ACTIVE CLEARANCE TECHNOLOGY

PleuraFlow is a unique system that proactively clears chest tubes and prevents the retention of blood in the chest cavity

EASY INTEGRATION INTO WORKFLOW

•  Reduces time required for nurses to manage blocked tubes (up to 2 hours per patient per day)

Cook, et al., Cleveland Clinic Foundation, Presented at AATS 2014 Poster session

ACT MAINTAINS CHEST TUBE PATENCY

Clogged conventional tubes and clear PleuraFlow ACT tubes removed from the same patients 24-48 hours post-surgery

Top: PleuraFlow ACT Bottom: Conventional

Top: Conventional Bottom: PleuraFlow ACT

Left & Right: PleuraFlow ACT Middle: Conventional

Patients with Retained Blood Syndrome incurred significantly higher reinterventions, length of stay, readmissions & total cost of care.

HEART CENTER IN NÜRNBERG

Historic data (2011-2012 incl. n= 1,869)

Independent German Data Presented at 2014 EACTS (Milan) and 2014 FACTS-CARE (Washington DC)

20% Measure Non-RBS RBS Increase

Length of Stay (Days) 12.6 20.75 +65%

ICU Stay (Days) 4.1 10.1 +149%

Ventilation Time (Hrs.) 40.2 111.3 +149%

Cardiac Arrest (%) 2 5.6 +182%

Atrial Fibrillation (%) 27.5 36.8 +34%

Permanent Stroke (%) 0.89 2.3 +163%

Mortality 6.3 8.5 +34%

required one or more reinterventions due to RBS

Patients receiving PleuraFlow in a Prospective Registry arm showed a markedly lower rate of Retained Blood Syndrome.

PLEURAFLOW WORKS!

Reduction in RBS with PleuraFlow (p=0.025) 42%

256 with PleuraFlow With regular drains 1,869 RBS Interventions (29 total)

RBS Interventions (374 total) 20%

Retrospective data 2011-2012 Prospective Same-site data 2014

11%

Independent German Data Presented at 2014 EACTS (Milan) and 2014 FACTS-CARE (Washington DC)

Patients receiving PleuraFlow in a Prospective Registry arm showed a markedly lower rate of Atrial Fibrillation.

LESS POAF/A-FIB OBSERVED

Reduction in A-Fib. with PleuraFlow (p,=0.0055) 30%

256 with PleuraFlow With regular drains 1,869 A-Fib. (52 total) A-Fib. (543 total) 29%

Retrospective data 2011-2012 Prospective same-site data 2014

20%

Independent German Data Presented at 2014 EACTS (Milan) and 2014 FACTS-CARE (Washington DC)

20%

11%

18%

0%

5%

10%

15%

20%

25%

Phase 1 (n=1,869) Phase 2 (n=256) Phase 3 (n=222)

RBS RETURNED TO BASELINE AFTER!

No ACT

% R

BS I

nter

vent

ions

No ACT ACT

42% reduction p=0.0021

p=0.54 not significant

PREVENTING EVEN A FRACTION OF RBS LEADS TO SUBSTANTIAL HOSPITAL SAVINGS

All cardiothoracic hospitals can immediately reduce their total cost of care by adopting PleuraFlow ACT.

Cardiac Surgery Procedures/year 1,200 800 400

Rate of RBS Complications @ 17%1 204 136 68

Cost of RBS Complications1,2 $5,878,056 $3,918,704 $1,959,352

42% Reduction3 $2,468,784 $1,645,856 $822,928

Cost of ACT4 $474,000 $316,000 $158,000

Projected Hospital Savings $1,994,784 $1,329,856 $664,928

1 Based on over 313,000 US adult heart surgery patients from the 2010 Nationwide Inpatient Sample (NIS)/(AHRQ)/(HCUP). 2 $28,814 average cost per patient who had 1 or more RBS complications that required re-operation or intervention 3 Clinical trial results from Paracelsus Medical University Klinikum Nürnberg Germany, 2014 4 $395 per PleuraFlow ACT System

NOT INCLUDED IN $28,814 COST

The documented cost savings may represent only the “tip of the iceberg” for actual costs to treat patients with retained blood. •  POAF management (in ~30% of patients)1,2

