Transcript Hospitalist Referring Physician Presentation

Hospitalists
New options for DVT Treatment –
Beyond the current standard of care
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. PI-368802-AB MAR2016
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Hospitalists are the frontline providers that
diagnose and manage hospital-acquired
VTEs in hospitalized patients.
Nearly half of all venous thromboembolism (VTE)
events occur during or soon after hospitalizations
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What Is Deep Vein Thrombosis (DVT)?
DVT is a blood
clot that forms
in a vein deep
in the body
Most often occurs in
the deep veins of the
legs, either above the
knee or below it
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The blood clot or part of it can break
free (called embolism) and become
lodged in the blood vessels of the lung,
causing pulmonary embolism (PE)
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VTE: A Major Source of Mortality and Morbidity
Over 200,000
deaths per year due to
PE annually in the
U.S. alone.
More than HIV,
MVAs & Breast
Cancer combined
Over 600,000
patients diagnosed with
DVT annually in the US
alone
10% of Hospital Deaths
most common
preventable death
Huge Costs
and Morbidity
Recurrence of DVT, postthrombotic syndrome and
chronic PE / PAH are long
term sequelae
Some Causes of Death in the US
Annual Number of Deaths
PE
Up to 200,000
AIDS
16,371
Breast Cancer
40,580
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DVT Development Risks
VTE prophylaxis has already made The Joint Commission's list of
Patient Safety Goals, which call for anticoagulation to be managed
by protocol. Using unfractionated heparin and even low-molecularweight heparin, we're going to have to have a guideline to manage
those patients.
Several studies, including last year's Million Women Study, have shown
that patients who have surgery for abdominal and pelvic cancers face a
clot risk for at least a month. In the @RISTOS trial, 40% of surgical
cancer patients' VTEs occurred after discharge, and the risk factors
were the same, whether the clot appeared early or late.
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DVT: What we know
Venous thromboembolism (VTE) is manifested clinically by deep venous thrombosis
(DVT) and pulmonary embolism (PE). DVT, usually of the lower extremity, nearly always
precedes PE. The risk of VTE increases greatly after age 50.
Other Risk Factors
• Age
• Trauma
• Immobilization,
• Surgery
• Anti-estrogen tamoxifen also increases the
risk of VTE
• Inherited conditions that increase risk
(thrombophilia) usually present before age
40, although it is not unusual to see the
first episode of VTE in a patient with factor
V Leiden appear after total hip replacement
at age 65
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. PI-368802-AB MAR2016
Occurrence
The disease most often occurs in
hospitalized patients, particularly
those with cancer or following
surgical procedures, but also
occurs sporadically in the
community. In both settings,
multiple risk factors are usually
present.
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Risk of DVT in Hospitalized Patients
No prophylaxis + routine objective screening for DVT
Patient Group
DVT Incidence
Medical patients
10 - 26 %
Major gyne/urol/gen surgery
15 - 40 %
Neurosurgery
15 - 40 %
Stroke
11 - 75 %
Hip/knee surgery
40 - 60 %
Major trauma
40 - 80 %
Spinal cord injury
60 - 80 %
Critical care patients
15 - 80 %
Heit – Mayo Clin Proc 2001;76:1102
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VTE is a Disease of Hospitalized and Recently
Hospitalized Patients
Cases per 10,000 person-years
1000
100
Recently hospitalized
10
1
Hospitalized patients
Community residents
Heit – Mayo Clin Proc 2001;76:1102
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VTE According to Service (N=384)
Patients
Total VTE (%)
44
Medical
16
General surgery
10
Medical oncology
Total VTE
PE
DVT
Orthopaedic surgery
9
8
Thoracic surgery
14
Other
0
25
50
75
100
125
150
175
Number of VTE events
Goldhaber SZ et al. Chest 2000;118:1680-4.
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DVT and the risk our patients face:
Stasis
Hypercoagulability
Age > 40
Immobility
CHF
Stroke
Paralysis
Spinal Cord injury
Hyperviscosity
Polycythemia
Severe COPD
Anesthesia
Obesity
Varicose Veins
Cancer
High estrogen states
Inflammatory Bowel
Nephrotic Syndrome
Sepsis
Smoking
Pregnancy
Thrombophilia
Endothelial
Damage
Surgery
Prior VTE
Central lines
Trauma
Most hospitalized patients have at least one risk factor for DVT
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Hospital Performance for Pharmacologic Venous
Thromboembolism Prophylaxis and Rate of Venous
Thromboembolism: A Cohort
JAMA Intern Med.
