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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3865_Библиотеки_им_академика_М_И_Перельмана
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400 Anticoagulation Therapy
Multicenter, prospective, randomized, unblinded, controlled
First 3 months, warfarin target INR 2–3 + ASA 81
mg/day; then INR target 1.5–2 + ASA 81 mg/day.
Duration (mean)
Thromboembolic
ASA: acetylsalicylic acid, AVR: aortic valve replacement, INR: international normalized ratio, pt: patient, yr: year, TIA : transient ischemic attack
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21
LOWERING-IT
20
PROACT
TABLE 16-5: Evidence Supporting Lower INR Ranges for Specific Valves or Valve Types
Sorin Bicarbon
St Jude Medical
Edwards Mira
Study patients AVR with On-X valve AVR with:
Single-center, open-label, prospective, randomized, controlled
Carbomedics
Total N 375 396
Design
Treatment: INR 1.5–2.5
Control: INR 2–3
No ASA was added
Control: Warfarin target INR 2–3 + ASA 81 mg/day
3.82 years 5.6 years
Groups Treatment:
Results Treatment Control p-Value Treatment Control p-Value
Mean INR 1.89 ± 0.49 2.50 ± 0.63 <.0001 1.94 ± 0.21 2.61 ± 0.25 <.001
2.67%/pt-yr 1.59%/pt-yr 0.164 0.91 per 1000 pt/yr 2.73 per 1000 pt/yr p =.62, OR 0.33, 95% CI 0.006–4.20
Total bleeding 2.67%/pt-yr 6.62%/pt-yr <.001 5.62 per 1000 pt/yr 15.69 per 1000 pt/yr p =.04, OR 0.36, 95% CI 0.11–0.99
Major bleeding 1.48%/pt-yr 3.31%/pt-yr 0.032 0 events 3 events
events
Minor bleeding 1.18%/pt-yr 3.31%/pt-yr 0.011 6 events 16 events
Stroke-TIA 2.07%/pt-yr 1.46%/pt-yr 0.380 1 event 3 events
PROSTHETIC HEART VALVES 401
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•
Direct-acting oral anticoagulants (DOACs)
DOACs require more data before their use for thromboprophylaxis
in patients with mechanical valve replacement can be recom
mended.
RE-ALIGN trial
22
:
Design: Open-label, prospective, randomized, multi-
center, phase 2 trial.
Study patients: 252 patients with mechanical bi-leaflet
in aortic, mitral, or both, and implantation ≤7 days, or
>3 months.
Study groups:
Dabigatran adjusted for CrCl
<70 mL/min: 150 mg BID
70–109 mL/min: 220 mg BID
≥110 mL/min: 300 mg BID
Warfarin INR
“Low risk” 2–3
“High risk” 2.5–3.5
Duration: 12 weeks, terminated early by safety monitors
Results (dabigatran vs warfarin, respectively):
Thromboembolic events: 9% vs. 5%, p = 0.24
Any bleeding: 27% vs. 12%, p = 0.01
Major bleeding: 4% vs. 2%, p = 0.48
The data on DOACs for atrial fibrillation patients with concurrent
bioprosthetic valves is limited as very few patients were included
in phase III clinical trials.
•
Bridging for diagnostic or therapeutic procedures (see Chapter 10: Transitions
in Care—Periprocedural Bridging and Transitions Between Agents).
•
Patients who have systemic embolism despite a therapeutic INR (Table 16-6).
If patient was not previously on acetylsalicylic acid (ASA), then add
ASA 50–100 mg daily, and
Titrate VKA to a higher INR range.
-
TABLE 16-6: INR Adjustments for Patients Who Have Systemic
Embolism Despite Therapeutic INR
Previous INR Target (Range) Post-Systemic Embolism INR Target (Range)
2.5 (2–3) 3 (2.5–3.5) 3 (2.5–3.5)
3 (2.5–3.5) 3.5 (3–4.5) 3.5 (3–4)
ACC: American College of Cardiology, ACCP: American College of Chest Physicians, AHA:
American Heart Association, INR: international normalized ratio
ACC/AHA ACCP
402 Anticoagulation Therapy
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•
Example: If a patient with a prior TE event were having an aortic valve replaced
with a bileaflet MVR, then the VKA should be adjusted to an INR of 2.5–3.5 and
low dose ASA added.
Bioprosthetic Valves
•
Because of the lower thrombogenicity, many patients will not need lifelong
anticoagulation with bioprosthetic replacement (Table 16-7).
•
However, recent updated guidelines indicate that stroke risk and mortality are
lower if patients receive anticoagulation for up to 6 months.
may also reduce risk of thrombosis of bioprosthetic valves.