•  ICU Nursing time (if tubes clogged ~2 hrs/pt)3

•  •  Opportunity Costs for ICU bed occupancy

•  Hospital and general ward workflow impact

•  P4P Penalties under Affordable Healthcare Act

•  Medical/legal liability for death or injury 1 American Association for Thoracic Surgery (AATS) evidence-based guidelines for the prevention and treatment of perioperative and postoperative atrial fibrillation states: “POAF is associated with longer intensive care unit and hospital stays, increased morbidity, including strokes and new central neurologic events, as well as use of more resources. Patients who develop POAF tend to stay two to four days longer in the hospital.” http://www.eurekalert.org/pub_releases/2014-09/aaft-ngi092214.php_ 2. Two studies quote from $6,500 to $11,000 extra per patient for POAF management: http://www.ncbi.nlm.nih.gov/pubmed/12022486; http://www.ncbi.nlm.nih.gov/pubmed/25087786 2 Cook, et al. Patient and Nurse Factors that Drain Nursing Time in Chest Tube Management. Poster from AATS 2014.

SUMMARY OF CLINICAL IMPACT

•  36% of chest tubes become completely clogged and in 86% of these cases it cannot be seen by the nursing staff.1

•  There is a Class III recommendation against current practice which states milking and stripping:

“May be harmful; no benefit documented”.2

 1  Karimov,  Eur  J  Cardiothorac  Surg.  2013  2  Halm,  et  al.  Am  Journal  Cri5cal  Care,  2007  

SUMMARY OF FINANCIAL IMPACT

•  Clogged chest tubes lead to expensive and avoidable additional re-operations and interventions in 16-23% of all cardiac surgery patients.1,2,3

•  A conservative estimate of the average cost to treat only those complications that require interventions is $489,838 for every 100 cardiac surgeries performed.2

1  Karimov,  Eur  J  Cardiothorac  Surg.  2013  2  Based  on  over  313,000  US  adult  heart  surgery  pa<ents  from  the  2010  Na<onwide  Inpa<ent  Sample  (NIS)/(AHRQ)/(HCUP).  3  Addi<onal  references  from  published  literature  available  upon  request  

SUMMARY OF SOLUTION

PleuraFlow is the only FDA approved System with Active Clearance Technology®.

It is easy to implement and has been shown in a German clinical study to reduce RBS complications like bloody pleural and pericardial effusions by 42% and post-operative AFib (POAF) by 30%.1

 1  Clinical  trial  results  from  Paracelsus  Medical  University  Klinikum  Nürnberg  Germany,  2014  

Arakawa, Y., Shiose, A., Takaseya, T. et al. Superior Chest Drainage With an Active Tube Clearance System: Evaluation of a Downsized Chest Tube. Ann Thorac Surg. 2011;91:580-583. doi: 10.1016/j.athoracsur.2010.10.018.

Christensen, M., Krapf, S., Kempel, A. et al. Costs of excessive postoperative hemorrhage in cardiac surgery. J Thorac Cardioasc Surg. 2009;138(3):687-93. PMID: 19698857.

Day, T., Perring. R., Gofton, T., Is manipulation of mediastinal chest drains useful or harmful after cardiac surgery? Interact CardioVasc Thorac Surg. 2008;7:888-890.

Dixon, B., Santamaria, J.D., Reid, D., et al. The association of blood transfusion with mortality after cardiac surgery: cause or confounding? Transfusion. 2013;53(1):19-27. doi: 10.1111/j.1537-2995.2012.03697.x.

Hannan, E., Zhong, Y., Lahey, S., et al. 30-day readmissions after coronary artern buypass graft surgery in New York State. J Am Coll Cardiol Intv. 2011;4(5):569-576. doi:10.1016.jcin 2011.01.010.

Karimov, J.H., Gillinov, A.M., Schenck, L., et al. Incidence of chest tube clogging after cardiac surgery: a single-centre prospective observational study. Eur J Cardiothorac Surg. 2013;44(6):1029-1036. doi:10.1093/ejcts/ezt140.