2014;174(10):1577-1584.
doi:10.1001/jamainternmed.2014.3
384
Figure Legend:
Flow Diagram of Patient Progress
Through the 90-Day Observation
Period -- ICU indicates intensive care
unit; VTE, venous thromboembolism.
Studies continue to identify the risks showing the need for DVT awareness in the ICU
2015 American Medical Association.
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Icoper: Cumulative Mortality After Diagnosis of PE
25
17.5%
At 90days
Mortality (%)
20
15
10
5
0
7
14
30
60
90
Days From Diagnosis
Lancet. 1999;353:1386-1389.
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Associated Illnesses that are a
Consequence of VTE events
Chronic thromboembolic
pulmonary hypertension
Post thrombotic
Syndrome
Mean pulmonary artery pressure
greater than 25 mm Hg that persists
6 months after PE
2-4% of patients after PE
Calf swelling and skin pigmentation;
venous ulceration in severe cases
Up to 43% of patients develop PTS within
2 years
Goldhaber SZ, Bounameaux H. Lancet. 2012 May 12; 379:1835-46
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Venous Thromboembolism (VTE)
remains a major health problem
In addition to the risk of sudden death
30% of survivors
28% of survivors
develop recurrent VTE
within 10 years
develop venous stasis
syndrome within 20 years
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DVT and the Risks
DVT risk and prophylaxis in the hospitalized patient
Low Risk
Moderate Risk
High Risk
Ambulatory patient without
additional VTE Risk Factors
All other patients. Most patients
(not LOW or HIGH category)
Elective major lower extremity
arthroplasty
Ambulatory patient with
expected LOS ≤ 2 days, or same
day/minor surgery
Hip, pelvic, or sever lower
extremity fractures
Only a few patients!
Acture spinal cord injury with
paresis
Multiple major trauma
Abdominal or pelvic surgery for
cancer
Ambulation and Education
LMWH or UFH 5000 units SQ q8h
LMWH or Arixtra or Coumadin
Physicians at UCSD use these checklists to assess all adult inpatients when they are admitted, transferred between units, or post-op
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DVT and the Risks
DVT risk factors
Low
Moderate
High
Age > 50 years
Prior History of VTE
Acture or chronic lung disease
Myeloproliferative disorder
Impaired mobility
Obesity
Dehydration
Inflammatory bowel disease
Known thrombophilic state
CHF
Active rheumatic disease
Varicose veins/chronic stasis
Active malignancy
Sickel cell disease
Recent post-partum w/
immobility
Hormonal replacement
Estrogen-based contraceptives
Nephrotic syndrome
Moderate to Major surgery
Central venous catheter
Myocardial infarction
Physicians at UCSD use these checklists to assess all adult inpatients when they are admitted, transferred between units, or post-op
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. PI-368802-AB MAR2016
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DVT and Your Cancer Patient
Patients with cancer who develop VTE are at higher risk of both recurrence and
death than other patients with VTE. Because of improved treatment and longer
survival, patients with cancer account for an increasing proportion of those with VTE.
• VTE can occur before cancer is evident, at the time of the cancer diagnosis and
at any point in the clinical course of patients with known cancer.
• VTE is particularly likely to occur during intensive chemotherapy and as a
complication of cancer surgery.
• For years, clinicians have been aware of so-called "warfarin failure"-the
tendency to develop recurrent VTE despite an INR between 2.0 and 3.0-in
patients with VTE and cancer. Recent clinical trials have shown that long-term
LMWH in a treatment dose reduces the recurrence rate of VTE in cancer
patients by 50% compared with warfarin (INR 2.0-3.0).
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Strategies to Improve
Thromboprophylaxis Success
• Excellent quality guidelines
• National body endorsement
• Hospital accreditation (JCAHO)
• Pay for performance (CMS)
•
•
•
•
Local written policy (care pathway) for the hospital / program / patient care unit
Multidisciplinary team
Goals and Measures
Standardized risk assessment and order sets
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National Recommendations
American College of Chest Physicians (ACCP)
“We recommend that every hospital develop a
formal strategy that addresses the prevention
of thromboembolic complications.”