TABLE 16-7: Summary of Recommendations for Prophylactic
Antithrombotics for Bioprosthetics Valve Replacements
Condition ACC/AHA
AVR
Agent(s)
VKA At least 3 months*
Target INR
Aspirin Preferred Preferred over VKA for
Aspirin Dose 75–100 mg/day 50–100 mg/day
MVR
Agent(s)
VKA At least 3 months* First 3 months
Target INR 2.5 (range 2–3) 2.5 (range 2–3)
Aspirin After first 3–6 months** After first 3 months**
Aspirin Dose 75–100 mg/day 50–100 mg/day
*As long as 6 months in patients at low risk of bleeding.
**Presence of AF, previous TE, hypercoagulable condition, or other indication for VKA requires
long-term VKA therapy.
ACC: American College of Cardiology, ACCP: American College of Chest Physicians, AHA:
American Heart Association, AVR: aortic valve replacement, INR: international normalized ratio,
MVR: mitral valve replacement, VKA, vitamin K antagonist
2.5 (range 2−3)
18-19
ACCP
patients in sinus rhythm with
no other indication for VKA
19
Anticoagulation
6
Transcatheter Aortic Valve Replacements
•
Limited data comparing antithrombotic strategies
•
ACCP: ASA 50–100 mg/day + clopidogrel 75 mg/day for first 3 months, then
long-term ASA
•
ACC/AHA: ASA 75–100 mg/day + clopidogrel 75 mg/day for first 6 months,
then lifelong ASA
6
18
PROSTHETIC HEART VALVES 403
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REFERENCES AND KEY ARTICLES*
1. Vongpatanasin W, Hillis LD, Lange RA. Prosthetic heart valves. N Engl J Med.
1996;335(6):407-416.
2. Ghanbari H, Viatge H, Kidane AG, et al. Polymeric heart valves: New materials,
emerging hopes. Trends Biotechnol. 2009;27(6):359-367.
3. Schoen FJ. Evolving concepts of cardiac valve dynamics: The continuum of
development, functional structure, pathobiology, and tissue engineering. Circulation.
2008;118(18):1864-1880.
4.
Björk VO, Henze A. Management of thrombo-embolism after aortic valve replacement
with the björk-shiley tilting disc valve. Medicamental prevention with dicumarol in
comparison with dipyridamole - acetylsalicylic acid. Surgical treatment of prosthetic
thrombosis. Scand J Thorac Cardiovasc Surg. 1975;9(3):183-191.
5. Cannegieter S, Rosendaal F, Briet E. Thromboembolic and bleeding complications in
patients with mechanical heart valve prostheses. Circulation. 1994;89(2):635-641.
*6. Whitlock RP, Sun JC, Fremes SE, et al. Antithrombotic and thrombolytic therapy for
valvular disease. Chest. 2012;141(2 suppl):e576S-e600S.
7. Benussi S, Verzini A, Alfieri O. Mitral valve replacement and thromboembolic risk. J
Heart Valve Dis. 2004;13(Suppl 1):S81-S83.
8. Roudaut R, Serri K, Lafitte S. Thrombosis of prosthetic heart valves: Diagnosis and
therapeutic considerations. Heart. 2007;93(1):137-142.
9. Baudet EM, Puel V, McBride JT, et al. Long-term results of valve replacement with the
St. Jude medical prosthesis. J Thorac Cardiovasc Surg. 1995;109(5):858-870.
10. Macmanus Q, Grunkemeier G, Thomas D, et al. The Starr-Edwards model 6000
valve. A fifteen-year follow-up of the first successful mitral prosthesis. Circulation.
1977;56(4):623-625.
Horstkotte D, Schulte H, Bircks W, et al. Unexpected findings concerning
11.
thromboembolic complications and anticoagulation after complete 10 year follow up of
patients with St. Jude medical prostheses. J Heart Valve Dis. 1993;2(3):291-301.
*12.
Kvidal P, Bergström R, Malm T, et al. Long-term follow-up of morbidity and mortality
after aortic valve replacement with a mechanical valve prosthesis. Eur Heart J.
2000;21(13):1099-1111.
*13. Burchfiel C, Hammermeister K, Krause-Steinrauf H, et al. Left atrial dimension
and risk of systemic embolism in patients with a prosthetic heart valve. Department
of Veterans Affairs Cooperative Study on valvular heart disease. J Am Coll Cardiol.
1990;15(1):32-41.
14. Arom K, Nicoloff D, Lindsay W, et al. Should valve replacement and related procedures
be performed in elderly patients? Ann Thorac Surg. 1984;38(5):466-472.
