PULMONARY EMBOLISM/VTE CARE PROCESS MODEL

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1 PULMONARY EMBOLISM/VTE CARE PROCESS MODEL IMCP FALL CONFERENCE 2017 Scott Stevens, MD Co-Director, Thrombosis Clinic & Thrombosis Research Group Intermountain Medical Center Professor of Clinical Medicine The University of Utah School of Medicine

2 Why a VTE Care Process Model? VTE is COMMON

3 The Scope of the Problem Fatal PE N= 30,000 PE N= 300,000 VTE N= 950,000 Fatal PE N= 60,000 PE N= 600,000 VTE N= 1,820,000 Arterioscler Thromb Vasc Biol March ; 28(3): Am J Hematol 2011;86:217-20

4 Why a VTE Care Process Model? VTE is CHALLENGING TO DIAGNOSE

5 Recommendations Recommendations 3.2. In patients with a low pretest probability of first lower extremity DVT (see Fig 1 ), we recommend one of the following initial tests: (i) a moderately sensitive d-dimer, (ii) a highly sensitive d-dimer, or (iii) CUS of the proximal veins rather than (i) no diagnostic testing (Grade 1B for all comparisons), (ii) venography (Grade 1B for all comparisons), or (iii) wholeleg US (Grade 2B for all comparisons). We suggest initial use of a moderately sensitive (Grade 2C) or highly sensitive (Grade 2B) D-dimer rather than proximal CUS. Algorithm Figures Chest 2012;141;e351S-e418S

6 Why a VTE Care Process Model? IMAGING for VTE is OVERUTILIZED

7 VTE Imaging >90% of VTE imaging is negative 1592 of 3500 (45.5%) CTPA studies were avoidable in an Intermountain series Isolated subsegmental PE and isolated distal DVT may not require treatment, but comprise 15-40% of cases Events per 100,000 persons CTPA Enters Widespread Use Anticoagulant Complications Fatal PE Am J Med 2013;126: J Thromb Haemost 2017;15: Chest 2016;149: Arch Intern Med. 2011; 171:831-9

8 Why a VTE Care Process Model? VTE has MANY THERAPEUTIC CHOICES

9 VTE Therapy At least eight different anticoagulant regimens are available for VTE Additionally Systemic thrombolysis Catheter-directed thrombolysis Pharmaco-mechanical thrombus removal Surgical (open) embolectomy JAMA. 2014;312(11):

10 Diagnosis Confirm Diagnosis VTE Care Process Model Flow of Care Severity Assessment & Special Procedures Anticoagultion Initiation Determine Venue of Treatment Determine Need for Special Procedures Choose Anticoagulant Agent Determine Initiation Strategy Acute Phase Anticoagulation Monitor Safety and Efficacy of Therapy Secondary Prevention/Indefinite Anticoagulation Determine Need for Ongoing Anticoagulation vs. Cessation

11 VTE Suspected Pregnant Patient: See PE Diagnosis in Pregnancy Algorithm PE Diagnosis Algorithm SVT Diagnosed: SVT Management Algorithm DVT Diagnosis Algorithm VTE Care Process Model Detailed Roadmap IVC Filter Algorithm AC Contraindication Assessment PE Risk Assessment & Interventional Treatment Algorithm IVC Filter Algorithm AC Contraindication Assessment DVT Risk Assessment & Interventional Treatment Algorithm Low Risk Low-Intermediate Risk High-Intermediate Risk High Risk Interventional Therapy for DVT Subsegmental PE Assessment Anticoagulation Initiation Algorithm Interventional Therapy for PE Interventional Therapy for PE Anticoagulation Initiation Algorithm Anticoagulation Initiation Algorithm Acute Phase Anticoagulation* Anticoagulation Initiation Algorithm Anticoagulation Initiation Algorithm Acute Phase Anticoagulation* Acute Phase Anticoagulation* Indefinite Anticoagulation vs. Cessation Algorithm Acute Phase Anticoagulation* Acute Phase Anticoagulation* Indefinite Anticoagulation vs. Cessation Algorithm *If unfractionated heparin or unfractionated heparin used and a fall in platelets occurs, refer to: HIT Algorithm Indefinite Anticoagulation vs. Cessation Algorithm Indefinite Anticoagulation vs. Cessation Algorithm Indefinite Anticoagulation vs. Cessation Algorithm

12 Overview Page Provides a view of the entire process from diagnosis through decisionmaking regarding duration of anticoagulant treatment. The gray trapezoids are hyperlinks to more detailed information and decision support.