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The Real Question:
What do we do with those
patients that develop a DVT?
Prompt diagnosis and treatment of deep vein
thrombosis (DVT) is essential to decrease both the risk
of recurrence and a potentially fatal pulmonary embolism (PE)
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. PI-368802-AB MAR2016
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In-Hospital DVT
Is Current in-hospital treatment adequate?
Anticoagulation
Compression Stockings
We can do better for these patients?
Using multidisciplinary team approach
Understanding the options for thrombus removal
Setting a goal of quickly removing the thrombus
Offering minimally invasive solutions
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Treating DVT Once It Has Occurred
Interventional Treatment of DVT can help
reduce the risk of complications, such as PE
The current goals in treating DVT support:
Stop the clot from progressing and getting larger
Reduce the chance of having another clot develop
Prevent the clot from breaking off in your vein and moving to your lungs
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. PI-368802-AB MAR2016
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Treating DVT Once It Has Occurred
The best strategy once a DVT
has been diagnosed is clot removal
The option of “clot removal”
Dissolving and/or Mechanical removal
Restores flow decreases risk of clot
Allows venous valves to return to normal function
Can decrease long term anticoagulation
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. PI-368802-AB MAR2016
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A New Option For Venous Thrombus Removal
New options exist for minimally invasive treatment to remove the venous clot
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. PI-368802-AB MAR2016
•
Infusion
of clot busting
medication to
assist in removal
•
Followed by
thrombus removal
using a mechanical
device to remove
the clot from the
vessel and body
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DVT Clot Removal
We Believe We Can
Efficiently remove the thrombus
Provide quick restoration of venous flow
Decrease risk of embolic complications
Assist in restoring normal venous valve function
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DVT Clot Removal
Interventional Treatment offers Patient's
A minimally invasive procedure
Potential to minimize treatment time
Possibly eliminate or decrease dose and duration of thrombolytic
Potential for quick resolution of signs and symptoms
Improved short-term & long-term outcomes
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. PI-368802-AB MAR2016
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An option for DVT thrombus Removal
ANGIOJET™ ULTRA Thrombectomy System
MECHANISM OF ACTION
1. The AngioJet Ultra
Console monitors and
controls the system.
2. The Console energizes the
pump which sends
pressurized saline to the
catheter tip.
3. Saline Jets travel
backwards to create a low
pressure zone causing a
vacuum effect.
4. Thrombus is drawn into the
in-flow windows and the jets
push the thrombus back down
the catheter.
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. PI-368802-AB MAR2016
5. Thrombus is
evacuated from the
body and into the
collection bag.
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There is an indication and data behind thrombus removal
Outcomes – Interventional Approach To Remove DVT Thrombus
97%
84%
had venographic
improvement
had freedom from
re-thrombosis
at 1 year
Improved quality of
life score for mental
and physical baseline
out to 1 year
Patients treated: 67% acute, 19% sub-acute and 14% Chronic thrombus age
Bleeding complication rate was 4.5%, however not related to the use of AngioJet
The PEARL Registry looked at 371 DVT patients treated using an interventional approach
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. PI-368802-AB MAR2016
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There is an indication and data behind thrombus removal
PEARL Registry data demonstrates that mechanical
thrombectomy treatment of DVT is safe and effective
and can potentially reduce the need for concomitant
catheter directed lytic and intensive care stay.
The PEARL Registry looked at 371 DVT patients treated using an interventional approach
© 2016 Boston Scientific Corporation or its affiliates. All rights reserved. PI-368802-AB MAR2016
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There Is An Indication And Data Behind Thrombus Removal
Using an interventional approach
for DVT results showed
Overall, 75% cases completed in < 24 hours
38% of DVT treatment times were completed in < 6 hours
87% had two or less interventional treatments
The PEARL Registry looked at 371 DVT patients treated using an interventional approach
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Moving Forward
Consults available for your patients that have developed a DVT
Offer a multidisciplinary team approach to in-hospital DVT
Create best practice model
Develop treatment pathways to benefit patients for quicker recovery
Reduce the potential risks for those that develop DVT
Decrease hospital stay and cost associated with DVT
Potential to improve short and long term outcomes
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Case Example
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Questions
Thank you
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Solent Catheters combined w/console
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse
Events, and Operator’s Instructions.
