 2017; 390:

18 Diagnostic failures managed without CTPA Sex Age Years score D-dimer, ng/ml Interval, days Outcome Circumstances of outcome event Female Death Developed cardiac arrest during admission for acute severe pancreatitis. Known with myotonic dystrophy type 1 with severe cardiomyopathy and arrhythmias. ICD was earlier deactivated after regular unjustified defibrillations. Resuscitation was unsuccessful Male Death Diagnosed with end-stage metastasized oropharyngeal carcinoma. Found deceased in nursing home Adjudicated as PE not excluded as cause of death PE not excluded as cause of death Female PE Subsegmental PE diagnosed on CTPA during admission for pneumonia and Non-fatal PE acute heart failure related to severe aortic valve stenosis and mitral valve insufficiency. Patient died seven days after treatment was voluntarily withheld Male DVT DVT 14 days after surgery for glioblastoma multiforme DVT Female PE CTPA performed due to protocol violation at baseline Non-fatal PE Male PE CTPA performed due to protocol violation at baseline Non-fatal PE Female PE CTPA performed due to protocol violation at baseline Non-fatal PE

19 Diagnostic failures managed with CTPA Sex Age Years D- Interval, Outcome Circumstances of outcome event Adjudicated as age score dimer, days mg/ml Male DVT Vena cava superior syndrome caused by thrombosis at the site of pacemaker leads Female Death Died in hospital under the clinical diagnosis of a pneumonia and acute heart failure Female PE Initiation of anticoagulation because of suspected PE without CTPA confirmation after hospital admission because of heart failure and COPD exacerbation Thrombosis of the vena cava superior PE not excluded as cause of death Non-fatal PE Female Unknow Death Died in nursing home after hospital admission because of acute heart failure PE not excluded n and exacerbation of COPD as cause of death Female PE Known with a recurrent sarcoma of the uterus. Subsegmental PE diagnosed postoperatively. Died 33 days after diagnosis of PE during palliative care in a hospice Non-fatal PE

20 Diagnostic failures managed with CTPA (2) Sex Age Years D- Interval, Outcome Circumstances of outcome event Adjudicated as age score dimer, days mg/ml Female Death Died after sudden collapse followed by unsuccessful resuscitation 1 day after surgery for gastric carcinoma Female DVT Known with leukemia. Developed thrombosis of the brachial vein after thrombophlebitis related to an intravenous catheter Male DVT Known with metastasized prostate cancer. Developed DVT after immobilization during admission at the hospital Female Death Known with lung cancer for which curative treatment. Post-radiation stenosis of the trachea for which a stent placed. Died at home after sudden hemoptysis PE not excluded as cause of death DVT DVT PE not excluded as cause of death Male DVT Subclavian vein thrombus associated with intravenous catheter DVT Female DVT Developed DVT and was diagnosed with antiphospholipid syndrome DVT

21 Opmerkingen Arts niet blind voor uitkomst D-dimeer Relatief jonge patiënten Weinig oncologische patiënten Alleen hemodynamisch stabiele patiënten

22 Time to diagnosis Patients discharged 47 min earlier without CTPA Patients discharged 59 min earlier for complete population Patients diagnosed with PE by CTPA received first dose of anticoagulants 53 minutes faster

23 Adjust study JAMA 2014 Patients > 50 years: age x 10 μg/l Patient 76 years: 76 x 10 μg/l = 760 μg/l

24 Adjust and YEARS Adjust + YEARS: 47% of patients managed without CTPA vs 48% in YEARS Adjust + YEARS: 4 more patients with PE missed at baseline

25 Conclusions The YEARS algorithm safely excludes PE Efficient at Emergency departments Large reduction of CTPA 14% Particularly in young (female) patients Van der Hulle T et al. Lancet 2017; 390:

26 Infographic: Follow-up initiative by Dutch health insurance

27 Acknowledgements MV Huisman FA Klok C. Heringhaus WY Cheung LFM Beenen J van Es S Middeldorp MJHA Kruip S Schol-Gelok LM Faber RF Loeffen RCJ van Klink S Kooij LM van der Pol ATA Mairuhu GM Hazelaar MMC Hovens T van Bemmel M ten Wolde M Nijkeuter KAH Kaasjager H Hofstee

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