“Preventing VTE: a collaborative approach” Prof Mary Day, Prof Fionnuala Ní Áinle, Ms Annmarie O’Neill

@fniainle @Thrombosisirl @annmarieo9

Thrombosis Ireland Friday 22nd November

IRISH MEDICATION SAFETY NETWORK

‘FROM THE BEGINNING’

@thrombosisirl @annmarieo9

Thrombosis Ireland

Created by: The Thrombosis Ireland Team

THE FACTS :

• More people die from blood clots than from Breast Cancer, Prostate Cancer & Road Traffic COMBINED!

No.1 Cause of PREVENTABLE DEATH in our hospitals.

No.1 Cause of Direct Maternal death in our Maternity Hospitals.

60% of all these cases occur as a direct result of a hospital stay or in the 90 Days after discharge.

1 IN 5 CANCER PATIENTS will get a blood clot.

Blood clots are preventable and treatable in many cases if caught early.

WHAT DO WE NEED?

Investment…This cannot be done properly in a voluntary way.

Appointed Clinical Lead

Clinical program designed and implemented.

VTE Specialist Nurse Appointed in every hospital to lead…

VTE Committee in each hospital.

Mandatory, Audited VTE assessments for every patient.

Inform all Patients about their Risk, the signs, seek help fast.

Accurate local/National Statistics & VTE Research.

Alert Card

What are the symptoms and signs of DVT?

9

What are the symptoms and signs of pulmonary embolism?

10

Hospital Acquired Thrombosis (HAT)

• Any VTE that occurs during a hospital admission

Or

• Within 90 days of discharge

• At least ~50-60% related to hospital admissions

• Leading preventable cause of hospital death

VTE risk assessment and appropriate thromboprophylaxis

reduces VTE-related death

Will Lester et al. Heart 2013;99:1734-1739

Copyright © BMJ Publishing Group Ltd & British Cardiovascular Society. All rights reserved.

Impact of VTE in pregnancy

Illustration by Renata Donciu

50

O’Shaughnessy (Ní Áinle, Cleary) et al. J. Thromb Haemost. 2019

VTE risk factors are common in pregnancy AND POSTPARTUM

• Cross-sectional study of prospectively collected data

• 21,019 postpartum electronic VTE risk assessments

• Representing >90% of all women giving birth in a single institution

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VTE risk factors are common in pregnancy AND POSTPARTUM

• 78% of women had at least 1 VTE risk factor including:

• Overweight and obesity (36%)

• Age ≥35 (35%)

• >40% had 2 or more VTE risk factors.

• One fifth of women had no VTE risk factors prior to delivery, but developed them during delivery/postpartum period.

It is important to repeat a VTE risk assessment postpartum!

O’Shaughnessy (Ní Áinle, Cleary) et al. J. Thromb Haemost. 2019

• Guidelines mainly based on expert opinion rather than high-quality evidence

Bates SM et al. American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141(2 Suppl):e691-736S; Chan WS et al. VTE in Pregnancy Guideline Working Group Society of Obstetricians and Gynecologists of Canada. J Obstet Gynaecol Can 2014;36:527-53; Royal College of Obstetricians and Gynaecologists guideline No. 37a.RCOG Press, 2015; Lindqvist PG, Hellgren M. Obstetric thromboprophylaxis: the Swedish guidelines. Adv Hematol 2011;2011:157483.

Can we ↓VTE risk with pharmacological thromboprophylaxis?

Illustration by Renata Donciu

• RCT: Low vs intermediate dose LMWH

• Prevention of pregnancy-related VTE recurrence

• NCT 01828697

• Netherlands, France, Ireland, Belgium, Norway, US, Canada, …

• 901/ ~1200 inclusions to date

HighLow Study

Eligibility criteria: • Age ≥18 years • <14 weeks pregnant • Previous objectively confirmed VTE: - Unprovoked - Provoked by hormones - VTE in pregnancy - VTE postpartum (PP) - Minor provoking factor www.highlowstudy.org

PI: Prof. dr. Saskia Middeldorp AMC, Netherlands

Primary efficacy outcome: • Symptomatic recurrent VTE up

to 6 weeks PP Primary safety outcomes: • Major bleeding • Composite: major & clinically

relevant non-major bleeding • Early & late PP haemorrhage • PP blood transfusion • Mortality

O’Shaughnessy (Ní Áinle) et al, AOGS. 2017 Honorable Mention, US CDC 2015 Healthcare-Associated Venous Thromboembolism prevention Challenge. O’Shaughnessy (Ní Áinle, Cleary) et al. JTH 2019

Does a package consisting of VTE AWARENESS, risk assessment and appropriate thromboprophylaxis ↓ VTE?

