This is the current release of the guideline.

This guideline updates a previous version: Salem DN, Stein PD, Al-Ahmad A, Bussey HI, Horstkotte D, Miller N, Pauker SG. Antithrombotic therapy in valvular heart disease--native and prosthetic: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004 Sep;126(3 Suppl):457S-82S. [234 references]

The grades of recommendation (1A, 1B, 1C, 2A, 2B, 2C) are defined at the end of the "Major Recommendations" field.

Rheumatic Mitral Valve Disease

Rheumatic Mitral Valve Disease with Atrial Fibrillation (AF) or a History of Systemic Embolism

1. For patients with rheumatic mitral valve disease complicated singly or in combination by the presence of AF, previous systemic embolism, or left atrial thrombus, the guideline developers recommend vitamin K antagonists (VKA) therapy (target international normalized ratio [INR], 2.5; range, 2.0 to 3.0) (Grade 1A).
2. For patients with rheumatic mitral valve disease with AF who suffer systemic embolism or have left atrial thrombus while receiving VKAs at a therapeutic INR, the guideline developers suggest the addition of low-dose aspirin (ASA) (50 to 100 mg/d) therapy after consideration of the additional hemorrhagic risks (Grade 2C). An alternative strategy might be the adjustment of VKA dosing to achieve a higher target INR (target INR, 3.0; range, 2.5 to 3.5) (Grade 2C).

Patients with Mitral Valve Disease in Sinus Rhythm

1. In patients with rheumatic mitral valve disease and normal sinus rhythm with the left atrial diameter > 55 mm, the guideline developers suggest VKA therapy (target INR, 2.5; range, 2.0 to 3.0) (Grade 2C).

   Underlying values and preferences: This recommendation places a relatively high value on preventing systemic embolism and its consequences, and a relatively low value on avoiding the bleeding risk and inconvenience associated with VKA therapy.

2. In patients with rheumatic mitral valve disease and normal sinus rhythm with a left atrial diameter < 55 mm, the guideline developers do not suggest antithrombotic therapy, unless a separate indication exists (Grade 2C).

Patients Undergoing Percutaneous Mitral Balloon Valvotomy (PMBV)

1. For patients being considered for percutaneous mitral balloon valvotomy (PMBV), the guideline developers recommend a preprocedural transesophageal echocardiography (TEE) to exclude left atrial thrombus (Grade 1C).
2. For patients being considered for PMBV with preprocedural TEE showing left atrial thrombus, the guideline developers recommend postponement of PMBV and VKA therapy (target INR 3.0; range, 2.5 to 3.5) until thrombus resolution is documented by repeat TEE (Grade 1C). If left atrial thrombus does not resolve with VKA therapy, the guideline developers recommend that PMBV not be performed (Grade 1C).

Mitral Valve Prolapse

1. In patients with mitral valve prolapse (MVP) who have had systemic embolism, unexplained transient ischemic attacks (TIAs) or ischemic stroke, and do not have AF, the guideline developers recommend against any antithrombotic therapy (Grade 1C).
2. In patients with MVP who have documented but unexplained TIAs or ischemic stroke, the guideline developers recommend ASA (50 to 100 mg/d) (Grade 1B).
3. In patients with MVP who have AF, documented systemic embolism or recurrent TIAs despite ASA therapy, the guideline developers suggest long-term VKA therapy (target INR, 2.5; range 2.0 to 3.0) (Grade 2C).

Mitral Annular Calcification

1. In patients with mitral annular calcification (MAC) complicated by systemic embolism, ischemic stroke, or TIA, who do not have AF, the guideline developers recommend ASA (50 to 100 mg/d) (Grade 1B). For recurrent events despite ASA therapy, the guideline developers suggest treatment with VKA therapy be considered (target INR, 2.5; range, 2.0 to 3.0) (Grade 2C). In patients with mitral annular calcification (MAC) who have a single embolus documented to be calcific, the data are not sufficient to allow recommendation for or against antithrombotic therapy.

2. In patients with MAC and AF, the guideline developers recommend long-term VKA therapy (target INR, 2.5; range, 2.0 to 3.0) (Grade 1C).

Aortic Valve and Aortic Arch Disorders

Calcific Aortic Valve Disease

1. In patients with isolated calcific aortic valve disease who have not had ischemic stroke or TIA, the guideline developers suggest against antithrombotic therapy (Grade 2C).
2. In patients with isolated calcific aortic valve disease who have experienced ischemic stroke or TIA not attributable to another source, the guideline developers suggest aspirin (50 to 100 mg/d) (Grade 2C).