13 Highlights Diagnosis

14 VTE: The Early Diagnostic Toolkit Pre 1960 s 1980 s

15 The Contemporary Diagnostic Toolkit + +

16 Pretest Probability Clinical Prediction Guides (CPG s) Rates of DVT by Category Item Wells Score - DVT Active Cancer 1 Paralysis, Paresis, Recent Cast 1 Bedridden or Surgery in last 12 weeks Localized Tenderness 1 Entire leg swollen 1 > 3cm calf asymmetry 1 Pitting edema (affected leg) 1 Collateral (non-varicose) veins 1 Previous DVT 1 Alternate Diagnosis as likely -2 Points < 0 = Low 1-2 = Moderate > 3 = High %DVT 53% 17% 5% Low Moderate High JAMA 2006;295 (2):

17 Pretest Probability Clinical Prediction Guides (CPG s) Rates of PE by Category Item Revised Geneva Score Age > 65 1 Points Previous VTE 3 Surgery/Fracture (within 4 weeks) 2 Active Cancer 2 Pulse Pulse > 94 5 Leg pain on palpation or edema 4 Unilateral leg pain 3 Hemoptysis = Low 4-10 = Intermediate 11 = High <10 = PE Unlikely >10 = PE Likely Low Int High % PE Thromb Haemost 2000; 83: Ann Intern Med 2006; 349:

18 PE Diagnosis Published Models Model McGinn Scale VTE Rate (With DD) % With no Imaging Revised Geneva 1 0.5% 22% Wells 1 0.5% 23% Simplified Wells 2 0.6% 23% Simplified Revised Geneva 3 0.5% 24% Arch Intern Med 2001;161:92-7. Ann Intern Med 2006;144: Thromb Haemost 2000;83: Eur J Nucl Med Mol Imaging 2003;30: Am J Med 2003;114: Ann Emerg Med 2002;39: Arch Intern Med 2008;168: Thromb Haemost 2008;99: J Thromb Haemost Feb Ann Intern Med Jun 7;154(11):

19 Laboratory Highly Sensitive Sensitivity 93-95% ELISAs, quantitative latex or immunoturbidimetric Moderately Sensitive Sensitivity 85% Whole blood assay Di Nisio et al. J Thromb Haemost 2007;5 (2):

20 Advances in D-dimer Age-adjusted thresholds Rationale D-dimer elevates with age Active PE likely further adds to this baseline value D-dimer negative o < Age x 10 (age 50+) % Negative VTE Rate <Age x 10 < JAMA. 2014;311(11):

21 Is D-dimer always needed? D-dimer is nonspecific A positive d-dimer obliges an imaging order, even if pretest probability of PE is very low The PERC score safely rules out PE in 20% of patients without d-dimer Item PE likelihood 15% or more (Gestalt) PERC Score Age > 50 years 1 Sa0 2 < 93% 1 Surgery or Hospitalization within 4 weeks Unilateral Leg Swelling 1 Previous VTE 1 Estrogen Use 1 Pulse > 100 bpm 1 Hemoptysis 1 Score = 0 Score > 0 Points 1 1 PE Ruled Out Obtain d-dimer Thromb Haemost 2008;6:772-80

22 VTE Diagnosis Algorithmic approach reduces imaging by 25-30% while safely excluding VTE Checklists assist with pretest probability scoring

23 Highlights Selection of Anticoagulant

24 Initiation Phase Long-Term Phase Extended Phase Phases of Treatment for Acute VTE Suppress Thrombin Burst Prevent Embolization Prevent propagation while thrombus heals/organizes Prevent new episodes of thrombosis 5 Days 3 Weeks 3 Months No planned stop date

25 Cancer Loaders Switchers Treatment Options Initiation Long Term Extended UFH/LMWH + Warfarin (5+ Days) INR 2-3 INR 2-3 Enoxaparin 1mg/kg BID (5-10 days) Dabigatran 150 BID Dabigatran 150 BID Enoxaparin 1mg/kg BID Edoxaban 60mg Daily Edoxaban 60mg Daily (7 days) Apixaban 10mg BID (7 days) Rivaroxaban 15mg BID (21 days) Dalteparin 200 IU/Kg Daily (1 month) Apixaban 5mg BID (6 months) Rivaroxaban 20mg Daily Dalteparin 150 IU/Kg Daily Apixaban 2.5mg BID Rivaroxaban 20mg Daily Dalteparin 150 IU/Kg Daily (? Reduce dose) Enoxaparin 1mg/kg BID Enoxaparin 1mg/kg BID Enoxaparin 1mg/kg BID (?Reduce Dose)