INDICATIONS AND USAGE
The AngioJet SOLENT proxi & omni Thrombectomy Sets are intended for use with the AngioJet Ultra Console to break apart and remove thrombus from:
• upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, • upper extremity peripheral veins ≥ 3.0mm in diameter, • ileofemoral and lower extremity veins ≥ 3.0mm in diameter, • A-V access conduits ≥ 3.0mm in diameter and • for use with
the AngioJet Ultra Power Pulse technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.
The AngioJet SOLENT dista Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from:
• upper and lower extremity peripheral arteries and • for use with the AngioJet Ultra Power Pulse technique for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system. The
minimum vessel diameter for each Thrombectomy Set model is listed in Table 1 (in the IFU).
CONTRAINDICATIONS
Do not use the catheter in patients: • Who are contraindicated for endovascular procedures • Who cannot tolerate contrast media • In whom the lesion cannot be accessed with the guide wire
WARNINGS AND PRECAUTIONS
• The Thrombectomy Set has not been evaluated for treatment of pulmonary embolism. There are reports of serious adverse events, including death, associated with cases where the catheter was used in treatment of pulmonary embolism. • The
Thrombectomy Set has not been evaluated for use in the carotid or cerebral vasculature. • The Thrombectomy Set has not been evaluated for use in the coronary vasculature (unless accompanied by a separate coronary IFU). • Operation of the
catheter may cause embolization of some thrombus and/or thrombotic particulate debris. Debris embolization may cause distal vessel occlusion, which may further result in hypoperfusion or tissue necrosis. • Cardiac arrhythmias during catheter
operation have been reported in a small number of patients. Cardiac rhythm should be monitored during catheter use and appropriate management, such as temporary pacing, be employed, if needed. • Use of the catheter may cause a vessel
dissection or perforation. • Do not use the AngioJet Ultra System in patients who have a nonhealed injury due to recent mechanical intervention, in the vessel to be treated, to avoid further injury, dissection, or hemorrhage. • Do not use the
Thrombectomy Set in vessels smaller than minimum vessel diameter for each Thrombectomy Set model as listed in Table 1 (in the IFU); such use may increase risk of vessel injury. • Systemic heparinization is advisable to avoid pericatheterization
thrombus and acute rethrombosis. This is in addition to the heparin added to the saline supply bag. • Operation of the AngioJet System causes transient hemolysis which may manifest as hemoglobinuria. Table 1 (in the IFU) lists maximum
recommended run times in a flowing blood field and total operating time for each Thrombectomy Set. Evaluate the patient’s risk tolerance for hemoglobinemia and related sequelae prior to the procedure. Consider hydration prior to, during, and after
the procedure as appropriate to the patient’s overall medical condition. • Large thrombus burdens in peripheral veins and other vessels may result in significant hemoglobinemia which should be monitored to manage possible renal, pancreatic, or
other adverse events. • Monitor thrombotic debris/fluid flow exiting the Thrombectomy Set via the waste tubing during use. If blood is not visible in the waste tubing during AngioJet Ultra System activation, the catheter may be occlusive within the
vessel; verify catheter position, vessel diameter and thrombus status. Operation under occlusive conditions may increase risk of vessel injury. • Do not exchange the guide wire. Do not retract the guide wire into the catheter during operation. The
guide wire should extend at least 3 cm past the catheter tip at all times. If retraction of the guide wire into the Thrombectomy Set occurs, it may be necessary to remove both the Thrombectomy Set and the guide wire from the patient in order to reload the catheter over the guide wire. (Dista only) • Use of a J-tip guide wire is not recommended as it is possible for the tip of the guide wire to exit through a side window on the distal end of the catheter. (Omni, Proxi only) • Do not pull the catheter
against abnormal resistance. If increased resistance is felt when removing the catheter, remove the catheter together with the sheath or guide catheter as a unit to prevent possible tip separation. • If resistance is felt during the advancement of the
Thrombectomy Set to lesion site, do not force or torque the catheter excessively as this may result in deformation of tip components and thereby degrade catheter performance.