Atherosclerotic Plaque of the Aortic Arch

In patients with ischemic stroke associated with aortic atherosclerotic lesions, the guideline developers recommend low-dose ASA (50 to 100 mg/d) over no therapy (Grade 1C). For patients with ischemic stroke associated with mobile aortic arch thrombi, the guideline developers suggest therapy with either VKAs (target INR, 2.5; range, 2.0 to 3.0) or low-dose ASA (50 to 100 mg/d) (Grade 2C).

Patent Foramen Ovale (PFO) and Atrial Septal Aneurysm

1. In patients with ischemic stroke and a PFO, the guideline developers recommend antiplatelet agent (APA) therapy (Grade 1A), and suggest APA therapy over VKA therapy (Grade 2A).
2. In patients with cryptogenic ischemic stroke and PFO, with evidence of deep vein thrombosis (DVT) or another indication for VKA therapy, such as AF or an underlying hypercoagulable state, the guideline developers recommend VKA therapy (target INR, 2.5; range, 2.0 to 3.0) (Grade 1C).

Prosthetic Heart Valves—Mechanical Prosthetic Heart Valves

1. In patients with mechanical heart valves, the guideline developers recommend VKA therapy (Grade 1A). In patients immediately following mechanical valve replacement, and as dictated by clinical concerns regarding postoperative bleeding, the guideline developers suggest administration of intravenous (IV) unfractionated heparin (UFH) or subcutaneous (SC) low-molecular weight heparin (LMWH) until the INR is < 2.0 for 2 consecutive days (Grade 2C).
2. In patients with a bileaflet mechanical valve or a Medtronic Hall tilting-disk valve in the aortic position who are in sinus rhythm and without left atrial enlargement, the guideline developers recommend long-term VKA therapy (target INR, 2.5; range, 2.0 to 3.0) (Grade 1B).
3. In patients with a tilting-disk or bileaflet mechanical valve in the mitral position, the guideline developers recommend VKA therapy (target INR, 3.0; range, 2.5 to 3.5) (Grade 1B).
4. In patients with a caged ball or caged disk valve, the guideline developers recommend long-term VKA therapy (target INR, 3.0; range, 2.5 to 3.5) (Grade 1B).
5. In patients with mechanical heart valves in either or both the aortic or mitral positions, and additional risk factors for thromboembolism, such as AF, anterior-apical ST-segment elevation myocardial infarction, left atrial enlargement, hypercoagulable state, or low ejection fraction, the guideline developers recommend VKA therapy (target INR, 3.0; range, 2.5 to 3.5) (Grade 1B).
6. In patients with mechanical heart valves who have additional risk factors for thromboembolism, such as AF, hypercoagulable state, or low ejection fraction, or who have a history of atherosclerotic vascular disease, the guideline developers recommend the addition of low-dose ASA (50 to 100 mg/d) to long-term VKA therapy (Grade 1B). The guideline developers suggest aspirin not be added to VKA therapy in patients with mechanical heart valves who are at particularly high risk of bleeding; such as in patients with history of gastrointestinal (GI) bleed or in patients > 80 years of age (Grade 2C).
7. In patients with mechanical prosthetic heart valves who have systemic embolism despite a therapeutic INR, the guideline developers suggest the addition of ASA (50 to 100 mg/d) if not previously provided and/or upward titration of VKA therapy to achieve a higher target INR. For a previous target INR of 2.5, the guideline developers suggest the VKA dose be increased to achieve a target INR of 3.0 (range, 2.5 to 3.5). For a previous target INR of 3.0, the guideline developers suggest the VKA dose be increased to achieve a target INR of 3.5 (range, 3.0 to 4.0) (Grade 2C).