26 Treatment Selection JAMA. 2014;312(11):

27 AT10 Choice of anticoagulant for long-term treatment of DVT and PE: DOAC vs. warfarin AT10 Guideline Statement: In patients with DVT of the leg or PE and no cancer, as long-term (first 3 months) anticoagulant therapy, we suggest apixaban or edoxaban or rivaroxaban or dabigatran over VKA therapy (Grade 2B). Remarks: Acute therapy with parenteral anticoagulation is given before dabigatran and edoxaban. Chest 2016;149(2):315-52

28 Selection of Anticoagulant DOAC preferred in most cases Assistance with selection and dosing strategy

29 Highlights Treatment Venue

30 Acute PE PESI Score PE Risk Stratification ESC System Item Points Age Age x 1 Male 10 History of Cancer 30 Low Risk Low-Intermediate Risk High-Intermediate Risk High-Risk History of Heart Failure 10 History of Chronic Lung Disease 10 Pule > 110 bpm 20 SBP < 100 mmhg 30 Respirations > 30/min 20 Temperature < Altered Mental Status 60 Sa0 2 < 90% 20 Class I < 65 Class II Eur Heart J 2008;29: Lancet 2011;378:41-8

31 VTE Hospitalization Rates Venue of Care PE An RCT and multiple prospective trials support outpatient treatment for low-risk PE (PESI < 85) o Watch for a study from Intermountain Higher risk PE requires ICU care DVT Outpatient management of DVT has been supported by RCT data since the early 1990 s o o Mortality does not differ Morbidity is better in outpatients US Versus Canada Chart Title DVT US Canada PE Thromb Res 2017;156:149-54

32 AT10 Treatment of Acute PE Out of the Hospital AT10 Guideline Statement: In patients with low-risk PE and whose home circumstances are adequate, we suggest treatment at home or early discharge over standard discharge (eg, after first 5 days of treatment) (Grade 2B). Chest 2016;149(2):315-52

33 Venue of Care Assistance with prognostic scoring Protocol support for outpatient care of selected low-risk PE Emergency/ICU treatment for high-risk PE

34 Highlights Avoiding Overtreatment

35 Isolated Distal DVT Outcomes and Prognosis Proximal DVT Rate of PE >40% Rate of PTS 20-40% IDDVT Rate of PE <5% (Axial) Rate of PTS ~10% (Axial) Rate of Propagation 21.4% (10-29%) (Axial) ~3% (Muscular) J Vasc Surg 2003;37: Chest 2012;141;e351S-e418S. Health Technol Assess. 2006; 10 ( 15 ):

36 AT10: Whether to Anticoagulate Isolated Distal Deep Vein Thrombosis 13. In patients with acute isolated distal DVT of the leg and (i) without severe symptoms or risk factors for extension (see text), we suggest serial imaging of the deep veins for 2 weeks over anticoagulation (Grade 2C). Extension Risk Factors Positive D dimer Extensive or close to the proximal veins No reversible provocation Cancer Prior DVT Inpatient Chest 2016;149(2):315-52

37 Is PE Overtreated? Secular Trend in Anticoagulation Complications following CTPA CTPA Enters Widespread Use Events per 100,000 persons Anticoagulant Complications Fatal PE Wiener RS et al. Arch Intern Med. 2011; 171:831-9

38 AT10: Whether to Anticoagulate Subsegmental Pulmonary Embolism 42. In patients with subsegmental PE (no involvement of more proximal pulmonary arteries), no proximal DVT in the legs, and a low risk Evaluation for recurrent of Individuals with Pulmonary Progression Nodules: General Risk Factors Approach VTE (see text), we suggest clinical surveillance over anticoagulation (Grade 2C). Active cancer 43. In patients with subsegmental PE (no involvement of more proximal pulmonary arteries), no proximal DVT in the legs, and a high risk for recurrent VTE (see text), we suggest anticoagulation over clinical surveillance (Grade 2C). Hospitalized or immobile patient No reversible risk factors D-dimer elevated (marked, unexplained) Chest 2016;149(2):315-52

39 Avoiding Overtreatment Assistance for deciding whether to offer anticoagulation therapy for: Isolated subsegmental PE Isolated Distal DVT

40 This is Intermountain, right? Where are my eprotocols? The VTE Care Pathway in icentra

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46 The VTE CPM Team Stacy Hilling Carl Black Colleen Roberts David Jackson Don Lappe C. Gregory Elliott James Hellewell Joseph Bledsoe Karen Conner Kathryn Kutler Mark Kringlen Mark Mankivsky Nancy Nelson Peter Haug Rich Patten Scott Stevens Scott Woller Steven Hess Terry Clemmer

47 Type ClinicalProcess into your browser (cpms).aspx Thank you! Please help us improve the CPM

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