Lee, Y.C., Vaz, M.A., Ely, K.A., McDonald, E.C., Thompson, P.J., Nesbitt, J.C., and Light, R.W. 2001. Symptomatic persistent post-coronary artery bypass graft pleural effusions requiring operative treatment : clinical and histologic features. Chest 119:795-800.

Light, R.W., Rogers, J.T., Moyers, J.P., et al. Prevalence and Clinical Course of Pleural Effusions at 30 Days after Coronary Artery and Cardiac Surgery. Am J Respir Crit Care Med. 2002;166:1567-1571. doi: 10.1164/rccm.200203-184OC.

Mangus, P.C., et al. Causes of 30-Day Readmission After Cardiac Surgery in Northern New England, Abstract 13474. Circulation. 2011;124-134.

Perrault, L.P., Pellerin, M., Carrier, M., et al. The PleuraFlow Active Chest Tube Clearance System: Initial Clinical Experience in Adult Cardiac Surgery. Innovations (Phila). 2012;7(5):354-8. doi: 10.1097/IMI.0b013e31827e2b4d.

Shalli, S., Saeed, D., Fukamachi, K., et al. Chest Tube Selection in Cardiac and Thoracic Surgery: A Survey of Chest Tube-Related Complications and Their Management. J Card Surg. 2009;24:503-509. doi: 10.1111/j.1540-8191.2009.00905.x.

Shiose, A., Takaseya, T., Fumoto, H., et al. Improved drainage with active chest tube clearance. Interact Cardiovasc Thorac Surg. 2010;10:685-688. doi: 10.1510/icvts.2009.229393.

Wallen, M.M., Morrison, A.L., Gillies D, et al. Mediastinal chest drain clearance for cardiac surgery (Review). The Cochrane Library. 2008, Issue 3.

Wheatcroft, M., Shrivastava, V., Nyawo, B., Rostron, A., and Dunning, J. 2005. Does pleurotomy during internal mammary artery harvest increase post-operative pulmonary complications? Interact Cardiovasc Thorac Surg 4:143-146.

Based on over 313,000 US adult heart surgery patients. Data extracted using ICD-9 codes from the 2010 Nationwide Inpatient Sample (NIS), from the DHHS Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP).

CLINICAL REFERENCES

APPENDIX

POSTOPERATIVE BLEEDING PATHWAY M

ON

THS

W

EEK

S

DA

YS

H

OU

RS

CHRONIC RBS

Clinically Large Volume of Retained Blood/Clot

SUB-ACUTE RBS

ACUTE RBS

ADEQUATE BLOOD EVACUATION INADEQUATE BLOOD EVACUATION

Subclinical Volume of Retained Blood/Clot Recovery

Clot causes Inflammation/VEGF Production and Fluid

Inflammation Transitions to Fibrosis

Pericardial Effusion

Pleural Effusion

Postoperative Constrictive Pericarditis

Fibrothorax

Pericardial Tamponade

Hemothorax

EVERYONE IS ON THE BELL CURVE

Rate of reintervention for Retained Blood Syndrome (RBS)

16-23% Documented complications in the literature

17%  Hospital 1 n=6,909 16%  

Hospital 2 n=1,869 20%  

Hospital 3 n=77 (VAD) 51%  

NIS ICD-9 codes n=313,000

RBS IS FREQUENT AND SERIOUS

No RBS - 83.7%

Thoracentesis - 8.9%

Re-exploration - 6.7%

Pericardial Effusion - 1.6%

Hemothorax - 3.3%

Tamponade - 1.6%

* Patient may have more than one RBS event

N=6,909 Cardiac Surgery Patients at Charité Hospital 5,784 (83.7%) = No Retained Blood Syndrome (RBS) 1,125 (16.3%) = One or more RBS complications

RBS IN THE LITERATURE

RBS Type Range Reference Source % Incidence

Acute pleural & pericardial intervention

3.0 – 6.4% Vivacqua, 2011 Unsworth-White, 1995 Moulton, 1996 Christensen, 2012 Price, 2004

