A perspective on Hospital in the Home Management of DVT and PE

Dr Karyn Cuthbert FACEM

Medical Director, Calvary at Home The Calvary Hospital ACT

Overview

HITH

DVT treatment at home

PE treatment at home

Hospital in the Home The delivery of acute and post-acute care in the

patient’s home as a substitute for being in hospital

Provided by clinicians from many specialties Nurses visit patients at home and review

progress, check vital signs, administer parenteral medication

Must be appropriate social circumstances for HITH admission (patient may attend hospital for treatment as an alternative)

HITH Admission Diagnoses

Common admission diagnoses – infections not responding to oral antibiotic therapy or severe from onset (stable patient)

Anticoagulation therapy – deep venous thrombosis, pulmonary embolism, atrial fibrillation/valvular HD, perioperative

CCF, COAD, postoperative care (POSH!)

Advantages of HITH Equivalent or better clinical outcomes

Avoidance of nosocomial infection

Less confusion in elderly

High patient satisfaction – own food and bed, quality of life, visitors, responsibility for self

No extra burden on carers

Frees up hospital beds for those who need them

Cheaper – HITH Society commissioned Deloitte’s Access Economics report 2011 average 22% saving compared to in hospital treatment for 6 common HITH diagnoses (DVT 25%, PE 16%)

(Potential)Disadvantages of HITH Patient compliance

Staff Safety

After Hours patient problems

Inequitable access

Clinical Governance (need for guidelines, minimum standards, executive input) (now have HITH Society and capacity to submit QIs to ACHS)

DVT and HITH Cochrane collaboration study July 2008 re home

versus in patient Rx of DVT. 6 RCTS, 1708 patients

Summary – LMWH more effective in preventing VTE recurrence when given at home versus in hospital LMWH or IV heparin, trends to less bleeding and deaths at home but more minor bleeding. Limited evidence of cost effectiveness.

Trial limitations – high exclusion rates, partial in hospital treatment not accounted for

At home treatment likely to become the norm

DVT and HITH Less suitable patients

RIETE - independent association for increased risk for adverse events - body weight <70kg, cancer, immobility, chronic heart failure, renal insufficiency, bilateral DVT

British Standards for Haematology Guideline – coexistent serious medical comorbidity, severe acute venous obstruction, severe pain, renal impairment, communication/mobility problems, heparin allergy, active/high risk of bleeding

DVT Therapy - Aims

Prevention of thrombus extension

Prevention of pulmonary embolism

Prevention of post-thrombotic leg syndrome (30-50% of DVT patients within 2 years, venous leg ulceration in 2-10%)

Prevention of recurrent VTE

DVT Therapy Anticoagulation Prevention of thrombus extension, PE and recurrent

VTE

ACT warfarin therapy guidelines

Concurrent commencement of sc LMWH (enoxaparin) and warfarin therapy. LMWH for minimum of 5 days, initial warfarin dose age based

Check renal function and baseline FBC, coagulation studies and LFTs

Patient education re VTE and warfarin therapy

Calvary at Home Guideline for DVT Therapy

Warfarin therapy LMWH injections whilst warfarin is subtherapeutic,

minimum 5 days and until INR between 2-3 for 2 consecutive measures. INR checked every 1-2 days.

Monitor for HITTS

Future - up coming direct thrombin/direct factor Xa inhibitors, ?lesser role for HITH with these – perhaps still appropriate for monitoring however (especially for proximal DVT/PE)

**

Clinical situation Duration

VTE provoked by a transient major risk factor unprovoked distal DVT

3 months [NB1]

first unprovoked proximal DVT or PE

6 months [NB1]

recurrent unprovoked VTE first unprovoked VTE and: active cancer multiple thrombophilias antiphospholipid antibody syndrome

indefinite

VTE = venous thromboembolism; DVT = deep venous thrombosis; PE = pulmonary embolism NB1: consider longer duration depending on patient preference, presentation with symptomatic pulmonary embolism or the presence of minor additional risk factors for recurrence including male sex, the post-thrombotic syndrome, positive D-dimer, single thrombophilia

Risk categories for recurrent venous thromboembolism and recommendations

for the duration of therapy (Table 3.15) Therapeutic Guidelines Cardiovascular

2008/2012

DVT Therapy Graduated Compression Stockings

The combination of early mobilisation and GCS aids in the prevention of post-thrombotic syndrome (50% reduction) and in the reduction of clot progression

Elastic GCS to knee level, to provide 30-40mmHg compression at ankle (class II provide 25-32mmHg) – for to 2 years and longer if do develop Post Thrombotic Syndrome

Prescription only for proper fitting, avoid with peripheral vascular disease, cost, comfort issues