• Obstructing lesions that are difficult to cross with the catheter to access thrombus may be balloon dilated with low pressure (≤ 2 atm). Failure to pre-dilate difficult-to-cross lesions prior to catheter operation may result in vessel injury. • The potential
for pulmonary thromboembolism should be carefully considered when the Thrombectomy Sets are used to break up and remove peripheral venous thrombus. . (Below is Omni, Proxi only) • Hand injection of standard contrast medium may be
delivered through the thrombectomy catheter via the manifold port stopcock. Follow the steps to remove air from the catheter when delivering fluid through the catheter stopcock. • Fluids should be injected only under the direction of a physician and
all solutions prepared according the manufacturer instructions. • The Thrombectomy Set waste lumen is rated for 50psi. Delivering a hand injection of contrast medium with excessive force can create injection pressures greater than 50psi, potentially
causing leaks in the waste lumen of the catheter. • Do not use a power injector to deliver contrast medium through the catheter stopcock. Power injectors can deliver pressures greater than 50psi, potentially causing leaks in the waste lumen of the
catheter. • Some fluids, such as contrast agents, can thicken in the catheter lumen and block proper catheter operation if left static too long. The catheter should be operated to clear the fluid within 15 minutes of injection.
Console WARNINGS and PRECAUTIONS:
• Use the AngioJet Ultra Console only with an AngioJet Ultra Thrombectomy Set. This Console will not operate with a previous model pump set and catheter.
• Do not attempt to bypass any of the Console safety features. • If the catheter is removed from the patient and/or is inoperative, the waste tubing lumen, guide catheter, and sheath should be flushed with sterile, heparinized solution to avoid
thrombus formation and maintain lumen patency. Reprime the catheter by submerging the tip in sterile, heparinized solution and operating it for at least 20 seconds before reintroduction to the patient. • Refer to the individual AngioJet Ultra
Thrombectomy Set Information for Use manual for specific warnings and precautions.
• Do not move the collection bag during catheter operation as this may cause a collection bag error. • Monitor thrombotic debris/fluid flow exiting the catheter through the waste tubing during use. If blood is not visible during console activation, the
catheter may be occlusive within the vessel or the outflow lumen may be blocked. • Ensure adequate patient anticoagulation to prevent thrombus formation in outflow lumen.
• Refer to individual Thrombectomy Set Instructions for Use manual for specific instructions regarding heparinization of the Thrombectomy Set. • The Console contains no user-serviceable parts. Refer service to qualified personnel. • Removal of
outer covers may result in electrical shock. • This device may cause electromagnetic interference with other devices when in use. Do not place Console near sensitive equipment when operating. • Equipment not suitable for use in the presence of
flammable anesthetic mixture with air or with oxygen or nitrous oxide. • To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • Where the “Trapping Zone Hazard for Fingers” symbol is
displayed on the console, there exists a risk of trapping or pinching fingers during operation and care must be exercised to avoid injury. • Do not reposition or push the console from any point other than the handle designed for that purpose. A
condition of overbalance or tipping may ensue.
• The AngioJet Ultra Console should not be used adjacent to or stacked with other equipment, and if adjacent or stacked use is necessary, the AngioJet Ultra Console should be observed to verify normal operation in the configuration in which it will
be used. • Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT. • The use of accessories and cables other than those specified, with the exception of accessories and cables sold by Bayer
HealthCare as replacement parts for internal components, may result in increased EMISSIONS or decreased IMMUNITY of the Ultra Console. • MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding Electro-Magnetic
Compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in the tables provided in the IFU.
ADVERSE EVENTS
Potential adverse events which may be associated with use of the AngioJet Ultra Thrombectomy System are similar to those associated with other interventional procedures and include, but are not limited to: • abrupt closure of treated vessel • acute
myocardial infarction • acute renal failure • bleeding from access site • cerebrovascular accident • death • dissection • embolization, proximal or distal • hematoma • hemolysis • hemorrhage, requiring transfusion • hypotension/hypertension • infection
at the access site • pain • pancreatitis • perforation • pseudoaneurysm • reactions to contrast medium • thrombosis/occlusion • total occlusion of treated vessel • vascular aneurysm • vascular spasm • vessel wall or valve damage
Final PEARL Data Aug 2013; Presented by Dr. Mark Garcia at CIRSE 2013;
AngioJet, Solent, AVX, Power Pulse and Cross-Stream are trademarks of Boston Scientific.
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