Lawrie GM, Earle EA, Earle NR. Abstract 2308: Conventional aortic valve replacement
15.
in very elderly patients. Circulation. 2008;118(18_MeetingAbstracts):S_703-c.
16. Jebara VA, Dervanian P, Acar C, et al. Mitral valve repair using Carpentier techniques
in patients more than 70 years old. Early and late results. Circulation. 1992;86(5
Suppl):II53-9.
17.
Chan V, Jamieson WRE, Germann E, et al. Performance of bioprostheses and
mechanical prostheses assessed by composites of valve-related complications to 15 years
after aortic valve replacement. J Thorac Cardiovasc Surg. 2006;131(6):1267-
1273.
404 Anticoagulation Therapy
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*18. Nishimura RA, Otto CM, Bonow RO, et al. 2014 AHA/ACC Guideline for the
management of patients with valvular heart disease: a report of the American College
of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll
Cardiol. 2014;63(22):e57-e185.
Nishimura RA, Otto CM, Bonow RO, et al. 2017 AHA/ACC Focused Update of the
*19.
2014 AHA/ACC Guideline for the management of patients with valvular heart disease:
a report of the American College of Cardiology/American Heart Association Task Force
on Clinical Practice Guidelines. Circulation. 2017;135:e1159-e1195. DOI: 10.1161/
CIR.0000000000000503
*20.
Puskas J, Gerdisch M, Nichols D, et al. Reduced anticoagulation after mechanical
aortic valve replacement: Interim results from the prospective randomized on-X valve
anticoagulation clinical trial randomized food and drug administration investigational
device exemption trial. J Thorac Cardiovasc Surg. 2014;147(4):1202-1211.e2.
*21. Torella M, Torella D, Chiodini P, et al. LOWERing the INtensity of oral anticoaGulant
therapy in patients with bileaflet mechanical aortic valve replacement: Results from the
“LOWERING-IT” trial. Am Heart J. 2010;160(1):171-178.
*22.
Eikelboom JW, Connolly SJ, Brueckmann M, et al. Dabigatran versus warfarin in
patients with mechanical heart valves. N Engl J Med. 2013;369(13):1206-1214.
17
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Chapter
MECHANICAL CIRCULATORY
SUPPORT DEVICES
Christopher Paciullo, Laura Baumgartner, and Lauren Roller
INTRODUCTION
The advancement of mechanical circulatory support (MCS) technology has allowed
for improved survival among patients with end-stage heart failure and acute cardiogenic shock. Many different devices exist, but all share a common purpose—to
increase the delivery of oxygenated blood and improve end-organ function. They
also require anticoagulation to prevent thrombosis, either systemically or in the
device itself. Improvements in device design have reduced, but not completely
alleviated, the need for anticoagulation. In addition, the devices themselves alter
the patient’s coagulation system, further complicating the prescribed anticoagulation regimen. Many patients on MCS will develop bleeding or thrombosis events
despite careful monitoring and recommended treatments.
MECHANICAL SUPPORT DEVICES
Diagnoses Requiring Mechanical Circulatory Support
Mechanical circulatory support may be utilized either temporarily for acute management issues, or long term that may include permanent for life (see Table 17-1).
Anticoagulation in many cases is required when these devices are in use.
1-5
405
406 Anticoagulation Therapy
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TABLE 17-1: Diagnoses Requiring Mechanical Circulatory
Support
Temporary (Nondurable) Mechanical
Circulatory Support
•
Acute cardiac failure
Acute myocardial infarction, high-risk
•
coronary intervention
•
Acute myocarditis with shock
•
Acute rejection post-cardiac transplant
with hemodynamic compromise
Bridge to decision in a patient with a
•
relative contraindication to transplant or
durable mechanical circulatory support
• Cardiogenic shock
•
High-risk electrophysiologic ablations
Inability to wean from cardiopulmonary
•
bypass
Need for right-sided failure refractory to
•
maximal medical therapy following LVAD
placement
•
Valvular failure such as acute mitral
regurgitation
Long-Term (Durable) Mechanical Circulatory
Support
Class IV heart failure with severe
•
symptoms or refractory to optimal
therapy
•
Dependence on intravenous inotropic
support
LVAD: left ventricular assist device
Indications for Mechanical Circulatory Support
See Table 17-2.
•
Bridge to recovery (BTR): Patients who need short-term or temporary MCS and
are expected to recover cardiac function.
•
Bridge to decision (BTD): Provide temporary circulatory support when a patient’s
neurologic status is unknown or they have undetermined durable VAD or trans
plant candidacy, allowing for time to potentially reverse organ dysfunction to
appropriately assess the risks and benefits of durable options.