PE Outpatient Treatment

Practice Guidelines 2003-2008 (BTS, ACP/AAFP, ESC) advising that low risk PE can be treated at home from diagnosis or early discharge – in practice most still inpatients

> 5 various prognostic models - Pulmonary Embolism Severity Index largest and most widely validated (derived from 10,534 retrospectively identified inpatients/validation on 221) Aujesky D et al Am J Respir Crit Care Med 2005/Annal Int med 2006. Prospective validation study (367 inpts) EHJ 2006

PE Severity Index Age +1 per year

Male sex +10

Cancer* +30

Heart failure +10

Chronic lung disease +10

Pulse >110 beats per min +20

Systolic blood pressure <100 mm Hg +30

Respiratory rate >30 breaths per min +20

Temperature <36°C +20

Altered mental status† +60

Arterial oxygen saturation <90%‡ +20

*History of cancer or active cancer. †Disorientation, lethargy, stupor, or

coma. ‡With or without the administration of supplemental oxygen.

PE Severity Index Risk Classes Overall point score obtained by summing the

patient’s age in years with the points for every applicable predictor.

A score of <66 is risk class I,66–85 is risk class II, 86–105 is risk class III, 106–125 is risk class IV, and >125 is risk class V.

Score meaning in ensuing (inpatient) validation trials Risk Class I-II < 1% mortality, no recurrent VTE or major bleeding

HOWEVER Until recently, lack of evidence comparing

inpatient versus outpatient management of PE - until OTPE trial Aujesky et al Lancet 2011. 339 patients with PESI score I or II (low death risk) randomised to in versus OP treatment

American Society of Haematology meeting Dec 2011 - Hestia Criteria. Criteria trialled on 297 outpatients 1% mort, 2% rec VTE, 0.7% major bleeding. Nonrandomised with historical controls. Upcoming randomised Vesta trial

Pulmonary Embolism and HITH

OTPE Trial. 19 EDs in US, Switz, Belgium, France. Randomised to in versus OP treatment in ED. Total 339 patients – 171 at home 168 in hospital. Noninferiority trial (margin of 4%)

Low risk patients with PE Severity Score of I or II

Exclusion – 02 sats <90%,syst BP <100, chest pain requiring opioids, high risk of bleeding - active bleeding, stroke past 10 days, GI bleed prior 14 days, severe renal failure, low plats <75000/mm3, extreme obesity, pregnancy, Hx of HITTS or heparin allergy, problems affecting treatment or follow up, already therapeutic INR

OTPE Trial – Results No significant difference in groups re

Mortality at 90 days (0.6% each group)

Major bleeding within 14 days (2 more in OP group within 90 days at >50 days (1.8% vs 0%)

Recurrent DVT or PE (0.6% vs 0%)

Health service utilisation within 90 days

Out patients were on LMWH for longer, but same amount of time with therapeutic INR

Consistent with prior smaller and/or retrospective and/or nonrandomised studies

3.4 day reduction in initial mean hospital LOS

Authors Conclusions OTPE – 30% met eligibility criteria, 73% enrolled

(eligibility criteria of Dx of PE in past 23 hours may have excluded some otherwise appropriate patients for OP treatment). Compares with 13-51% in prior studies

Young patients with low incidence of cancer

Outpatient treatment protocols and follow up in thrombosis units may safely allow greater numbers at home

Implications At home treatment of low risk patients with acute,

symptomatic PE is not inferior to in patient treatment in terms of effectiveness, safety and patient acceptance – but does reduce time spent in hospital

Low risk patients with symptomatic PE and appropriate social circumstances should be treated at home!

Other Predictors of Favourable Outcome

Absence of Right Ventricular dysfunction as predicted by negative cardiac biomarkers – Troponin, BNP, pro-BNP

Absence of RV enlargement on echocardiogram or spiral CT

HITH Service Initiatives for anticoagulation

Portable electronic device use for safer communication of INR results

Nurse led warfarin dosing

Coagucheck use

Take Home Points

HITH is good! (cheaper, saves beds, good outcomes, happy patients)

Most patients with DVT should be treated at home

about 30% of patients with PE can be safely treated at home – and possibly even more if they are admitted to HITH like services where they are more closely monitored

References Scottish Intercollegiate Guidelines Network (SIGN). Prevention

and Management of Venous Thromboembolism December 2010

ACCP Clinical Practice Guidelines Antithrombotic Therapy and Prevention of Thrombosis ed 9 Feb 2012

Therapeutic Guidelines Cardiovascular 2008 (new version coming March 2012)

Aujesky D et al. Outpatient versus inpatient treatment for patients with acute pulmonary embolism: an international, open-label, randomised, non-inferiority trial. Lancet 2011; 378:41-48

ASH 53rd annual meeting and exposition 2011 abstracts

Australian Prescriber Dec 2010 Compression Therapy for Venous Disease