Data from National IMIS report (Irish Maternity Indicator System))

0.58 0.5

0.41

0.57

0.88

0.63

0.4 0.47

0.59

0.31 0.23

0.46 0.46

0.77

1.13

1.04

0.80

0.12 0.12 0.12

0

0.2

0.4

0.6

0.8

1

1.2

2008(HIPE/NPRS)

2009(HIPE/NPRS)

2010(HIPE/NPRS)

2011(HIPE/NPRS)

2012(HIPE/NPRS)

2013(HIPE/NPRS)

2014 (IMIS) 2015 (IMIS) 2016 (IMIS) 2017 (IMIS)

Pulmonary embolism, 2008-17

PE, National PE, Rotunda

Rollout of VTE awareness initiative

Ireland East Hospital Group (IEHG)

Venous Thromboembolism (VTE) Service Review Group

Irish Medication Safety Conference 22nd November 2019

IEHG at a glance

Largest of the hospital groups

11 hospitals (6 voluntary and 5 HSE)

1.1 million population and 12,000 staff

4 CHOs and 4/5 active LICCs

Covering counties Dublin, Meath,

Westmeath, Carlow, Kilkenny, Wicklow

and Wexford

IEHG – Largest Hospital Group

IEHG Focus on

VTE

The IEHG places a very strong emphasis on saving lives by raising awareness of VTE and through prevention of hospital-associated VTE through group-wide initiatives

The IEHG VTE Service Review Group is the 1st group wide VTE initiative ever to be established in Ireland

IEHG Focus on VTE

In Ireland estimated 5,000 VTEs every year with >60% related to hospital admissions!

In May 2017, the inaugural meeting of the IEHG VTE Service Review Group took place with Thrombosis Ireland representation

Meet quarterly with key workflows assigned and ongoing

Focuses on the promotion of evidence-based care pathways for the prevention, diagnosis, and treatment of VTE. Where feasible, including harmonising pathways across IEHG hospitals

IEHG Focus on

VTE

This group has strong patient representation with the founder of Thrombosis Ireland, Anne-Marie O’ Neill, as a full member. As a blood clot survivor, she and the Chair of the IEHG VTE Committee, have spoken twice in the European Parliament to raise VTE awareness with the aim of saving lives. In 2018, Anne - Marie was runner up at World Thrombosis Day (WTD) Ambassador of the year

The WTD campaign is a global awareness campaign starting at grass roots that in 2018 had a global reach of 3 billion

IEHG Focus on

VTE

In 2018, the IEHG was the first nationally to determine VTE incidence and the burden of hospital acquired VTE events

This IEHG study confirmed that within the IEHG catchment area the incidence of VTE can be estimated at 1.44 per 1000 annually. At least 47% of these cases are hospital-acquired

As a result of the study a change management process is underway. IEHG is fully aware that implementation of VTE risk reduction strategies are urgently required

• During the study period, 2727 VTE events were recorded within the IEHG

• Incidence of 1.44 (95% CI 1.36 to 1.51) per 1000 per annum.

• 1273 (47%) of VTE events were recorded as secondary VTE.

• The incidence of VTE was highest among individuals over 85 years of age (16.03 per 1000;95% CI 12.81 to 19.26)

IEHG VTE Key

Milestones

Manuscript submission to BMJ Open, IEHG’s VTE incidence paper was recommended for publication in BMJ open

IEHG Superficial Vein Thrombosis Guideline – drawn up, approved and adopted by member sites

Approval for dedicated Consultant Haematologist /VTE specialist Mater/IEHG

IEHG VTE Key

Milestones

‘Stop the Clot Roadshow’

VTE audit app platform trialled by sites - audit tool to facilitate thrombosis appropriateness -

with feedback at IEHG forum

Funding for IEHG VTE audit app tool sought and approved - procurement process

underway - RISK ASSESSMENT IS A KEY FACTOR IN REDUCING MORTALITY

IEHG New VTE Dashboard October 2019

Additional IEHG VTE Initiatives Underway

Ambulance Service (NAS & DFB) PE Survey (ASSURE)

Evolving National NQAIS VTE with HSE Health Atlas – looking at evolving a Scientific Group to evolve a national NQAIS VTE dashboard

Consultant post with sessional commitment to IEHG VTE - lead for IEHG OPD VTE pathways

‘Stop the CLOT’- Roadshow 2019

• 6 Weeks, 11 Hospital, 4 CHOs, 11,000 staff and in excess of 1m patients

• Tour of hospitals started September 10th to October 15th (World Thrombosis Day)

• Fully kitted out double decker bus as main venue for services

• Specialist speakers and information on bus

• Two information sessions

– Hospital

– Community

• Local media and radio engagement

• Advertised locally with pamphlets, flyers, posters

• Secured sponsorship

The Big Red Bus

“Stop the CLOT”

Roadshow 2019

The Big Red Bus…

“Stop the CLOT” Roadshow 2019

• 5 Weeks, 11 Hospital, 11,000 staff & Over 1 Million Patients

• Tour hospitals starting September 12st thru to October 13th (World Thrombosis Day)

• Location

– Hospital

– Community

• Reach

– Healthcare Professionals

– Patients

– Public

Stop the Clot Roadshow with Anne-Marie O’Neill

IEHG: Fostering Research and Innovation in VTE

UCD Conway SPHERE

Launched Sept 2015

Translational Team based in the UCD Conway Institute

Study Platelets & Thrombosis in Inflammatory Disease

Funding: €3 million Prof Patricia Maguire Professor in Biochemistry, UCD

Director of the UCD Institute for Discovery

SPHERE Systemic inflammatory disorders: role of blood Particles, Haemostatic factors and ExtRacEllular vesicles

Disease-specific alterations?