•
Destination therapy (DT): Patients who need long-term MCS and are not candidates for transplant.
•
Bridge to transplant (BTT): Patients awaiting transplantation who need MC to
survive to transplant or to keep end-organ dysfunction from occurring while
waiting for a donor organ to become available.
•
Bridge to transplant candidacy (BTC): Provide support to patients who have
reversible risk factors for transplant. The goal is to eventually transition to bridge
to transplant once the risk factors have been corrected.
ANTITHROMBOTIC MANAGEMENT
CONSIDERATIONS
Although guidelines for some devices exist, local practice varies widely.1 Each
hospital or health system should develop local protocols to guide therapy
-
MECHANICAL CIRCULATORY SUPPORT DEVICES 407
Example of a VV ECLS Circuit Example of a VA ECLS Circuit*
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Oxygenator
Pump
IVC
RA
LA
RV
LV
A.
Oxygenator
Pump
IVC
RA
RV
FIGURE 17-1. Examples of the VV and VA ECLS Circuit and
Common Areas for Cannulation in to the Large Vessels
*In VA ECLS, arterial access can be via the femoral artery and venous access by the
femoral vein.
for each device and possible complications. Evidence is limited, and their
use is in a very diverse population. Interaction of blood cells with the device
surface leads to activation of the coagulation system. Thrombotic events in
MCS are a major contributor to morbidity and mortality. MCS devices may
be broadly divided into two categories:
1. Temporary support devices: Indicated for short-term (days to weeks) support
of cardiac function.
Typically act as a bridge to something else—recovery, a durable
support device; heart transplant, or death.
2. Durable support devices: Indicated for long-term (months to years) support of
cardiac function.
These devices may also act as a bridge, typically to a heart trans-
plant, or as destination therapy for permanent support in patients
who are not candidates for a heart transplant.
•
Anticoagulants utilized for patients on MCS range from short-acting parenteral
medications to warfarin:
Heparin may be utilized in the early postoperative period in
durable support devices; however, this practice is increasingly
less common.
Intravenous heparin is the most utilized parenteral agent for tempo-
rary support devices.
14,15
LA
LV
A.
408 Anticoagulation Therapy
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TABLE 17-2: Mechanical Circulatory Support Devices
Device Implantation Duration of
Support
Cardiac Support
Intraaortic
balloon pump
Impella
VA-ECMO
(Figure 17-1)
TandemHeart Percutaneous Days to weeks Centrifugal
Thoratec PVAD Surgical Days to weeks Pulsatile
Temporary Devices
BVS 5000 Surgical Days to weeks Pulsatile
AB 5000 Surgical Days to weeks Pulsatile
Centrimag VAD
Percutaneous Days Pulsatile Bridge to recovery
Percutaneous
or surgical
Percutaneous
or surgical
Percutaneous
or surgical
Days Axial
Days to weeks Centrifugal
Days to weeks Centrifugal
Flow Type Indication
Bridge to recovery
(Impella RP for right
heart)
Bridge to recovery,
decision, transplant
Bridge to recovery,
decision
Bridge to recovery,
decision, transplant
Bridge to recovery,
decision, transplant
Bridge to recovery,
decision, transplant
Bridge to recovery,
decision
4-13
Cardiac Support
Syncardia TAH Implanted Weeks to
Heartware
HVAD
Durable Devices
Heartmate II Implanted Weeks to years Axial Bridge to transplant
VA-ECMO: veno-arterial extracorporeal membrane oxygenation
months
Implanted Weeks to years Centrifugal Bridge to transplant
Pulsatile Bridge to transplant
destination therapy
destination therapy
destination therapy
MECHANICAL CIRCULATORY SUPPORT DEVICES 409
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Bivalirudin or argatroban may be substituted for heparin in tempo-
rary support devices if there is a history or suspicion of heparininduced thrombocytopenia (HIT), hypersensitivity, or resistance to
heparin.
Warfarin is initiated in durable support patients when they are able
16-18
to tolerate oral medications.
The international normalized ratio (INR) goal is device-
specific and discussed in Table 17-3.
Direct-acting oral anticoagulants (DOACs) have not been studied
in this patient population, and are not recommended.
•
Anticoagulation goals should be individualized based on patient-specific risks
for thrombosis and bleeding. Goals may need to be modified during therapy if
the patient experiences a bleeding or thrombotic complication.
•
The use of antiplatelet agents in temporary support devices is not well studied,
but may be indicated for the patient’s underlying condition (i.e. acute coronary
syndromes, coronary artery bypass surgery, coronary stent placement).
•
Acquired Von Willebrand disease has been observed in most devices, leading
to decreased platelet function.
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