ANGEL2015

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www.aquilantservices.com

Angel – Critical Care Catheter Rapid protection against VTE in the Emergency Department using an established ITU technique

Paul F Stephenson

Sales Development Leader – Aquilant Interventional

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www.aquilantservices.com

Problem: 2012 - 60,000 people had a VTE in UK. An estimated 25,000 of them died of VTE related issues (source: NICE Guidance for VTE Protection 2012).

Kroger et al: People who survive a VTE related event cost the health economy between 25,000-28,000 Euros in the first year.

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What’s all the fuss about – cuts & austerity ?

Harvard Business Review “Providers must lead the way in making ‘value’ the overarching goal” . – M Porter HBR Oct 2013.where Value Based Health Care is defined as:- Outcomes that matter to a patient

Cost of DeliveryThere are two aspects for any company to solve: • FINANCIAL BENEFIT - NHS Corporate want to be able to know and see a Return on Investment (ROI)• QUALITY & CLINICAL BENEFIT – As CCG’s are redesigning services due to cost pressure and austerity management – they want waste out of the budget, without a drop in quality

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Angel® Catheter to Prevent Venous Thromboembolism (VTE) in high risk patients in intensive care:Summary

Cost of PE’s to UHNS NHS Foundation Trust 2011-12Source: NHS Information Centre for Health & Social Care (Hospital Episode Statistics)

There were 481 hospital VTE’s at UHNS NHS Foundation Trust. 189 of these were classed as emergencies, therefore 292 could be classed as hospital acquired.

• The 481 VTE’s accounted for 2442 additional bed days.

HRG CODING available to Angel Catheter under primary diagnosis code of I269 = £3159

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Benefit for UHNS is that everyone is talking about the tariff implications for

extended stay in the ICU ,and the general loss of activity inside the hospital as a

result of increased bed stay- e.g. Cancellations of elective procedures as a result of

blocked beds. This has big implications for the level of Quality and Care at a

Hospital. The Angel Critical Care Catheter can help address this issue.


HRG - emergency tariff

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Trauma patients – The ED & PE

PE in Trauma patients often kills immediately, causing sudden death in around 20% of affected patients. Survivors usually require intensive care and may take weeks or months to recover, a process associated with significant health care costs. • Trauma patients represent a specific population of patients who are at substantially increased risk of venous thromboembolism (VTE), which contributes significantly to their morbidity and mortality. Within this group of patients treated without thrombolytics prophylaxis, the incidence of DVT has been estimated at 30%, with a 15% incidence of PE, of which 5% may be fatal.


NHS England have put a cost saving figure on delivering high quality Pulmonary Embolism Protection (VTE) at £12,000 per 100,000 of population. They also estimate that the NHS could also benefit from significant savings through the avoidance of clinical negligence claims made as a result of its failure to implement best practice in VTE Protection – estimated to have cost £112 million from 2005 to 2011 .

Clinical Negligence Scheme for Trusts could be reduced – (CNST)


Angel Critical Care Catheter

The Angel® Catheter is a temporary inferior vena cava (IVC) filter that is permanently attached to a central venous catheter (CVC) and has been designed to reduce the rates of PE-related morbidity and mortality by trapping venous emboli. It is designed from ‘Hour Zero’ to provide protection from PE in patients who are contraindicated for standard thromboprophylaxis or require additional protection. The Angel® Catheter was the first IVC filter to receive CE Mark approval for a prophylactic indication, in addition to traditional IVC filter & CVC indications.


Angel Catheter - Indications

Patients with multiple trauma such as:• severe head injury• head injury with a long bone fracture• spinal cord injury with paraplegia or quadriplegiaCritically ill patients in ICU with:• haemorrhagic or ischemic stroke • multiple organ failure• active or recent bleedingCritically ill patients needing surgery that requires interruption of medical prophylaxis


Clinical Indications for Use

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PE with AC Contraindica-tions17%

Emergent Tx for PE2%

Prophylactic48%

Interruption of AC11%

Other/Unknown22%

48% Prophylactic use



If complications - Patient transferred (with all equipment) to IR Suite for IVC filter ( fear that movement will lead to clot displacement )Cost -£1,100 for device & retrieval sheathProcedure cost ??

Possibility of surgery taking place at peak PE time ie 5-7

days post accident

Cost Issues with additional medications / X Rays / ECG’s extra health professionals time etc

CCG KEEN TO CUT ‘WASTED MEDICINES

BUDGET MO

RTALITY & M

ORBID

ITY ISSUES

Patient transferred to ITU (to be stabilised prior to surgery ) usually for a period of 3 to 4 days.Cost – £2,000 + per day

As patient improves they are transferred to level one support (HDU) – I nurse per 2 patients

Cost – £1,800 pd . Hospital only receives £1,500 from DRG tariffs

High VTE risk patient enters hospitale.g: RTA Pelvic fracture & long bone fracture

Unspecified level of recovery either in hospital or at home COSTS

UNKNOWNU


Clinical Data from ISICEM 2014

60 patient registry - presented at ISICEM of the Angel Catheter.

0 –Blood stream infections in 381 catheter days

0 - PE’s reported

7 – Captured thrombus’s in 60 cases

7.9 days – Average length of insertion

PE’s cost hospital budgets an additional 2.6 ITU days. However, the

mortality rate rises from 6% to 12% ( Millennium Research Group )


Discussion points (2)

1. Kaufman et al: 2006:17 – 449-459 Journal of Vascular Interventional Radiology –

34% of IVC Filters are not retrieved leading to patients staying on DAPT

therapy. See also MHRA Device Alert May2013/028


Discussion – Conclusion

PE is a significant health issue in hospitalised patients The critically ill patient is at highest risk

Prophylactic anticoagulation is the best studied and most recommended prophylactic measure

- It cannot be used in all patients

- Is not universally effective & increases the risk of bleeding

The Angel Catheter offers

- An IVC Filter that can be easily placed at the bedside

- Is removed in all patients when the risk of PE is lower and/or anticoagulation can be started

- A fully functional triple lumen catheter for volume resuscitation, medicine administration and CVP monitoring




THANK YOU !!


Angel Catheter - Evaluation Feedback Form

Part II. Evaluation of Session a) What did you most like/dislike about the meeting?

Poor Fair Good V Good N/A

Ease of insertion ☐ ☐ ☐ ☐ ☐

Management of Catheter in Unit ☐ ☐ ☐ ☐ ☐

Visibility of Angel Catheter in Situ ☐ ☐ ☐ ☐ ☐

Retrieval Procedure of Angel Catheter ☐ ☐ ☐ ☐ ☐

Overall Performance of Anger Catheter ☐ ☐ ☐ ☐ ☐

Other Comments ------------------------------------------------------------------------------------------------------------

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Please email to Paul Stephenson [email protected]

Reason for insertion 1. ☐ DAPT Issues (Tick if applicable) 2. ☐ Neuro Issues

3. ☐ Thoracic Issues 4. ☐ Long Bone Injury 5. ☐ Pre enclampsia 6. ☐ Other

Device inserted 7. ☐ Adult Intensive Care Unit 8. ☐ High Dependency Unit 9. ☐ Neuro ICU

10. ☐ Radiology Suite (IR) 11. ☐ Other

Period of insertion days

☐ Presence of clot in filter post removal ☐ Yes ☐ No

Date: Hospital:

Physician Name: Lot No:


Angel® Catheter to Prevent Venous Thromboembolism (VTE) in high risk patients in intensive careSummaryCost of PE’s to Oxford University Hospital NHS Foundation Trust 2011-12 Source: NHS Information Centre for Health & Social Care (Hospital Episode Statistics)

There were 482 hospital VTE’s at Oxford University Hospital NHS Trust. 354 of these were classed as emergencies, therefore 128 could be classed as hospital acquired. 40% of these occurred in the ITU setting - Using the Millennium Research Group classification of 2.6 additional ITU bed days (@£12,000) per PE, this means that PE’s cost the Trust £614,400.• Bed Days for total 482 VTE’s accounted for 2198 bed days.




Angel® Catheter to Prevent Venous Thromboembolism (VTE) in high risk patients in intensive careSummaryCost of PE’s to Plymouth Hospitals NHS Trust 2011-12 Source: NHS Information Centre for Health & Social Care (Hospital Episode Statistics)

There were 421 hospital VTE’s at Plymouth Hospital NHS Trust. 217 of these were classed as emergencies, therefore 203 could be classed as hospital acquired. 40% of these occurred in the ITU setting - Using the Millennium Research Group classification of 2.6 additional ITU bed days @£12,000per PE, this means that PE’s cost the Trust £974,000.• The 421 VTE’s accounted for 1587 lost bed days.• Mean length of stay = 6.4 days• Plymouth Hospitals NHS Trust Quality Account 2013/14 (page 10) –” The Priority 1 improvement

for 2013/14 is to reduce the number of patients who develop a thrombus (blood clot) whilst in hospital”


Angel® Catheter to Prevent Venous Thromboembolism (VTE) in high risk patients in intensive careSummaryCost of PE’s to UHNS NHS Foundation Trust 2011-12 Source: NHS Information Centre for Health & Social Care (Hospital Episode Statistics)

There were 481 hospital VTE’s at UHNS NHS Foundation Trust. 189 of these were classed as emergencies, therefore 292 could be classed as hospital acquired.

• The 481 VTE’s accounted for 2442 additional bed days.


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ANGEL2015