Coagulation Factors/Thrombin generation

Megakaryocytes Platelets

Haemostasis Thrombosis

Immune response Inflammation Angiogenesis

Bone formation Foetal vascular remodelling

Inflammation Atherosclerosis

Calcification MS plaque formation

Tumour metastasis

Ischaemic Stroke Multiple Sclerosis

Early-onset Preeclampsia Pulmonary hypertension

Liver Cirrhosis

Coronary Artery Disease Alzheimer’s Disease

Rheumatoid Arthritis Cancer

Platelets and their contents play a much broader role than just clotting: Disease-specific interests of UCD Conway SPHERE

Recent Publications: Sklanna et al, Proteomics Clin Applic 2019 (Pregnancy; patent application submitted) Parsons et al, Proteomics 2018 (MS/platelet releasate) Kevane et al, J Thromb Haemost 2018 (Pulmonary hypertension)

Kevane et al, RPTH 2017 (cancer) Egan et al, Thromb Haemost 2017 (preeclampsia) Dillon et al, RPTH 2018 (Liver cirrhosis) Neary et al, J Thromb Haemost 2016 (neonatology)

Platelets store their “secrets” in their ‘Releasate’

Resting Platelets Activated Platelets

Proof of concept: Pregnancy test

The “barcode’ of the platelet releasate changes in pregnancy

Sklanna (Ní Áinle, Maguire) et al, Proteomics Clinical Applications 2018 Oct 14; Parsons (Ní Áinle, Maguire) et al, Proteomics 2018

11 predictive proteins: 87.6% accuracy in correctly classifying pregnant vs non-pregnant women

INViTE

• An Irish, patient-oriented research network

• Mission: To develop and participate in excellent National and International Venous Thromboembolism (VTE)-related research.

• We are honoured to work with Thrombosis Ireland

Sowing the seeds: VTE Dublin International Conference

International friends: >5 years of Network- Building

Partner organizations

INVENT-VTE

Launch: 12th Sept 2018

• INViTE was launched at VTE Dublin 2018 by Minister for Business, Enterprise and Innovation Heather Humphries

TILLIRI

A Prospective multicentre study to assess the risk factors that contribute to (T) thrombosis in patients with (L) lower (L) limb (I) injuries (R)requiring (I) immobilization to identify a group of patients with a

high predicted VTE risk. (TiLLIRI study)

Steering Committee: Dr D O’Keeffe,Prof. Mike Watts, Prof. F Ni Ainle, Dr T. Breslin and Dr D Horner (UK)

• Inclusion Criteria

1. Age ≥ 18 years

2. Lower limb trauma

3. Requirement for lower limb immobilisation

• Sample size: 3,500 (400 recruited to date)

• Based on VTE rate of 4% ( ±0.4%)

• Planned interim review @ 1,000 patients to assess VTE rate and factors

• A Prospective Trial Assessing Quality and Safety of an Optimised CTPA protocol in Pregnancy

• A LOW-DOSE CTPA protocol can reliably achieve low breast doses at NOISE levels (Image Quality) that are SAFE in pregnancy

• Aims • DEFINE a low-dose CTPA protocol OPTIMISED for pregnancy

• Prospectively demonstrate safety of out-ruling PE in the pregnant/post partum population

• Outcome: Incidence of PE at 3 months • Subsequent diagnosis or mortality attributed to PE

• Telephone follow up

OPTICA Study

Gillespie et al, Oral presentation, VTE Dublin 2018; First prize VTE Dublin 2019 Gillespie et al, Thrombosis Research 2019 (protocol publication) Gillespie et al, WHITH conference 2019

Partnering with HSE, patients and knowledge users: the “VIP “project

VTE in Inclusion Health Populations

• PI: Prof Cliona Ní Cheallaigh (Clinical Lead: Inclusion Health Service SJH; Founder: All-Ireland Inclusion Health Forum

• Partnership with HSE Knowledge Users

• Dr Vida Hamilton: National Clinical Advisor and Group Lead for the Acute Hospitals Division

• HSE dept of Health Intelligence

• Partnership with UCD PPI Ignite team, Thrombosis Ireland and De Paul Ireland

Outputs 2019: Publications

Thank You