Prosthetic Heart Valves—Bioprosthetic Valves

1. In patients with a bioprosthetic valve in the mitral position, the guideline developers recommend VKA therapy (target INR, 2.5; range, 2.0 to 3.0) for the first 3 months after valve insertion (Grade 1B). In the early postoperative period, in the absence of concerns for significant bleeding, the guideline developers suggest administration of IV UFH or SC LMWH until the INR is at therapeutic levels for 2 consecutive days (Grade 2C). After the first 3 months, in patients who are in sinus rhythm and have no other indication for VKA therapy, the guideline developers recommend ASA (50 to 100 mg/d) (Grade 1B).
2. In patients with aortic bioprosthetic valves, who are in sinus rhythm and have no other indication for VKA therapy, the guideline developers recommend aspirin (50 to 100 mg/d) (Grade 1B).
3. In patients with bioprosthetic valves who have a history of systemic embolism, the guideline developers recommend VKA therapy (target INR 2.5; range, 2.0 to 3.0) for at least 3 months after valve insertion, followed by clinical reassessment (Grade 1C).
4. In patients with bioprosthetic valves who have evidence of a left atrial thrombus at surgery, the guideline developers recommend VKA therapy (target INR, 2.5; range, 2.0 to 3.0) until documented thrombus resolution (Grade 1C).
5. In patients with bioprosthetic valves who have additional risk factors for thromboembolism, including AF, hypercoagulable state, or low ejection fraction, the guideline developers recommend VKA therapy (target INR, 2.5; range, 2.0 to 3.0) (Grade 1C). The guideline developers suggest the addition of low-dose aspirin (50 to 100 mg/d) be considered, particularly in patients with history of atherosclerotic vascular disease (Grade 2C). The guideline developers suggest ASA not be added to long-term VKA therapy patients with bioprosthetic heart valves who are at particularly high risk of bleeding, such as in patients with history of GI bleed or in patients > 80 years of age (Grade 2C).

Prosthetic Heart Valves—Valve Thrombosis

1. For patients with right-sided prosthetic valve thrombosis (PVT) with large thrombus size or New York Heart Association (NYHA) functional class III to IV, the guideline developers recommend administration of fibrinolytic therapy (Grade 1C).
2. For patients with left-sided PVT, NYHA functional class I to II, and small thrombus area (< 0.8 cm²), the guideline developers suggest administration of fibrinolytic therapy. Alternatively, administration of IV UFH accompanied by serial Doppler echocardiography to document thrombus resolution or improvement can be considered for very small nonobstructive thrombus (Grade 2C).
3. For patients with left-sided PVT, NYHA functional class III to IV, and small thrombus area (< 0.8 cm²), the guideline developers suggest fibrinolytic therapy (Grade 2C).
4. For patients with left-sided PVT and large thrombus area (> 0.8 cm²), the guideline developers suggest emergency surgery be considered. If surgery is not available or considered high-risk, the guideline developers suggest fibrinolytic therapy (Grade 2C).
5. For patients who have had successful resolution of PVT, the guideline developers suggest initiation of IV UFH and VKA therapy. The guideline developers suggest IV UFH be continued until a therapeutic INR is achieved. For a mechanical valve in the aortic position, the guideline developers suggest maintaining a higher INR (target, 3.5; range, 3.0 to 4.0) plus ASA (50 to 100 mg/d). For a mechanical valve in the mitral position, the guideline developers suggest maintaining a higher INR (target 4.0; range 3.5 to 4.5) plus ASA (50 to 100 mg/d) (Grade 2C).

Infective Endocarditis and Nonbacterial Thrombotic Endocarditis

Infective Endocarditis

1. In patients with infective endocarditis (IE), the guideline developers recommend against routine antithrombotic therapy, unless a separate indication exists (Grade 1B).
2. In the patient treated with VKA therapy who has IE, the guideline developers suggest VKA be discontinued at the time of initial presentation and UFH substituted, until it is clear that invasive procedures will not be required and the patient has stabilized without signs of central nervous system (CNS) involvement. When the patient is deemed stable without contraindications or neurologic complications, the guideline developers suggest reinstitution of long-term VKA therapy (Grade 2C).

Nonbacterial Thrombotic Endocarditis

1. In patients with nonbacterial thrombotic endocarditis (NBTE) and systemic or pulmonary emboli, the guideline developers recommend treatment with full-dose IV UFH or SC LMWH (Grade 1C).
2. In patients with disseminated cancer or debilitating disease with aseptic vegetations, the guideline developers suggest administration of full-dose IV UFH or SC LMWH (Grade 2C).

Definitions:

*The guideline developers use the wording recommend for strong (Grade 1) recommendations and suggest for weak (Grade 2) recommendations.

None provided

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").

Not applicable: The guideline was not adapted from another source.