3.0 3.8 4.2 6.4 6.4

Subacute pericardial intervention

1.2 – 2.0% Ashikhmina 2010 Russo, 1993 Pompilio, 2011

1.2 2.0 2.0

Subacute pleural intervention

5.9 – 10.0% Lancey, 2001 Light, 2002

5.9 10.0

Chronic complications

2 – 3% Gaudino, 2013 2-3.0

References Available Upon Request

RBS DEFINITION BY ICD-9 CODE

0.00% 2.00% 4.00% 6.00% 8.00% 10.00% 12.00% Pleural Effusions

Insertion of intercostal catheter for drainage Thoracentesis

Reopening of recent thoracotomy site Cardiac tamponade

Pericardiotomy Other incision of pleura

Diagnostic ultrasound of other sites of thorax Open chest cardiac massage

Pericardiocentesis Hemopericardium

Incision of chest wall Decortication of lung

Empyema Transpleural thoracoscopy

Thoracoscopic drainage of pleural cavity Thoracoscopic decortication of lung

Scarification of pleura

ICD-9 Procedures and Diagnoses that indicate RBS after Heart Surgery

Total US Inpatients (2010)

~40MM

Adult Cardiac Inpatient Sample

313,766

Inpatients with RBS

53,018 (17%)

Based on over 313,000 US adult heart surgery patients. Data extracted using ICD-9 codes from the 2010 Nationwide Inpatient

Sample (NIS), from the DHHS Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP).

SUMMARY OF NIS DATA ANALYSIS OF OVER 313,000 US CARDIAC SURGERY PATIENTS

•  Approximately 53,000, or 17%, of patients had additional codes consistent with Retained Blood Syndrome (RBS) with the following results:

–  Mean LOS increased from 9.2 days to 15 days compared to patients without RBS –  Total charges and costs were about 55% higher ($28,814) than for patients

without RBS –  Routine discharges declined to 29% from 39%, with an increase in both assisted

discharges and expired patients over average cardiac surgery patients –  Mortality doubled from 3% to 6% over average cardiac surgery patients

Based on over 313,000 US adult heart surgery patients. Data extracted using ICD-9 codes from the 2010 Nationwide Inpatient Sample (NIS), from the DHHS Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP).

50% LESS DIAMETER = 94% LESS FLOW

50% = 94% Restriction Less Flow

75% = 98% Restriction Less Flow

25% = 50% Restriction Less Flow

10% = 10% Restriction Less Flow

READMITTED AFTER NINE MONTHS

“A collection of bloody fluid caused scar tissue to form and squeeze the lower lobe of his left lung, impeding his breathing capacity by more than 25%...

…doctors removed a large, unspecified amount of bloody fluid…

…(then found) a large thick rind of inflammatory tissue encasing the lower lobe of the lung...some sections were five to eight millimeters (thick).”

SIGNIFICANT AND AVOIDABLE COST

For every 100 cardiac surgery patients, 17 will suffer one or more interventions for Retained Blood Syndrome.

Non reimbursable costs

17 x $28,814 =

$489,838

Based on over 313,000 US adult heart surgery patients. Data extracted using ICD-9 codes from the 2010 Nationwide Inpatient Sample (NIS), from the DHHS Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP).

Based on over 313,000 US adult heart surgery patients. Data extracted using ICD-9 codes from the 2010 Nationwide Inpatient Sample (NIS), from the DHHS Agency for Healthcare Research and Quality (AHRQ) Healthcare Cost and Utilization Project (HCUP).

SIGNIFICANT ECONOMIC VALUE

The average RBS intervention costs US hospitals $28,814 per patient, which covers the cost of ~75 PleuraFlow Systems at $395 each

Cost of 1 RBS

$28,814

Cost of 1 PleuraFlow $395

~75

PleuraFlow Catheters

AWARD-WINNING TECHNOLOGY

PleuraFlow has won 7 design & innovation awards including:

Innovations in Cardiovascular Interventions Award (ICI)

Act as a catalyst, address problems & improves lives

Best Startup Innovation

Pro Design Award

European Association of Cardio-Thoracic Surgery (EACTS)

Techno-College Innovation

Most Technologically Significant

salutes the 100 most significant products introduced into the marketplace over year