2001 Jan (revised 2008 Jun)

American College of Chest Physicians - Medical Specialty Society

American College of Chest Physicians

American College of Chest Physicians (ACCP) Expert Panel on Antithrombotic and Thrombolytic Therapy

Primary Authors: Deeb N. Salem, MD, FCCP; Patrick T. O'Gara, MD; Christopher Madias, MD; and Stephen G. Pauker, MD

Committee Co-Chairs: Jack Hirsh, MD, FCCP (Chair); Gordon H. Guyatt, MD, FCCP; Gregory W. Albers, MD; Robert A. Harrington, MD, FCCP; Holger J. Schünemann, MD, PhD, FCCP

Participants: Giancarlo Agnelli, MD; Pierre Amarenco, MD; Jack E. Ansell, MD; Collin Baigent; Shannon M. Bates, MD; Kenneth A. Bauer, MD; Richard C. Becker, MD; Peter B. Berger, MD; David Bergqvist, MD, PhD; Rebecca J. Beyth, MD; Christopher P. Cannon, MD; Elizabeth A. Chalmers, MB, ChB, MD; Anthony K.C. Chan, MBBS; Clifford W. Colwell, Jr., MD; Anthony J. Comerota, MD; Deborah Cook, MD; Mark A. Crowther, MD; James E. Dalen, MD; Gabrielle deVeber, MD, MHSc; Maria Benedetta Donati, MD, PhD; James D. Douketis, MD; Andrew Dunn, MD; J. Donald Easton, MD; Michael Ezekowitz, MD; Margaret Fang; William H. Geerts, MD, FCCP; Alan S. Go, MD; Samuel Z. Goldhaber, MD, FCCP; Shaun D. Goodman, MD; Michael Gould, MD, FCCP; Ian A. Greer, MD; Andreas Greinacher, MD; David Gutterman, MD, FCCP, HSP; Jonathan L. Halperin, MD; John A. Heit, MD; Elaine M. Hylek, MD; Alan Jacobson, MD; Roman Jaeschke, MD, PhD; Amir K. Jaffer, MD; Susan Kahn; Clive Kearon, MBBCh, PhD; Fenella Kirkham, MBBC; Andreas Koster, MD, PhD; Michael R. Lassen, MD; Mark N. Levine, MD, MSc; Sandra Zelman Lewis, PhD; A. Michael Lincoff, MD; Gregory YH Lip, MD; Christopher Madias, MD; Warren J. Manning, MD; Daniel B. Mark, MD; M. Patricia Massicotte, MD, MSc; David Matchar, MD; Thomas W. Meade, DM, FCCP; Venu Menon, MD; Tracy Minichiello, MD; Paul Monagle, MBBS, MSc, MD, FCCP; Christopher M. O'Connor, MD; Patrick O'Gara, MD; E. Magnus Ohman, MD; Ingrid Pabinger, MD; Gualtiero Palareti, MD; Carlo Patrono, MD; Stephen G. Pauker, MD; Graham F. Pineo, MD; Jeffrey J. Popma, MD; Gary Raskob, PhD; Gerald Roth, MD; Ralph L. Sacco, MD; Deeb N. Salem, MD, FCCP; Charles-Marc Samama, MD, FCCP; Meyer Michel Samama, MD; Sam Schulman, MD, PhD; Daniel Singer, MD; Michael Sobel, MD; Shoshanna Sofaer, DrPH; Alex C. Spyropoulos, MD FCCP; Ph. Gabriel Steg, MD; Philip Teal, MD; Raymond Verhaeghe, MD; David A. Vorchheimer, MD; Theodore E. Warkentin, MD; Jeffrey Weitz, MD

Not stated

American College of Clinical Pharmacy - Medical Specialty Society
American Society of Health-System Pharmacists - Professional Association

This is the current release of the guideline.

This guideline updates a previous version: Salem DN, Stein PD, Al-Ahmad A, Bussey HI, Horstkotte D, Miller N, Pauker SG. Antithrombotic therapy in valvular heart disease--native and prosthetic: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2004 Sep;126(3 Suppl):457S-82S. [234 references]

None available

This summary was completed by ECRI on July 30, 2001. The information was verified by the guideline developer on October 31, 2001. This NGC summary was updated by ECRI on December 8, 2004. The updated information was verified by the guideline developer on January 12, 2005. This summary was updated by ECRI on March 6, 2007 following the U.S. Food and Drug Administration (FDA) advisory on Coumadin (warfarin sodium). This summary was updated by ECRI Institute on June 22, 2007 following the U.S. Food and Drug Administration (FDA) advisory on heparin sodium injection. This summary was updated by ECRI Institute on September 7, 2007 following the revised U.S. Food and Drug Administration (FDA) advisory on Coumadin (warfarin). This summary was updated by ECRI Institute on March 14, 2008 following the updated FDA advisory on heparin sodium injection. This NGC summary was updated by ECRI Institute on December 8, 2008. The updated information was verified by the guideline developer on January 7, 2009.

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions.